FOR IMMEDIATE RELEASE
Washington, DC, March 25, 2024—The American Society for Bone and Mineral Research (ASBMR) announced today the U.S. Food and Drug Administration (FDA) has communicated to the SABRE (Study to Advance BMD as a Regulatory Endpoint) project team that a ruling on its application to qualify the treatment-related change in bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs would be provided within 10 months.
If BMD is qualified by the FDA as a surrogate endpoint, it will be the first such biomarker accepted by the FDA for a surrogate endpoint under the 21st Century Cures Act and could also pave the way for the qualification of biomarkers in other disease areas. Currently, clinical trials of new anti-osteoporosis drugs must demonstrate a significant reduction in fractures, demanding relatively large and long studies.
“FDA qualification of the change in BMD as a surrogate endpoint for fractures would promote innovation in drug development for osteoporosis by reducing the costs and time to bring new treatments to patients,” said Dennis Black, PhD, Principal Investigator on the SABRE project at the University of California, San Francisco.
According to the Centers for Disease Control and Prevention, more than 53 million people in the United States have or are at a high-risk for osteoporosis, a bone disease that develops when bone mass decreases, leading to an increase in the risk of fractures. Fractures, particularly of the hip, are considered the most serious consequence of osteoporosis, which predominantly affects postmenopausal women and older men. Patients and their families collectively spend an estimated $52 billion annually in healthcare costs for osteoporosis-related bone breaks, an expense that is predicted to double in the next decades due to the increased aging of the US population.
"Preventing and treating osteoporosis-related fractures isn't just about strengthening bones; it's about enhancing quality of life and saving lives,” added ASBMR President Laura Calvi, MD. “Embracing BMD as a surrogate endpoint in clinical trials will revolutionize the journey of novel therapeutic agents to the clinic, reducing both time and costs, and ultimately it will lead to improved treatment options for individuals with osteoporosis.”
Initiated in 2013, the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium Bone Quality Project assembled data from more than 150,000 participants across more than 50 clinical trials of anti-osteoporosis drugs. Analysis of these data by the project team indicated a strong association between the treatment-related increase in bone mineral density, as measured by dual-energy X-ray absorptiometry (DXA), and the observed reduction in fracture risk. These findings provide strong evidence that the change in bone mineral density could be used in future clinical trials to determine the effectiveness of osteoporosis drugs. Through a partnership with ASBMR, the FNIH extended and continues to support the original study, renamed SABRE, to seek FDA approval for the surrogate biomarker.
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About the ASBMR
The American Society for Bone and Mineral Research (ASBMR) is the leading professional, scientific and medical society established to bring together clinical and experimental scientists involved in the study of bone, mineral and musculoskeletal research. ASBMR encourages and promotes the study of this expanding field through annual scientific meetings, two official journals (Journal of Bone and Mineral Research® and JBMR® Plus), the Primer on Metabolic Bone Diseases and Disorders of Mineral Metabolism, advocacy and interaction with government agencies and related societies. To learn more about upcoming meetings and publications, please visit www.asbmr.org.