We are proud to spotlight a groundbreaking advance in osteoporosis research that has meaningful implications for patients and clinical science alike. The Study to Advance BMD as a Regulatory Endpoint (SABRE) Project recently achieved a major regulatory milestone: the U.S. Food and Drug Administration (FDA) has qualified the use of bone mineral density (BMD) as the first surrogate endpoint for osteoporosis clinical trials, a designation that will help speed development of new therapies to prevent fractures.
A cornerstone of this achievement is the leadership and contribution of Dennis M. Black, PhD, primary faculty in the UCSF Department of Epidemiology and Biostatistics (DEB). Dr. Black co-led the SABRE Project, an extensive international collaboration that pooled data from 52 randomized clinical trials comprising more than 160,000 participants, to demonstrate that treatment-related changes in BMD reliably predict fracture risk reduction.
Reflecting on the effort, Dr. Black noted the scale and significance of the work:
“We had this very ambitious effort to collect data from about 15 different companies who had conducted major trials of osteoporosis medications. In the end, we collected data from 52 randomized trials including 160,000 randomized patients.”
This qualification by the FDA represents a major shift in how osteoporosis clinical trials can be conducted — allowing future studies to be more efficient, less costly, and faster, ultimately bringing new treatment options to people at risk of debilitating fractures.
The SABRE Project exemplifies UCSF DEB’s commitment to rigorous methodological innovation and collaborative science with real-world impact. We congratulate Dr. Black and the SABRE team on this milestone achievement and the promise it holds for advancing osteoporosis treatment.
FDA Qualifies First Surrogate Endpoint for Use in Osteoporosis Clinical Trials
FNIH Announces FDA Qualification of First Surrogate Endpoint for Use in Osteoporosis Clinical Trials