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EVENITY is a medication, developed by biotechnology company Amgen. It treats post-menopausal women with osteoporosis and at a high risk of fracture. Your physician may refer to it by its product name, Romosozumab. EVENITY is its trade or marketing name.

It is one of the newest treatments available for osteoporosis. The Food and Drug Administration approved EVENITY  in 2019.

For a better understanding of EVENITY, I reached out to Dr. Janet Rubin — a practicing endocrinologist, the Sarah Graham Kenan Distinguished Professor, and Vice Chair for Research at the Department of Medicine of the University of North Carolina.

Dr. Rubin kindly gave me time to speak with her and she generously shared her experience treating patients with EVENITY.

Dr. Rubin has a busy clinical practice treating patients with osteoporosis. She has been investigating bone remodelling for decades. Her particular focus has been on how exercise and mechanical force affects the cell cytoskeleton.

Conflict of Interest Disclosure

Dr. Rubin has no commercial relationship with Amgen (the manufacturer of EVENITY) or any of the other companies that make osteoporosis medications.

How EVENITY is Given (Administered)

Your physician administers EVENITY at their office. You will receive two injections each month over a one year period. The injection site is either the abdomen, thigh, or upper arm.

Dr. Rubin has not had a patient experience any problems with the double injection.

How EVENITY Works

EVENITY is a monoclonal antibody. It works by inhibiting a protein molecule called sclerostin. According to the U.S. National Library of Medicine on MedlinePlus, sclerostin “is produced in osteocytes, which are a type of bone cell. The main function of sclerostin is to stop (inhibit) bone formation. The maintenance of bone over time requires a balance between the formation of new bone tissue and the breakdown and removal (resorption) of old bone tissue. Inhibition of bone formation is necessary to ensure that bones are of the correct shape, size, and density.” (1)

Researchers found that if you block sclerostin, bone formation occurs. Scientists in the pharmaceutical industry repurposed the inhibition of this molecule in order to treat diseases of low bone density.

This finding lead to the development of Romosozumab (EVENITY) — an anti-sclerostin antibody.

Dr. Rubin points out that EVENITY has considerable potential for women with very low bone mineral density who need to move their bone density up into more target ranges. Her experience so far is that the drug “seems to work very well.”

Remember: by inhibiting sclerostin (an agent produced by your body to stop bone formation), you encourage the formation of bone — which is good.

However, EVENITY does more than stimulate bone formation by suppressing sclerostin. Dr. Rubin discusses this secondary activity in the next section.

How Long Can You be On EVENITY?

In our interview Dr. Rubin states that EVENITY is given for a one year period.

After that, it is discontinued and replaced by a different osteoporosis pharmaceutical to preserve the gains made by EVENITY. (This duration may change in the future as more studies are done on the drug.)

At that point, the bone formation has become more antiresorptive — meaning that the resorption of bone (the process by which osteoclasts break down the tissue in bones) is reduced.

In other words, inhibiting sclerostin with EVENITY also leads to decreased bone turnover or bone resorption.

At the end of the one year application of EVENITY (like all anabolic agents such as the parathyroid hormone-like drugs and this new drug), if you don’t follow EVENITY with an intervention, you will lose what you gained.

Studies have used either Prolia (Denosumab) or traditional bisphosphonates to follow EVENITY.

Exercise Recommendations for Osteoporosis

Exercise is an essential ingredient to bone health. If you have osteoporosis, therapeutic exercise needs to be part of your osteoporosis treatment program.

But what exercises should you do and which ones should you avoid? What exercises build bone and which ones reduce your chance of a fracture? Is Yoga good for your bones? Who should you trust when it comes to exercises for osteoporosis?

A great resource on exercise and osteoporosis is my free, seven day email course called Exercise Recommendations for Osteoporosis. After you provide your email address, you will receive seven consecutive online educational videos on bone health — one lesson each day. You can look at the videos at anytime and as often as you like.

I cover important topics related to osteoporosis exercise including:

  • Can exercise reverse osteoporosis?
  • Stop the stoop — how to avoid kyphosis and rounded shoulders.
  • Key components of an osteoporosis exercise program.
  • Key principles of bone building.
  • Exercises you should avoid if you have osteoporosis.
  • Yoga and osteoporosis — should you practice yoga if you have osteoporosis?
  • Core strength and osteoporosis — why is core strength important if you have osteoporosis?

Enter your email address and I will start you on this free course. I do not SPAM or share your email address (or any information) with third parties. You can unsubscribe from my mail list at any time.

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EVENITY Side Effects

Dr. Rubin states that there is one potential adverse effect of the drug. The side effect was identified during two separate studies of Romosozumab.

One is called the ARCH study (2) and the other is called the FRAME study (3). They were slightly different in the way that they were set up.

ARCH Study: Romosozumab

The ARCH study included slightly older women than the FRAME study with potentially a little more hypertension than the FRAME participants.

Over 4,000 individuals participated in the ARCH study. The participants were evenly spilt between those receiving romosozumab for one year and those receiving a weekly oral alendronate (bisphosphonate).

The group that received the bisphosphonate had slightly less cardiovascular events than the group who were treated with Romosozumab.

Keep in mind that the difference in number of cardiovascular events between the two groups in the ARCH study is a very small amount. In addition this was a long-term study and the incidence of cardiovascular disease a regular feature of this age group.

Dr. Rubin states that there were 38 cardiovascular events in the bisphosphonate group (Dr. Rubin uses the term “arm” to describe a study group in the interview) and 50 events in the Romosozumab group.

While the difference was small, it was enough to catch the attention of the FDA and cause the manufacturer, Amgen, to place a warning on the EVENITY package label.

FRAME Study: Romosozumab

As Dr. Rubin mentioned, the participants in the FRAME study, were younger than the ARCH study. The research team reported that there were no differences in cardiovascular events.

Dr. Rubin’s Position on Romosozumab

Because of the findings of the ARCH study, Dr. Rubin is using EVENITY in people who she feels really need it because of an elevated risk of fracture.

With younger women who are worried about fractures in the future, she is waiting for more data and finding from the real world application of EVENITY.

She has put many patients on it who have had bad fractures in order to stop them from fracturing again. So far she is pleased with the results, but is not changing her approach to the standard osteoperosis patient until she sees more data.

However, because of the cardiovascular risk potential, Dr. Rubin recommends that a patient who has had a cardiovascular event within the last 12 months, should not receive this drug. That may change in the future as we learn more about the drug.

EVENITY and Bone Quality

EVENITY, because it suppresses sclerostin, stimulates the growth or formation of new, high quality bone.

As Dr. Rubin goes onto state: “If this drug really made bad quality bone, it wouldn’t prevent fractures, which in hundreds of studies these kinds of drugs prevent fractures. That’s why we use them. They are really, really good drugs.”

EVENITY, Forteo and Tymlos

Tymlos and Forteo are both different formulations of a parathyroid hormone (PTH) and bind to the parathyroid hormone receptor.

These drugs are administered daily, As a result, rather than having a sustained hyper-parathyroidism, you get these daily hits of PTH.

Like EVENITY, Forteo and Tymlos stimulate the osteoblasts to make more bone. However, EVENITY has an antiresorptive effect in the long run, whereas the PTH drugs don’t.

EVENITY and Men with Osteoporosis

I asked Dr. Rubin her thoughts on EVENITY for men with osteoporosis.

There are few male studies for EVENITY – but they all suggest similar effects. She mentioned the findings of an efficacy and safety paper published in 2018 in the Journal of Clinical Endocrinology & Metabolism (4).

This was a bridging study to extrapolate the fracture benefit observed in women with osteoporosis in FRAME to men by demonstrating that the BMD profile in the male population is comparable to that in the female population. Amgen sponsored the study.

The study included 245 subjects (163 Romosozumab, 82 placebo). At month 12 of the study, the mean percentage change from baseline in the LS (lumbar spine) and TH (total hip) BMD was significantly greater for the Romosozumab group than for the placebo group (LS, 12.1% vs 1.2%; TH, 2.5% vs 20.5%; P , 0.001).

The adverse events and serious adverse events were balanced between the two group.

However, there was a numerical imbalance in the positively adjudicated cardiovascular serious adverse events [Romosozumab, 8 (4.9%) vs placebo, 2 (2.5%)].

This was similar to the increase in cardiovascular events as in the ARCH study (described above). Dr. Rubin noted that since men have more of these cardiovascular events, she might be more hesitant about using it.

Exercise Recommendations for Osteoporosis

Exercise is an essential ingredient to bone health. If you have osteoporosis, therapeutic exercise needs to be part of your osteoporosis treatment program.

But what exercises should you do and which ones should you avoid? What exercises build bone and which ones reduce your chance of a fracture? Is Yoga good for your bones? Who should you trust when it comes to exercises for osteoporosis?

A great resource on exercise and osteoporosis is my free, seven day email course called Exercise Recommendations for Osteoporosis. After you provide your email address, you will receive seven consecutive online educational videos on bone health — one lesson each day. You can look at the videos at anytime and as often as you like.

I cover important topics related to osteoporosis exercise including:

  • Can exercise reverse osteoporosis?
  • Stop the stoop — how to avoid kyphosis and rounded shoulders.
  • Key components of an osteoporosis exercise program.
  • Key principles of bone building.
  • Exercises you should avoid if you have osteoporosis.
  • Yoga and osteoporosis — should you practice yoga if you have osteoporosis?
  • Core strength and osteoporosis — why is core strength important if you have osteoporosis?

Enter your email address and I will start you on this free course. I do not SPAM or share your email address (or any information) with third parties. You can unsubscribe from my mail list at any time.

  • This field is for validation purposes and should be left unchanged.

Summary

This article introduces the reader to EVENITY. Dr. Rubin described how EVENITY works, identified potential side effects and described the type of patient she treats with EVENITY.

If you want to learn more about osteoporosis medications, I encourage you to listen to the interview below I did with Dr. Rubin on this topic.

References

  1. SOST gene (sclerostin). https://medlineplus.gov/genetics/gene/sost/
  2. Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis (ARCH). https://clinicaltrials.gov/ct2/show/NCT01631214
  3. Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (FRAME). https://clinicaltrials.gov/ct2/show/NCT01575834
  4. Lewiecki, et al. A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis, Journal of Clinical Endocrinology & Metabolism. September 2018, 103(9):3183–3193.

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