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Efforts to identify older men at risk for osteoporosis and treat those who are eligible received a boost from results reported from a Veterans Affairs (VA) study that showed a significant increase in screening, treatment, and medication adherence.
The cluster randomized trial used a centralized nurse-led intervention to assess men for traditional osteoporosis risk factors, offer bone density testing, and recommend treatment for eligible men. Over 2 years, the intervention group had a higher average femoral neck bone density than patients who underwent usual care.
“We designed this study to see if a risk factor-based approach, which is what most of the guidelines use, made sense and was feasible — that men would be accepting of screening and [the approach] would yield a similar proportion of people who need osteoporosis treatment as screening in women, which is widely recommended and implemented. And sure enough, we found that about 85% of the men in the VA primary care practices in our target age range of between 65 and 85 actually met criteria for screening, and over half of them had low bone mass. They were very accepting of screening, very accepting of treatment, and had excellent compliance rates. So, our study, we believe, supports the idea of identifying men with at least one risk factor for fracture and offering them osteoporosis screening starting at age 65, similar to what we do for women,” Cathleen S. Colón-Emeric, MD, MHS, said in an interview. She is the lead author of the study, a physician in the Durham VA Health Care System, and professor of medicine at Duke University School of Medicine, Durham, North Carolina.
“We were able to see a positive effect on bone density in the bone health group, compared with the usual care group, which suggests that if we followed these folks longer and had enough of them, we would be able to show a fracture reduction benefit,” Colón-Emeric said.
There have been few randomized trials of screening interventions in men, leading to inconsistencies in guidelines, according to the authors of the new study, published online in JAMA Internal Medicine . Both the US Preventive Services Task Force and the Veterans Health Administration National Center for Health Promotion and Disease Prevention consider there to be insufficient evidence to recommend for or against screening in men who have not experienced a fracture. Some professional societies recommend such screening, but there are inconsistencies in the recommended criteria, such as age range or risk factors.
Beyond the age of 50 years, one in five men will experience an osteoporosis-related fracture at some point in their life, according to a 2009 study. Treatment is inexpensive and effective in both men and women, and economic models suggest that screening using dual-energy x-ray absorptiometry (DXA) would be cost-effective. Still, screening is rare among men, with fewer than 10% of men getting screened before having an osteoporosis-related fracture.
“It’s important to screen men at risk for osteoporosis due to the dramatically increased mortality men suffer after a fragility fracture compared with women. Within 1 year of a hip fracture, mortality is as high as 36%. Studies have also shown that osteoporosis in men is undertreated, with only 10%-50% being prescribed antifracture treatment within 1 year of a hip fracture. Most individuals do not regain their prior level of function after a hip fracture,” said Joe C. Huang, MD, who was asked for comment. He is a clinical assistant professor of gerontology and geriatric medicine at Harborview Medical Center Senior Care Clinic and Healthy Bones Clinic in Seattle.
Details of the Intervention
The bone health service (BHS) intervention employed an electronic health record case-finding tool and a nurse care manager who undertook screening and treatment monitoring. They identified potential risk factors that included hyperthyroidism, hyperparathyroidism, rheumatoid arthritis, alcohol dependence, chronic lung disease, chronic liver disease, stroke, parkinsonism, prostate cancer, smoking, diabetes, pernicious anemia, gastrectomy, or high-risk medication use in at least 3 months of the prior 2 years. These medications included traditional antiepileptics, glucocorticoids, and androgen deprivation therapy.
The BHS nurse invited eligible men to be screened using an initial letter, followed by up to three phone calls. After DXA screening, the nurse scheduled an electronic consult with an osteoporosis expert, and patients with a T-score between -1 and -2.4 and an elevated 10-year fracture risk as measured by the Fracture Risk Assessment Tool were recommended for osteoporosis medication, vitamin D, and dietary or supplemental calcium. Following the prescription, the nurse provided patient education over the phone and mailed out written instructions. The nurse also made phone calls at 1 month, 6 months, and 12 months to encourage adherence and address common treatment barriers such as forgetting to take medication or dealing with gastrointestinal effects. The researchers recruited 38 primary care physicians from two VA health systems. The study included 3112 male veterans between the ages of 65 and 85 years (40.4% Black and 56% White). Nearly all participants (85.5%) had at least one indication for screening according to VA undersecretary guidelines, and almost a third (32.1%) had been prescribed androgen deprivation therapy, traditional antiepileptic drugs, or glucocorticoids.
Over a mean follow-up of 1.5 years, there was a much higher screening rate in the BHS group (49.2% vs 2.3%; P < .001), with a similar overall yield of DXA results recommending osteoporosis treatment (22.4% vs 27.2%). In the BHS group, 84.4% of patients who had treatment recommended followed through with treatment initiation. The mean persistence over follow-up was 657 days (SD, 366 days), and adherence was high with a mean proportion of days covered of 91.7%.
It was not possible to statistically compare adherence with the usual-care group because there were too few screened patients found to be eligible for treatment in that group, but the historic mean proportion of days covered at the two participating facilities was 52%.
After 2 years, the mean femoral neck T-score tested randomly in a subset of patients was better in the BHS arm, although it did not meet statistical significance according to the Bonferroni corrected criterion of P < .025 (-0.55 vs -0.70; P = .04). Fracture rates were similar between the two groups (1.8% vs 2.0%; P = .69).
Can the Findings Be Translated Across Clinics?
It remains to be seen how well the model could translate to other healthcare settings, according to Kenny Lin, MD, MPH, who was asked for comment on the study. “Outside of the VA health system and perhaps integrated HMOs [health maintenance organizations] such as Kaiser, Geisinger, etc., it seems unlikely that most primary care docs will have access to a centralized bone health service. Who’s going to pay for it? It leaves unanswered the question of whether it’s more efficient to address [osteoporosis] screening on a practice or population level. I suspect the latter is probably superior, but this study doesn’t provide any empiric evidence that this is so,” said Lin, associate director of the Penn Medicine Lancaster General Hospital’s Family Medicine Residency Program, Lancaster, Pennsylvania. The findings could help sway recommendations to screen men for osteoporosis, according to Susan Ott, MD, who was also asked for comment. Guideline committees “have been trying to be very scientific [about it]. I think they overdo it because they only look at one or two kinds of studies, and there are more kinds of science than just a randomized clinical trial. But they’re kind of stuck on that. The fact that this study was a randomized trial maybe they will finally change their recommendation, because there really shouldn’t be any difference in screening for men and for women. The men are actually discriminated against,” said Ott, emeritus professor of medicine at the University of Washington, Seattle.
In fact, she noted that the risks for men are similar to those for women, except that men tend to develop issues 5-10 years later in life. To screen and treat men, healthcare systems can “do the same thing they do with women. Just change the age range,” Ott said.
Lin sounded a different note, suggesting that the focus should remain on improvement of screening and treatment adherence in women. “We know that up to two thirds of women discontinue osteoporosis drugs within a year, and if we can’t figure out how to improve abysmal adherence in women, it’s unlikely we will persuade enough men to take these drugs to make a difference,” he said.
The study was funded by a grant from the VA Health Systems Research. Colón-Emeric, Lin, Ott, and Huang reported having no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
Efforts to identify older men at risk for osteoporosis and treat those who are eligible received a boost from results reported from a Veterans Affairs (VA) study that showed a significant increase in screening, treatment, and medication adherence.
The cluster randomized trial used a centralized nurse-led intervention to assess men for traditional osteoporosis risk factors, offer bone density testing, and recommend treatment for eligible men. Over 2 years, the intervention group had a higher average femoral neck bone density than patients who underwent usual care.
“We designed this study to see if a risk factor-based approach, which is what most of the guidelines use, made sense and was feasible — that men would be accepting of screening and [the approach] would yield a similar proportion of people who need osteoporosis treatment as screening in women, which is widely recommended and implemented. And sure enough, we found that about 85% of the men in the VA primary care practices in our target age range of between 65 and 85 actually met criteria for screening, and over half of them had low bone mass. They were very accepting of screening, very accepting of treatment, and had excellent compliance rates. So, our study, we believe, supports the idea of identifying men with at least one risk factor for fracture and offering them osteoporosis screening starting at age 65, similar to what we do for women,” Cathleen S. Colón-Emeric, MD, MHS, said in an interview. She is the lead author of the study, a physician in the Durham VA Health Care System, and professor of medicine at Duke University School of Medicine, Durham, North Carolina.
“We were able to see a positive effect on bone density in the bone health group, compared with the usual care group, which suggests that if we followed these folks longer and had enough of them, we would be able to show a fracture reduction benefit,” Colón-Emeric said.
There have been few randomized trials of screening interventions in men, leading to inconsistencies in guidelines, according to the authors of the new study, published online in JAMA Internal Medicine . Both the US Preventive Services Task Force and the Veterans Health Administration National Center for Health Promotion and Disease Prevention consider there to be insufficient evidence to recommend for or against screening in men who have not experienced a fracture. Some professional societies recommend such screening, but there are inconsistencies in the recommended criteria, such as age range or risk factors.
Beyond the age of 50 years, one in five men will experience an osteoporosis-related fracture at some point in their life, according to a 2009 study. Treatment is inexpensive and effective in both men and women, and economic models suggest that screening using dual-energy x-ray absorptiometry (DXA) would be cost-effective. Still, screening is rare among men, with fewer than 10% of men getting screened before having an osteoporosis-related fracture.
“It’s important to screen men at risk for osteoporosis due to the dramatically increased mortality men suffer after a fragility fracture compared with women. Within 1 year of a hip fracture, mortality is as high as 36%. Studies have also shown that osteoporosis in men is undertreated, with only 10%-50% being prescribed antifracture treatment within 1 year of a hip fracture. Most individuals do not regain their prior level of function after a hip fracture,” said Joe C. Huang, MD, who was asked for comment. He is a clinical assistant professor of gerontology and geriatric medicine at Harborview Medical Center Senior Care Clinic and Healthy Bones Clinic in Seattle.
Details of the Intervention
The bone health service (BHS) intervention employed an electronic health record case-finding tool and a nurse care manager who undertook screening and treatment monitoring. They identified potential risk factors that included hyperthyroidism, hyperparathyroidism, rheumatoid arthritis, alcohol dependence, chronic lung disease, chronic liver disease, stroke, parkinsonism, prostate cancer, smoking, diabetes, pernicious anemia, gastrectomy, or high-risk medication use in at least 3 months of the prior 2 years. These medications included traditional antiepileptics, glucocorticoids, and androgen deprivation therapy.
The BHS nurse invited eligible men to be screened using an initial letter, followed by up to three phone calls. After DXA screening, the nurse scheduled an electronic consult with an osteoporosis expert, and patients with a T-score between -1 and -2.4 and an elevated 10-year fracture risk as measured by the Fracture Risk Assessment Tool were recommended for osteoporosis medication, vitamin D, and dietary or supplemental calcium. Following the prescription, the nurse provided patient education over the phone and mailed out written instructions. The nurse also made phone calls at 1 month, 6 months, and 12 months to encourage adherence and address common treatment barriers such as forgetting to take medication or dealing with gastrointestinal effects. The researchers recruited 38 primary care physicians from two VA health systems. The study included 3112 male veterans between the ages of 65 and 85 years (40.4% Black and 56% White). Nearly all participants (85.5%) had at least one indication for screening according to VA undersecretary guidelines, and almost a third (32.1%) had been prescribed androgen deprivation therapy, traditional antiepileptic drugs, or glucocorticoids.
Over a mean follow-up of 1.5 years, there was a much higher screening rate in the BHS group (49.2% vs 2.3%; P < .001), with a similar overall yield of DXA results recommending osteoporosis treatment (22.4% vs 27.2%). In the BHS group, 84.4% of patients who had treatment recommended followed through with treatment initiation. The mean persistence over follow-up was 657 days (SD, 366 days), and adherence was high with a mean proportion of days covered of 91.7%.
It was not possible to statistically compare adherence with the usual-care group because there were too few screened patients found to be eligible for treatment in that group, but the historic mean proportion of days covered at the two participating facilities was 52%.
After 2 years, the mean femoral neck T-score tested randomly in a subset of patients was better in the BHS arm, although it did not meet statistical significance according to the Bonferroni corrected criterion of P < .025 (-0.55 vs -0.70; P = .04). Fracture rates were similar between the two groups (1.8% vs 2.0%; P = .69).
Can the Findings Be Translated Across Clinics?
It remains to be seen how well the model could translate to other healthcare settings, according to Kenny Lin, MD, MPH, who was asked for comment on the study. “Outside of the VA health system and perhaps integrated HMOs [health maintenance organizations] such as Kaiser, Geisinger, etc., it seems unlikely that most primary care docs will have access to a centralized bone health service. Who’s going to pay for it? It leaves unanswered the question of whether it’s more efficient to address [osteoporosis] screening on a practice or population level. I suspect the latter is probably superior, but this study doesn’t provide any empiric evidence that this is so,” said Lin, associate director of the Penn Medicine Lancaster General Hospital’s Family Medicine Residency Program, Lancaster, Pennsylvania. The findings could help sway recommendations to screen men for osteoporosis, according to Susan Ott, MD, who was also asked for comment. Guideline committees “have been trying to be very scientific [about it]. I think they overdo it because they only look at one or two kinds of studies, and there are more kinds of science than just a randomized clinical trial. But they’re kind of stuck on that. The fact that this study was a randomized trial maybe they will finally change their recommendation, because there really shouldn’t be any difference in screening for men and for women. The men are actually discriminated against,” said Ott, emeritus professor of medicine at the University of Washington, Seattle.
In fact, she noted that the risks for men are similar to those for women, except that men tend to develop issues 5-10 years later in life. To screen and treat men, healthcare systems can “do the same thing they do with women. Just change the age range,” Ott said.
Lin sounded a different note, suggesting that the focus should remain on improvement of screening and treatment adherence in women. “We know that up to two thirds of women discontinue osteoporosis drugs within a year, and if we can’t figure out how to improve abysmal adherence in women, it’s unlikely we will persuade enough men to take these drugs to make a difference,” he said.
The study was funded by a grant from the VA Health Systems Research. Colón-Emeric, Lin, Ott, and Huang reported having no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
Efforts to identify older men at risk for osteoporosis and treat those who are eligible received a boost from results reported from a Veterans Affairs (VA) study that showed a significant increase in screening, treatment, and medication adherence.
The cluster randomized trial used a centralized nurse-led intervention to assess men for traditional osteoporosis risk factors, offer bone density testing, and recommend treatment for eligible men. Over 2 years, the intervention group had a higher average femoral neck bone density than patients who underwent usual care.
“We designed this study to see if a risk factor-based approach, which is what most of the guidelines use, made sense and was feasible — that men would be accepting of screening and [the approach] would yield a similar proportion of people who need osteoporosis treatment as screening in women, which is widely recommended and implemented. And sure enough, we found that about 85% of the men in the VA primary care practices in our target age range of between 65 and 85 actually met criteria for screening, and over half of them had low bone mass. They were very accepting of screening, very accepting of treatment, and had excellent compliance rates. So, our study, we believe, supports the idea of identifying men with at least one risk factor for fracture and offering them osteoporosis screening starting at age 65, similar to what we do for women,” Cathleen S. Colón-Emeric, MD, MHS, said in an interview. She is the lead author of the study, a physician in the Durham VA Health Care System, and professor of medicine at Duke University School of Medicine, Durham, North Carolina.
“We were able to see a positive effect on bone density in the bone health group, compared with the usual care group, which suggests that if we followed these folks longer and had enough of them, we would be able to show a fracture reduction benefit,” Colón-Emeric said.
There have been few randomized trials of screening interventions in men, leading to inconsistencies in guidelines, according to the authors of the new study, published online in JAMA Internal Medicine . Both the US Preventive Services Task Force and the Veterans Health Administration National Center for Health Promotion and Disease Prevention consider there to be insufficient evidence to recommend for or against screening in men who have not experienced a fracture. Some professional societies recommend such screening, but there are inconsistencies in the recommended criteria, such as age range or risk factors.
Beyond the age of 50 years, one in five men will experience an osteoporosis-related fracture at some point in their life, according to a 2009 study. Treatment is inexpensive and effective in both men and women, and economic models suggest that screening using dual-energy x-ray absorptiometry (DXA) would be cost-effective. Still, screening is rare among men, with fewer than 10% of men getting screened before having an osteoporosis-related fracture.
“It’s important to screen men at risk for osteoporosis due to the dramatically increased mortality men suffer after a fragility fracture compared with women. Within 1 year of a hip fracture, mortality is as high as 36%. Studies have also shown that osteoporosis in men is undertreated, with only 10%-50% being prescribed antifracture treatment within 1 year of a hip fracture. Most individuals do not regain their prior level of function after a hip fracture,” said Joe C. Huang, MD, who was asked for comment. He is a clinical assistant professor of gerontology and geriatric medicine at Harborview Medical Center Senior Care Clinic and Healthy Bones Clinic in Seattle.
Details of the Intervention
The bone health service (BHS) intervention employed an electronic health record case-finding tool and a nurse care manager who undertook screening and treatment monitoring. They identified potential risk factors that included hyperthyroidism, hyperparathyroidism, rheumatoid arthritis, alcohol dependence, chronic lung disease, chronic liver disease, stroke, parkinsonism, prostate cancer, smoking, diabetes, pernicious anemia, gastrectomy, or high-risk medication use in at least 3 months of the prior 2 years. These medications included traditional antiepileptics, glucocorticoids, and androgen deprivation therapy.
The BHS nurse invited eligible men to be screened using an initial letter, followed by up to three phone calls. After DXA screening, the nurse scheduled an electronic consult with an osteoporosis expert, and patients with a T-score between -1 and -2.4 and an elevated 10-year fracture risk as measured by the Fracture Risk Assessment Tool were recommended for osteoporosis medication, vitamin D, and dietary or supplemental calcium. Following the prescription, the nurse provided patient education over the phone and mailed out written instructions. The nurse also made phone calls at 1 month, 6 months, and 12 months to encourage adherence and address common treatment barriers such as forgetting to take medication or dealing with gastrointestinal effects. The researchers recruited 38 primary care physicians from two VA health systems. The study included 3112 male veterans between the ages of 65 and 85 years (40.4% Black and 56% White). Nearly all participants (85.5%) had at least one indication for screening according to VA undersecretary guidelines, and almost a third (32.1%) had been prescribed androgen deprivation therapy, traditional antiepileptic drugs, or glucocorticoids.
Over a mean follow-up of 1.5 years, there was a much higher screening rate in the BHS group (49.2% vs 2.3%; P < .001), with a similar overall yield of DXA results recommending osteoporosis treatment (22.4% vs 27.2%). In the BHS group, 84.4% of patients who had treatment recommended followed through with treatment initiation. The mean persistence over follow-up was 657 days (SD, 366 days), and adherence was high with a mean proportion of days covered of 91.7%.
It was not possible to statistically compare adherence with the usual-care group because there were too few screened patients found to be eligible for treatment in that group, but the historic mean proportion of days covered at the two participating facilities was 52%.
After 2 years, the mean femoral neck T-score tested randomly in a subset of patients was better in the BHS arm, although it did not meet statistical significance according to the Bonferroni corrected criterion of P < .025 (-0.55 vs -0.70; P = .04). Fracture rates were similar between the two groups (1.8% vs 2.0%; P = .69).
Can the Findings Be Translated Across Clinics?
It remains to be seen how well the model could translate to other healthcare settings, according to Kenny Lin, MD, MPH, who was asked for comment on the study. “Outside of the VA health system and perhaps integrated HMOs [health maintenance organizations] such as Kaiser, Geisinger, etc., it seems unlikely that most primary care docs will have access to a centralized bone health service. Who’s going to pay for it? It leaves unanswered the question of whether it’s more efficient to address [osteoporosis] screening on a practice or population level. I suspect the latter is probably superior, but this study doesn’t provide any empiric evidence that this is so,” said Lin, associate director of the Penn Medicine Lancaster General Hospital’s Family Medicine Residency Program, Lancaster, Pennsylvania. The findings could help sway recommendations to screen men for osteoporosis, according to Susan Ott, MD, who was also asked for comment. Guideline committees “have been trying to be very scientific [about it]. I think they overdo it because they only look at one or two kinds of studies, and there are more kinds of science than just a randomized clinical trial. But they’re kind of stuck on that. The fact that this study was a randomized trial maybe they will finally change their recommendation, because there really shouldn’t be any difference in screening for men and for women. The men are actually discriminated against,” said Ott, emeritus professor of medicine at the University of Washington, Seattle.
In fact, she noted that the risks for men are similar to those for women, except that men tend to develop issues 5-10 years later in life. To screen and treat men, healthcare systems can “do the same thing they do with women. Just change the age range,” Ott said.
Lin sounded a different note, suggesting that the focus should remain on improvement of screening and treatment adherence in women. “We know that up to two thirds of women discontinue osteoporosis drugs within a year, and if we can’t figure out how to improve abysmal adherence in women, it’s unlikely we will persuade enough men to take these drugs to make a difference,” he said.
The study was funded by a grant from the VA Health Systems Research. Colón-Emeric, Lin, Ott, and Huang reported having no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
