Osteoporosis treatment equally lowers hip fracture risk for both men and women
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Key takeaways:
- Older men have a similar reduction in hip fracture risk with osteoporosis treatment as women.
- Researchers said the study provides strong evidence supporting the use of osteoporosis drugs for men.
Osteoporosis treatment reduces the risk for hip fractures for older men just as well as it does for older women, according to a study published in Journal of Bone and Mineral Research.
“There is abundant evidence that men are not adequately screened for osteoporosis, and those with osteoporosis are frequently untreated,” Eric Orwoll, MD, professor of medicine at Oregon Health & Science University, told Healio. “A major reason for this is the perception that the effectiveness of treatments is not sufficiently documented in men. Some official guidelines do not recommend screening and treatment for osteoporosis in men because of this perception. The results of our study provide strong evidence that treatment is indeed effective to reduce fracture risk in men. We hope that this will change current practice approaches to improve the prevention of osteoporotic fractures in men.”
Assessing hip fracture risk
Orwoll and colleagues conducted a case-control observational study assessing electronic health data from Kaiser Permanente Southern California health care system. Adults aged 65 years or older who had an abdominal or pelvic CT scan performed from Jan. 1, 2005, to July 1, 2018, and did not have a hip fracture prior to their CT scan were eligible for inclusion in the study. Researchers identified 2,413 women and 792 men at high risk for a hip fracture, which was defined as a femoral neck or total hip bone mineral density T-score of –2.5 or lower. Tony M. Keaveny, PhD, distinguished professor in the departments of mechanical engineering and bioengineering at University of California, Berkeley, discussed how fracture risk was assessed in the study.
“The key innovations were mining extensive medical record data from the Kaiser Permanente Southern California health care system and utilizing biomechanical computed tomography technology to re-purpose CT scans taken for past clinical care, to perform an accurate assessment of osteoporosis and fracture risk for each patient,” Keaveny told Healio.
Adults who had at least 180 days of osteoporosis medication prescription fills in the year following their CT scan were defined as receiving treatment, those who had prescription fills for 1 to 179 days received partial treatment and adults with no prescription fills were considered to have not received osteoporosis treatment.
Osteoporosis therapy benefits men
At 2 years, hip fractures occurred in 29.9% of women and 34% of men. Of adults who remained in the study for 2 years of follow-up, 33.9% of women and 24% of men were treated for osteoporosis, and 51.5% of women and 66.3% of men received no treatment. Alendronate prescriptions were filled by 80.4% of women and 89.7% of men, the researchers reported.
In adjusted logistic regression analyses, both women (adjusted OR = 0.26; 95% CI, 0.21-0.33) and men (aOR = 0.21; 95% CI, 0.13-0.34) receiving osteoporosis treatment were less likely to sustain a hip fracture than those receiving no treatment. There was no significant difference in the ORs for hip fractures between men and women, according to the study. There were also no differences for hip fractures odds between men and women in secondary analyses restricted to adults using alendronate, those aged 70 years and older, when the follow-up period was extended to 5 years and when adults who were lost to follow-up were added as no fracture controls.
Keaveny said he hopes that the findings will lead to changes in coverage of osteoporosis treatment for older men.
“Because of the lack of supporting clinical data, Medicare and private insurers do not typically cover osteoporosis testing for older men unless there are very specific risk factors, which most men don’t have,” Keaveny said. “As a result, although one in about every three hip fractures occurs in men, very few older men get tested for osteoporosis and fracture prevention for men is suboptimal. Our results will hopefully enable the relevant stakeholders to adjust guidelines and recommendations for how osteoporosis will be managed in men.”
For more information:
Tony M. Keaveny, PhD, can be reached at tonykeaveny@berkeley.edu.
Eric Orwoll, MD, can be reached at orwoll@ohsu.edu.
Perspective
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E. Michael Lewiecki, MD, FACE, FACP
Osteoporosis is an underrecognized and undertreated disease, with most patients who could benefit from interventions to reduce fracture risk not receiving it or not taking medications long enough to benefit. This large osteoporosis treatment gap, which is a major concern with women, is even worse for men. Factors contributing to poor treatment rates in men include the perception of health care providers and patients that osteoporosis is a woman’s disease and inconsistent recommendations for screening and treating men. As examples, the U.S. Bone Health & Osteoporosis Foundation recommends bone density testing for all men aged 70 years and older, and for men aged 50 years and older with an adult fracture, with treatment according to FDA-approved pharmacological agents, of which there are many that have been tested and approved for use in men. On the other hand, the U.S. Preventive Services Task Force has stated that there is insufficient evidence to recommend screening men for osteoporosis and lack of evidence for effectiveness of medications for the treatment of osteoporosis in men.
What is the evidence? Three bisphosphonates, two osteoanabolic agents, and denosumab (Prolia, Amgen) are FDA-approved for the treatment of osteoporosis in men. Approval was based on “bridging studies” operating on the reasonable assumption that once a medication is proven to reduce fracture risk in women, men who have a similar increase in bone density are likely to have a similar reduction in fracture risk. A randomized placebo-controlled trial has shown that zoledronic acid reduces vertebral fracture risk in men. The FOCUS observational study has now demonstrated that standard-of-care osteoporosis treatment reduces hip fracture risk in men as it does in women.
Considering the accumulated medical evidence showing that outcomes of osteoporotic fractures are worse in men than women, the availability of a broad range of medications that are FDA-approved for the treatment of osteoporosis in men, and studies showing reduction of vertebral fractures and hip fractures in men treated with approved medications, it is time to consistently incorporate this information into clinical practice guidelines and close the osteoporosis treatment gap in men.
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