x ray of a broken hip with steel pins

The FDA has just approved a new drug for osteoporosis that works differently than existing medications. Romosozumab will be sold under the brand name Evenity. This injectable monoclonal antibody actually builds bone unlike many prior medications that work primarily by slowing bone breakdown. The FDA has only approved Evenity for postmenopausal women who are at very high risk of bone fracture because of osteoporosis. There are some potentially serious side effects.

The Pros and Cons of Bisphosphonates:

To date there have been no perfect osteoporosis drugs. Although osteoporosis is common, we do not have a magic wand to prevent fractures in older people. When someone breaks a hip it can lead to disability or death. That’s why building strong bones is important for healthy aging. You may find our radio show/podcast on this topic of interest:

Show 1139: Will Supplements Keep Your Bones Strong?

For years, doctors relied upon a class of drugs called bisphosphonates. They work by slowing bone breakdown (aka resorption). These are drugs such as:

Alendronate (Fosamax)

Risedronate (Actonel)

Ibandronate (Boniva)

Zoledronic acid (Reclast)

Some experts describe bisphosphonates as brakes on the bone remodeling system. That is not a bad way to think of these drugs. It is not very physiological, though. Bone is constantly being broken down and rebuilt. Bisphosphonates throw a monkey wrench into the breakdown system. 

Side effects of bisphosphonates include heartburn, abdominal pain and/or severe digestive tract upset. Fatigue is another possible complication. Less well recognized are symptoms of joint pain. You can read about this and other serious side effects at this link:

Will Osteoporosis Drugs Make Your Joints Hurt?

Will Osteoporosis Drugs Make Your Joints Hurt?

Other osteoporosis drugs include raloxifene (Evista), denosumnab (Prolia), teriparatide (Forteo) and abaloparatide (Tymlos). We will be expanding our Guide to Osteoporosis over the next few months and provide additional information on these and nondrug options to building bones.

The Pros and Cons of Evenity:

Good News:

Some of the drug commentators have called Evenity a breakthrough. Others describe it as “an extraordinarily important drug” (New York Times, April 9, 2019).  That’s because Evenity actually builds bone. According to Gina Kolata:

“In one study, spinal fractures occurred in 127 of 2,046 patients taking the new drug, compared with 243 of 2,047 taking aldendronate, an older drug.”

Here at The People’s Pharmacy we like to give you absolute numbers so you can see the research up close and personal. A study published in the New England Journal of Medicine (Oct. 20, 2016) reports that after one year of Evenity injections, 16 people out of 3,321 (0.5%) experienced a back fracture (vertebral fracture). In the placebo group, 59 out of 3,322 (1.8%) had a vertebral fracture. 

Nonvertebral fractures (such as a hip fracture) occurred in “56 of 3,589 patients (1.6%) in the romosozumab group.” In the placebo group, 75 out of 3,591 people had a nonvertebral fracture (2.1%). That is an absolute risk reduction of 0.5%. 

Bad News:

That’s the good news. The bad news is that Evenity almost did not get approved by the FDA. During its first review at the agency in 2017 the drug was rejected. That’s because it did not protect against non-vertebral fractures. We interpret that to mean that Evenity did not reduce the likelihood of hip fractures. The drug also appeared to have some disturbing cardiovascular complications.

Approval by the FDA now comes with some distinct cautions. It will only be appropriate for women who have experienced fractures because of osteoporosis. If a woman has several risk factors for developing a fracture, the drug would also be appropriate. And people who cannot tolerate older osteoporosis drugs or have not benefited from such drugs could also be prescribed Evenity.

Beware the Black Box Warning:

There will be a black box warning that the drug can increase the risk for cardiovascular events such as heart attacks and strokes. Anyone who has had a heart attack or a stroke or is at especially high risk for such events should probably be considered a poor candidate for Evenity.

Less worrisome side effects include injection site reactions, joint pain and headaches. Evenity is injected once a month for 12 months. After that, patients will likely need to switch to a different osteoporosis drug to maintain bone density. One analyst predicts the cost will be approximately $600 a month.

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  1. DJ
    Riverside
    Reply

    Terry,
    Judi (above) says her nutritionist recommended strontium for her bones, and she has had positive results. What is your opinion on that? My recent bone density test showed -3.1. My doctor is recommending Reclast infusion once a year, and the negative side effects make me very wary.

  2. Betti F
    Greenville, NC 27834
    Reply

    The doctors says my bones are healthy and strong, and I am well into my 70s. Are you saying they are only looking at the outside of my bones, and don’t know if the inside of my bones are healthy, and that is what matters most during a fall?

    How do we fix that, or get the doctors to tell their patients they really don’t know if our bones are healthy, even from a bone density study. This should be a wake-up call for all seniors.

    • Terry Graedon
      Reply

      If your doctors think your bones are strong, they presumably have done some tests to determine that. No guarantees, of course, but you should be OK.

  3. Elena
    Mukilteo, WA
    Reply

    I am with the Veterans Health Care System in Seattle. One good thing regarding the VA is that I don’t have to worry about doctors overprescribing drugs or pushing me to get scans I don’t need. But I have osteoporosis (I have shrunk from 5’4″ to 5’2 1/2″), have broken an ankle just by twisting it a little while walking, and the Xrays of my spine showed that it’s thinning. I am on Alendronate once a week for 10 years. My doctor also prescribed calcium and vit. D to be taken daily. She advised weight exercises, as mentioned in another person’s comment, that are important to maintain bone health.

  4. Judi
    Seattle
    Reply

    In early menopause I got a Dexa test that showed osteopenia. My grandmother and mother had significant osteoporosis. I talked to
    my nutritionist who recommended taking strontium. I started that day and the following year my Dexa was great! I’ve taking it since, had spine fusion surgery and my bones fused right on schedule.

  5. J
    Reply

    I have osteoporosis and 2 years ago started a weight bearing exercise program in the hopes of strengthening my bones. Unfortunately, for no apparent reason, I developed fractures in my pelvis. Taking a long time to heal…yet I am scared to death to begin one of these recommended drugs due to increased risk of future fractures upon completion of treatment. Nobody seems to have an answer.☹

  6. Jane
    Reply

    This sounds fairly lucrative, I’m sure before long we’ll see countless expensive commercials encouraging everyone who has bones to “ask their doctor” if they too can benefit.

  7. Roxane
    Tempe AZ
    Reply

    What is the point of this drug? Just like forteo which also builds bone, once that treatment is over (one year for this drug and two years for forteo) you must go back to one of the older drugs all with horrific side effects and all that cause old bone to stick around. Older bone is more brittle, more likely to break. It might make your numbers look better on a DEXA but that is about it. I also suspect that the cost would be astronomical. What is really needed is a drug that physiologically mimics what our bones naturally do in the body. A drug that can be taken over a lifetime (the way people take synthroid).

  8. Anne
    Wisconsin
    Reply

    Here we go again. Doctors love prescribing this stuff, even though it has all kinds of side effects. Along with that, they all want patients to get bone scans in order to justify adding another prescription drug they can push. I’ve yet to have any doctor encourage me to do weight bearing exercise, which I believe, has been proven to improve bone strength. Plus, it is also my understanding that these scans only show the density of the “shell.” I’ve read that it’s the interior structure that keeps bones from easily breaking.

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