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Strengthening research on fracture prevention drugs

Dr. Lyndon Joseph
Lyndon JOSEPH,
Health Scientist Administrator,
Division of Geriatrics and Clinical Gerontology (DGCG)
.

Falls and fractures are among the biggest health concerns for many older adults, with more than a third of adults over age 65 falling each year. Conditions like osteoporosis can worsen the risk of fractures, and fall-related injuries are often the start of snowballing health problems. Falls are also expensive, with osteoporosis fractures costing the American public an estimated $57 billion per year in 2018, an amount expected to grow to more than $95 billion by 2040.

NIA has funded significant, large longitudinal studies on musculoskeletal health, function, and outcomes like the Study of Muscle, Mobility and Aging, the Osteoporotic Fractures in Men Study, and the Multicenter Osteoarthritis Study. We continue to explore ways to improve musculoskeletal health and prevent falls and fractures in older adults via a diverse research portfolio.

Addressing research gaps on prescriptions

Bisphosphonates are a class of drugs shown to be effective at reducing the incidence of hip and other types of fractures. But it is unclear how best to use these drugs in long-term settings. In addition, there are growing concerns about very rare side effects of long-term bisphosphonate regimens, such as atypical femur fracture and osteonecrosis of the jaw.

As a result, many patients, even those who unequivocally need treatment, are either not being prescribed osteoporosis medications at all, or are reluctant to take medications that have been prescribed for fear of experiencing an adverse event. Scientists and clinicians are concerned that these trends, which contributed to a more than 50% drop in bisphosphonate use between 2008 and 2012, may cause a corresponding spike in preventable fractures.

In response, NIA and the broader NIH community are building on their leadership roles in the interdisciplinary science of physical activity, physical function, musculoskeletal health, and falls prevention. The goal is to drill down into the scientific evidence on appropriate long-term use of bisphosphonates, including how to mitigate side effects, so that older adults and their caregivers, along with their doctors, can make informed decisions.

NIH collaboration is on the case

I’ve been fortunate recently to help lead the NIH Pathways to Prevention effort designed to analyze the risks and benefits of long-term use of fracture prevention drugs and to determine if taking occasional doctor-approved breaks from using an osteoporosis drug can help reduce the risk of rare side effects. We’re excited that this collaborative initiative and related funding opportunities are evolving fast!

Teaming up with colleagues at NIH’s National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and the Office of Disease Prevention, we have already made good progress by co-hosting a 2018 workshop to review the available scientific evidence; assembling an independent expert panel to look at these data and make specific research recommendations; and working with NIH and other federal agency partners to prioritize the research recommendations into short- and long-term goals.

Funding to help fight fractures

In partnership with NIAMS, we are pleased to announce a request for applications to support more intensive and precise data analyses to identify risks and benefits of long-term osteoporosis treatment. Many previous fracture prevention clinical trials were short-term and primarily focused on outcomes needed for regulatory consideration of new drugs. We need more research on how best to use the osteoporosis medications in long-term settings, including optimal treatment duration.

This includes an assessment of the use of temporary medication breaks on the risk of these rare but serious side effects, and, if so, how to manage these drug holiday intervals. Along the way, we hope to learn more about how to tailor treatment plans based on patients’ other health conditions, their medications, and their demographics or social factors, all of which may affect fall and fracture risk.

If you’re interested in the science of safely staying strong and mobile as we age, and in getting involved in this important field, apply for funding! Please contact me if I can answer any questions.

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