Boston-based Beth Israel Deaconess Medical Center played a role in a new FDA decision that allows bone mineral density, measured through noninvasive imaging, to serve as a qualified endpoint in clinical trials for osteoporosis treatments.
Previously, to prove effectiveness, drugmakers had to demonstrate fracture reduction, which required larger trials over longer periods. The new ruling enables smaller, faster studies using bone density increases as a marker of treatment efficacy, according to a Dec. 22 news release.
The change stems from the “Study to Advance BMD as a Regulatory Endpoint” initiative, a decade-long effort led by orthopedic researcher Mary Bouxsein, PhD, of Beth Israel Deaconess, along with researchers from University of California, San Francisco and University of Sheffield in England.
The project analyzed data from 52 trials involving more than 160,000 participants. It was supported by the Foundation for the National Institutes of Health Biomarkers Consortium and the American Society for Bone and Mineral Research.
The decision could accelerate drug development, lower trial costs and attract renewed investment in osteoporosis treatments.
