FDA

FDA qualifies hip bone density as surrogate endpoint for osteoporosis drug trials

January 13, 2026

FDA has qualified total hip bone mineral density (BMD), measured by dual energy X-ray absorptiometry (DXA), as a validated surrogate endpoint for assessing investigational therapies in postmenopausal women with osteoporosis at risk for fracture. Traditionally, fracture outcomes were required as primary endpoints, making trials lengthy and costly. Using BMD as a surrogate could streamline clinical development and accelerate access to new treatments. The qualified measure is percentage change from baseline at 24 months in total hip BMD.

Source:

(2026, December 19). FDA. FDA Qualifies Total Hip Bone Mineral Density (BMD) as Surrogate Endpoint for Osteoporosis Drug Development. https://www.fda.gov/drugs/drug-safety-and-availability/fda-qualifies-total-hip-bone-mineral-density-bmd-surrogate-endpoint-osteoporosis-drug-development