A study led by the University of Bristol in the UK has found that the mechanism of action of the osteoporosis drug romosozumab (Evenity) increases the risk of heart attack and other cardiovascular problems.
While previous studies had already associated romosozumab with an increased risk of heart attack, this new study took a novel approach to confirming the association without studying the impacts of the drug itself.
We’ll look at their unique methodology and you’ll learn about the dangerous side effects of this recently approved osteoporosis drug.
All About Romosozumab (Evenity)
To understand the contents of the study, it’s important to first know what romosozumab is and what it does in the body.
Romosozumab (Evenity) is an injectable osteoporosis drug, administered monthly. It aims to increase bone density by inhibiting a protein called sclerostin. Sclerostin is produced by bone cells, and it inhibits bone formation.
Romosozumab artificially suppresses sclerostin levels, resulting in more new bone formation, which increases bone mineral density (BMD). However, like all pharmaceutical interventions, forcing this change in the body has unintended consequences.
One of those effects is an apparent decline in the effectiveness of the drug. Studies found that over the course of a year, romosozumab loses its ability to spur additional bone formation.1 Big Pharma predictably recommends immediately starting another type of drug, bisphosphonates, to try and maintain the artificially created increase in bone mass.
However, the downsides don't stop there.
Synopsis
Romosozumab is an osteoporosis drug, injected monthly to inhibit a protein called sclerostin. Sclerostin inhibits bone formation, so reducing sclerostin allows for more bone formation. However, this action has unintended consequences.
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A Drug With A History Of Heart Attack
Romosozumab (Evenity) was developed by Big Pharma drug maker Amgen in the 2010s. But when it first applied for FDA approval in 2017 the drug was rejected due to the high incidence of cardiovascular events in clinical trials. The FDA decided the drug's ability to increase bone formation simply wasn't worth the risk.
Amgen submitted the exact same drug again the next year with a narrower target demographic: this time it was only proposed for use in women considered to be at the highest risk of fracture. The FDA took the bait. They approved the drug with the added requirement of a boxed warning about the increased risk of cardiovascular problems and ruled that it shouldn't be used for women who have suffered a heart attack or stroke within the past year.
Additional studies have come to the same conclusion as Amgen's own clinical trials: the drug is dangerous due to the increased risk of heart attack.2 In spite of that, it’s still on the market, being pushed by Big Pharma and doctors onto patients who may think there’s no other path
Synopsis
Romosozumab causes an increased risk of stroke, heart attack, and cardiovascular problems. This potentially deadly side effect got the drug rejected by the FDA in 2017. But it was approved the next year for women at the highest risk of fracture.
New Study Does Novel Genetic Evaluation
Some questions remained about the reason why romosozumab causes cardiovascular problems. To find out whether the suppression of sclerostin is truly the cause, a new study, published in the journal Arthritis & Rheumatology, examined the rates of cardiovascular events among people with naturally low levels of sclerostin.
The researchers analyzed the genetic data of 33,961 European participants and located several genetic variations associated with lower levels of sclerostin. They used an analytical model called Mendelian randomization to determine the effect of reduced sclerostin levels on 15 atherosclerosis-related diseases. Atherosclerosis is the thickening or hardening of the arteries.
They then compared these participants' occurrence of cardiovascular events or conditions to their naturally occurring lower-than-normal levels of sclerostin.
The researchers found that low sclerostin levels may cause a 30 percent increased risk of heart attack, as well as an increased risk of Type 2 diabetes, hypertension, and calcification of the arteries of the heart.3
This new finding underscores how potentially dangerous romosozumab really is, and clarifies that the intended mechanism of the drug– inhibiting sclerostin– puts patients at risk of cardiovascular events.
Synopsis
A study analyzed genetic data from 33,961 participants to locate genetic variances that caused naturally low sclerostin levels. Researchers used Mendelian randomization to link genetically reduced sclerostin levels to 15 atherosclerosis-related diseases. They found that naturally lower sclerostin levels were linked to a 30 percent increase in the risk of heart attack, and increased risk of other cardiovascular events.
What This Means To You
A drug-free approach to reversing or preventing osteoporosis is not only possible, but it’s also the only approach that doesn’t come with the risk of life-altering, or even life-ending, negative side effects.
If you use a drug like Evenity you substitute concern about breaking a bone with concern about developing hypertension, calcified arteries, type 2 diabetes, or having a heart attack.
Instead, pursue an approach that improves your overall health. The Osteoporosis Reversal Program utilizes strategies and behaviors that do more than just reduce your risk of fracture, they improve your chance of a long, independent, fuller life.
Instead of giving yourself new things to worry about, give yourself new things to look forward to. Take on the challenge of improving your diet, moving your body, and living a healthier lifestyle. You’ll be glad you did.
References
1 https://www.sciencedirect.com/science/article/pii/S2405525518300062
Is Evenity and Evista the same drug?
This information is very much appreciated as I have been under pressure to take the medication and feel I might be written off as a ‘difficult’ patient because I have, so far, successfully resisted. I suspect that there is an age-connected attitude to how much side effects matter, ie the older the patient the less important any resulting damage to other health aspects. The implication seems to be that it’s easier to deal with/less important to have cardio vascular problems than low bone density and the, admittedly, sometimes devastating consequences of damage to the skeleton.
I just saw a commercial for this drug on TV. Very convincing. Thank you for this timely warning.
Could you please tell us the date of this latest study on Evenity? Than you.
Linda, the study was published on April 25, 2023. You can read it when you click the reference link below the article.
I took Evenity- at the time I had tried other drugs and had been working on malabsorption issues with an alternative medicine program. This natural approach always takes a long time so I let my endocrinologist talk me into Evenity. I thought since it was supposed to break down bone and build bone as the body does, it might be a stop-gap measure until I could get to the point where my leaky gut was no longer a problem, and being gluten-free would help with digestion and maybe my bones. After a year, nothing changed on my bone density test, but I did have a heart attack- 3 months later. Other than telling my endocrinologist is there someplace I could report this so it could be counted against taking the drug?
I’m so sorry about what happened to you, Karen! The FDA has a website called Medwatch where you can report adverse drug events. I hope you’ve recovered and can live a happy and healthy life!
Thank you , Ita.
My pleasure, Ita!
My doctor says he wants to talk to me about starting Prolia because I already have a couple of compression fractures and low bone density. How can I convince him that I consider the risks too great because of Prolia’s possible side effects?
Pat, you don’t need to convince him… just do what you think is right and, if necessary, change doctors. Your situation happens very often, and that’s why we included Doctor Communication Tutorials in the ORP.
Here are previous articles that can help you:
https://saveourbones.com/who-should-you-trust/
https://saveourbones.com/five-signs-you-need-to-find-a-new-doctor/
Let us know how that goes.
I am interested in your response to Dan Russell’s question as I have reluctantly started Prolia, following two years of Forteo injection every day.
Doesn’t Prolia inhibit the protein sclerostin also? If so wouldn’t Prolia have the same effect on heart problems?
Dan,
Prolia (denosumab) is the first fully human monoclonal (laboratory-made) antibody and RANK Ligand inhibitor to be approved as a drug. RANK Ligand (RANKL for short) is a protein that activates osteoclasts and is involved in immune-response regulation. The natural inhibitor of RANKL is osteoprotegerin, a tumor necrosis factor (TNF) cytokine that binds to RANKL, preventing interaction with its receptor-activator RANK on the surface of osteoclasts. Cytokines are chemical messengers that help regulate the nature and intensity of an immune response.
In essence, Prolia mimics osteoprotegerin by blocking the effects of RANKL and de-activating osteoclasts.
In a study titled “Sclerostin and DKK1 in postmenopausal osteoporosis treated with denosumab” published in the Journal of Bone and Mineral Research, the researchers found that:
“Denosumab treatment was associated with significant (p < 0.05) increases (28% to 32%) in serum sclerostin over the entire study follow-up... The changes in bone turnover markers associated with denosumab treatment of postmenopausal osteoporosis is associated with significant increase in sclerostin similar to those seen after long-term treatment with bisphosphonates and significant decrease in DKK1."
Thankyou once again SaveInstitute for this information. My dear Mum was given a bone strengthening injection when she was 92 and she later experienced TIAs and strokes. It could be a coincidence but this information is vital, upsetting but many thanks. I doubt this knowledge would be shared anywhere else.
You’re welcome, Gwyneth! I’m so sorry about what happened to your mother…