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@normahorn

That is misleading. Evenity was denied approval the first time because phase 3 data linked it to increased risk of cardiovascular adverse effects. Approval was granted only after it's use was restricted to those who have not had a recent heart attack or stroke.

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Replies to "That is misleading. Evenity was denied approval the first time because phase 3 data linked it..."

@normahorn I was citing info from the Arch and Frame studies. This article is slightly different from others I have seen but sharing excerpts. I hope that the entire article is helpful in clearing up any misunderstandings on this topic. As I wrote at bottom, I have seen other articles that mention protective aspects of alendronate as a factor in the ARCH study but this one disagrees ultimately. Anyone with heart attack or stroke history should certainly avoid Evenity but this article says it might be protective in certain heart issues. I think, honestly, not enough is known. I am more concerned with other side effects of sclerostin suppression.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9511529/

In the FRAME study, adverse and serious adverse events were well balanced between patients who received romosozumab–denosumab and those who received placebo–denosumab. 24 Notably, there was no difference in the incidence of adjudicated serious cardiovascular events in both groups.

BUT

In the ARCH study, adjudicated serious cardiovascular events were imbalanced. In the ARCH study’s first year, a higher frequency of serious cardiovascular adverse events (50 patients in the romosozumab group versus 38 patients in the alendronate group: difference not statistically significant)

AND
Almost 90% of patients in the ARCH and BRIDGE trial who had a cardiovascular event in the ARCH trial had a history of cardiovascular disease or one or more cardiovascular risk factors.

AND

The possibility of the cardioprotective effects of alendronate has been raised as a possible explanation of the finding in the ARCH trial. Retrospective cohort studies have suggested the possibility of a cardioprotective effect of bisphosphonates.

Note: this article goes on to attempt to define the reason for the difference in the ARCH trial and concludes it was probably chance. I have seen in other articles the possibility that protective factors from alendronate were a possible factor but this article does try to eliminate both that and harmful effects of Evenity in favor of chance as the main factor.