ENP 112
The U.S. Food and Drug Administration recently qualified "total hip bone mineral density" as a surrogate endpoint to support clinical trials for osteoporosis drugs. This decision will significantly impact clinical trials moving forward, as the traditional endpoint of "fracture outcomes" presented many challenges regarding sample size, duration, and cost.
The change came about because of findings from the study to advance bone mineral density as a Regulatory Endpoint Project, also known as the SABRE project.
What is the SABRE project, and how did it arrive at these findings? How will this decision affect the design of clinical trials and time to approval of new osteoporosis therapies?
To help answer these questions and many more, Host Aaron Lohr spoke with three leaders of the SABRE Project: Dennis M. Black, PhD, professor of epidemiology and biostatistics at the University of California, San Francisco; Richard Eastell, MBChB, PhD, FRCP, FMedSci, professor of bone metabolism at the University of Sheffield, and Mary L. Bouxsein, PhD, professor of orthopedic surgery at Harvard Medical School.
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