FOR IMMEDIATE RELEASE
Contact: Erin Espy +1 (312) 673-4945
Washington, D.C. — December 19, 2025 — The American Society for Bone and Mineral Research (ASBMR) announced today that the Food and Drug Administration (FDA) has qualified image-based biomarkers of bone mineral density (BMD) as a surrogate endpoint for bone fractures in clinical trials for osteoporosis drug candidates.
This determination is a result of the Study to Advance BMD as a Regulatory Endpoint (SABRE) Project, a multi-sector partnership initiated by the FNIH’s Biomarkers Consortium and led by ASBMR leaders Dennis Black, PhD, from the University of California, San Francisco, Mary Bouxsein, PhD, from Harvard Medical School, and Richard Eastell, MD from the University of Sheffield School of Medicine and Population Health.
“To me, this news represents the synergy of what we can accomplish together through cooperation, said Emma Duncan, MBBS, FRCP, FRACP, PhD, ASBMR’s President. “This is great news for the new year and for patients, clinicians, and researchers everywhere.”
Data for the SABRE Project was collected and shared through private-public partnerships with the FNIH. “We had this very ambitious effort to collect data from about 15 different companies who had conducted major trials of osteoporosis medications,” said Dennis Black, PhD. “In the end, we collected data from 52 randomized trials including 160,000 randomized patients.” Statistical analysis guidance was provided by the FDA’s 21st Century Cures Act.
“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. This will speed development of new drugs to treat osteoporosis, a chronic bone condition estimated to affect up to 500 million people worldwide. New drug development will lead to more patient choices, supporting FNIH, FDA, and ASBMR’s joint mission to alleviate the vast undertreatment of osteoporosis.
About ASBMR
The American Society for Bone and Mineral Research is the leading scientific society for clinical and experimental scientists involved in the study of bone, mineral, and musculoskeletal biology. ASBMR promotes excellence in bone and mineral research, fosters integration of clinical and basic science, and facilitates the translation of science to health care and clinical practice.
For media inquiries, please contact:
Erin Espy
Senior Manager, Marketing & Communications
eespy@asbmr.org
+1 (312) 673-4945