[Editorial] A new dawn for osteoporosis drug development

On Dec 19, 2025, the US Food and Drug Administration (FDA) announced a major milestone by qualifying total hip bone mineral density (BMD), assessed by dual-energy X-ray absorptiometry, as a surrogate endpoint for fractures in phase 3 trials of investigational drugs in postmenopausal women with osteoporosis. The qualification was based on data generated by the Study to Advance Bone Mineral Density as a Regulatory Endpoint (SABRE)—a public–private partnership funded by the Foundation for the National Institutes of Health (FNIH)—initiated and managed by the FNIH Biomarkers Consortium.