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What We Don’t Know About Osteoporosis Treatment

A “body of high-quality evidence” has established the general safety and effectiveness of osteoporosis drug therapy (ODT)—yet many people at high risk for fracture are not prescribed, not taking, or not sticking with, the available drugs. Why?


 

A 5-member panel of experts in primary care, geriatrics, and behavioral sciences, among others, convened by the National Institutes of Health (NIH), sought to answer that question. In the Pathways to Prevention (P2P) Workshop: Appropriate Use of Drug Therapies for Osteoporotic Fracture Prevention, the panel discussed the available evidence on long-term drug therapies, in hopes of identifying research gaps and ways to “advance the field.” Then they published a report that summarizes their findings, along with recommendations for “new strengthened research.”

Trials have found 3 to 5 years of ODT is safe and effective, the panel notes, and that some ODTs reduce the incidence of nonvertebral fractures. But those studies have been done mainly in white postmenopausal women. Men, people of other race and ethnicity, residents in facilities, people with advanced and multiple comorbid conditions, and other populations are absent or underrepresented. Thus, estimates on benefits and harms may differ in practice. Moreover, the trial results presented no data on nonfracture patient outcomes or sequelae, such as mobility, hospitalizations, and nursing home placement. The studies also offered limited or no evidence on whether patient characteristics would result in different fracture outcomes.

The panel also noted that few trials extended beyond 5 years, although some observational studies provided “limited evidence” on potential benefits and harms from longer term use. Gaps exist in how to use information on bone biomarkers and other patient characteristics, such as concurrent medication use, that might modify the effects of ODT, the panel concluded.

One of the main issues the panel investigated was how to make sure that the people at highest risk of fracture get the medicine they need. Only about one-third of women at high risk have reported treatment with osteoporosis medication. And among older adults with a hip fracture, only 11% to 13% filled any prescription for osteoporosis medication within 3 months of the fracture.

Information about ODT use and adherence was not included in the systematic evidence review, so the report relies on material provided by the workshop speakers, who say low rates of diagnosis and treatment probably stem from multiple clinician and patient factors. For instance, they said, with regard to clinicians, the problems may be lack of time, knowledge gaps, and lack of appropriate systems in primary care.

The panelists also cited another gap: in communication between clinicians about treatment as patients transition from one setting to another. One solution could be a hospital-based fracture liaison service to coordinate care, they suggest.

Patient factors include perceptions that osteoporosis is a normal part of aging, or that drugs do not work or that they are harmful and risky. Studies about decision making have found that people often overestimate their risk for rare adverse effects (AEs) and underestimate the likelihood of having a fracture.

In their assessment of studies, the workshop panelists found education-based interventions sometimes increase rates of filled prescriptions but not adherence 6 or 10 months down the road. They also found coaching and counseling have been “largely ineffective.”

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