Osteoporosis Canada is excited to share the US 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.
ASBMR (American Society for Bone and Mineral Research) and the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium, initiated a multi-sector partnership led by ASBMR thought 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. The Study to Advance BMD as a Regulatory Endpoint, which has been called SABRE.
ASBMR provided financial support and institutional backing for the study, with the support of a number of public-private partnerships. It has continued under the leadership of multiple ASBMR Councils and presidents, including most recently Dr. Peter Ebeling, Dr. Mary Bouxsein, Dr. Laura Calvi and Dr. Jennifer Westendorf.
To learn more about this important news you can watch this video and hear from Dr. Black and Dr. Bouxsein about the ambitious effort and the tremendous impact this study will have on future clinical trials which will speed development of new drugs to treat osteoporosis.
This achievement will impact the lives of people affected with osteoporosis worldwide.
Congratulations to all involved!
