FOR IMMEDIATE RELEASE
Washington, DC, November 9, 2023—The American Society for Bone and Mineral Research (ASBMR) announces that the SABRE (Strategy to Advance BMD as a Regulatory Endpoint) project team has submitted to the U.S. Food and Drug Administration (FDA) its full qualification plan to use the treatment-related change in bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs.
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.
“Fractures are currently the main outcome in clinical trials of new drugs for osteoporosis. If we could instead utilize a reliable and non-invasive measurement to replace fractures as a trial endpoint, we could significantly reduce the length and cost of new clinical trials,” 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.
“Development and use of a surrogate endpoint for fractures in new clinical trials will reduce a key barrier for new drug development and promote innovation, ultimately reducing the pain and suffering caused by fragility fractures in older adults,” said Mary L. Bouxsein, PhD, Director of the Center for Advanced Orthopedic Studies at Beth Israel Deaconess Medical Center and Immediate Past-President of ASBMR.
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. The project team re-evaluated these existing data to understand which measurements could predict the ability of the treatment to reduce fractures. The study findings identified an increase in bone mineral density, as measured by a low-dose X-ray imaging technique, as a strong predictor of the extent to which treatments reduce fracture risk. A change in bone mineral density could therefore 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.
“Prevention and treatment of osteoporosis-related fractures is essential for saving lives and improving quality of life, particularly in older adults,” added ASBMR President Laura Calvi, MD. “The reduction of length and cost of clinical trials enabled by using BMD as a surrogate endpoint will be a game-changer for bringing novel therapeutic agents to patients. ASBMR proudly supports this important initiative that brought together researchers from the University of California, San Francisco, Harvard Medical School, and the University of Sheffield (UK) – as well as leading experts from the NIH and industry, and patient advocacy partners – to assemble the remarkable database that makes this study possible.”
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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.