The U.S. Food and Drug Administration has qualified bone mineral density (BMD) as a surrogate endpoint for bone fractures in osteoporosis clinical trials, a decision that could accelerate drug development for a condition that disproportionately affects women.
The qualification resulted from the SABRE (Study to Advance BMD as a Regulatory Endpoint) Project, a partnership initiated by the FNIH’s Biomarkers Consortium and led by researchers from the University of California San Francisco, Harvard Medical School, and the University of Sheffield. The project collected data from 52 randomized trials including 160,000 patients.
According to the Bone Health & Osteoporosis Foundation, of the estimated 10 million Americans with osteoporosis, about 80% are women. CDC data shows prevalence among women over 50 is 19.6%, compared with 4.4% for men. Approximately one in two women over age 50 will break a bone because of osteoporosis, and a woman’s risk of breaking a hip is equal to her combined risk of breast, uterine, and ovarian cancer.
Estrogen, which protects bones, decreases sharply when women reach menopause, causing bone loss. Globally, osteoporosis is estimated to affect 200 million women.
“The ability to use bone mineral density as a primary endpoint in future clinical trials is going to have a big impact. Trials will be able to be conducted with fewer patients, making them more affordable and perhaps quicker,” said Mary Bouxsein, PhD, one of the project leads.
Previously, osteoporosis drug trials required measuring actual fracture outcomes, which necessitated larger patient populations and longer study durations. BMD testing can now serve as a proxy for fracture risk, potentially reducing the time and cost of bringing new treatments to market.
“This is great news for the new year and for patients, clinicians, and researchers everywhere,” said Emma Duncan, MBBS, FRCP, FRACP, PhD, President of the American Society for Bone and Mineral Research.
Osteoporosis is estimated to affect up to 500 million people worldwide and remains significantly undertreated.
