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FDA Qualifies Total Hip Bone Mineral Density (BMD) as Surrogate Endpoint for Osteoporosis Drug Development
The U.S. Food and Drug Administration (FDA) qualified total hip bone mineral density (BMD) as assessed by dual energy X-ray absorptiometry (DXA) as a validated surrogate endpoint to support clinical trials of investigational therapies for post-menopausal women with osteoporosis at risk for fracture.
Osteoporosis-related fractures represent a major public health challenge, affecting one in two women and one in four men over age 50. Despite the availability of effective FDA-approved therapies, there remains an urgent need for new osteoporosis medications with improved safety profiles and efficacy.
Traditional clinical trials for anti-osteoporosis drugs have required fracture endpoints as primary efficacy measures, necessitating large studies that can take two to five years. Qualifying BMD as a surrogate endpoint would allow for more efficient clinical trials, potentially enabling faster approval of new osteoporosis treatments and improving patient access. A BMD test measures calcium and other minerals in the bones, with more minerals indicating denser bones that are less prone to fracture.
The qualified tool is the percentage change from baseline at 24 months in total hip BMD assessed by DXA. This biomarker can be used as a validated surrogate endpoint for assessment of investigational therapies for post-menopausal women with osteoporosis at risk for fracture in phase 3 clinical trials, providing an alternative to fracture endpoints.
Drug development tools play an important role in bringing new therapies to patients by providing well-defined, scientifically sound approaches to clinical trial design and regulatory decision-making.
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