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Vitamin K: High Doses of MK-4 and MK-7 Show Promising Results
Osteoporosis & Bone Health | Last Active: Jun 6 10:56pm | Replies (107)Comment receiving replies
@daisy17 BMD is important; it is what we measure and medicate according to results but the only reason (I think?) we treat osteoporosis is to prevent fractures...or am I missing something?!? I believe the goal first and foremost is to prevent fractures (why else would we medicate) and the resulting disability that can come with them.
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@jozer @daisy17 You can see the related 2025 FDA change in what they accept for drug development, swapping fracture risk for BMD change. I applaud the goal of getting new, hopefully better, drugs faster. Not sure about what the unintended consequences of this will be.
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
EXCERPT: " ... percentage change from baseline at 24 months in total hip BMD ... . 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."