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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."

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Replies to "@jozer @daisy17 You can see the related 2025 FDA change in what they accept for drug..."

@kfhoz Wow, that is interesting. The reasoning was to make it easier for drug companies to get their drugs to market because it won't take as long for them to conduct studies on a drug's effectiveness or possible harm. But isn't the real goal of any bone drug to reduce fractures? I mean, if your BMD improves on the DEXA test, but your bone isn't stronger so fractures will be prevented, what is the benefit to the patient?

Personally, I don't see this as good news for patients. Many of us already distrust the drug companies that now have bone drugs on the market because they or doctors don't adequately inform patients of the side effects and what fracture benefit the patient will receive. If BMD improves, but we are left with bones that are not only not stronger, but possibly weaker, the only ones benefitting are the drug companies.

This article explains (please note the comment about fluoride): "Moving from doing trials with fractures as the endpoint to a surrogate marker, which could be BMD after 24 months, is going to change the opportunities for pharma to produce new drugs for osteoporosis. We’ve had no new drugs since 2019 because the companies won’t make that investment,” said Bente Langdahl, MD, PhD... a clinical professor endocrinology and internal medicine in Denmark.

Historically, the need for fracture risk reduction as an endpoint grew out of clinical trials of fluoride treatments, according to Langdahl. The fluoride was incorporated into bone, but unexpectedly it led to poor bone quality that actually increased the risk of fracture. “That was a scare. Before that, you could have a drug approved by BMD changes, but because of that specific drug, FDA and EMA [European Medicines Agency] and all the other regulatory agencies said, ‘that’s not good enough.’ But now, so much more is done before the studies with respect to bone quality analysis in animals, so we know it’s not fragile bone they [build]. So maybe now is the correct time” to reestablish surrogate markers, she said."
https://www.medscape.com/viewarticle/what-bmds-impact-surrogate-osteoporosis-endpoint-2025a1000p2b

@kfhoz I've already replied to your comment, but have been thinking about this ever since. New FDA guidelines allow drug companies to market new bone drugs without providing proof that taking them will result in fewer fractures. The drug companies only have to prove that the drugs raise BMD (bone mineral density). It's then assumed that higher BMD will most likely result in fewer fractures.

We already know that the newer bone drugs are so expensive that most health insurance policies won't cover them, as they can cost thousands of dollars a month. Meaning these drugs are very profitable for the drug companies.

Also, studies have shown that at least 50% of individuals over the age of 50 who experience a fracture do not have osteoporosis. This indicates that fractures can occur even in those with normal bone density. https://academic.oup.com/jcem/article/104/8/3514/5427152

We also know that the FDA has been known to approve medications without requiring the drug manufacturers to actually prove that they work -- or that they won't cause undue harm. https://www.msn.com/en-us/health/other/the-fda-is-approving-drugs-without-evidence-they-work/ar-AA1G9znW

This doesn't make me feel very hopeful or have trust in any current or new bone meds.