Kerri Wachter

NEW ORLEANS — Very elderly Americans are rarely assessed and treated for low bone density and osteoporosis despite significant potential benefits, experts said at the annual meeting of the International Society for Clinical Densitometry.

“It's the oldest old, those over age 85,” whose numbers are increasing most dramatically. “In fact, people over 100—the centenarians—are the fastest growing group of Americans,” said Neil Binkley, M.D., of the University of Wisconsin, Madison.

Bone loss happens faster in the very elderly than it does in the less elderly, resulting in higher prevalence rates of osteoporosis, hip fractures, and other serious fractures, said Michael McClung, M.D., of the Oregon Osteoporosis Center, Portland.

Yet despite these risks, the rates of bone density screening go down as age increases, Dr. Binkley said.

“We aren't doing a very good job of paying attention to elderly patients,” Dr. McClung agreed.

One possible explanation is that physicians may be overwhelmed by the problem and incorrectly assume that everyone over a certain age has osteoporosis when in fact about half of the patients over age 85 have osteoporosis.

As a result, physicians miss the opportunity to obtain the significant benefits they could reap from targeted interventions, Dr. McClung said.

The very elderly tend to fall into two groups: the ambulatory and reasonably healthy and nursing home residents, who tend to be in poor health and not ambulatory.

Virtually all nursing home residents have osteoporosis or low bone density and a very high risk of fractures. Yet these patients rarely receive even calcium and vitamin D supplementation.

The cost of withholding such basic interventions is huge. For the current population of approximately 1,600,000 nursing home residents, the cost of hip fractures is about $700 million per year, assuming an annual hip fracture rate of 2.3% and a cost of $18,500 per hip fracture.

In deciding how to care for these patients, it's helpful to divide them into three groups, Dr. Binkley said.

Some patients come to nursing homes for terminal care and these patients probably won't benefit from osteoporosis treatment. A number of patients come to nursing homes for rehabilitation following a hip fracture and these people should be treated for low bone density and osteoporosis, Dr. Binkley said.

The third group poses the real treatment challenge: long-term care patients who are in nursing homes because of cognitive decline or the need for help with daily living tasks. There are no data on the effectiveness of treatments for this type of patient.

“The easy answer might be that we ensure that they have adequate calcium intake and give them vitamin D,” Dr. Binkley proposed.

Vitamin D supplementation, in particular, “is an incredibly cost-effective way to intervene,” Dr. McClung agreed. Vitamin D deficiency is very common in the elderly, even in those who still have good mobility.

“The older we get, the more dependent we are on higher levels of vitamin D to maintain calcium homeostasis,” Dr. McClung said.

Vitamin D deficiency not only has skeletal consequences, but is also associated with muscle weakness, an increased risk of falls and, as a result, an increased risk of fractures.

A number of studies have demonstrated a reduced fracture risk in elderly patients who use vitamin D supplementation. In particular, results of these studies have suggested that 400 IU of vitamin D per day may not be adequate for many older individuals.

Dr. McClung added that in his own clinic, individuals over the age of 70 are given a 50,000-U dose of vitamin D taken once a month.

Although a number of drugs have been shown to reduce fracture risk in osteoporotic patients, most of the trials have not involved patients over the age of 80. Several studies have shown that bisphosphonates are effective in reducing the risk of hip fracture in patients between 70 and 80 years old, but only a few have shown effectiveness in patients older than age 80.

Yet “there is no evidence that age is a factor in limiting any of the treatment effects of the drugs that we currently use,” Dr. McClung said.

Given the lack of supportive data, deciding whether or not to use bisphosphonates in nursing home residents, however, is tricky.

“My approach, in the absence of data, is to utilize cognition,” Dr. Binkley said. He asks his patients if this type of treatment is feasible in their living situation, and he inquires about their desire to take the drug and how their family feels about the approach. If the responses are favorable, he prescribes a bisphosphonate.

Prevention Tips For the Elderly

▸ Measure bone density and diagnose osteoporosis in this age group.

▸ Think beyond age: General health and frailty may be better predictors of fracture risk.

▸ Bisphosphonates actually work quickly, and patients will see a benefit.

▸ Anticipate vitamin D deficiencies: High doses are acceptable in this population.

▸ Age is not a barrier to drug response.

▸ Drugs are not the only interventions: Exercise, tools for daily living, and training to prevent falls are effective as well.

Sources: Dr. Binkley and Dr. McClung.

NEW ORLEANS — Very elderly Americans are rarely assessed and treated for low bone density and osteoporosis despite significant potential benefits, experts said at the annual meeting of the International Society for Clinical Densitometry.

“It's the oldest old, those over age 85,” whose numbers are increasing most dramatically. “In fact, people over 100—the centenarians—are the fastest growing group of Americans,” said Neil Binkley, M.D., of the University of Wisconsin, Madison.

Bone loss happens faster in the very elderly than it does in the less elderly, resulting in higher prevalence rates of osteoporosis, hip fractures, and other serious fractures, said Michael McClung, M.D., of the Oregon Osteoporosis Center, Portland.

Yet despite these risks, the rates of bone density screening go down as age increases, Dr. Binkley said.

“We aren't doing a very good job of paying attention to elderly patients,” Dr. McClung agreed.

One possible explanation is that physicians may be overwhelmed by the problem and incorrectly assume that everyone over a certain age has osteoporosis when in fact about half of the patients over age 85 have osteoporosis.

As a result, physicians miss the opportunity to obtain the significant benefits they could reap from targeted interventions, Dr. McClung said.

The very elderly tend to fall into two groups: the ambulatory and reasonably healthy and nursing home residents, who tend to be in poor health and not ambulatory.

Virtually all nursing home residents have osteoporosis or low bone density and a very high risk of fractures. Yet these patients rarely receive even calcium and vitamin D supplementation.

The cost of withholding such basic interventions is huge. For the current population of approximately 1,600,000 nursing home residents, the cost of hip fractures is about $700 million per year, assuming an annual hip fracture rate of 2.3% and a cost of $18,500 per hip fracture.

In deciding how to care for these patients, it's helpful to divide them into three groups, Dr. Binkley said.

Some patients come to nursing homes for terminal care and these patients probably won't benefit from osteoporosis treatment. A number of patients come to nursing homes for rehabilitation following a hip fracture and these people should be treated for low bone density and osteoporosis, Dr. Binkley said.

The third group poses the real treatment challenge: long-term care patients who are in nursing homes because of cognitive decline or the need for help with daily living tasks. There are no data on the effectiveness of treatments for this type of patient.

“The easy answer might be that we ensure that they have adequate calcium intake and give them vitamin D,” Dr. Binkley proposed.

Vitamin D supplementation, in particular, “is an incredibly cost-effective way to intervene,” Dr. McClung agreed. Vitamin D deficiency is very common in the elderly, even in those who still have good mobility.

“The older we get, the more dependent we are on higher levels of vitamin D to maintain calcium homeostasis,” Dr. McClung said.

Vitamin D deficiency not only has skeletal consequences, but is also associated with muscle weakness, an increased risk of falls and, as a result, an increased risk of fractures.

A number of studies have demonstrated a reduced fracture risk in elderly patients who use vitamin D supplementation. In particular, results of these studies have suggested that 400 IU of vitamin D per day may not be adequate for many older individuals.

Dr. McClung added that in his own clinic, individuals over the age of 70 are given a 50,000-U dose of vitamin D taken once a month.

Although a number of drugs have been shown to reduce fracture risk in osteoporotic patients, most of the trials have not involved patients over the age of 80. Several studies have shown that bisphosphonates are effective in reducing the risk of hip fracture in patients between 70 and 80 years old, but only a few have shown effectiveness in patients older than age 80.

Yet “there is no evidence that age is a factor in limiting any of the treatment effects of the drugs that we currently use,” Dr. McClung said.

Given the lack of supportive data, deciding whether or not to use bisphosphonates in nursing home residents, however, is tricky.

“My approach, in the absence of data, is to utilize cognition,” Dr. Binkley said. He asks his patients if this type of treatment is feasible in their living situation, and he inquires about their desire to take the drug and how their family feels about the approach. If the responses are favorable, he prescribes a bisphosphonate.

Prevention Tips For the Elderly

▸ Measure bone density and diagnose osteoporosis in this age group.

▸ Think beyond age: General health and frailty may be better predictors of fracture risk.

▸ Bisphosphonates actually work quickly, and patients will see a benefit.

▸ Anticipate vitamin D deficiencies: High doses are acceptable in this population.

▸ Age is not a barrier to drug response.

▸ Drugs are not the only interventions: Exercise, tools for daily living, and training to prevent falls are effective as well.

Sources: Dr. Binkley and Dr. McClung.

NEW ORLEANS — Very elderly Americans are rarely assessed and treated for low bone density and osteoporosis despite significant potential benefits, experts said at the annual meeting of the International Society for Clinical Densitometry.

“It's the oldest old, those over age 85,” whose numbers are increasing most dramatically. “In fact, people over 100—the centenarians—are the fastest growing group of Americans,” said Neil Binkley, M.D., of the University of Wisconsin, Madison.

Bone loss happens faster in the very elderly than it does in the less elderly, resulting in higher prevalence rates of osteoporosis, hip fractures, and other serious fractures, said Michael McClung, M.D., of the Oregon Osteoporosis Center, Portland.

Yet despite these risks, the rates of bone density screening go down as age increases, Dr. Binkley said.

“We aren't doing a very good job of paying attention to elderly patients,” Dr. McClung agreed.

One possible explanation is that physicians may be overwhelmed by the problem and incorrectly assume that everyone over a certain age has osteoporosis when in fact about half of the patients over age 85 have osteoporosis.

As a result, physicians miss the opportunity to obtain the significant benefits they could reap from targeted interventions, Dr. McClung said.

The very elderly tend to fall into two groups: the ambulatory and reasonably healthy and nursing home residents, who tend to be in poor health and not ambulatory.

Virtually all nursing home residents have osteoporosis or low bone density and a very high risk of fractures. Yet these patients rarely receive even calcium and vitamin D supplementation.

The cost of withholding such basic interventions is huge. For the current population of approximately 1,600,000 nursing home residents, the cost of hip fractures is about $700 million per year, assuming an annual hip fracture rate of 2.3% and a cost of $18,500 per hip fracture.

In deciding how to care for these patients, it's helpful to divide them into three groups, Dr. Binkley said.

Some patients come to nursing homes for terminal care and these patients probably won't benefit from osteoporosis treatment. A number of patients come to nursing homes for rehabilitation following a hip fracture and these people should be treated for low bone density and osteoporosis, Dr. Binkley said.

The third group poses the real treatment challenge: long-term care patients who are in nursing homes because of cognitive decline or the need for help with daily living tasks. There are no data on the effectiveness of treatments for this type of patient.

“The easy answer might be that we ensure that they have adequate calcium intake and give them vitamin D,” Dr. Binkley proposed.

Vitamin D supplementation, in particular, “is an incredibly cost-effective way to intervene,” Dr. McClung agreed. Vitamin D deficiency is very common in the elderly, even in those who still have good mobility.

“The older we get, the more dependent we are on higher levels of vitamin D to maintain calcium homeostasis,” Dr. McClung said.

Vitamin D deficiency not only has skeletal consequences, but is also associated with muscle weakness, an increased risk of falls and, as a result, an increased risk of fractures.

A number of studies have demonstrated a reduced fracture risk in elderly patients who use vitamin D supplementation. In particular, results of these studies have suggested that 400 IU of vitamin D per day may not be adequate for many older individuals.

Dr. McClung added that in his own clinic, individuals over the age of 70 are given a 50,000-U dose of vitamin D taken once a month.

Although a number of drugs have been shown to reduce fracture risk in osteoporotic patients, most of the trials have not involved patients over the age of 80. Several studies have shown that bisphosphonates are effective in reducing the risk of hip fracture in patients between 70 and 80 years old, but only a few have shown effectiveness in patients older than age 80.

Yet “there is no evidence that age is a factor in limiting any of the treatment effects of the drugs that we currently use,” Dr. McClung said.

Given the lack of supportive data, deciding whether or not to use bisphosphonates in nursing home residents, however, is tricky.

“My approach, in the absence of data, is to utilize cognition,” Dr. Binkley said. He asks his patients if this type of treatment is feasible in their living situation, and he inquires about their desire to take the drug and how their family feels about the approach. If the responses are favorable, he prescribes a bisphosphonate.

Prevention Tips For the Elderly

▸ Measure bone density and diagnose osteoporosis in this age group.

▸ Think beyond age: General health and frailty may be better predictors of fracture risk.

▸ Bisphosphonates actually work quickly, and patients will see a benefit.

▸ Anticipate vitamin D deficiencies: High doses are acceptable in this population.

▸ Age is not a barrier to drug response.

▸ Drugs are not the only interventions: Exercise, tools for daily living, and training to prevent falls are effective as well.

Sources: Dr. Binkley and Dr. McClung.

The availability of a newly released set of standard magnetic resonance reference images may usher in even greater use of the technology in the evaluation of patients with rheumatoid arthritis.

The European League Against Rheumatism-Outcome Measures in Rheumatoid Arthritis Clinical Trials (EULAR-OMERACT) MRI reference image atlas published in February is intended to improve the performance and generalizability of the MRI scoring system previously developed by the group (Ann. Rheum. Dis. 2005;64 [suppl. 1]:i1-155). In 2002, OMERACT released the Rheumatoid Arthritis MRI Score (RAMRIS) for the evaluation of inflammatory and destructive changes in RA hands and wrists.

Intended for clinical researchers, but also translatable as an educational tool for practicing physicians, the atlas is composed of 1,002 representative images of synovitis, bone erosion, and edema in the metacarpophalangeal and wrist joints.

The document displays all severity grades of synovitis in the metacarpophalangeal joints and in each of the wrist joint areas. In addition, it maps out various severity grades of bone erosion and edema in the metacarpal head and phalangeal base and in five selected wrist joint bones (distal radius, scaphoid, lunate, capitate, and metacarpal base). For each individual grade, the atlas includes examples of both the “low” and “high” ends of the spectrum.

The collection of reference images provides a much-needed visual touchstone for MR assessment of RA, said Orrin M. Troum, M.D., of the University of Southern California, Los Angeles. “This is a positive step forward … I think ultimately we may be able to do away with x-ray.”

A number of studies have demonstrated the superior sensitivity of MRI compared with conventional radiography, particularly in identifying early disease, which is crucial to improving outcomes for patients with aggressive disease. MRI has been shown to be two to nine times more sensitive than x-rays for the detection of bone erosion.

“It's been well documented that people with RA, if identified and treated earlier, do better,” Dr. Troum said. MRI can make all the difference in the patient with aggressive RA because erosions can be visualized earlier, allowing treatment to be initiated and disease progression to be halted, which all leads to less disability later.

The advent of structure-modifying therapies gave rise to the necessity of MRI assessment in RA patients, said Charles Peterfy, M.D., a musculoskeletal radiologist and a coauthor of the atlas.

Before biologics, there was no real need to have such detailed information about joint structure, because having it didn't alter the course of clinical management. The availability of agents that halt disease progression changed everything, he said.

The challenge now is to identify those patients who will go on to develop aggressive disease before severe impairment sets in. It's estimated that “20%-40% of patients with early disease aren't going to progress,” said Dr. Peterfy, who also is chief medical officer of Synarc, a San Francisco-based company that does MR imaging for clinical trials.

Treating these patients empirically with biologics would be much too expensive and would entail an unacceptable level of unnecessary toxicity.

MRI can help identify those with aggressive disease because the technique allows direct visualization and assessment of synovitis and bone edema, which is a probable precursor of bone erosion.

“In early disease, MR identifies the aggressive phenotype much more sensitively than x-ray or any other test does so far,” Dr. Peterfy said.

MRI could potentially be used to monitor the effect of treatment, allowing physicians to adjust the dosage or change the treatment regimens altogether.

The availability of a newly released set of standard magnetic resonance reference images may usher in even greater use of the technology in the evaluation of patients with rheumatoid arthritis.

The European League Against Rheumatism-Outcome Measures in Rheumatoid Arthritis Clinical Trials (EULAR-OMERACT) MRI reference image atlas published in February is intended to improve the performance and generalizability of the MRI scoring system previously developed by the group (Ann. Rheum. Dis. 2005;64 [suppl. 1]:i1-155). In 2002, OMERACT released the Rheumatoid Arthritis MRI Score (RAMRIS) for the evaluation of inflammatory and destructive changes in RA hands and wrists.

Intended for clinical researchers, but also translatable as an educational tool for practicing physicians, the atlas is composed of 1,002 representative images of synovitis, bone erosion, and edema in the metacarpophalangeal and wrist joints.

The document displays all severity grades of synovitis in the metacarpophalangeal joints and in each of the wrist joint areas. In addition, it maps out various severity grades of bone erosion and edema in the metacarpal head and phalangeal base and in five selected wrist joint bones (distal radius, scaphoid, lunate, capitate, and metacarpal base). For each individual grade, the atlas includes examples of both the “low” and “high” ends of the spectrum.

The collection of reference images provides a much-needed visual touchstone for MR assessment of RA, said Orrin M. Troum, M.D., of the University of Southern California, Los Angeles. “This is a positive step forward … I think ultimately we may be able to do away with x-ray.”

A number of studies have demonstrated the superior sensitivity of MRI compared with conventional radiography, particularly in identifying early disease, which is crucial to improving outcomes for patients with aggressive disease. MRI has been shown to be two to nine times more sensitive than x-rays for the detection of bone erosion.

“It's been well documented that people with RA, if identified and treated earlier, do better,” Dr. Troum said. MRI can make all the difference in the patient with aggressive RA because erosions can be visualized earlier, allowing treatment to be initiated and disease progression to be halted, which all leads to less disability later.

The advent of structure-modifying therapies gave rise to the necessity of MRI assessment in RA patients, said Charles Peterfy, M.D., a musculoskeletal radiologist and a coauthor of the atlas.

Before biologics, there was no real need to have such detailed information about joint structure, because having it didn't alter the course of clinical management. The availability of agents that halt disease progression changed everything, he said.

The challenge now is to identify those patients who will go on to develop aggressive disease before severe impairment sets in. It's estimated that “20%-40% of patients with early disease aren't going to progress,” said Dr. Peterfy, who also is chief medical officer of Synarc, a San Francisco-based company that does MR imaging for clinical trials.

Treating these patients empirically with biologics would be much too expensive and would entail an unacceptable level of unnecessary toxicity.

MRI can help identify those with aggressive disease because the technique allows direct visualization and assessment of synovitis and bone edema, which is a probable precursor of bone erosion.

“In early disease, MR identifies the aggressive phenotype much more sensitively than x-ray or any other test does so far,” Dr. Peterfy said.

MRI could potentially be used to monitor the effect of treatment, allowing physicians to adjust the dosage or change the treatment regimens altogether.

The availability of a newly released set of standard magnetic resonance reference images may usher in even greater use of the technology in the evaluation of patients with rheumatoid arthritis.

The European League Against Rheumatism-Outcome Measures in Rheumatoid Arthritis Clinical Trials (EULAR-OMERACT) MRI reference image atlas published in February is intended to improve the performance and generalizability of the MRI scoring system previously developed by the group (Ann. Rheum. Dis. 2005;64 [suppl. 1]:i1-155). In 2002, OMERACT released the Rheumatoid Arthritis MRI Score (RAMRIS) for the evaluation of inflammatory and destructive changes in RA hands and wrists.

Intended for clinical researchers, but also translatable as an educational tool for practicing physicians, the atlas is composed of 1,002 representative images of synovitis, bone erosion, and edema in the metacarpophalangeal and wrist joints.

The document displays all severity grades of synovitis in the metacarpophalangeal joints and in each of the wrist joint areas. In addition, it maps out various severity grades of bone erosion and edema in the metacarpal head and phalangeal base and in five selected wrist joint bones (distal radius, scaphoid, lunate, capitate, and metacarpal base). For each individual grade, the atlas includes examples of both the “low” and “high” ends of the spectrum.

The collection of reference images provides a much-needed visual touchstone for MR assessment of RA, said Orrin M. Troum, M.D., of the University of Southern California, Los Angeles. “This is a positive step forward … I think ultimately we may be able to do away with x-ray.”

A number of studies have demonstrated the superior sensitivity of MRI compared with conventional radiography, particularly in identifying early disease, which is crucial to improving outcomes for patients with aggressive disease. MRI has been shown to be two to nine times more sensitive than x-rays for the detection of bone erosion.

“It's been well documented that people with RA, if identified and treated earlier, do better,” Dr. Troum said. MRI can make all the difference in the patient with aggressive RA because erosions can be visualized earlier, allowing treatment to be initiated and disease progression to be halted, which all leads to less disability later.

The advent of structure-modifying therapies gave rise to the necessity of MRI assessment in RA patients, said Charles Peterfy, M.D., a musculoskeletal radiologist and a coauthor of the atlas.

Before biologics, there was no real need to have such detailed information about joint structure, because having it didn't alter the course of clinical management. The availability of agents that halt disease progression changed everything, he said.

The challenge now is to identify those patients who will go on to develop aggressive disease before severe impairment sets in. It's estimated that “20%-40% of patients with early disease aren't going to progress,” said Dr. Peterfy, who also is chief medical officer of Synarc, a San Francisco-based company that does MR imaging for clinical trials.

Treating these patients empirically with biologics would be much too expensive and would entail an unacceptable level of unnecessary toxicity.

MRI can help identify those with aggressive disease because the technique allows direct visualization and assessment of synovitis and bone edema, which is a probable precursor of bone erosion.

“In early disease, MR identifies the aggressive phenotype much more sensitively than x-ray or any other test does so far,” Dr. Peterfy said.

MRI could potentially be used to monitor the effect of treatment, allowing physicians to adjust the dosage or change the treatment regimens altogether.

NEW ORLEANS — Patients with vertebral fractures have a four- to fivefold higher risk for subsequent fragility fractures and should be targeted for aggressive therapy, Michael McClung, M.D., said at the annual meeting of the International Society for Clinical Densitometry.

“The combination of bone density testing and vertebral fracture assessment is a powerful combination as we attempt to stratify patients into those at very high risk who would clearly benefit from treatment,” added Dr. McClung of the Oregon Osteoporosis Center in Portland.

Both severity and number of existing vertebral fractures are the best predictors of future vertebral fracture risk, regardless of bone density.

Payers are also starting to appreciate the benefit of assessing patients for such fractures. Medicare has agreed to reimburse physicians for vertebral fracture assessment (VFA) based on the new CPT code, 76077. Reimbursement is set at $43 and a referring physician must order the test. The International Society for Clinical Densitometry is set to take up the subject of VFA criteria at its position development conference later this year in Vancouver, B.C.

VFA is conducted using dual-energy x-ray absorptiometry and has a number of advantages that make it an attractive marker for evaluating an individual's future fracture risk. As an in-office procedure, patients don't have to be sent elsewhere as is the case with radiography. The radiation dose required for VFA is also substantially lower than for conventional radiographs. The whole spine is pictured in one image, not in a series, making it easier to read.

The images are also digitized which allows for magnification and other image manipulation. The images can be archived and reviewed side by side with images from follow-up examinations.

The main drawback is that VFA resolution is lower than for conventional radiographs. In particular, the upper spine is harder to visualize because of artifacts related to the lungs and ribs.

VFA should be considered for:

▸ Women aged 65 years or older.

▸ Men aged 70 years or older.

▸ Patients who have known height loss of at least 1.5 inches.

▸ Patients with a clinical history or nonradiologic assessment findings suggestive of vertebral fracture.

▸ Patients with bone density evidence of osteoporosis at the hip or spine.

▸ Patients with kyphosis on physical exam.

▸ Patients on long-term glucocorticoid therapy.

Vertebral Fracture Assessment Tips

In performing VFA, the Genant semiquantitative method provides a visual reference for grading fracture types (wedge, biconcave, or crush) and severity (mild, moderate, and severe). Wedge compression fractures are more likely to occur in the thoracic spine, while biconcave fractures are more likely to occur in the lumbar spine, Dr. McClung said.

It's important to be very cautious in attempting to diagnose mild or grade 1 fractures using VFA alone unless the resolution of the scan is very good, he added. This is particularly true of wedge fractures of the thoracic spine and biconcave fractures of the lumbar spine. But the technique is very good for identifying grades 2 and 3 fractures, which have more clinical significance. There are a number of conditions that make it difficult to interpret VFA findings, including severe scoliosis, motion, rib/scapular shadows, bowel gas, and calcifications. Dr. McClung, therefore, advises against making the diagnosis of an osteoporotic fracture until considering the differential diagnoses and identifying the cause of the fracture.

Follow up with x-ray when there is an equivocal fracture; if vertebrae (T6-L4) are unidentifiable; if there are confounding factors or artifacts; or there are osteosclerotic, lytic, or suspect deformities. Also, get an x-ray if there are unspecified soft tissue or bone abnormalities.

NEW ORLEANS — Patients with vertebral fractures have a four- to fivefold higher risk for subsequent fragility fractures and should be targeted for aggressive therapy, Michael McClung, M.D., said at the annual meeting of the International Society for Clinical Densitometry.

“The combination of bone density testing and vertebral fracture assessment is a powerful combination as we attempt to stratify patients into those at very high risk who would clearly benefit from treatment,” added Dr. McClung of the Oregon Osteoporosis Center in Portland.

Both severity and number of existing vertebral fractures are the best predictors of future vertebral fracture risk, regardless of bone density.

Payers are also starting to appreciate the benefit of assessing patients for such fractures. Medicare has agreed to reimburse physicians for vertebral fracture assessment (VFA) based on the new CPT code, 76077. Reimbursement is set at $43 and a referring physician must order the test. The International Society for Clinical Densitometry is set to take up the subject of VFA criteria at its position development conference later this year in Vancouver, B.C.

VFA is conducted using dual-energy x-ray absorptiometry and has a number of advantages that make it an attractive marker for evaluating an individual's future fracture risk. As an in-office procedure, patients don't have to be sent elsewhere as is the case with radiography. The radiation dose required for VFA is also substantially lower than for conventional radiographs. The whole spine is pictured in one image, not in a series, making it easier to read.

The images are also digitized which allows for magnification and other image manipulation. The images can be archived and reviewed side by side with images from follow-up examinations.

The main drawback is that VFA resolution is lower than for conventional radiographs. In particular, the upper spine is harder to visualize because of artifacts related to the lungs and ribs.

VFA should be considered for:

▸ Women aged 65 years or older.

▸ Men aged 70 years or older.

▸ Patients who have known height loss of at least 1.5 inches.

▸ Patients with a clinical history or nonradiologic assessment findings suggestive of vertebral fracture.

▸ Patients with bone density evidence of osteoporosis at the hip or spine.

▸ Patients with kyphosis on physical exam.

▸ Patients on long-term glucocorticoid therapy.

Vertebral Fracture Assessment Tips

In performing VFA, the Genant semiquantitative method provides a visual reference for grading fracture types (wedge, biconcave, or crush) and severity (mild, moderate, and severe). Wedge compression fractures are more likely to occur in the thoracic spine, while biconcave fractures are more likely to occur in the lumbar spine, Dr. McClung said.

It's important to be very cautious in attempting to diagnose mild or grade 1 fractures using VFA alone unless the resolution of the scan is very good, he added. This is particularly true of wedge fractures of the thoracic spine and biconcave fractures of the lumbar spine. But the technique is very good for identifying grades 2 and 3 fractures, which have more clinical significance. There are a number of conditions that make it difficult to interpret VFA findings, including severe scoliosis, motion, rib/scapular shadows, bowel gas, and calcifications. Dr. McClung, therefore, advises against making the diagnosis of an osteoporotic fracture until considering the differential diagnoses and identifying the cause of the fracture.

Follow up with x-ray when there is an equivocal fracture; if vertebrae (T6-L4) are unidentifiable; if there are confounding factors or artifacts; or there are osteosclerotic, lytic, or suspect deformities. Also, get an x-ray if there are unspecified soft tissue or bone abnormalities.

NEW ORLEANS — Patients with vertebral fractures have a four- to fivefold higher risk for subsequent fragility fractures and should be targeted for aggressive therapy, Michael McClung, M.D., said at the annual meeting of the International Society for Clinical Densitometry.

“The combination of bone density testing and vertebral fracture assessment is a powerful combination as we attempt to stratify patients into those at very high risk who would clearly benefit from treatment,” added Dr. McClung of the Oregon Osteoporosis Center in Portland.

Both severity and number of existing vertebral fractures are the best predictors of future vertebral fracture risk, regardless of bone density.

Payers are also starting to appreciate the benefit of assessing patients for such fractures. Medicare has agreed to reimburse physicians for vertebral fracture assessment (VFA) based on the new CPT code, 76077. Reimbursement is set at $43 and a referring physician must order the test. The International Society for Clinical Densitometry is set to take up the subject of VFA criteria at its position development conference later this year in Vancouver, B.C.

VFA is conducted using dual-energy x-ray absorptiometry and has a number of advantages that make it an attractive marker for evaluating an individual's future fracture risk. As an in-office procedure, patients don't have to be sent elsewhere as is the case with radiography. The radiation dose required for VFA is also substantially lower than for conventional radiographs. The whole spine is pictured in one image, not in a series, making it easier to read.

The images are also digitized which allows for magnification and other image manipulation. The images can be archived and reviewed side by side with images from follow-up examinations.

The main drawback is that VFA resolution is lower than for conventional radiographs. In particular, the upper spine is harder to visualize because of artifacts related to the lungs and ribs.

VFA should be considered for:

▸ Women aged 65 years or older.

▸ Men aged 70 years or older.

▸ Patients who have known height loss of at least 1.5 inches.

▸ Patients with a clinical history or nonradiologic assessment findings suggestive of vertebral fracture.

▸ Patients with bone density evidence of osteoporosis at the hip or spine.

▸ Patients with kyphosis on physical exam.

▸ Patients on long-term glucocorticoid therapy.

Vertebral Fracture Assessment Tips

In performing VFA, the Genant semiquantitative method provides a visual reference for grading fracture types (wedge, biconcave, or crush) and severity (mild, moderate, and severe). Wedge compression fractures are more likely to occur in the thoracic spine, while biconcave fractures are more likely to occur in the lumbar spine, Dr. McClung said.

It's important to be very cautious in attempting to diagnose mild or grade 1 fractures using VFA alone unless the resolution of the scan is very good, he added. This is particularly true of wedge fractures of the thoracic spine and biconcave fractures of the lumbar spine. But the technique is very good for identifying grades 2 and 3 fractures, which have more clinical significance. There are a number of conditions that make it difficult to interpret VFA findings, including severe scoliosis, motion, rib/scapular shadows, bowel gas, and calcifications. Dr. McClung, therefore, advises against making the diagnosis of an osteoporotic fracture until considering the differential diagnoses and identifying the cause of the fracture.

Follow up with x-ray when there is an equivocal fracture; if vertebrae (T6-L4) are unidentifiable; if there are confounding factors or artifacts; or there are osteosclerotic, lytic, or suspect deformities. Also, get an x-ray if there are unspecified soft tissue or bone abnormalities.

WASHINGTON — Higher intake of n-3 fatty acids may have a protective effect against cognitive impairment, according to data presented at the annual meeting of the Gerontological Society of America.

In a study of almost 1,000 people aged 65 years and older, those with dementia had significantly lower plasma levels of n-3 fatty acids, said Antonio Cherubini, M.D., of the Institute of Gerontology and Geriatrics in Perugia, Italy.

The n-3 fatty acids are an important component of the neuronal membrane, influencing membrane fluidity and all the related functions, such as signal transduction and enzyme function. Fish—particularly fatty fish, such as mackerel and albacore tuna—are the primary source of n-3 fatty acids.

Dr. Cherubini presented data from the Aging in Chianti (InCHIANTI) study conducted between 1998 and 2000 in the Chianti region of Italy.

The 935 volunteers were categorized as having normal cognition (725 subjects), cognitive impairment without meeting criteria for dementia (153 subjects), or dementia (57 subjects). Cognitive function was screened using the Mini-Mental State Examination. The subjects with age- and education-unadjusted scores lower than 26 on the examination underwent more detailed tests. The diagnosis of dementia was made according to DSM-IV criteria. Plasma fatty acid levels were determined using gas chromatography.

Subjects with dementia had the lowest n-3 fatty acid plasma concentrations—as a percentage of total fatty acid plasma concentrations in mg/L—with a mean of 2.7% vs. 3.0% for the cognitively impaired group and 3.2% for the normal cognition group. Subjects with dementia had the highest plasma concentrations of saturated fatty acids—as a percentage of total fatty acid plasma concentrations in mg/L—with a mean of 31.4% vs. 30.1% for the cognitive impairment group and 30.3% for the normal cognition group.

“Subjects in the second group—those who have cognitive impairment but not dementia—tended to have intermediate values in many of the fatty acids,” Dr. Cherubini said.

The finding of lower n-3 fatty acid plasma concentrations in subjects with dementia persisted even after adjusting for age, gender, education, smoking status, cholesterol and triacylglycerol levels, alcohol, fatty acid and total energy daily intakes, and total plasma levels of fatty acids. The difference between normal subjects and those with mild cognitive impairment was not ignificant after adjustment.

Previous studies have examined the relationship between n-3 fatty acid consumption and the development of dementia, but the results have been conflicting, Dr. Cherubini said.

WASHINGTON — Higher intake of n-3 fatty acids may have a protective effect against cognitive impairment, according to data presented at the annual meeting of the Gerontological Society of America.

In a study of almost 1,000 people aged 65 years and older, those with dementia had significantly lower plasma levels of n-3 fatty acids, said Antonio Cherubini, M.D., of the Institute of Gerontology and Geriatrics in Perugia, Italy.

The n-3 fatty acids are an important component of the neuronal membrane, influencing membrane fluidity and all the related functions, such as signal transduction and enzyme function. Fish—particularly fatty fish, such as mackerel and albacore tuna—are the primary source of n-3 fatty acids.

Dr. Cherubini presented data from the Aging in Chianti (InCHIANTI) study conducted between 1998 and 2000 in the Chianti region of Italy.

The 935 volunteers were categorized as having normal cognition (725 subjects), cognitive impairment without meeting criteria for dementia (153 subjects), or dementia (57 subjects). Cognitive function was screened using the Mini-Mental State Examination. The subjects with age- and education-unadjusted scores lower than 26 on the examination underwent more detailed tests. The diagnosis of dementia was made according to DSM-IV criteria. Plasma fatty acid levels were determined using gas chromatography.

Subjects with dementia had the lowest n-3 fatty acid plasma concentrations—as a percentage of total fatty acid plasma concentrations in mg/L—with a mean of 2.7% vs. 3.0% for the cognitively impaired group and 3.2% for the normal cognition group. Subjects with dementia had the highest plasma concentrations of saturated fatty acids—as a percentage of total fatty acid plasma concentrations in mg/L—with a mean of 31.4% vs. 30.1% for the cognitive impairment group and 30.3% for the normal cognition group.

“Subjects in the second group—those who have cognitive impairment but not dementia—tended to have intermediate values in many of the fatty acids,” Dr. Cherubini said.

The finding of lower n-3 fatty acid plasma concentrations in subjects with dementia persisted even after adjusting for age, gender, education, smoking status, cholesterol and triacylglycerol levels, alcohol, fatty acid and total energy daily intakes, and total plasma levels of fatty acids. The difference between normal subjects and those with mild cognitive impairment was not ignificant after adjustment.

Previous studies have examined the relationship between n-3 fatty acid consumption and the development of dementia, but the results have been conflicting, Dr. Cherubini said.

WASHINGTON — Higher intake of n-3 fatty acids may have a protective effect against cognitive impairment, according to data presented at the annual meeting of the Gerontological Society of America.

In a study of almost 1,000 people aged 65 years and older, those with dementia had significantly lower plasma levels of n-3 fatty acids, said Antonio Cherubini, M.D., of the Institute of Gerontology and Geriatrics in Perugia, Italy.

The n-3 fatty acids are an important component of the neuronal membrane, influencing membrane fluidity and all the related functions, such as signal transduction and enzyme function. Fish—particularly fatty fish, such as mackerel and albacore tuna—are the primary source of n-3 fatty acids.

Dr. Cherubini presented data from the Aging in Chianti (InCHIANTI) study conducted between 1998 and 2000 in the Chianti region of Italy.

The 935 volunteers were categorized as having normal cognition (725 subjects), cognitive impairment without meeting criteria for dementia (153 subjects), or dementia (57 subjects). Cognitive function was screened using the Mini-Mental State Examination. The subjects with age- and education-unadjusted scores lower than 26 on the examination underwent more detailed tests. The diagnosis of dementia was made according to DSM-IV criteria. Plasma fatty acid levels were determined using gas chromatography.

Subjects with dementia had the lowest n-3 fatty acid plasma concentrations—as a percentage of total fatty acid plasma concentrations in mg/L—with a mean of 2.7% vs. 3.0% for the cognitively impaired group and 3.2% for the normal cognition group. Subjects with dementia had the highest plasma concentrations of saturated fatty acids—as a percentage of total fatty acid plasma concentrations in mg/L—with a mean of 31.4% vs. 30.1% for the cognitive impairment group and 30.3% for the normal cognition group.

“Subjects in the second group—those who have cognitive impairment but not dementia—tended to have intermediate values in many of the fatty acids,” Dr. Cherubini said.

The finding of lower n-3 fatty acid plasma concentrations in subjects with dementia persisted even after adjusting for age, gender, education, smoking status, cholesterol and triacylglycerol levels, alcohol, fatty acid and total energy daily intakes, and total plasma levels of fatty acids. The difference between normal subjects and those with mild cognitive impairment was not ignificant after adjustment.

Previous studies have examined the relationship between n-3 fatty acid consumption and the development of dementia, but the results have been conflicting, Dr. Cherubini said.

NEW ORLEANS — Patients with vertebral fractures have a four- to fivefold higher risk for subsequent fragility fractures and should be targeted for aggressive therapy, Michael McClung, M.D., said at the annual meeting of the International Society for Clinical Densitometry.

“The combination of bone density testing and vertebral fracture assessment is a powerful combination as we attempt to stratify patients into those at very high risk who would clearly benefit from treatment,” added Dr. McClung of the Oregon Osteoporosis Center in Portland.

Both the severity and number of existing vertebral fractures are the best predictors of future vertebral fracture risk, regardless of bone density.

Payers are also starting to appreciate the benefit of assessing patients for such fractures. Medicare has agreed to reimburse physicians for vertebral fracture assessment (VFA) based on the new CPT code, 76077. Reimbursement is set at $43 and a referring physician must order the test. The International Society for Clinical Densitometry plans to take up the subject of VFA criteria at its position development conference later this year in Vancouver, B.C.

VFA is conducted using dual-energy x-ray absorptiometry and has a number of advantages that make it an attractive marker for evaluating an individual's future fracture risk. It's an in-office procedure, and the radiation dose required for VFA is substantially lower than for conventional radiographs. The whole spine is pictured in one image, not in a series, making it easier to read. The images are also digitized which allows for magnification and other image manipulation. The images can be archived and reviewed side by side with images from follow-up examinations.

The main drawback is that VFA resolution is lower than for conventional radiographs. In particular, the upper spine is harder to visualize because of artifacts related to the lungs and ribs.

VFA should be considered for:

▸ Women aged 65 years or older.

▸ Men aged 70 years or older.

▸ Patients with known height loss of at least 1.5 inches.

▸ Patients with a clinical history or nonradiologic assessment findings suggestive of vertebral fracture.

▸ Patients with bone density evidence of osteoporosis at the hip or spine.

▸ Patients with kyphosis on physical examination.

▸ Patients on long-term glucocorticoid therapy.

VFA is contraindicated during pregnancy. Nor is it recommended for the patient with recent spine x-ray for whom nothing has changed clinically.

As a rule, consider whether the diagnosis of vertebral fractures would alter the course of therapy, Dr. McClung said. VFA is not necessary in cases where the results wouldn't change the course of therapy.

Tips for Performing VFA

In performing VFA, the Genant semiquantitative method (see other box) provides a visual reference for grading fracture types (wedge, biconcave, or crush) and severity (mild, moderate, and severe).

Wedge compression fractures are more likely to occur in the thoracic spine, while bioconcave fractures are more likely to occur in the lumbar spine, Dr. McClung said.

Unless the resolution of the scan is very good, be cautious about diagnosing mild or grade 1 fractures using VFA alone, he added. This is particularly true of wedge fractures of the thoracic spine and biconcave fractures of the lumbar spine. But the technique is very good for identifying grades 2 and 3 fractures, which have more clinical significance.

There are a number of conditions that make it difficult to interpret VFA findings, including severe scoliosis, motion, rib/scapular shadows, bowel gas, and calcifications. Dr. McClung advises against making the diagnosis of osteoporotic fracture until the differential diagnoses are considered and the fracture cause identified.

In the event of uncertainty, “remember that this is not an x-ray and it's not meant to take the place of an x-ray. This is a very convenient way to make an assessment of vertebral deformity but we should not be reluctant, ashamed, or put off by saying 'I don't know what I see,'” he said.

If there's a question, get more information. Follow up with x-ray when there is an equivocal fracture; if vertebrae (T6-L4) are unidentifiable; if there are confounding factors or artifacts; or there are osteosclerotic, lytic, or suspect deformities. Also, get an x-ray if there are unspecified soft tissue or bone abnormalities.

NEW ORLEANS — Patients with vertebral fractures have a four- to fivefold higher risk for subsequent fragility fractures and should be targeted for aggressive therapy, Michael McClung, M.D., said at the annual meeting of the International Society for Clinical Densitometry.

“The combination of bone density testing and vertebral fracture assessment is a powerful combination as we attempt to stratify patients into those at very high risk who would clearly benefit from treatment,” added Dr. McClung of the Oregon Osteoporosis Center in Portland.

Both the severity and number of existing vertebral fractures are the best predictors of future vertebral fracture risk, regardless of bone density.

Payers are also starting to appreciate the benefit of assessing patients for such fractures. Medicare has agreed to reimburse physicians for vertebral fracture assessment (VFA) based on the new CPT code, 76077. Reimbursement is set at $43 and a referring physician must order the test. The International Society for Clinical Densitometry plans to take up the subject of VFA criteria at its position development conference later this year in Vancouver, B.C.

VFA is conducted using dual-energy x-ray absorptiometry and has a number of advantages that make it an attractive marker for evaluating an individual's future fracture risk. It's an in-office procedure, and the radiation dose required for VFA is substantially lower than for conventional radiographs. The whole spine is pictured in one image, not in a series, making it easier to read. The images are also digitized which allows for magnification and other image manipulation. The images can be archived and reviewed side by side with images from follow-up examinations.

The main drawback is that VFA resolution is lower than for conventional radiographs. In particular, the upper spine is harder to visualize because of artifacts related to the lungs and ribs.

VFA should be considered for:

▸ Women aged 65 years or older.

▸ Men aged 70 years or older.

▸ Patients with known height loss of at least 1.5 inches.

▸ Patients with a clinical history or nonradiologic assessment findings suggestive of vertebral fracture.

▸ Patients with bone density evidence of osteoporosis at the hip or spine.

▸ Patients with kyphosis on physical examination.

▸ Patients on long-term glucocorticoid therapy.

VFA is contraindicated during pregnancy. Nor is it recommended for the patient with recent spine x-ray for whom nothing has changed clinically.

As a rule, consider whether the diagnosis of vertebral fractures would alter the course of therapy, Dr. McClung said. VFA is not necessary in cases where the results wouldn't change the course of therapy.

Tips for Performing VFA

In performing VFA, the Genant semiquantitative method (see other box) provides a visual reference for grading fracture types (wedge, biconcave, or crush) and severity (mild, moderate, and severe).

Wedge compression fractures are more likely to occur in the thoracic spine, while bioconcave fractures are more likely to occur in the lumbar spine, Dr. McClung said.

Unless the resolution of the scan is very good, be cautious about diagnosing mild or grade 1 fractures using VFA alone, he added. This is particularly true of wedge fractures of the thoracic spine and biconcave fractures of the lumbar spine. But the technique is very good for identifying grades 2 and 3 fractures, which have more clinical significance.

There are a number of conditions that make it difficult to interpret VFA findings, including severe scoliosis, motion, rib/scapular shadows, bowel gas, and calcifications. Dr. McClung advises against making the diagnosis of osteoporotic fracture until the differential diagnoses are considered and the fracture cause identified.

In the event of uncertainty, “remember that this is not an x-ray and it's not meant to take the place of an x-ray. This is a very convenient way to make an assessment of vertebral deformity but we should not be reluctant, ashamed, or put off by saying 'I don't know what I see,'” he said.

If there's a question, get more information. Follow up with x-ray when there is an equivocal fracture; if vertebrae (T6-L4) are unidentifiable; if there are confounding factors or artifacts; or there are osteosclerotic, lytic, or suspect deformities. Also, get an x-ray if there are unspecified soft tissue or bone abnormalities.

NEW ORLEANS — Patients with vertebral fractures have a four- to fivefold higher risk for subsequent fragility fractures and should be targeted for aggressive therapy, Michael McClung, M.D., said at the annual meeting of the International Society for Clinical Densitometry.

“The combination of bone density testing and vertebral fracture assessment is a powerful combination as we attempt to stratify patients into those at very high risk who would clearly benefit from treatment,” added Dr. McClung of the Oregon Osteoporosis Center in Portland.

Both the severity and number of existing vertebral fractures are the best predictors of future vertebral fracture risk, regardless of bone density.

Payers are also starting to appreciate the benefit of assessing patients for such fractures. Medicare has agreed to reimburse physicians for vertebral fracture assessment (VFA) based on the new CPT code, 76077. Reimbursement is set at $43 and a referring physician must order the test. The International Society for Clinical Densitometry plans to take up the subject of VFA criteria at its position development conference later this year in Vancouver, B.C.

VFA is conducted using dual-energy x-ray absorptiometry and has a number of advantages that make it an attractive marker for evaluating an individual's future fracture risk. It's an in-office procedure, and the radiation dose required for VFA is substantially lower than for conventional radiographs. The whole spine is pictured in one image, not in a series, making it easier to read. The images are also digitized which allows for magnification and other image manipulation. The images can be archived and reviewed side by side with images from follow-up examinations.

The main drawback is that VFA resolution is lower than for conventional radiographs. In particular, the upper spine is harder to visualize because of artifacts related to the lungs and ribs.

VFA should be considered for:

▸ Women aged 65 years or older.

▸ Men aged 70 years or older.

▸ Patients with known height loss of at least 1.5 inches.

▸ Patients with a clinical history or nonradiologic assessment findings suggestive of vertebral fracture.

▸ Patients with bone density evidence of osteoporosis at the hip or spine.

▸ Patients with kyphosis on physical examination.

▸ Patients on long-term glucocorticoid therapy.

VFA is contraindicated during pregnancy. Nor is it recommended for the patient with recent spine x-ray for whom nothing has changed clinically.

As a rule, consider whether the diagnosis of vertebral fractures would alter the course of therapy, Dr. McClung said. VFA is not necessary in cases where the results wouldn't change the course of therapy.

Tips for Performing VFA

In performing VFA, the Genant semiquantitative method (see other box) provides a visual reference for grading fracture types (wedge, biconcave, or crush) and severity (mild, moderate, and severe).

Wedge compression fractures are more likely to occur in the thoracic spine, while bioconcave fractures are more likely to occur in the lumbar spine, Dr. McClung said.

Unless the resolution of the scan is very good, be cautious about diagnosing mild or grade 1 fractures using VFA alone, he added. This is particularly true of wedge fractures of the thoracic spine and biconcave fractures of the lumbar spine. But the technique is very good for identifying grades 2 and 3 fractures, which have more clinical significance.

There are a number of conditions that make it difficult to interpret VFA findings, including severe scoliosis, motion, rib/scapular shadows, bowel gas, and calcifications. Dr. McClung advises against making the diagnosis of osteoporotic fracture until the differential diagnoses are considered and the fracture cause identified.

In the event of uncertainty, “remember that this is not an x-ray and it's not meant to take the place of an x-ray. This is a very convenient way to make an assessment of vertebral deformity but we should not be reluctant, ashamed, or put off by saying 'I don't know what I see,'” he said.

If there's a question, get more information. Follow up with x-ray when there is an equivocal fracture; if vertebrae (T6-L4) are unidentifiable; if there are confounding factors or artifacts; or there are osteosclerotic, lytic, or suspect deformities. Also, get an x-ray if there are unspecified soft tissue or bone abnormalities.

NEW ORLEANS — Very elderly Americans are rarely assessed and treated for low bone density and osteoporosis despite significant potential benefits, experts said at the annual meeting of the International Society for Clinical Densitometry.

“It's the oldest old, those over age 85,” whose numbers are increasing most dramatically. “In fact, people over 100—the centenarians—are the fastest growing group of Americans,” said Neil Binkley, M.D., of the University of Wisconsin, Madison.

Bone loss happens faster in the very elderly than in the less elderly, resulting in higher prevalence rates of osteoporosis, hip fractures, and other serious fractures, said Michael McClung, M.D., of the Oregon Osteoporosis Center, Portland.

Yet despite these risks, the rates of bone density screening go down as age increases, Dr. Binkley said. “We aren't doing a very good job of paying attention to elderly patients,” Dr. McClung agreed.

The very elderly tend to fall into two groups: the ambulatory and reasonably healthy and nursing home residents, who tend to be in poor health and not ambulatory. Virtually all nursing home residents have osteoporosis or low bone density and a very high risk of fractures. Yet these patients rarely receive even calcium and vitamin D supplementation.

The cost of withholding such basic interventions is huge. For the current population of roughly 1,600,000 nursing home residents, the cost of hip fractures is about $700 million per year, assuming an annual hip fracture rate of 2.3% and a cost of $18,500 per hip fracture.

In deciding how to care for these patients, it's helpful to divide them into three groups, Dr. Binkley said. Some patients come to nursing homes for terminal care and these patients probably won't benefit from osteoporosis treatment. A number of patients come to nursing homes for rehabilitation following a hip fracture and these people should be treated for low bone density and osteoporosis.

The third group poses the real treatment challenge: long-term care patients who are in nursing homes because of cognitive decline or the need for help with daily living tasks. There are no data on the effectiveness of treatments for this type of patient. “The easy answer might be that we ensure that they have adequate calcium intake and give them vitamin D,” Dr. Binkley said.

Vitamin D supplementation, in particular, “is an incredibly cost-effective way to intervene,” Dr. McClung agreed. Vitamin D deficiency is very common in the elderly, even in those who still have good mobility. “The older we get, the more dependent we are on higher levels of vitamin D to maintain calcium homeostasis.”

Dr. McClung added that in his own clinic, individuals over the age of 70 are given a 50,000-U dose of vitamin D taken once a month. Study results have suggested that 400 IU of vitamin D per day may not be adequate for many older individuals.

Although a number of drugs have been shown to reduce fracture risk in osteoporotic patients, most of the trials have not involved patients over the age of 80.

Given the lack of supportive data, deciding whether to use bisphosphonates in nursing home residents, however, is tricky.

“My approach, in the absence of data, is to utilize cognition,” Dr. Binkley said. He asks patients if this type of treatment is feasible in their living situation, and he inquires about their desire to take the drug, and how their family feels about the approach. If the responses are favorable, he prescribes a bisphosphonate.

Six Tips to Prevent Fractures

▸ Measure bone density and diagnose osteoporosis in this age group.

▸ Think beyond age: General health and frailty may be better predictors of fracture risk.

▸ Bisphosphonates actually work quickly, and patients will see a benefit.

▸ Anticipate vitamin D deficiencies: High doses are acceptable in this population.

▸ Age is not a barrier to drug response.

▸ Drugs are not the only interventions: Exercise, tools for daily living, and training to prevent falls are effective as well.

Sources: Dr. Binkley, and Dr. McClung.

NEW ORLEANS — Very elderly Americans are rarely assessed and treated for low bone density and osteoporosis despite significant potential benefits, experts said at the annual meeting of the International Society for Clinical Densitometry.

“It's the oldest old, those over age 85,” whose numbers are increasing most dramatically. “In fact, people over 100—the centenarians—are the fastest growing group of Americans,” said Neil Binkley, M.D., of the University of Wisconsin, Madison.

Bone loss happens faster in the very elderly than in the less elderly, resulting in higher prevalence rates of osteoporosis, hip fractures, and other serious fractures, said Michael McClung, M.D., of the Oregon Osteoporosis Center, Portland.

Yet despite these risks, the rates of bone density screening go down as age increases, Dr. Binkley said. “We aren't doing a very good job of paying attention to elderly patients,” Dr. McClung agreed.

The very elderly tend to fall into two groups: the ambulatory and reasonably healthy and nursing home residents, who tend to be in poor health and not ambulatory. Virtually all nursing home residents have osteoporosis or low bone density and a very high risk of fractures. Yet these patients rarely receive even calcium and vitamin D supplementation.

The cost of withholding such basic interventions is huge. For the current population of roughly 1,600,000 nursing home residents, the cost of hip fractures is about $700 million per year, assuming an annual hip fracture rate of 2.3% and a cost of $18,500 per hip fracture.

In deciding how to care for these patients, it's helpful to divide them into three groups, Dr. Binkley said. Some patients come to nursing homes for terminal care and these patients probably won't benefit from osteoporosis treatment. A number of patients come to nursing homes for rehabilitation following a hip fracture and these people should be treated for low bone density and osteoporosis.

The third group poses the real treatment challenge: long-term care patients who are in nursing homes because of cognitive decline or the need for help with daily living tasks. There are no data on the effectiveness of treatments for this type of patient. “The easy answer might be that we ensure that they have adequate calcium intake and give them vitamin D,” Dr. Binkley said.

Vitamin D supplementation, in particular, “is an incredibly cost-effective way to intervene,” Dr. McClung agreed. Vitamin D deficiency is very common in the elderly, even in those who still have good mobility. “The older we get, the more dependent we are on higher levels of vitamin D to maintain calcium homeostasis.”

Dr. McClung added that in his own clinic, individuals over the age of 70 are given a 50,000-U dose of vitamin D taken once a month. Study results have suggested that 400 IU of vitamin D per day may not be adequate for many older individuals.

Although a number of drugs have been shown to reduce fracture risk in osteoporotic patients, most of the trials have not involved patients over the age of 80.

Given the lack of supportive data, deciding whether to use bisphosphonates in nursing home residents, however, is tricky.

“My approach, in the absence of data, is to utilize cognition,” Dr. Binkley said. He asks patients if this type of treatment is feasible in their living situation, and he inquires about their desire to take the drug, and how their family feels about the approach. If the responses are favorable, he prescribes a bisphosphonate.

Six Tips to Prevent Fractures

▸ Measure bone density and diagnose osteoporosis in this age group.

▸ Think beyond age: General health and frailty may be better predictors of fracture risk.

▸ Bisphosphonates actually work quickly, and patients will see a benefit.

▸ Anticipate vitamin D deficiencies: High doses are acceptable in this population.

▸ Age is not a barrier to drug response.

▸ Drugs are not the only interventions: Exercise, tools for daily living, and training to prevent falls are effective as well.

Sources: Dr. Binkley, and Dr. McClung.

NEW ORLEANS — Very elderly Americans are rarely assessed and treated for low bone density and osteoporosis despite significant potential benefits, experts said at the annual meeting of the International Society for Clinical Densitometry.

“It's the oldest old, those over age 85,” whose numbers are increasing most dramatically. “In fact, people over 100—the centenarians—are the fastest growing group of Americans,” said Neil Binkley, M.D., of the University of Wisconsin, Madison.

Bone loss happens faster in the very elderly than in the less elderly, resulting in higher prevalence rates of osteoporosis, hip fractures, and other serious fractures, said Michael McClung, M.D., of the Oregon Osteoporosis Center, Portland.

Yet despite these risks, the rates of bone density screening go down as age increases, Dr. Binkley said. “We aren't doing a very good job of paying attention to elderly patients,” Dr. McClung agreed.

The very elderly tend to fall into two groups: the ambulatory and reasonably healthy and nursing home residents, who tend to be in poor health and not ambulatory. Virtually all nursing home residents have osteoporosis or low bone density and a very high risk of fractures. Yet these patients rarely receive even calcium and vitamin D supplementation.

The cost of withholding such basic interventions is huge. For the current population of roughly 1,600,000 nursing home residents, the cost of hip fractures is about $700 million per year, assuming an annual hip fracture rate of 2.3% and a cost of $18,500 per hip fracture.

In deciding how to care for these patients, it's helpful to divide them into three groups, Dr. Binkley said. Some patients come to nursing homes for terminal care and these patients probably won't benefit from osteoporosis treatment. A number of patients come to nursing homes for rehabilitation following a hip fracture and these people should be treated for low bone density and osteoporosis.

The third group poses the real treatment challenge: long-term care patients who are in nursing homes because of cognitive decline or the need for help with daily living tasks. There are no data on the effectiveness of treatments for this type of patient. “The easy answer might be that we ensure that they have adequate calcium intake and give them vitamin D,” Dr. Binkley said.

Vitamin D supplementation, in particular, “is an incredibly cost-effective way to intervene,” Dr. McClung agreed. Vitamin D deficiency is very common in the elderly, even in those who still have good mobility. “The older we get, the more dependent we are on higher levels of vitamin D to maintain calcium homeostasis.”

Dr. McClung added that in his own clinic, individuals over the age of 70 are given a 50,000-U dose of vitamin D taken once a month. Study results have suggested that 400 IU of vitamin D per day may not be adequate for many older individuals.

Although a number of drugs have been shown to reduce fracture risk in osteoporotic patients, most of the trials have not involved patients over the age of 80.

Given the lack of supportive data, deciding whether to use bisphosphonates in nursing home residents, however, is tricky.

“My approach, in the absence of data, is to utilize cognition,” Dr. Binkley said. He asks patients if this type of treatment is feasible in their living situation, and he inquires about their desire to take the drug, and how their family feels about the approach. If the responses are favorable, he prescribes a bisphosphonate.

Six Tips to Prevent Fractures

▸ Measure bone density and diagnose osteoporosis in this age group.

▸ Think beyond age: General health and frailty may be better predictors of fracture risk.

▸ Bisphosphonates actually work quickly, and patients will see a benefit.

▸ Anticipate vitamin D deficiencies: High doses are acceptable in this population.

▸ Age is not a barrier to drug response.

▸ Drugs are not the only interventions: Exercise, tools for daily living, and training to prevent falls are effective as well.

Sources: Dr. Binkley, and Dr. McClung.

Medicare is extending coverage of PET scans to include patients who meet the criteria for both frontotemporal dementia and Alzheimer's disease but for whom the diagnosis remains unclear.

The Centers for Medicare and Medicaid Services concluded in September that 18fluorodeoxyglucose PET (FDG-PET) imaging can be useful in patients with a documented cognitive decline of at least 6 months and a recently established diagnosis of dementia.

To be eligible for the new coverage, these patients must meet criteria for both frontotemporal dementia (FTD) and Alzheimer's disease (AD), but have an unclear diagnosis even after extensive clinical evaluation and alternative imaging (MRI and CT).

The specific conditions required to receive PET scan coverage to distinguish FTD and AD include:

▸ The onset, clinical presentation, or course of impairment is atypical for AD, and FTD is suspected as an alternative neurodegenerative cause.

▸ The patient has had a comprehensive clinical evaluation–as defined by the American Academy of Neurology–encompassing a medical history from both the patient and a well-acquainted informant, a physical and mental status examination aided by cognitive scales or neuropsychological testing, laboratory tests, and structural imaging.

▸ The patient has been evaluated by a physician experienced in the diagnosis and assessment of dementia.

▸ The evaluation did not identify a likely, specific neurodegenerative disease that is causing the clinical symptoms.

It's estimated that 12%-16% of patients with degenerative dementia may have FTD, which is often misdiagnosed as AD.

FTD is characterized by the formation of microvacuoles, gliosis with or without inclusion bodies, and swollen neurons.

FDG-PET imaging can be particularly useful in distinguishing frontotemporal dementia from Alzheimer's disease.

FDG-PET imaging assesses brain activity, with regions of atrophy appearing inactive.

FTD leads to frontotemporally predominant atrophy, while AD pathology is typically more severe in posterior temporoparietal regions–patterns that are distinguishable in a PET scan.

“This is important because the treatments for Alzheimer's disease do not help patients with frontotemporal dementia,” Gary W. Small, M.D., the director of the Center on Aging at the University of California, Los Angeles, said at a recent symposium on imaging sponsored by the Institute of Molecular Technologies.

Alzheimer's symptoms of memory and cognitive function impairment appear gradually.

Signs of frontotemporal dementia tend to appear as deficits in judgment and conduct, appearing early in disease development.

“There tends to be sort of a loosening of personality,” Dr. Small said.

CMS also concluded that although there are not adequate data to support the use of PET imaging for the diagnosis of patients with mild cognitive impairment or early dementia, the technique shows promise.

Medicare is extending coverage of PET scans to include patients who meet the criteria for both frontotemporal dementia and Alzheimer's disease but for whom the diagnosis remains unclear.

The Centers for Medicare and Medicaid Services concluded in September that 18fluorodeoxyglucose PET (FDG-PET) imaging can be useful in patients with a documented cognitive decline of at least 6 months and a recently established diagnosis of dementia.

To be eligible for the new coverage, these patients must meet criteria for both frontotemporal dementia (FTD) and Alzheimer's disease (AD), but have an unclear diagnosis even after extensive clinical evaluation and alternative imaging (MRI and CT).

The specific conditions required to receive PET scan coverage to distinguish FTD and AD include:

▸ The onset, clinical presentation, or course of impairment is atypical for AD, and FTD is suspected as an alternative neurodegenerative cause.

▸ The patient has had a comprehensive clinical evaluation–as defined by the American Academy of Neurology–encompassing a medical history from both the patient and a well-acquainted informant, a physical and mental status examination aided by cognitive scales or neuropsychological testing, laboratory tests, and structural imaging.

▸ The patient has been evaluated by a physician experienced in the diagnosis and assessment of dementia.

▸ The evaluation did not identify a likely, specific neurodegenerative disease that is causing the clinical symptoms.

It's estimated that 12%-16% of patients with degenerative dementia may have FTD, which is often misdiagnosed as AD.

FTD is characterized by the formation of microvacuoles, gliosis with or without inclusion bodies, and swollen neurons.

FDG-PET imaging can be particularly useful in distinguishing frontotemporal dementia from Alzheimer's disease.

FDG-PET imaging assesses brain activity, with regions of atrophy appearing inactive.

FTD leads to frontotemporally predominant atrophy, while AD pathology is typically more severe in posterior temporoparietal regions–patterns that are distinguishable in a PET scan.

“This is important because the treatments for Alzheimer's disease do not help patients with frontotemporal dementia,” Gary W. Small, M.D., the director of the Center on Aging at the University of California, Los Angeles, said at a recent symposium on imaging sponsored by the Institute of Molecular Technologies.

Alzheimer's symptoms of memory and cognitive function impairment appear gradually.

Signs of frontotemporal dementia tend to appear as deficits in judgment and conduct, appearing early in disease development.

“There tends to be sort of a loosening of personality,” Dr. Small said.

CMS also concluded that although there are not adequate data to support the use of PET imaging for the diagnosis of patients with mild cognitive impairment or early dementia, the technique shows promise.

Medicare is extending coverage of PET scans to include patients who meet the criteria for both frontotemporal dementia and Alzheimer's disease but for whom the diagnosis remains unclear.

The Centers for Medicare and Medicaid Services concluded in September that 18fluorodeoxyglucose PET (FDG-PET) imaging can be useful in patients with a documented cognitive decline of at least 6 months and a recently established diagnosis of dementia.

To be eligible for the new coverage, these patients must meet criteria for both frontotemporal dementia (FTD) and Alzheimer's disease (AD), but have an unclear diagnosis even after extensive clinical evaluation and alternative imaging (MRI and CT).

The specific conditions required to receive PET scan coverage to distinguish FTD and AD include:

▸ The onset, clinical presentation, or course of impairment is atypical for AD, and FTD is suspected as an alternative neurodegenerative cause.

▸ The patient has had a comprehensive clinical evaluation–as defined by the American Academy of Neurology–encompassing a medical history from both the patient and a well-acquainted informant, a physical and mental status examination aided by cognitive scales or neuropsychological testing, laboratory tests, and structural imaging.

▸ The patient has been evaluated by a physician experienced in the diagnosis and assessment of dementia.

▸ The evaluation did not identify a likely, specific neurodegenerative disease that is causing the clinical symptoms.

It's estimated that 12%-16% of patients with degenerative dementia may have FTD, which is often misdiagnosed as AD.

FTD is characterized by the formation of microvacuoles, gliosis with or without inclusion bodies, and swollen neurons.

FDG-PET imaging can be particularly useful in distinguishing frontotemporal dementia from Alzheimer's disease.

FDG-PET imaging assesses brain activity, with regions of atrophy appearing inactive.

FTD leads to frontotemporally predominant atrophy, while AD pathology is typically more severe in posterior temporoparietal regions–patterns that are distinguishable in a PET scan.

“This is important because the treatments for Alzheimer's disease do not help patients with frontotemporal dementia,” Gary W. Small, M.D., the director of the Center on Aging at the University of California, Los Angeles, said at a recent symposium on imaging sponsored by the Institute of Molecular Technologies.

Alzheimer's symptoms of memory and cognitive function impairment appear gradually.

Signs of frontotemporal dementia tend to appear as deficits in judgment and conduct, appearing early in disease development.

“There tends to be sort of a loosening of personality,” Dr. Small said.

CMS also concluded that although there are not adequate data to support the use of PET imaging for the diagnosis of patients with mild cognitive impairment or early dementia, the technique shows promise.

WASHINGTON – Methylphenidate appears to be effective and safe for the treatment of attention-deficit hyperactivity disorder in preschool-age children, according to preliminary data presented at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

The results come from the Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children study (PATS), sponsored by the National Institute of Mental Health.

Several studies have previously suggested that preschool-age children with ADHD would respond to and tolerate methylphenidate, and this multisite study is the first major effort aimed at directly assessing the safety and efficacy of a stimulant for the treatment of attention-deficit hyperactivity disorder in children aged 3-5 years.

“The take-home message is that 85% of the children responded to the methylphenidate,” during the 5-week crossover period to determine the optimal dosing for each of the children, said study investigator Howard B. Abikoff, Ph.D., of the New York University Child Study Center.

The optimal dose for each child was determined during a 5-week period. Over that period, all of the children were given a placebo or a dose of 1.25 mg, 2.5 mg, 5 mg, or 7.5 mg three times daily for 1 week each. Overall, 144 children completed this 5-week trial. Each week, a composite score of symptom severity was assigned based on parent and teacher responses to the Conners, Loney, and Milich (CLAM) Questionnaire and the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale.

Two blinded assessors were then asked to identify the best dose for each child. A full panel of all investigators decided upon the appropriate dose when the two assessors did not agree. Just over half (51%) of the children were referred to the full panel of investigators to determine the optimal dose.

Children also could be evaluated at a 10-mg dose if investigators agreed that there was a good chance that the child would have an even better response with a higher dose. This happened in 15 of the cases.

“First of all, we got a very significant effect per dose relative to placebo,” said Dr. Abikoff. For the 2.5-mg, 5-mg, and 7.5-mg doses, the children's composite scores were significantly lower than for placebo.

“We got small to moderate effect sizes at the intermediate doses [2.5 mg and 5 mg] and a reasonably robust effect size at the 7.5-mg dose,” Dr. Abikoff said. There was also a trend toward significantly lower scores for children in the 1.25-mg group.

After the 5-week crossover period, 113 children were randomized to receive either the optimal dose (61 children) or placebo (52 children) for 4 weeks. In the analysis of this portion of the trial, all children were included even if they left the trial early, with the last observation for that child carried through.

In the second portion of the study, a statistically significant difference was found in the composite scores–1.79 points for those in the placebo group and 1.49 points for those receiving the optimum dose of methylphenidate. “The effect sizes are linear from 1.25 mg up to 7.5 mg. … The effect size for 10 mg was somewhat lower,” said Dr. Abikoff.

Over the course of the trial there were 39 adverse events, including difficulty falling asleep, decreased appetite, emotional outbursts, and stomach discomfort, he said.

Safety was a significant concern, given the age group involved. The researchers worked closely with the Food and Drug Administration in designing the trial to ensure safety. In fact, the original study design was altered to account for the concern that children in this age group might be uniquely sensitive to stimulants and have a number of adverse events. Originally, the lowest dose of methylphenidate was planned to be 2.5 mg three times a day, but the dose was lowered to 1.25 mg three times daily to ease FDA concerns about adverse reactions.

There was also a 40-week open-label maintenance phase, with children receiving a mean total daily dose of 14 mg. During this phase, the child was given the dose that the clinician thought was appropriate. “What's interesting is that we see a noticeable increase of 23% in absolute dose,” Dr. Abikoff said.

At the end of this maintenance period, the optimal dose had increased to 20 mg/day. This suggests “the doses used here were a bit low in terms of clinical optimization,” he said.

WASHINGTON – Methylphenidate appears to be effective and safe for the treatment of attention-deficit hyperactivity disorder in preschool-age children, according to preliminary data presented at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

The results come from the Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children study (PATS), sponsored by the National Institute of Mental Health.

Several studies have previously suggested that preschool-age children with ADHD would respond to and tolerate methylphenidate, and this multisite study is the first major effort aimed at directly assessing the safety and efficacy of a stimulant for the treatment of attention-deficit hyperactivity disorder in children aged 3-5 years.

“The take-home message is that 85% of the children responded to the methylphenidate,” during the 5-week crossover period to determine the optimal dosing for each of the children, said study investigator Howard B. Abikoff, Ph.D., of the New York University Child Study Center.

The optimal dose for each child was determined during a 5-week period. Over that period, all of the children were given a placebo or a dose of 1.25 mg, 2.5 mg, 5 mg, or 7.5 mg three times daily for 1 week each. Overall, 144 children completed this 5-week trial. Each week, a composite score of symptom severity was assigned based on parent and teacher responses to the Conners, Loney, and Milich (CLAM) Questionnaire and the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale.

Two blinded assessors were then asked to identify the best dose for each child. A full panel of all investigators decided upon the appropriate dose when the two assessors did not agree. Just over half (51%) of the children were referred to the full panel of investigators to determine the optimal dose.

Children also could be evaluated at a 10-mg dose if investigators agreed that there was a good chance that the child would have an even better response with a higher dose. This happened in 15 of the cases.

“First of all, we got a very significant effect per dose relative to placebo,” said Dr. Abikoff. For the 2.5-mg, 5-mg, and 7.5-mg doses, the children's composite scores were significantly lower than for placebo.

“We got small to moderate effect sizes at the intermediate doses [2.5 mg and 5 mg] and a reasonably robust effect size at the 7.5-mg dose,” Dr. Abikoff said. There was also a trend toward significantly lower scores for children in the 1.25-mg group.

After the 5-week crossover period, 113 children were randomized to receive either the optimal dose (61 children) or placebo (52 children) for 4 weeks. In the analysis of this portion of the trial, all children were included even if they left the trial early, with the last observation for that child carried through.

In the second portion of the study, a statistically significant difference was found in the composite scores–1.79 points for those in the placebo group and 1.49 points for those receiving the optimum dose of methylphenidate. “The effect sizes are linear from 1.25 mg up to 7.5 mg. … The effect size for 10 mg was somewhat lower,” said Dr. Abikoff.

Over the course of the trial there were 39 adverse events, including difficulty falling asleep, decreased appetite, emotional outbursts, and stomach discomfort, he said.

Safety was a significant concern, given the age group involved. The researchers worked closely with the Food and Drug Administration in designing the trial to ensure safety. In fact, the original study design was altered to account for the concern that children in this age group might be uniquely sensitive to stimulants and have a number of adverse events. Originally, the lowest dose of methylphenidate was planned to be 2.5 mg three times a day, but the dose was lowered to 1.25 mg three times daily to ease FDA concerns about adverse reactions.

There was also a 40-week open-label maintenance phase, with children receiving a mean total daily dose of 14 mg. During this phase, the child was given the dose that the clinician thought was appropriate. “What's interesting is that we see a noticeable increase of 23% in absolute dose,” Dr. Abikoff said.

At the end of this maintenance period, the optimal dose had increased to 20 mg/day. This suggests “the doses used here were a bit low in terms of clinical optimization,” he said.

WASHINGTON – Methylphenidate appears to be effective and safe for the treatment of attention-deficit hyperactivity disorder in preschool-age children, according to preliminary data presented at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

The results come from the Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children study (PATS), sponsored by the National Institute of Mental Health.

Several studies have previously suggested that preschool-age children with ADHD would respond to and tolerate methylphenidate, and this multisite study is the first major effort aimed at directly assessing the safety and efficacy of a stimulant for the treatment of attention-deficit hyperactivity disorder in children aged 3-5 years.

“The take-home message is that 85% of the children responded to the methylphenidate,” during the 5-week crossover period to determine the optimal dosing for each of the children, said study investigator Howard B. Abikoff, Ph.D., of the New York University Child Study Center.

The optimal dose for each child was determined during a 5-week period. Over that period, all of the children were given a placebo or a dose of 1.25 mg, 2.5 mg, 5 mg, or 7.5 mg three times daily for 1 week each. Overall, 144 children completed this 5-week trial. Each week, a composite score of symptom severity was assigned based on parent and teacher responses to the Conners, Loney, and Milich (CLAM) Questionnaire and the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale.

Two blinded assessors were then asked to identify the best dose for each child. A full panel of all investigators decided upon the appropriate dose when the two assessors did not agree. Just over half (51%) of the children were referred to the full panel of investigators to determine the optimal dose.

Children also could be evaluated at a 10-mg dose if investigators agreed that there was a good chance that the child would have an even better response with a higher dose. This happened in 15 of the cases.

“First of all, we got a very significant effect per dose relative to placebo,” said Dr. Abikoff. For the 2.5-mg, 5-mg, and 7.5-mg doses, the children's composite scores were significantly lower than for placebo.

“We got small to moderate effect sizes at the intermediate doses [2.5 mg and 5 mg] and a reasonably robust effect size at the 7.5-mg dose,” Dr. Abikoff said. There was also a trend toward significantly lower scores for children in the 1.25-mg group.

After the 5-week crossover period, 113 children were randomized to receive either the optimal dose (61 children) or placebo (52 children) for 4 weeks. In the analysis of this portion of the trial, all children were included even if they left the trial early, with the last observation for that child carried through.

In the second portion of the study, a statistically significant difference was found in the composite scores–1.79 points for those in the placebo group and 1.49 points for those receiving the optimum dose of methylphenidate. “The effect sizes are linear from 1.25 mg up to 7.5 mg. … The effect size for 10 mg was somewhat lower,” said Dr. Abikoff.

Over the course of the trial there were 39 adverse events, including difficulty falling asleep, decreased appetite, emotional outbursts, and stomach discomfort, he said.

Safety was a significant concern, given the age group involved. The researchers worked closely with the Food and Drug Administration in designing the trial to ensure safety. In fact, the original study design was altered to account for the concern that children in this age group might be uniquely sensitive to stimulants and have a number of adverse events. Originally, the lowest dose of methylphenidate was planned to be 2.5 mg three times a day, but the dose was lowered to 1.25 mg three times daily to ease FDA concerns about adverse reactions.

There was also a 40-week open-label maintenance phase, with children receiving a mean total daily dose of 14 mg. During this phase, the child was given the dose that the clinician thought was appropriate. “What's interesting is that we see a noticeable increase of 23% in absolute dose,” Dr. Abikoff said.

At the end of this maintenance period, the optimal dose had increased to 20 mg/day. This suggests “the doses used here were a bit low in terms of clinical optimization,” he said.

The addition of x-rays and gamma rays to a national list of carcinogens has prompted some concern among radiology professionals who worry that the inclusion could unnecessarily deter patients from undergoing diagnostic tests.

Three types of ionizing radiation—x-rays, gamma rays, and neutrons—were labeled as known carcinogens in the National Toxicology Program's “11th Report on Carcinogens.”

“This is certainly not a surprise to anyone in this field,” said Richard L. Morin, Ph.D., chairman of the American College of Radiology's (ACR) commission on medical physics.

The potential health effects of ionizing radiation have been acknowledged for more than 50 years. A number of agencies in the United States and worldwide—the Environmental Protection Agency, the Nuclear Regulatory Commission, and the World Health Organization—already recognize ionizing radiation as carcinogenic.

Yet the potential for this latest document to be sensationalized is of concern, particularly because it's not clear how much ionizing radiation can potentially lead to cancer. Some researchers contend that there is a risk associated with x-ray or gamma ray exposure at any level. However, this is “somewhat controversial at the low levels that we're talking about” in the medical setting, Dr. Morin noted.

It's well established that at very high levels, x-rays and gamma rays are carcinogens. But when x-rays and gamma rays are used for diagnosis, “the levels are very significantly less than in any studies in which cancers have been produced,” Dr. Morin added.

“The report could lead patients to mistakenly believe that they are being placed at undue risk by undergoing a [radiologic] procedure, and cause many, who may desperately need care, to avoid seeking appropriate medical attention,” James Borgstede, M.D., chairman of the ACR Board of Chancellors, said in a statement.

When radiation exposure is performed appropriately, its benefits outweigh any accompanying risk. In addition, the total exposure is optimized to be as low as is reasonably achievable, David A. Schauer, Ph.D., executive director of the National Council on Radiation Protection and Measurements, wrote in an e-mail.

Advising a patient who has concerns about the cancer risk from x-ray or gamma ray procedures should include a discussion of the genuine need for such a diagnostic test and the real risks of not correctly diagnosing a condition, Dr. Morin said.

Without the diagnostic information provided by x-rays and other imaging tests, “there are only two other options,” Dr. Morin said. “One is to do nothing and wait and see if the patient gets worse.” The other is to do an exploratory surgery. “Clearly the risk associated with exploratory surgery is greater than the risk of diagnostic imaging,” he said.

The National Toxicology Program's latest report emphasizes that the listing identifies potential cancer hazards but does not establish that a substance presents a cancer risk to an individual in daily life. The report also does not attempt to weigh the potential benefits of exposure to certain carcinogenic substances in special situations, such as diagnostic testing. Nor does the report address acceptable dose ranges for diagnostic procedures.

The annual limit on public exposure from a single source of ionizing radiation is 100 mrem (1 mSv), both in the United States and internationally.

Medical applications are excluded from this limit in the United States. With the exception of mammography, there are no nationally set limits on radiation exposure. Mammography has an established maximum exposure limit of 300 mrem (3 mSv).

In perspective, the average person in the United States is exposed to about 360 mrem/yr (3.6 mSv/yr) from all sources of radiation, including cosmic and natural background radiation.

Radiation exposure from a medical procedure is generally minimal in terms of the biologic risk of developing cancer, Dr. Morin said. “Of all the risks there are in life to the patient, this is a very low one.”

Patient information about radiology topics is available at www.radiologyinfo.org

Viruses Make List For First Time; Hepatitis Added

For the first time, a national list of known carcinogens includes several viruses.

Hepatitis B and C viruses and certain human papillomaviruses are listed as carcinogens in the National Toxicology Program's recently released “11th Report on Carcinogens.” The report identifies agents that are known—or are reasonably expected—to cause cancer. The report is published every other year.

The report identifies only potential cancer hazards. It does not establish that a substance presents a substantial cancer risk to an individual in daily life.

The inclusion of the hepatitis B and C viruses was based on epidemiologic studies that have demonstrated that infections with either of these viruses can lead to liver cancer.

There also is some evidence to suggest that chronic hepatitis C infection may increase the risk of B-cell lymphoma.

The human papillomaviruses (HPVs) that were listed as carcinogens are of the genital-mucosal type. Epidemiologic studies have shown that that these types cause cervical cancer. Case-control studies have reported strong associations of HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 58, and 59 with cervical cancer.

In particular, cohort studies have shown that infection with HPV-16 or with high-risk HPVs as a class occurs before the development of high-grade cervical intraepithelial neoplasia, which is thought to be a precursor of invasive cancer.

HPV-16 has also been associated with other anogenital cancers, especially cancer of the vulva.

The addition of x-rays and gamma rays to a national list of carcinogens has prompted some concern among radiology professionals who worry that the inclusion could unnecessarily deter patients from undergoing diagnostic tests.

Three types of ionizing radiation—x-rays, gamma rays, and neutrons—were labeled as known carcinogens in the National Toxicology Program's “11th Report on Carcinogens.”

“This is certainly not a surprise to anyone in this field,” said Richard L. Morin, Ph.D., chairman of the American College of Radiology's (ACR) commission on medical physics.

The potential health effects of ionizing radiation have been acknowledged for more than 50 years. A number of agencies in the United States and worldwide—the Environmental Protection Agency, the Nuclear Regulatory Commission, and the World Health Organization—already recognize ionizing radiation as carcinogenic.

Yet the potential for this latest document to be sensationalized is of concern, particularly because it's not clear how much ionizing radiation can potentially lead to cancer. Some researchers contend that there is a risk associated with x-ray or gamma ray exposure at any level. However, this is “somewhat controversial at the low levels that we're talking about” in the medical setting, Dr. Morin noted.

It's well established that at very high levels, x-rays and gamma rays are carcinogens. But when x-rays and gamma rays are used for diagnosis, “the levels are very significantly less than in any studies in which cancers have been produced,” Dr. Morin added.

“The report could lead patients to mistakenly believe that they are being placed at undue risk by undergoing a [radiologic] procedure, and cause many, who may desperately need care, to avoid seeking appropriate medical attention,” James Borgstede, M.D., chairman of the ACR Board of Chancellors, said in a statement.

When radiation exposure is performed appropriately, its benefits outweigh any accompanying risk. In addition, the total exposure is optimized to be as low as is reasonably achievable, David A. Schauer, Ph.D., executive director of the National Council on Radiation Protection and Measurements, wrote in an e-mail.

Advising a patient who has concerns about the cancer risk from x-ray or gamma ray procedures should include a discussion of the genuine need for such a diagnostic test and the real risks of not correctly diagnosing a condition, Dr. Morin said.

Without the diagnostic information provided by x-rays and other imaging tests, “there are only two other options,” Dr. Morin said. “One is to do nothing and wait and see if the patient gets worse.” The other is to do an exploratory surgery. “Clearly the risk associated with exploratory surgery is greater than the risk of diagnostic imaging,” he said.

The National Toxicology Program's latest report emphasizes that the listing identifies potential cancer hazards but does not establish that a substance presents a cancer risk to an individual in daily life. The report also does not attempt to weigh the potential benefits of exposure to certain carcinogenic substances in special situations, such as diagnostic testing. Nor does the report address acceptable dose ranges for diagnostic procedures.

The annual limit on public exposure from a single source of ionizing radiation is 100 mrem (1 mSv), both in the United States and internationally.

Medical applications are excluded from this limit in the United States. With the exception of mammography, there are no nationally set limits on radiation exposure. Mammography has an established maximum exposure limit of 300 mrem (3 mSv).

In perspective, the average person in the United States is exposed to about 360 mrem/yr (3.6 mSv/yr) from all sources of radiation, including cosmic and natural background radiation.

Radiation exposure from a medical procedure is generally minimal in terms of the biologic risk of developing cancer, Dr. Morin said. “Of all the risks there are in life to the patient, this is a very low one.”

Patient information about radiology topics is available at www.radiologyinfo.org

Viruses Make List For First Time; Hepatitis Added

For the first time, a national list of known carcinogens includes several viruses.

Hepatitis B and C viruses and certain human papillomaviruses are listed as carcinogens in the National Toxicology Program's recently released “11th Report on Carcinogens.” The report identifies agents that are known—or are reasonably expected—to cause cancer. The report is published every other year.

The report identifies only potential cancer hazards. It does not establish that a substance presents a substantial cancer risk to an individual in daily life.

The inclusion of the hepatitis B and C viruses was based on epidemiologic studies that have demonstrated that infections with either of these viruses can lead to liver cancer.

There also is some evidence to suggest that chronic hepatitis C infection may increase the risk of B-cell lymphoma.

The human papillomaviruses (HPVs) that were listed as carcinogens are of the genital-mucosal type. Epidemiologic studies have shown that that these types cause cervical cancer. Case-control studies have reported strong associations of HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 58, and 59 with cervical cancer.

In particular, cohort studies have shown that infection with HPV-16 or with high-risk HPVs as a class occurs before the development of high-grade cervical intraepithelial neoplasia, which is thought to be a precursor of invasive cancer.

HPV-16 has also been associated with other anogenital cancers, especially cancer of the vulva.

The addition of x-rays and gamma rays to a national list of carcinogens has prompted some concern among radiology professionals who worry that the inclusion could unnecessarily deter patients from undergoing diagnostic tests.

Three types of ionizing radiation—x-rays, gamma rays, and neutrons—were labeled as known carcinogens in the National Toxicology Program's “11th Report on Carcinogens.”

“This is certainly not a surprise to anyone in this field,” said Richard L. Morin, Ph.D., chairman of the American College of Radiology's (ACR) commission on medical physics.

The potential health effects of ionizing radiation have been acknowledged for more than 50 years. A number of agencies in the United States and worldwide—the Environmental Protection Agency, the Nuclear Regulatory Commission, and the World Health Organization—already recognize ionizing radiation as carcinogenic.

Yet the potential for this latest document to be sensationalized is of concern, particularly because it's not clear how much ionizing radiation can potentially lead to cancer. Some researchers contend that there is a risk associated with x-ray or gamma ray exposure at any level. However, this is “somewhat controversial at the low levels that we're talking about” in the medical setting, Dr. Morin noted.

It's well established that at very high levels, x-rays and gamma rays are carcinogens. But when x-rays and gamma rays are used for diagnosis, “the levels are very significantly less than in any studies in which cancers have been produced,” Dr. Morin added.

“The report could lead patients to mistakenly believe that they are being placed at undue risk by undergoing a [radiologic] procedure, and cause many, who may desperately need care, to avoid seeking appropriate medical attention,” James Borgstede, M.D., chairman of the ACR Board of Chancellors, said in a statement.

When radiation exposure is performed appropriately, its benefits outweigh any accompanying risk. In addition, the total exposure is optimized to be as low as is reasonably achievable, David A. Schauer, Ph.D., executive director of the National Council on Radiation Protection and Measurements, wrote in an e-mail.

Advising a patient who has concerns about the cancer risk from x-ray or gamma ray procedures should include a discussion of the genuine need for such a diagnostic test and the real risks of not correctly diagnosing a condition, Dr. Morin said.

Without the diagnostic information provided by x-rays and other imaging tests, “there are only two other options,” Dr. Morin said. “One is to do nothing and wait and see if the patient gets worse.” The other is to do an exploratory surgery. “Clearly the risk associated with exploratory surgery is greater than the risk of diagnostic imaging,” he said.

The National Toxicology Program's latest report emphasizes that the listing identifies potential cancer hazards but does not establish that a substance presents a cancer risk to an individual in daily life. The report also does not attempt to weigh the potential benefits of exposure to certain carcinogenic substances in special situations, such as diagnostic testing. Nor does the report address acceptable dose ranges for diagnostic procedures.

The annual limit on public exposure from a single source of ionizing radiation is 100 mrem (1 mSv), both in the United States and internationally.

Medical applications are excluded from this limit in the United States. With the exception of mammography, there are no nationally set limits on radiation exposure. Mammography has an established maximum exposure limit of 300 mrem (3 mSv).

In perspective, the average person in the United States is exposed to about 360 mrem/yr (3.6 mSv/yr) from all sources of radiation, including cosmic and natural background radiation.

Radiation exposure from a medical procedure is generally minimal in terms of the biologic risk of developing cancer, Dr. Morin said. “Of all the risks there are in life to the patient, this is a very low one.”

Patient information about radiology topics is available at www.radiologyinfo.org

Viruses Make List For First Time; Hepatitis Added

For the first time, a national list of known carcinogens includes several viruses.

Hepatitis B and C viruses and certain human papillomaviruses are listed as carcinogens in the National Toxicology Program's recently released “11th Report on Carcinogens.” The report identifies agents that are known—or are reasonably expected—to cause cancer. The report is published every other year.

The report identifies only potential cancer hazards. It does not establish that a substance presents a substantial cancer risk to an individual in daily life.

The inclusion of the hepatitis B and C viruses was based on epidemiologic studies that have demonstrated that infections with either of these viruses can lead to liver cancer.

There also is some evidence to suggest that chronic hepatitis C infection may increase the risk of B-cell lymphoma.

The human papillomaviruses (HPVs) that were listed as carcinogens are of the genital-mucosal type. Epidemiologic studies have shown that that these types cause cervical cancer. Case-control studies have reported strong associations of HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 58, and 59 with cervical cancer.

In particular, cohort studies have shown that infection with HPV-16 or with high-risk HPVs as a class occurs before the development of high-grade cervical intraepithelial neoplasia, which is thought to be a precursor of invasive cancer.

HPV-16 has also been associated with other anogenital cancers, especially cancer of the vulva.

The Food and Drug Administration has issued a Class 1 recall of the ProbeTecET Urine Processing Kit, designed to aid in testing female and male urine specimens for chlamydia and gonorrhea.

The laboratory test—made by Becton Dickinson Diagnostic Systems—may cause indeterminate or false-negative clinical results, which could lead to the patient not receiving treatment. Untreated infection could result in worsening infections, further disease transmission, pelvic inflammatory disease, infertility, ectopic pregnancy, and other sequellae.

Class 1 recalls are the most serious type of recall and involve situations where there is a reasonable probability of serious injury or death.

To contact the company, call 1-800-666-6433, extension 4331, or send an e-mail to technical_services@bd.com

The Food and Drug Administration has issued a Class 1 recall of the ProbeTecET Urine Processing Kit, designed to aid in testing female and male urine specimens for chlamydia and gonorrhea.

The laboratory test—made by Becton Dickinson Diagnostic Systems—may cause indeterminate or false-negative clinical results, which could lead to the patient not receiving treatment. Untreated infection could result in worsening infections, further disease transmission, pelvic inflammatory disease, infertility, ectopic pregnancy, and other sequellae.

Class 1 recalls are the most serious type of recall and involve situations where there is a reasonable probability of serious injury or death.

To contact the company, call 1-800-666-6433, extension 4331, or send an e-mail to technical_services@bd.com

The Food and Drug Administration has issued a Class 1 recall of the ProbeTecET Urine Processing Kit, designed to aid in testing female and male urine specimens for chlamydia and gonorrhea.

The laboratory test—made by Becton Dickinson Diagnostic Systems—may cause indeterminate or false-negative clinical results, which could lead to the patient not receiving treatment. Untreated infection could result in worsening infections, further disease transmission, pelvic inflammatory disease, infertility, ectopic pregnancy, and other sequellae.

Class 1 recalls are the most serious type of recall and involve situations where there is a reasonable probability of serious injury or death.

To contact the company, call 1-800-666-6433, extension 4331, or send an e-mail to technical_services@bd.com