Peanut allergy immunotherapy now comes with approval from the US Food and Drug Administration (FDA), but it also comes with protocols, standards, and paperwork. Whether it will be widely adopted has yet to be determined.

A few dozen allergists around the world have been offering food allergy immunotherapy for many years, having developed their own measuring techniques using store-bought food.

But the vast majority of allergists are not interested in developing home-grown treatments, not only because it involves research and development, but also because it comes with legal risks.

“Finally we have another treatment option,” said Edwin Kim, MD, from the UNC Allergy and Immunology Clinic in Chapel Hill, N.C. “This is what we were waiting for. It’s not cowboy stuff; this works.”

In January, the FDA approved peanut allergen powder (Palforzia) for patients 4-17 years of age, as reported by Medscape Medical News.

The pill contains measured doses of peanut flour and comes with a protocol that will allow allergists to bring patients to a peanut tolerance of 300 mg (about one peanut) and a black-box warning about anaphylaxis risk.

And before allergists can prescribe it, they must take a Risk Evaluation and Mitigation Strategy course to learn about dosing and the allergic reaction protocol.

“That may scare some away,” said Dr. Kim, who discussed the FDA-approved option during his presentation at the American College of Allergy, Asthma & Immunology 2020 Annual Scientific Meeting.

Allergic reaction, including the potential for anaphylaxis, has always been an issue with immunotherapy.

“People make the argument that there is a difference” between an expected allergic reaction – such as one that occurs after the administration of immunotherapy – and an unexpected reaction, he said. Because an expected reaction can be treated quickly, “some feel these expected reactions don’t matter so much.”

“Others say a reaction is a reaction” and argue that if, a treatment causes reaction, then it doesn’t make sense, he explained.

It comes down to patients – they must be willing to take a risk to develop tolerance and improve their quality of life – and the allergists willing to treat them.

The peanut powder involves paperwork, preauthorization forms, denials of care, a higher price tag, regimented procedures, and a prerequisite number of visits with patients. “Not everyone will want to do this,” said Dr. Kim.

The regimen involves three phases. During initial dose escalation, five doses are administered in the office on day 1. Then, over the next 6 months, updoses are administered during 11 in-office sessions and a 300-mg tolerance is achieved. Finally, to maintain tolerance to one peanut, daily doses are administered at home.

The drug cost alone is about $4,200 a year, according to Institute for Clinical and Economic Review. Peanut flour from the grocery store is cheaper, but comes with the risk of bacteria or other contamination.

“This product offers some reassurance, and that matters,” Dr. Kim said.

It’s good to have more options for food allergy treatment. “We need a more proactive way to treat food allergy; avoidance is not good enough,” he explained. “And presumably, at some point, the patient will be able to eat a grocery-store peanut instead of buying the pills.”
 

The art of medicine

But not all allergists will be able to make the protocol work. And it’s not clear whether there is room to alter treatment and offer patients with a higher tolerance a higher starting dose. What we do know, though, is that “the product leaves little room for ‘the art of medicine,’ ” Kim said.

That art is practiced by Arnon Elizur, MD, from the Shamir Medical Center in Tzrifin, Israel, but it’s backed by a rigid home-grown protocol.

Since 2010, he has treated 1,800 patients for peanut allergy, updosing slowly to a tolerance of 3,000 mg of peanut, the equivalent of 10 peanuts. He keeps the maintenance dose at four peanuts (1,200 mg). His center takes a personalized approach, starting patients on the highest dose they can tolerate and working up, with daily patient check-ins from home and a staff available around the clock to answer questions and deal with reactions.

“We aim for full sensitization,” Dr. Elizur said in an interview.

The peanut pill is “a big step forward” for immunotherapy, he said. It is “a standardized product, checked for bacteria and allergen content, which is available to a wide community of physicians.”

But, he pointed out, “it’s expensive.” And it’s only for peanut. “There are millions of food-allergic patients around the world dying from adverse reactions to many different kinds of food. We don’t want to wait for years for a product for all of them. We can use the actual food.”

He questions the lifelong maintenance protocol with a daily 300-mg pill. “If you can’t eat a peanut, why would you buy a drug that’s a peanut?” he asked.

He also said he’s disappointed that the product is not indicated for adults.

At the Shamir clinic, reactions are closely monitored. “Some are mild, others we treat with autoinjectors, epinephrine,” he reported. “Those are the most undesirable.”

Data from his center show that reactions occur in about 15% of patients. But his treatment success rates are good. In an average of 8 months, he is able to get 80% of his adult patients to full sensitization.

But it’s not for all patients or for all clinics, he acknowledged. “We continue to look at this balance in quality of life throughout the process. Our goal is to improve the quality of life threshold.”

Treatment that involves “native food” is “a lot of work” and requires “a lot of investment,” Dr. Elizur said. His center uses a web reporting system to maintain a 24/7 dialogue with patients, “and we look at the reports every day.” They also have a physician on call at all times. “Not everyone can commit to providing care throughout the day and night.”

His center charges the equivalent of $US3,000 per food allergy treated. “That’s whether it takes 6 months or 2 years,” he said.

There are more than 1,000 people on his 3-year waiting list.

“This is the first year that the American College of Allergy, Asthma, and Immunology is not hosting a pro–con debate on oral immunotherapy,” Dr. Kim pointed out. “We have a therapy now.”

However, the pandemic has slowed treatment uptake. “Immunotherapy is not easy to do, whether it’s FDA approved or not,” he explained. With at least 11 doctor visits in the first 6 months – each visit is between 30 minutes and 2-3 hours long – it hasn’t been possible to set up this year. “It’s not ideal.”

It will be interesting to see “how this will roll out and how it will be adopted,” Dr. Kim said. “From a food allergy point of view, the next 12 months are going to be very interesting.”

Dr. Kim reports receiving consulting honorarium from Aimmune, the maker of Palforzia; being on the clinical medical advisory board for DBV Technologies; and consulting for Aimmune, Allakos, Allergenis, DBV, Duke Clinical Research Institute, Ukko Incorporated, Vibrant America, and Kenota Health. Dr. Elizur has disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

Peanut allergy immunotherapy now comes with approval from the US Food and Drug Administration (FDA), but it also comes with protocols, standards, and paperwork. Whether it will be widely adopted has yet to be determined.

A few dozen allergists around the world have been offering food allergy immunotherapy for many years, having developed their own measuring techniques using store-bought food.

But the vast majority of allergists are not interested in developing home-grown treatments, not only because it involves research and development, but also because it comes with legal risks.

“Finally we have another treatment option,” said Edwin Kim, MD, from the UNC Allergy and Immunology Clinic in Chapel Hill, N.C. “This is what we were waiting for. It’s not cowboy stuff; this works.”

In January, the FDA approved peanut allergen powder (Palforzia) for patients 4-17 years of age, as reported by Medscape Medical News.

The pill contains measured doses of peanut flour and comes with a protocol that will allow allergists to bring patients to a peanut tolerance of 300 mg (about one peanut) and a black-box warning about anaphylaxis risk.

And before allergists can prescribe it, they must take a Risk Evaluation and Mitigation Strategy course to learn about dosing and the allergic reaction protocol.

“That may scare some away,” said Dr. Kim, who discussed the FDA-approved option during his presentation at the American College of Allergy, Asthma & Immunology 2020 Annual Scientific Meeting.

Allergic reaction, including the potential for anaphylaxis, has always been an issue with immunotherapy.

“People make the argument that there is a difference” between an expected allergic reaction – such as one that occurs after the administration of immunotherapy – and an unexpected reaction, he said. Because an expected reaction can be treated quickly, “some feel these expected reactions don’t matter so much.”

“Others say a reaction is a reaction” and argue that if, a treatment causes reaction, then it doesn’t make sense, he explained.

It comes down to patients – they must be willing to take a risk to develop tolerance and improve their quality of life – and the allergists willing to treat them.

The peanut powder involves paperwork, preauthorization forms, denials of care, a higher price tag, regimented procedures, and a prerequisite number of visits with patients. “Not everyone will want to do this,” said Dr. Kim.

The regimen involves three phases. During initial dose escalation, five doses are administered in the office on day 1. Then, over the next 6 months, updoses are administered during 11 in-office sessions and a 300-mg tolerance is achieved. Finally, to maintain tolerance to one peanut, daily doses are administered at home.

The drug cost alone is about $4,200 a year, according to Institute for Clinical and Economic Review. Peanut flour from the grocery store is cheaper, but comes with the risk of bacteria or other contamination.

“This product offers some reassurance, and that matters,” Dr. Kim said.

It’s good to have more options for food allergy treatment. “We need a more proactive way to treat food allergy; avoidance is not good enough,” he explained. “And presumably, at some point, the patient will be able to eat a grocery-store peanut instead of buying the pills.”
 

The art of medicine

But not all allergists will be able to make the protocol work. And it’s not clear whether there is room to alter treatment and offer patients with a higher tolerance a higher starting dose. What we do know, though, is that “the product leaves little room for ‘the art of medicine,’ ” Kim said.

That art is practiced by Arnon Elizur, MD, from the Shamir Medical Center in Tzrifin, Israel, but it’s backed by a rigid home-grown protocol.

Since 2010, he has treated 1,800 patients for peanut allergy, updosing slowly to a tolerance of 3,000 mg of peanut, the equivalent of 10 peanuts. He keeps the maintenance dose at four peanuts (1,200 mg). His center takes a personalized approach, starting patients on the highest dose they can tolerate and working up, with daily patient check-ins from home and a staff available around the clock to answer questions and deal with reactions.

“We aim for full sensitization,” Dr. Elizur said in an interview.

The peanut pill is “a big step forward” for immunotherapy, he said. It is “a standardized product, checked for bacteria and allergen content, which is available to a wide community of physicians.”

But, he pointed out, “it’s expensive.” And it’s only for peanut. “There are millions of food-allergic patients around the world dying from adverse reactions to many different kinds of food. We don’t want to wait for years for a product for all of them. We can use the actual food.”

He questions the lifelong maintenance protocol with a daily 300-mg pill. “If you can’t eat a peanut, why would you buy a drug that’s a peanut?” he asked.

He also said he’s disappointed that the product is not indicated for adults.

At the Shamir clinic, reactions are closely monitored. “Some are mild, others we treat with autoinjectors, epinephrine,” he reported. “Those are the most undesirable.”

Data from his center show that reactions occur in about 15% of patients. But his treatment success rates are good. In an average of 8 months, he is able to get 80% of his adult patients to full sensitization.

But it’s not for all patients or for all clinics, he acknowledged. “We continue to look at this balance in quality of life throughout the process. Our goal is to improve the quality of life threshold.”

Treatment that involves “native food” is “a lot of work” and requires “a lot of investment,” Dr. Elizur said. His center uses a web reporting system to maintain a 24/7 dialogue with patients, “and we look at the reports every day.” They also have a physician on call at all times. “Not everyone can commit to providing care throughout the day and night.”

His center charges the equivalent of $US3,000 per food allergy treated. “That’s whether it takes 6 months or 2 years,” he said.

There are more than 1,000 people on his 3-year waiting list.

“This is the first year that the American College of Allergy, Asthma, and Immunology is not hosting a pro–con debate on oral immunotherapy,” Dr. Kim pointed out. “We have a therapy now.”

However, the pandemic has slowed treatment uptake. “Immunotherapy is not easy to do, whether it’s FDA approved or not,” he explained. With at least 11 doctor visits in the first 6 months – each visit is between 30 minutes and 2-3 hours long – it hasn’t been possible to set up this year. “It’s not ideal.”

It will be interesting to see “how this will roll out and how it will be adopted,” Dr. Kim said. “From a food allergy point of view, the next 12 months are going to be very interesting.”

Dr. Kim reports receiving consulting honorarium from Aimmune, the maker of Palforzia; being on the clinical medical advisory board for DBV Technologies; and consulting for Aimmune, Allakos, Allergenis, DBV, Duke Clinical Research Institute, Ukko Incorporated, Vibrant America, and Kenota Health. Dr. Elizur has disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

Peanut allergy immunotherapy now comes with approval from the US Food and Drug Administration (FDA), but it also comes with protocols, standards, and paperwork. Whether it will be widely adopted has yet to be determined.

A few dozen allergists around the world have been offering food allergy immunotherapy for many years, having developed their own measuring techniques using store-bought food.

But the vast majority of allergists are not interested in developing home-grown treatments, not only because it involves research and development, but also because it comes with legal risks.

“Finally we have another treatment option,” said Edwin Kim, MD, from the UNC Allergy and Immunology Clinic in Chapel Hill, N.C. “This is what we were waiting for. It’s not cowboy stuff; this works.”

In January, the FDA approved peanut allergen powder (Palforzia) for patients 4-17 years of age, as reported by Medscape Medical News.

The pill contains measured doses of peanut flour and comes with a protocol that will allow allergists to bring patients to a peanut tolerance of 300 mg (about one peanut) and a black-box warning about anaphylaxis risk.

And before allergists can prescribe it, they must take a Risk Evaluation and Mitigation Strategy course to learn about dosing and the allergic reaction protocol.

“That may scare some away,” said Dr. Kim, who discussed the FDA-approved option during his presentation at the American College of Allergy, Asthma & Immunology 2020 Annual Scientific Meeting.

Allergic reaction, including the potential for anaphylaxis, has always been an issue with immunotherapy.

“People make the argument that there is a difference” between an expected allergic reaction – such as one that occurs after the administration of immunotherapy – and an unexpected reaction, he said. Because an expected reaction can be treated quickly, “some feel these expected reactions don’t matter so much.”

“Others say a reaction is a reaction” and argue that if, a treatment causes reaction, then it doesn’t make sense, he explained.

It comes down to patients – they must be willing to take a risk to develop tolerance and improve their quality of life – and the allergists willing to treat them.

The peanut powder involves paperwork, preauthorization forms, denials of care, a higher price tag, regimented procedures, and a prerequisite number of visits with patients. “Not everyone will want to do this,” said Dr. Kim.

The regimen involves three phases. During initial dose escalation, five doses are administered in the office on day 1. Then, over the next 6 months, updoses are administered during 11 in-office sessions and a 300-mg tolerance is achieved. Finally, to maintain tolerance to one peanut, daily doses are administered at home.

The drug cost alone is about $4,200 a year, according to Institute for Clinical and Economic Review. Peanut flour from the grocery store is cheaper, but comes with the risk of bacteria or other contamination.

“This product offers some reassurance, and that matters,” Dr. Kim said.

It’s good to have more options for food allergy treatment. “We need a more proactive way to treat food allergy; avoidance is not good enough,” he explained. “And presumably, at some point, the patient will be able to eat a grocery-store peanut instead of buying the pills.”
 

The art of medicine

But not all allergists will be able to make the protocol work. And it’s not clear whether there is room to alter treatment and offer patients with a higher tolerance a higher starting dose. What we do know, though, is that “the product leaves little room for ‘the art of medicine,’ ” Kim said.

That art is practiced by Arnon Elizur, MD, from the Shamir Medical Center in Tzrifin, Israel, but it’s backed by a rigid home-grown protocol.

Since 2010, he has treated 1,800 patients for peanut allergy, updosing slowly to a tolerance of 3,000 mg of peanut, the equivalent of 10 peanuts. He keeps the maintenance dose at four peanuts (1,200 mg). His center takes a personalized approach, starting patients on the highest dose they can tolerate and working up, with daily patient check-ins from home and a staff available around the clock to answer questions and deal with reactions.

“We aim for full sensitization,” Dr. Elizur said in an interview.

The peanut pill is “a big step forward” for immunotherapy, he said. It is “a standardized product, checked for bacteria and allergen content, which is available to a wide community of physicians.”

But, he pointed out, “it’s expensive.” And it’s only for peanut. “There are millions of food-allergic patients around the world dying from adverse reactions to many different kinds of food. We don’t want to wait for years for a product for all of them. We can use the actual food.”

He questions the lifelong maintenance protocol with a daily 300-mg pill. “If you can’t eat a peanut, why would you buy a drug that’s a peanut?” he asked.

He also said he’s disappointed that the product is not indicated for adults.

At the Shamir clinic, reactions are closely monitored. “Some are mild, others we treat with autoinjectors, epinephrine,” he reported. “Those are the most undesirable.”

Data from his center show that reactions occur in about 15% of patients. But his treatment success rates are good. In an average of 8 months, he is able to get 80% of his adult patients to full sensitization.

But it’s not for all patients or for all clinics, he acknowledged. “We continue to look at this balance in quality of life throughout the process. Our goal is to improve the quality of life threshold.”

Treatment that involves “native food” is “a lot of work” and requires “a lot of investment,” Dr. Elizur said. His center uses a web reporting system to maintain a 24/7 dialogue with patients, “and we look at the reports every day.” They also have a physician on call at all times. “Not everyone can commit to providing care throughout the day and night.”

His center charges the equivalent of $US3,000 per food allergy treated. “That’s whether it takes 6 months or 2 years,” he said.

There are more than 1,000 people on his 3-year waiting list.

“This is the first year that the American College of Allergy, Asthma, and Immunology is not hosting a pro–con debate on oral immunotherapy,” Dr. Kim pointed out. “We have a therapy now.”

However, the pandemic has slowed treatment uptake. “Immunotherapy is not easy to do, whether it’s FDA approved or not,” he explained. With at least 11 doctor visits in the first 6 months – each visit is between 30 minutes and 2-3 hours long – it hasn’t been possible to set up this year. “It’s not ideal.”

It will be interesting to see “how this will roll out and how it will be adopted,” Dr. Kim said. “From a food allergy point of view, the next 12 months are going to be very interesting.”

Dr. Kim reports receiving consulting honorarium from Aimmune, the maker of Palforzia; being on the clinical medical advisory board for DBV Technologies; and consulting for Aimmune, Allakos, Allergenis, DBV, Duke Clinical Research Institute, Ukko Incorporated, Vibrant America, and Kenota Health. Dr. Elizur has disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

Although the effects of vitamin K on blood coagulation are well-established, it is now clear that many extracellular proteins are carboxylated in a vitamin K-dependent manner, including bone matrix proteins such as osteocalcin and matrix gla protein. Previous studies have reported a relationship between vitamin K levels and bone density and fracture risk. However, optimal circulating vitamin K levels for skeletal health remain unknown. In this cross-sectional study of 374 women with post-menopausal osteoporosis, the authors assessed the relationship between vitamin K levels, vitamin K dependent bone-relevant circulating proteins, bone density, and fractures. In doing so, it was noted that women with prevalent fractures showed lower vitamin K levels than those without fractures. No relationship between vitamin K levels and bone density was noted. Interestingly, different serum levels of vitamin K were associated with optimal carboxylation of different vitamin K-dependent proteins: lower vitamin K levels are needed to support clotting factors than bone matrix proteins. Overall, this study suggests that higher intake is needed to obtain the full skeletal benefit of vitamin K versus its effects on coagulation. Future prospective studies are needed to test this intriguing hypothesis, and to further explore the relationship between vitamin K and bone quality.

For over 20 years, bisphosphonates have been first line therapy to increase bone density and reduce fracture risk in patients with osteoporosis. At present, multiple oral and intravenous bisphosphonates are approved for this indication by regulatory agencies worldwide. Several ‘next-generation’ bisphosphonates with optimized anti-resorptive and pharmacokinetic properties have been developed. Of these agents, minodronate is a particularly potent, third generation azaryl bisphosphonate that is currently approved for osteoporosis treatment in Japan. In this meta-analysis of 13 randomized controlled trials, the effects of minodronate were assessed versus other commonly-used osteoporosis medications. Compared with other drugs (alendronate, risedronate, raloxifene, or eldecalcitol), minodronate more potently suppressed serum bone resorption markers (NTX and TRAcP-5b) and, because bone formation and resorption are coupled, more potently suppressed the bone formation marker bone-specific alkaline phosphatase. In addition to these effects on serum markers, minodronate reduced vertebral fractures more than other medications. Across studies, no differences were noted between minodronate and comparators at the level of bone mineral density. Minodronate treatment is associated with a high incidence of gastrointestinal adverse effects than comparator medications. Taken together, these findings suggest that minodronate represents a potent, orally-available bisphosphonate for vertebral fracture reduction in patients with osteoporosis in Japan.

Chronic obstructive pulmonary disease (COPD) is well-known to be a risk factor for osteoporosis and fragility fractures. However, the interplay between inhaled corticosteroid use in COPD and skeletal outcomes remains unclear. While systemic glucocorticoid therapy clearly impairs bone mass and increases fracture risk, whether inhaled steroids have similar effects remain unknown. Furthermore, since inhaled corticosteroids can reduce lung inflammation and COPD flares, it is possible that, by controlling pulmonary disease, these agents may actually promote bone health. In this real-world retrospective Swedish cohort study, 9,651 COPD patients and 59,454 reference controls were identified. Matching using propensity scoring was performed to identify two populations (COPD and control) with similar characteristics other than the presence of COPD. As expected, COPD patients showed an increased rate of osteoporosis-related events versus controls over approximately 5 years of subsequent follow-up. Amongst COPD patients, high-dose inhaled corticosteroid treatment also increased risk of osteoporosis-related events compared to COPD patients on no or low-dose inhaled steroids. These findings confirm the known relationship between COPD and fracture risk, and suggest that extra attention should be paid to fracture risk in COPD patients receiving high-dose inhaled corticosteroids.

Wrist fractures are common in patients with osteoporosis. In addition to causing pain and triggering functional decline, the presence of a wrist fracture indicates an increased risk of additional fragility fractures in the near future. Most wrist fractures occur in the ultradistal radius, a skeletal site rich in trabecular bone. In contrast, wrist bone density by DXA is most commonly reported in the distal 1/3 radius, a region of the radius with more cortical bone. Abaloparatide is a PTHrP analog that increases bone density and reduces fracture risk. In this sub-analysis of the ACTIVE and ACTIVExtend randomized clinical trial, the effects of abaloparatide on wrist fractures and BMD at various regions of the wrist were assessed. Compared to placebo, abaloparatide treatment significantly increased ultradistal wrist BMD after 18 months of therapy. These gains were preserved during the subsequent extension study when patients were maintained on alendronate. Very few wrist fractures were noted during this study thus precluding robust statistical analysis of the effects of abaloparatide on wrist fracture risk. However, numerically fewer wrist fractures were noted in abaloparatide-treated patients versus controls. Taken together, these results highlight the potential importance of measuring ultradistal radius BMD for patients undergoing therapy with bone anabolic agents. Future studies are needed to better standardize methods for obtaining ultradistal radius BMD measurements and to define least significant change thresholds at this potentially-important skeletal site.

Marc Wein, M.D., Ph.D
Assistant Professor of Medicine
Massachusetts General Hospital Endocrine Unit, Harvard Medical School

Although the effects of vitamin K on blood coagulation are well-established, it is now clear that many extracellular proteins are carboxylated in a vitamin K-dependent manner, including bone matrix proteins such as osteocalcin and matrix gla protein. Previous studies have reported a relationship between vitamin K levels and bone density and fracture risk. However, optimal circulating vitamin K levels for skeletal health remain unknown. In this cross-sectional study of 374 women with post-menopausal osteoporosis, the authors assessed the relationship between vitamin K levels, vitamin K dependent bone-relevant circulating proteins, bone density, and fractures. In doing so, it was noted that women with prevalent fractures showed lower vitamin K levels than those without fractures. No relationship between vitamin K levels and bone density was noted. Interestingly, different serum levels of vitamin K were associated with optimal carboxylation of different vitamin K-dependent proteins: lower vitamin K levels are needed to support clotting factors than bone matrix proteins. Overall, this study suggests that higher intake is needed to obtain the full skeletal benefit of vitamin K versus its effects on coagulation. Future prospective studies are needed to test this intriguing hypothesis, and to further explore the relationship between vitamin K and bone quality.

For over 20 years, bisphosphonates have been first line therapy to increase bone density and reduce fracture risk in patients with osteoporosis. At present, multiple oral and intravenous bisphosphonates are approved for this indication by regulatory agencies worldwide. Several ‘next-generation’ bisphosphonates with optimized anti-resorptive and pharmacokinetic properties have been developed. Of these agents, minodronate is a particularly potent, third generation azaryl bisphosphonate that is currently approved for osteoporosis treatment in Japan. In this meta-analysis of 13 randomized controlled trials, the effects of minodronate were assessed versus other commonly-used osteoporosis medications. Compared with other drugs (alendronate, risedronate, raloxifene, or eldecalcitol), minodronate more potently suppressed serum bone resorption markers (NTX and TRAcP-5b) and, because bone formation and resorption are coupled, more potently suppressed the bone formation marker bone-specific alkaline phosphatase. In addition to these effects on serum markers, minodronate reduced vertebral fractures more than other medications. Across studies, no differences were noted between minodronate and comparators at the level of bone mineral density. Minodronate treatment is associated with a high incidence of gastrointestinal adverse effects than comparator medications. Taken together, these findings suggest that minodronate represents a potent, orally-available bisphosphonate for vertebral fracture reduction in patients with osteoporosis in Japan.

Chronic obstructive pulmonary disease (COPD) is well-known to be a risk factor for osteoporosis and fragility fractures. However, the interplay between inhaled corticosteroid use in COPD and skeletal outcomes remains unclear. While systemic glucocorticoid therapy clearly impairs bone mass and increases fracture risk, whether inhaled steroids have similar effects remain unknown. Furthermore, since inhaled corticosteroids can reduce lung inflammation and COPD flares, it is possible that, by controlling pulmonary disease, these agents may actually promote bone health. In this real-world retrospective Swedish cohort study, 9,651 COPD patients and 59,454 reference controls were identified. Matching using propensity scoring was performed to identify two populations (COPD and control) with similar characteristics other than the presence of COPD. As expected, COPD patients showed an increased rate of osteoporosis-related events versus controls over approximately 5 years of subsequent follow-up. Amongst COPD patients, high-dose inhaled corticosteroid treatment also increased risk of osteoporosis-related events compared to COPD patients on no or low-dose inhaled steroids. These findings confirm the known relationship between COPD and fracture risk, and suggest that extra attention should be paid to fracture risk in COPD patients receiving high-dose inhaled corticosteroids.

Wrist fractures are common in patients with osteoporosis. In addition to causing pain and triggering functional decline, the presence of a wrist fracture indicates an increased risk of additional fragility fractures in the near future. Most wrist fractures occur in the ultradistal radius, a skeletal site rich in trabecular bone. In contrast, wrist bone density by DXA is most commonly reported in the distal 1/3 radius, a region of the radius with more cortical bone. Abaloparatide is a PTHrP analog that increases bone density and reduces fracture risk. In this sub-analysis of the ACTIVE and ACTIVExtend randomized clinical trial, the effects of abaloparatide on wrist fractures and BMD at various regions of the wrist were assessed. Compared to placebo, abaloparatide treatment significantly increased ultradistal wrist BMD after 18 months of therapy. These gains were preserved during the subsequent extension study when patients were maintained on alendronate. Very few wrist fractures were noted during this study thus precluding robust statistical analysis of the effects of abaloparatide on wrist fracture risk. However, numerically fewer wrist fractures were noted in abaloparatide-treated patients versus controls. Taken together, these results highlight the potential importance of measuring ultradistal radius BMD for patients undergoing therapy with bone anabolic agents. Future studies are needed to better standardize methods for obtaining ultradistal radius BMD measurements and to define least significant change thresholds at this potentially-important skeletal site.

Marc Wein, M.D., Ph.D
Assistant Professor of Medicine
Massachusetts General Hospital Endocrine Unit, Harvard Medical School

Although the effects of vitamin K on blood coagulation are well-established, it is now clear that many extracellular proteins are carboxylated in a vitamin K-dependent manner, including bone matrix proteins such as osteocalcin and matrix gla protein. Previous studies have reported a relationship between vitamin K levels and bone density and fracture risk. However, optimal circulating vitamin K levels for skeletal health remain unknown. In this cross-sectional study of 374 women with post-menopausal osteoporosis, the authors assessed the relationship between vitamin K levels, vitamin K dependent bone-relevant circulating proteins, bone density, and fractures. In doing so, it was noted that women with prevalent fractures showed lower vitamin K levels than those without fractures. No relationship between vitamin K levels and bone density was noted. Interestingly, different serum levels of vitamin K were associated with optimal carboxylation of different vitamin K-dependent proteins: lower vitamin K levels are needed to support clotting factors than bone matrix proteins. Overall, this study suggests that higher intake is needed to obtain the full skeletal benefit of vitamin K versus its effects on coagulation. Future prospective studies are needed to test this intriguing hypothesis, and to further explore the relationship between vitamin K and bone quality.

For over 20 years, bisphosphonates have been first line therapy to increase bone density and reduce fracture risk in patients with osteoporosis. At present, multiple oral and intravenous bisphosphonates are approved for this indication by regulatory agencies worldwide. Several ‘next-generation’ bisphosphonates with optimized anti-resorptive and pharmacokinetic properties have been developed. Of these agents, minodronate is a particularly potent, third generation azaryl bisphosphonate that is currently approved for osteoporosis treatment in Japan. In this meta-analysis of 13 randomized controlled trials, the effects of minodronate were assessed versus other commonly-used osteoporosis medications. Compared with other drugs (alendronate, risedronate, raloxifene, or eldecalcitol), minodronate more potently suppressed serum bone resorption markers (NTX and TRAcP-5b) and, because bone formation and resorption are coupled, more potently suppressed the bone formation marker bone-specific alkaline phosphatase. In addition to these effects on serum markers, minodronate reduced vertebral fractures more than other medications. Across studies, no differences were noted between minodronate and comparators at the level of bone mineral density. Minodronate treatment is associated with a high incidence of gastrointestinal adverse effects than comparator medications. Taken together, these findings suggest that minodronate represents a potent, orally-available bisphosphonate for vertebral fracture reduction in patients with osteoporosis in Japan.

Chronic obstructive pulmonary disease (COPD) is well-known to be a risk factor for osteoporosis and fragility fractures. However, the interplay between inhaled corticosteroid use in COPD and skeletal outcomes remains unclear. While systemic glucocorticoid therapy clearly impairs bone mass and increases fracture risk, whether inhaled steroids have similar effects remain unknown. Furthermore, since inhaled corticosteroids can reduce lung inflammation and COPD flares, it is possible that, by controlling pulmonary disease, these agents may actually promote bone health. In this real-world retrospective Swedish cohort study, 9,651 COPD patients and 59,454 reference controls were identified. Matching using propensity scoring was performed to identify two populations (COPD and control) with similar characteristics other than the presence of COPD. As expected, COPD patients showed an increased rate of osteoporosis-related events versus controls over approximately 5 years of subsequent follow-up. Amongst COPD patients, high-dose inhaled corticosteroid treatment also increased risk of osteoporosis-related events compared to COPD patients on no or low-dose inhaled steroids. These findings confirm the known relationship between COPD and fracture risk, and suggest that extra attention should be paid to fracture risk in COPD patients receiving high-dose inhaled corticosteroids.

Wrist fractures are common in patients with osteoporosis. In addition to causing pain and triggering functional decline, the presence of a wrist fracture indicates an increased risk of additional fragility fractures in the near future. Most wrist fractures occur in the ultradistal radius, a skeletal site rich in trabecular bone. In contrast, wrist bone density by DXA is most commonly reported in the distal 1/3 radius, a region of the radius with more cortical bone. Abaloparatide is a PTHrP analog that increases bone density and reduces fracture risk. In this sub-analysis of the ACTIVE and ACTIVExtend randomized clinical trial, the effects of abaloparatide on wrist fractures and BMD at various regions of the wrist were assessed. Compared to placebo, abaloparatide treatment significantly increased ultradistal wrist BMD after 18 months of therapy. These gains were preserved during the subsequent extension study when patients were maintained on alendronate. Very few wrist fractures were noted during this study thus precluding robust statistical analysis of the effects of abaloparatide on wrist fracture risk. However, numerically fewer wrist fractures were noted in abaloparatide-treated patients versus controls. Taken together, these results highlight the potential importance of measuring ultradistal radius BMD for patients undergoing therapy with bone anabolic agents. Future studies are needed to better standardize methods for obtaining ultradistal radius BMD measurements and to define least significant change thresholds at this potentially-important skeletal site.

Marc Wein, M.D., Ph.D
Assistant Professor of Medicine
Massachusetts General Hospital Endocrine Unit, Harvard Medical School

Key clinical point: Hypogonadism is a major risk factor for the development of fractures in men and women treated with glucocorticoid (GC).

Major finding: Major risk factors for vertebral fracture were hypogonadism (odds ratio [OR], 12.38; P = .01) and receiving GC boluses (OR 3.45; P = .01) and that for friability fracture were hypogonadism (OR, 7.03; P = .01) and a FRAX index greater than 20 (OR, 7.08; P = .02).

Study details: A cross-sectional study of 127 adults receiving chronic GC treatment for a rheumatological autoimmune disease.

Disclosures: This study was funded in part by the Societat Catalana de Reumatologia. The authors declared no conflicts of interest.

Citation: Florez H et al. RMD Open. 2020 Sep 10. doi: 10.1136/rmdopen-2020-001355.

Key clinical point: Hypogonadism is a major risk factor for the development of fractures in men and women treated with glucocorticoid (GC).

Major finding: Major risk factors for vertebral fracture were hypogonadism (odds ratio [OR], 12.38; P = .01) and receiving GC boluses (OR 3.45; P = .01) and that for friability fracture were hypogonadism (OR, 7.03; P = .01) and a FRAX index greater than 20 (OR, 7.08; P = .02).

Study details: A cross-sectional study of 127 adults receiving chronic GC treatment for a rheumatological autoimmune disease.

Disclosures: This study was funded in part by the Societat Catalana de Reumatologia. The authors declared no conflicts of interest.

Citation: Florez H et al. RMD Open. 2020 Sep 10. doi: 10.1136/rmdopen-2020-001355.

Key clinical point: Hypogonadism is a major risk factor for the development of fractures in men and women treated with glucocorticoid (GC).

Major finding: Major risk factors for vertebral fracture were hypogonadism (odds ratio [OR], 12.38; P = .01) and receiving GC boluses (OR 3.45; P = .01) and that for friability fracture were hypogonadism (OR, 7.03; P = .01) and a FRAX index greater than 20 (OR, 7.08; P = .02).

Study details: A cross-sectional study of 127 adults receiving chronic GC treatment for a rheumatological autoimmune disease.

Disclosures: This study was funded in part by the Societat Catalana de Reumatologia. The authors declared no conflicts of interest.

Citation: Florez H et al. RMD Open. 2020 Sep 10. doi: 10.1136/rmdopen-2020-001355.

Key clinical point: Abaloparatide/alendronate treatment shows numerically lower risks for wrist fractures compared with placebo/alendronate, suggesting a potential correlation between ultradistal (UD) radius bone mineral density (BMD) and wrist fracture.

Major finding: BMD gains at the UD radius following treatment with abaloparatide in ACTIVE were maintained over the subsequent 24 months of treatment with alendronate in ACTIVExtend (cumulative month 43 treatment difference, 0.89%; P = .20). Conversely, UD radius BMD in the placebo group during ACTIVE decreased to below ACTIVE baseline.

Study details: The data come from a subanalysis of the phase 3 ACTIVExtend trial.

Disclosures: Funding for this study was provided by Radius Health, Inc. NB Watts, RK Dore, and MS LeBoff reported ties with various pharmaceutical companies. B Mitlak and Y Wang were employees of and own company stock in Radius Health, Inc. G Hattersley was a former employee of and a consultant to Radius Health, Inc. TD Rozental is the Editor in Chief of the Journal of Hand Surgery Global Online. S Baim reported no conflicts of interest.

Citation: Watts NB et al. Osteoporos Int. 2020 Sep 15. doi: 10.1007/s00198-020-05555-1.

Key clinical point: Abaloparatide/alendronate treatment shows numerically lower risks for wrist fractures compared with placebo/alendronate, suggesting a potential correlation between ultradistal (UD) radius bone mineral density (BMD) and wrist fracture.

Major finding: BMD gains at the UD radius following treatment with abaloparatide in ACTIVE were maintained over the subsequent 24 months of treatment with alendronate in ACTIVExtend (cumulative month 43 treatment difference, 0.89%; P = .20). Conversely, UD radius BMD in the placebo group during ACTIVE decreased to below ACTIVE baseline.

Study details: The data come from a subanalysis of the phase 3 ACTIVExtend trial.

Disclosures: Funding for this study was provided by Radius Health, Inc. NB Watts, RK Dore, and MS LeBoff reported ties with various pharmaceutical companies. B Mitlak and Y Wang were employees of and own company stock in Radius Health, Inc. G Hattersley was a former employee of and a consultant to Radius Health, Inc. TD Rozental is the Editor in Chief of the Journal of Hand Surgery Global Online. S Baim reported no conflicts of interest.

Citation: Watts NB et al. Osteoporos Int. 2020 Sep 15. doi: 10.1007/s00198-020-05555-1.

Key clinical point: Abaloparatide/alendronate treatment shows numerically lower risks for wrist fractures compared with placebo/alendronate, suggesting a potential correlation between ultradistal (UD) radius bone mineral density (BMD) and wrist fracture.

Major finding: BMD gains at the UD radius following treatment with abaloparatide in ACTIVE were maintained over the subsequent 24 months of treatment with alendronate in ACTIVExtend (cumulative month 43 treatment difference, 0.89%; P = .20). Conversely, UD radius BMD in the placebo group during ACTIVE decreased to below ACTIVE baseline.

Study details: The data come from a subanalysis of the phase 3 ACTIVExtend trial.

Disclosures: Funding for this study was provided by Radius Health, Inc. NB Watts, RK Dore, and MS LeBoff reported ties with various pharmaceutical companies. B Mitlak and Y Wang were employees of and own company stock in Radius Health, Inc. G Hattersley was a former employee of and a consultant to Radius Health, Inc. TD Rozental is the Editor in Chief of the Journal of Hand Surgery Global Online. S Baim reported no conflicts of interest.

Citation: Watts NB et al. Osteoporos Int. 2020 Sep 15. doi: 10.1007/s00198-020-05555-1.

Key clinical point: Use of high-dose inhaled corticosteroids (ICS) significantly increased the risk of osteoporosis and fracture in patients with chronic obstructive pulmonary disease (COPD).

Major finding: Patients with COPD using ICS were at an increased risk for any osteoporosis-related event (high dose: risk ratio [RR], 1.52; 95% confidence interval [CI], 1.24-1.82] and low dose: RR, 1.27; 95% CI, 1.13-1.56) compared with those not using ICS.

Study details: The data come from ARCTIC study of 9,651 patients with COPD and 59,454 matched reference controls.

Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. C Janson, K Lisspers, B Ställberg, G Johansson, and K Larsson reported relationships with various pharmaceutical companies, including Novartis. FS Gutzwiller and K Mezzi are employees of Novartis. L Mindeholm is a consultant to Novartis Institutes for Biomedical Research and holds stocks in Novartis. BK Bjerregaard and L Jorgensen are employees of IQVIA and have received remuneration in relation to statistical analyses.

Citation: Janson C et al. Eur Respir J. 2020 Sep 24. doi: 10.1183/13993003.00515-2020.

Key clinical point: Use of high-dose inhaled corticosteroids (ICS) significantly increased the risk of osteoporosis and fracture in patients with chronic obstructive pulmonary disease (COPD).

Major finding: Patients with COPD using ICS were at an increased risk for any osteoporosis-related event (high dose: risk ratio [RR], 1.52; 95% confidence interval [CI], 1.24-1.82] and low dose: RR, 1.27; 95% CI, 1.13-1.56) compared with those not using ICS.

Study details: The data come from ARCTIC study of 9,651 patients with COPD and 59,454 matched reference controls.

Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. C Janson, K Lisspers, B Ställberg, G Johansson, and K Larsson reported relationships with various pharmaceutical companies, including Novartis. FS Gutzwiller and K Mezzi are employees of Novartis. L Mindeholm is a consultant to Novartis Institutes for Biomedical Research and holds stocks in Novartis. BK Bjerregaard and L Jorgensen are employees of IQVIA and have received remuneration in relation to statistical analyses.

Citation: Janson C et al. Eur Respir J. 2020 Sep 24. doi: 10.1183/13993003.00515-2020.

Key clinical point: Use of high-dose inhaled corticosteroids (ICS) significantly increased the risk of osteoporosis and fracture in patients with chronic obstructive pulmonary disease (COPD).

Major finding: Patients with COPD using ICS were at an increased risk for any osteoporosis-related event (high dose: risk ratio [RR], 1.52; 95% confidence interval [CI], 1.24-1.82] and low dose: RR, 1.27; 95% CI, 1.13-1.56) compared with those not using ICS.

Study details: The data come from ARCTIC study of 9,651 patients with COPD and 59,454 matched reference controls.

Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. C Janson, K Lisspers, B Ställberg, G Johansson, and K Larsson reported relationships with various pharmaceutical companies, including Novartis. FS Gutzwiller and K Mezzi are employees of Novartis. L Mindeholm is a consultant to Novartis Institutes for Biomedical Research and holds stocks in Novartis. BK Bjerregaard and L Jorgensen are employees of IQVIA and have received remuneration in relation to statistical analyses.

Citation: Janson C et al. Eur Respir J. 2020 Sep 24. doi: 10.1183/13993003.00515-2020.

Key clinical point: Minodronate demonstrated better efficacy than alendronate, risedronate, raloxifene, or eldecalcitol in patients with osteoporosis.

Major finding: Compared with other drugs, minodronate significantly decreased N-telopeptide of type I collagen/creatinine (weighted mean difference [WMD], −13.669; 95% confidence interval [CI], −23.108 to −4.229), bone alkaline phosphatase (WMD, −1.26; 95% CI: −2.04 to −0.47), and tartrate-resistant acid phosphatase 5b (WMD, −154.11; 95% CI, −277.85 to −30.37).

Study details: A meta-analysis of 13 randomized controlled trials including 3,740 patients with osteoporosis.

Disclosures: This study received no financial support. The authors declared no conflicts of interest.

Citation: Liu Q et al. 2020 Oct 2. doi: 10.1097/MD.0000000000022542.

Key clinical point: Minodronate demonstrated better efficacy than alendronate, risedronate, raloxifene, or eldecalcitol in patients with osteoporosis.

Major finding: Compared with other drugs, minodronate significantly decreased N-telopeptide of type I collagen/creatinine (weighted mean difference [WMD], −13.669; 95% confidence interval [CI], −23.108 to −4.229), bone alkaline phosphatase (WMD, −1.26; 95% CI: −2.04 to −0.47), and tartrate-resistant acid phosphatase 5b (WMD, −154.11; 95% CI, −277.85 to −30.37).

Study details: A meta-analysis of 13 randomized controlled trials including 3,740 patients with osteoporosis.

Disclosures: This study received no financial support. The authors declared no conflicts of interest.

Citation: Liu Q et al. 2020 Oct 2. doi: 10.1097/MD.0000000000022542.

Key clinical point: Minodronate demonstrated better efficacy than alendronate, risedronate, raloxifene, or eldecalcitol in patients with osteoporosis.

Major finding: Compared with other drugs, minodronate significantly decreased N-telopeptide of type I collagen/creatinine (weighted mean difference [WMD], −13.669; 95% confidence interval [CI], −23.108 to −4.229), bone alkaline phosphatase (WMD, −1.26; 95% CI: −2.04 to −0.47), and tartrate-resistant acid phosphatase 5b (WMD, −154.11; 95% CI, −277.85 to −30.37).

Study details: A meta-analysis of 13 randomized controlled trials including 3,740 patients with osteoporosis.

Disclosures: This study received no financial support. The authors declared no conflicts of interest.

Citation: Liu Q et al. 2020 Oct 2. doi: 10.1097/MD.0000000000022542.

Key clinical point: The risk for moderate coronary artery calcification (CAC) is inversely and independently associated with bone mineral density (BMD) of the lumbar spine in adults with osteoporosis.

Major finding: After adjustments for significant factors of CAC, BMD of the lumbar spine was significantly and inversely associated with moderate CAC in patients with osteoporosis (odds ratio, 0.38; P = .035). However, no association between CAC and BMD was seen in patients with osteopenia.

Study details: The findings are based on a retrospective medical review study of 246 patients (osteoporosis group, n = 52; osteopenia group, n = 194).

Disclosures: The study was funded by Buddhist Tzu Chi Medical Foundation. The authors declared no conflicts of interest.

Citation: Chuang TL et al. Diagnostics (Basel). 2020 Sep 16. doi: 10.3390/diagnostics10090699.

Key clinical point: The risk for moderate coronary artery calcification (CAC) is inversely and independently associated with bone mineral density (BMD) of the lumbar spine in adults with osteoporosis.

Major finding: After adjustments for significant factors of CAC, BMD of the lumbar spine was significantly and inversely associated with moderate CAC in patients with osteoporosis (odds ratio, 0.38; P = .035). However, no association between CAC and BMD was seen in patients with osteopenia.

Study details: The findings are based on a retrospective medical review study of 246 patients (osteoporosis group, n = 52; osteopenia group, n = 194).

Disclosures: The study was funded by Buddhist Tzu Chi Medical Foundation. The authors declared no conflicts of interest.

Citation: Chuang TL et al. Diagnostics (Basel). 2020 Sep 16. doi: 10.3390/diagnostics10090699.

Key clinical point: The risk for moderate coronary artery calcification (CAC) is inversely and independently associated with bone mineral density (BMD) of the lumbar spine in adults with osteoporosis.

Major finding: After adjustments for significant factors of CAC, BMD of the lumbar spine was significantly and inversely associated with moderate CAC in patients with osteoporosis (odds ratio, 0.38; P = .035). However, no association between CAC and BMD was seen in patients with osteopenia.

Study details: The findings are based on a retrospective medical review study of 246 patients (osteoporosis group, n = 52; osteopenia group, n = 194).

Disclosures: The study was funded by Buddhist Tzu Chi Medical Foundation. The authors declared no conflicts of interest.

Citation: Chuang TL et al. Diagnostics (Basel). 2020 Sep 16. doi: 10.3390/diagnostics10090699.

Key clinical point: Metabolic syndrome (MetS) is associated with an increased risk for low bone mineral density (BMD) in women examined by dual-energy X-ray absorptiometry (DXA) for suspected osteoporosis.

Major finding: MetS was associated with an increased risk for low BMD (odds ratio [OR], 1.19; P = .001). Among MetS components, hypertension significantly correlated with an increased risk for low BMD (OR, 1.23; P = .002), whereas high fasting glucose level/diabetes correlated with a reduced occurrence of low BMD (OR, 0.84; P = .003).

Study details: The data come from a cross-sectional study of 13,182 free-living Caucasian women in Italy (mean age, 62.8 years) who underwent diagnostic assessment of BMD by DXA and of all MetS constitutive elements.

Disclosures: This study received no external funding. The authors declared no conflicts of interest.

Citation: Rendina D et al. J Endocrinol Invest. 2020 Sep 22. doi: 10.1007/s40618-020-01428-w.

Key clinical point: Metabolic syndrome (MetS) is associated with an increased risk for low bone mineral density (BMD) in women examined by dual-energy X-ray absorptiometry (DXA) for suspected osteoporosis.

Major finding: MetS was associated with an increased risk for low BMD (odds ratio [OR], 1.19; P = .001). Among MetS components, hypertension significantly correlated with an increased risk for low BMD (OR, 1.23; P = .002), whereas high fasting glucose level/diabetes correlated with a reduced occurrence of low BMD (OR, 0.84; P = .003).

Study details: The data come from a cross-sectional study of 13,182 free-living Caucasian women in Italy (mean age, 62.8 years) who underwent diagnostic assessment of BMD by DXA and of all MetS constitutive elements.

Disclosures: This study received no external funding. The authors declared no conflicts of interest.

Citation: Rendina D et al. J Endocrinol Invest. 2020 Sep 22. doi: 10.1007/s40618-020-01428-w.

Key clinical point: Metabolic syndrome (MetS) is associated with an increased risk for low bone mineral density (BMD) in women examined by dual-energy X-ray absorptiometry (DXA) for suspected osteoporosis.

Major finding: MetS was associated with an increased risk for low BMD (odds ratio [OR], 1.19; P = .001). Among MetS components, hypertension significantly correlated with an increased risk for low BMD (OR, 1.23; P = .002), whereas high fasting glucose level/diabetes correlated with a reduced occurrence of low BMD (OR, 0.84; P = .003).

Study details: The data come from a cross-sectional study of 13,182 free-living Caucasian women in Italy (mean age, 62.8 years) who underwent diagnostic assessment of BMD by DXA and of all MetS constitutive elements.

Disclosures: This study received no external funding. The authors declared no conflicts of interest.

Citation: Rendina D et al. J Endocrinol Invest. 2020 Sep 22. doi: 10.1007/s40618-020-01428-w.

Key clinical point: Higher serum vitamin K1 (phylloquinone) concentration is associated with a reduced risk for fracture in women with postmenopausal osteoporosis (PMO).

Major finding: Serum vitamin K1 was significantly lower in women with prevalent fractures vs. those without (0.53 μg/L vs. 0.65 μg/L; P = .04). Vitamin K1 inversely correlated with fracture risk (adjusted odds ratio per μg/L increase in serum vitamin K1, 0.550; P = .042). Hip geometry and mechanical strength parameters including cross-sectional area, cross-sectional moment of inertia, and section modulus ‘Z’ at the narrow neck of femur were positively associated with vitamin K1.

Study details: The data come from a cross-sectional study of 374 women with PMO (mean age, 68.7 years).

Disclosures: The study was funded, in part, by the Royal Osteoporosis Society, U.K. The authors declared no conflicts of interest.

Citation: Moore AE et al. Bone. 2020 Sep 10. doi: 10.1016/j.bone.2020.115630.

Key clinical point: Higher serum vitamin K1 (phylloquinone) concentration is associated with a reduced risk for fracture in women with postmenopausal osteoporosis (PMO).

Major finding: Serum vitamin K1 was significantly lower in women with prevalent fractures vs. those without (0.53 μg/L vs. 0.65 μg/L; P = .04). Vitamin K1 inversely correlated with fracture risk (adjusted odds ratio per μg/L increase in serum vitamin K1, 0.550; P = .042). Hip geometry and mechanical strength parameters including cross-sectional area, cross-sectional moment of inertia, and section modulus ‘Z’ at the narrow neck of femur were positively associated with vitamin K1.

Study details: The data come from a cross-sectional study of 374 women with PMO (mean age, 68.7 years).

Disclosures: The study was funded, in part, by the Royal Osteoporosis Society, U.K. The authors declared no conflicts of interest.

Citation: Moore AE et al. Bone. 2020 Sep 10. doi: 10.1016/j.bone.2020.115630.

Key clinical point: Higher serum vitamin K1 (phylloquinone) concentration is associated with a reduced risk for fracture in women with postmenopausal osteoporosis (PMO).

Major finding: Serum vitamin K1 was significantly lower in women with prevalent fractures vs. those without (0.53 μg/L vs. 0.65 μg/L; P = .04). Vitamin K1 inversely correlated with fracture risk (adjusted odds ratio per μg/L increase in serum vitamin K1, 0.550; P = .042). Hip geometry and mechanical strength parameters including cross-sectional area, cross-sectional moment of inertia, and section modulus ‘Z’ at the narrow neck of femur were positively associated with vitamin K1.

Study details: The data come from a cross-sectional study of 374 women with PMO (mean age, 68.7 years).

Disclosures: The study was funded, in part, by the Royal Osteoporosis Society, U.K. The authors declared no conflicts of interest.

Citation: Moore AE et al. Bone. 2020 Sep 10. doi: 10.1016/j.bone.2020.115630.

Key clinical point: Patients with osteoporosis with age-related macular degeneration (AMD) are at a significantly higher risk of developing spine and hip fractures.

Major finding: The AMD vs. non-AMD group had a significantly higher risk for spine and hip fractures (hazard ratio [HR], 1.09; P less than .001 and HR, 1.18; P = .001; respectively). The risk for mortality was significantly higher in patients with osteoporosis with older age, male sex, and all types of comorbidities (P less than .05), except for hyperthyroidism (P = .200).

Study details: This Taiwanese nationwide study included 1,206,247 patients with osteoporosis using insurance claims data. After propensity score matching, 13,548 and 54,336 patients were analyzed in the AMD and non-AMD groups, respectively.

Disclosures: The study was supported by Chang Gung Medical Research Foundation. The authors declared no conflicts of interest.

Citation: Sun CC et al. BMJ Open. 2020 Sep 17. doi: 10.1136/bmjopen-2020-037028.

Key clinical point: Patients with osteoporosis with age-related macular degeneration (AMD) are at a significantly higher risk of developing spine and hip fractures.

Major finding: The AMD vs. non-AMD group had a significantly higher risk for spine and hip fractures (hazard ratio [HR], 1.09; P less than .001 and HR, 1.18; P = .001; respectively). The risk for mortality was significantly higher in patients with osteoporosis with older age, male sex, and all types of comorbidities (P less than .05), except for hyperthyroidism (P = .200).

Study details: This Taiwanese nationwide study included 1,206,247 patients with osteoporosis using insurance claims data. After propensity score matching, 13,548 and 54,336 patients were analyzed in the AMD and non-AMD groups, respectively.

Disclosures: The study was supported by Chang Gung Medical Research Foundation. The authors declared no conflicts of interest.

Citation: Sun CC et al. BMJ Open. 2020 Sep 17. doi: 10.1136/bmjopen-2020-037028.

Key clinical point: Patients with osteoporosis with age-related macular degeneration (AMD) are at a significantly higher risk of developing spine and hip fractures.

Major finding: The AMD vs. non-AMD group had a significantly higher risk for spine and hip fractures (hazard ratio [HR], 1.09; P less than .001 and HR, 1.18; P = .001; respectively). The risk for mortality was significantly higher in patients with osteoporosis with older age, male sex, and all types of comorbidities (P less than .05), except for hyperthyroidism (P = .200).

Study details: This Taiwanese nationwide study included 1,206,247 patients with osteoporosis using insurance claims data. After propensity score matching, 13,548 and 54,336 patients were analyzed in the AMD and non-AMD groups, respectively.

Disclosures: The study was supported by Chang Gung Medical Research Foundation. The authors declared no conflicts of interest.

Citation: Sun CC et al. BMJ Open. 2020 Sep 17. doi: 10.1136/bmjopen-2020-037028.