Evenity and side effects: What helps joint and muscle pain?

I asked about estrogen and was told maybe if you were only 10 yrs past menopause. (Something about causing heart attacks?) I messaged a woman in Europe in her 70’s and she still is in estrogen..I’m sure it likely is a smaller dose…but what’s up with this picture? Do we all need such expensive meds that have many side effects…that are not small at all!! Any answers?

No, we don't need to risk jaw cancer, stroke or heart attacks or all these horrible reactions posted on this blog to receive treatment at out of control cost. I am not surprised to read about the 70 y/o European taking estrogen. The northern European countries are more advanced in treatment of most diseases and lean towards the natural remedies.

@jawgirl jaw necrosis (not cancer) is very rare and noone has had a stroke or heart attack on these meds at a rate greater than placebo. Insurance covers drugs with co-pays and companies offer financial assistance. I personally do not believe natural remedies can get us out of trouble but are certainly useful as adjuncts and after treatment during a drug holiday.

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.

@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.

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.

So Evenity should not have a black box warning for heart attack and stroke?

It is possible for people to have mild (silent) heart attacks and strokes and are not aware they occurred.

If these studies were done post approval, the participants were prescreened by the black box warning.

@jillgirl the black box warning stands for those who have had a stroke or heart attack in the past year: from the same link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9511529/

"Findings in the ARCH study raised the concern about romosozumab and cardiovascular risk. Due to these concerns, romosozumab carries a black box warning per the United States Food and Drug Administration (FDA). Romosozumab should not be initiated in patients with myocardial infarction or stroke in the preceding year. Per the European Medicines Agency (EMA), 34 romosozumab is contraindicated in patients with history of myocardial infarction or stroke. "

I would surmise this is for a couple of reasons. One, there is no definitive answer to why those on alendronate (Fosamax) had fewer cardiovascular events than those on Evenity (again, no difference with placebo). I have seen both theories, that alendronate is protective and that it was due to chance. But it is not definitely proven that it isn't due to the medication, as yet. Drug companies will be cautious on this kind of risk.

Second, there is a theoretical risk of vascular calcification from Evenity, that was not seen in monkeys and rats, but the idea is based on how Evenity works by suppressing sclerostin. You can read about this in detail in the article linked.

I think @normahorn is right in saying that it can be misleading to minimize risk when risk is unknown, despite studies that theorize that risk is actually quite low. The drug is just so new on the market and studies need to be ongoing.

I have other concerns that are understudied: suppressing sclerostin may cause bone marrow edema and affect B cell (immune cell) production, for instance. The neuro symptoms I have, of burning and tingling, are in the side effect list but I have seen no possible explanation for them.

Most people do really well on Evenity and it seems to have fewer side effects for many. For sensitive people like me, having a medication in me for 65 days (half life 12.8 so increasingly low level as time goes on) is problematic.

ps I am not trained to read studies. Never ever make decisions based on posts on a forum, though of course they can be helpful in raising questions and concerns. I have atrial fibrillation and checked the cardiovascular risks out with cardiology before going on Evenity and everyone should do the same. If nothing else, this educates the cardiologists!

Had you taken any other meds for your bones prior to Reclast? Did your Dr say you have to start taking another med after stopping the Reclast? Thanks.

@hopefullibrarian Yes. My appetite has changed. I gained 9 lbs since I started Evenity in October. I also suffered from brain fog. I’m fortunate that these side effects are minimal and tolerable. Good luck!