ENP112: Osteoporosis and the SABRE Project
About this episode
The episode discusses the impact of the FDA's qualification of total hip bone mineral density as a surrogate endpoint for osteoporosis clinical trials, featuring insights from leaders of the SABRE Project.
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.
People in this episode
Host: Aaron Lohr
Guests: Dennis M. Black, Richard Eastell, Mary L. Bouxsein
Topics covered
- osteoporosis
- clinical trials
- bone mineral density
- FDA regulations
- SABRE project
- healthcare
Keywords
- osteoporosis
- FDA
- clinical trials
- bone mineral density
- SABRE project
- drug approval
- fracture outcomes
Mentioned in this episode
Organizations: U.S. Food and Drug Administration, University of California, San Francisco, University of Sheffield, Harvard Medical School, SABRE Project
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