FNIH Announces FDA Qualification of First Surrogate Endpoint for Use in Osteoporosis Clinical Trials

Описание: The Foundation for the National Institutes of Health (FNIH) announces that the Food and Drug Administration (FDA) has qualified the treatment-related change in hip bone mineral density (BMD) as a surrogate endpoint for bone fractures in clinical trials of anti-osteoporosis drugs in post-menopausal women at risk for osteoporotic fracture.

Clinical trials investigating new osteoporosis therapies have traditionally relied on bone fractures as the primary measure of effectiveness. Trials were designed to follow thousands of participants for a lengthy period to determine if a drug prevented fractures, making the trials prohibitively expensive. With this new qualification, a change in BMD can now serve as the primary endpoint in future trials, replacing fracture rates and significantly reducing the time and expense required to develop and deliver much-needed treatments. BMD is measured via dual-energy X-ray absorptiometry (DEXA), a routine, noninvasive and relatively inexpensive imaging test.

The Study to Advance BMD as a Regulatory Endpoint (SABRE), which generated the data and evidence for this qualification, is a public-private partnership launched and managed by the FNIH Biomarkers Consortium.

Read the full press release here: https://fnih.org/press-release/fda-qu...