If you are one of the millions of Americans who have been diagnosed with osteoporosis, your doctor has likely at least suggested taking medication to increase your bone density. But there are many problems with current osteoporosis medications, from creating poor quality bone to inducing life-threatening side effects, and we want you to know the truth about their risks. Recently, we came across a new osteoporosis drug recently approved by the U.S. Food and Drug Administration (FDA) for post-menopausal women with osteoporosis called Evenity (romosozumab). The pharmaceutical giant Amgen claims their new drug builds bone quickly and improves bone density. Alluring as any promise of an instant cure is, this new medication may not be all it’s cracked up to be. Let’s examine the science behind Evenity, compare it to other major osteoporosis drugs, and give you the tools you need to make an informed choice for your health.
The FDA’s April 9, 2019 press release promoted Evenity for its ability to build new bone based on two large clinical studies involving over 11,000 post-menopausal women with osteoporosis that were funded by Amgen, with no independently funded studies to back up their results. Funding aside, what did those studies show, how does this drug work, and are the benefits worth the side effects?
Origins of and Claims about Evenity
A recent New York Times article positively spins this new drug, claiming in the title that, “most osteoporosis drugs don’t build bone- but this one does.” Great for Evenity’s fledgling reputation, but take a moment to process this statement. The global osteoporosis drug market is a huge business, expected to be valued at $8.9 billion by the year 2020. Osteoporosis medications including bisphosphonates, RANK ligand inhibitors, and synthetic hormone fragments are being marketed and prescribed to millions of people each year to treat osteoporosis. The problem with this is that emerging studies on these very drugs are showing that they may actually do more harm than good! Think about that for a moment- each year millions of people are being precribed osteoporosis drugs that research has shown to be ineffective and potenially dangerous – that’s crazy, right? Yet that is exactly what is happening everyday and it’s happening again with Evenity.
Evenity has an interesting origin story. Researchers observed a small group of Afrikaners (A South African ethnic group descended from Dutch, German and French settlers) that had exceptionally strong bones. However, some of these people had abnormal bone overgrowth of the skeleton and cranium that lead to increased cranial pressure, deafness, and other physical problems. These people had these abnormal bone overgrowths because they had a mutation that decreased activity of something called sclerostin, a communication molecule released by bone cells to drive bone resorption or breakdown. When researchers discovered this they quickly began developing a drug that could block sclerostin, allowing bone to grow quickly and thickly as in those with the mutation. That drug they created is called romosozumab (Evenity).
So is this drug different than the other osteoporosis drugs on the market? Is it an exception to the general rule of failure when it comes to safely and effectively building bone? When Amgen researchers studied Evenity’s ability to build bone in a one year clinical trial of 7180 women, half taking Evenity and half taking a placebo, and found that 43 vertebral (spine) fractures were prevented in the Evenity group, yielding an absolute risk reduction of only 1.3%. This absolute risk means that if 100 people at risk of vertebral fracture take Evenity for a year, only one vertebral fracture will be prevented. Beyond our concerns about side effects, an absolute risk reduction of only 1.3% is not very impressive, and the research only assessed vertebral fractures. We don’t see that as anywhere near the improvement that is possible by first addressing micronutrient deficiencies, exercise, or stress.
When researchers looked at more than just vertebral fractures the results were more promising for Evenity, but, like other osteoporosis drugs, improvements in bone density did not translate to reduced risk of fracture. In a second study of post-menopausal women with osteoporosis, researchers observed bone density gains of 5.8% in the hip, 5.2% in the femoral neck, and 12.7% in the lumbar spine. There results look good on a visual scan but did not translate into significant reductions in fracture risk, which is the most important outcome for improving quality of life, reducing hospitalizations, and decreasing mortality risk! But even more disturbing was that researchers also discovered that the bone built with Evenity will disappear within 12 months without a second medication to help preserve it, which has serious side effects.
How Does Eventity Build Bone?
Your osteoblasts (bone-building cells) and osteoclasts (bone-breakdown cells) drive bone formation and resorption, respectively. Chemical messengers and feedback from levels of nutrients and other compounds play an important role in regulating how you build and maintain bone. For example, our bone cells make sclerostin, a messenger molecule that acts as a natural “off” switch for bone formation in two ways. First, sclerostin blocks new bone formation by inhibiting the birth, development, and survival of osteoblasts (cells that make new bone). Second, sclerostin increases bone breakdown (resorption) by triggering nearby osteocytes to make a molecule called RANKL, which boosts the activity of osteoclasts, which are cells that break down existing bone.
Evenity is a small protein called a monoclonal antibody that blocks where sclerostin binds, reducing its activity, and producing an effect like the Afrikaners’ mutation. By blocking a natural check on bone growth, quick and significant bone growth can result. However, this quick growth can cause many unwanted health problems if left unchecked for too long, so the FDA has only approved Evenity for short term use up to one year.
Evenity’s ability to reduce osteoclast activity is a similar method of action to that of the class of osteoporosis drugs called RANK ligand inhibitors (such as denosumab, known as Prolia), human monoclonal antibodies that bind RANKL and prevent it from activating the RANK receptor on osteoclasts, which decreases bone resorption and and results in higher bone mass density.
Reason #1 (that we don’t recommend Evenity): Evenity is only marginally effective at building bone.
As noted above, long term use of Evenity can cause abnormal bone growth and dangerous problems, so you cannot take it longer than a year. Those who take it barely reduce their fracture risk, and the privately funded studies showing this benefit are of limited size and diversity. Given that Evenity is a very expensive drug, you may want to focus your resources elsewhere.
How Does Evenity Maintain Bone?
This is an important question- because it doesn’t. Not only is it dangerous to take Evenity longer than 12 months per FDA’s warnings, but the bone you build while taking Evenity will go away within a year without using a separate anti-resorption drugs that can cause nutritional deficiencies and have unpleasant side effects!
Reason #2: Evenity is completely ineffective at making bone that will be maintained without the use of a second medication- for life.
That’s right! When you finish your short-term stint on Evenity you are on secondary osteoporosis medications for life. Anti-resorptive agents include bisphosphonates and RANK ligand inhibitors, which come with a slew of side effects and can wreak havoc on your micronutrient status. You are pretty much stuck on these drugs forever if you want to maintain what you’ve gained.
So what can you expect from a lifetime on Bisphosphonates? Bisphosphonates come with cardiovascular and other risks similar to Evenity. 1 in 5 people that start bisphosphonates stop treatment due to side effects, according to a 2017 report in the medical journal BMJ. Bisphosphonates such as alendronate not only build brittle and ineffective bone, they also cause bone, joint, and muscle pain, may also cause nausea, heartburn, irritation of the esophagus, gastric ulcer, and even esophageal cancer in tablet form, and may cause flu-like symptoms if administered by IV. They have also been associated with osteonecrosis of the jaw, They increase risk of atrial fibrillation by 40 percent, increasing risk of heart failure, dementia, and stroke. Most importantly, they cause micronutrient deficiencies by interfering with your ability to absorb calcium and other minerals.
Reason #3: Evenity carries high risk and numerous, side effects.
How serious a risk? The risk is so serious that Evenity carries a “black box” warning from the FDA, the strongest warning the FDA can give for a drug. In order to carry a black box warning, the drug must meet one of the following criteria: if an adverse event has been so serious (such as death or disability) compared to the potential benefit of the drug that it is must be considered when prescribing the drug, if a serious adverse reaction can be prevented by following specific guidelines about patient selection and monitoring, or if there are mandatory restrictions, like additional medical training, set for prescribing the drug.
Evenities numerous, unwanted side-effects include:
- The most common side effects of Evenity include joint pain and headaches. This is common among osteoporosis drugs.
- Evenity may lower calcium levels in your blood. Calcium helps your nerves fire and your muscles contract, so low blood calcium puts you at risk for spasms, twitches, muscle cramps, numbness or nerve tingling (especially in fingers and toes), and can increase your risk of a cardiovascular event.
- “Evenity may increase the risk of heart attack, stroke, and cardiovascular death, so it’s important to carefully select patients for this therapy, which includes avoiding use in patients who have had a heart attack or stroke within the previous year,” according to the FDA’s Hylton V. Joffe, MD, MMSc, who directs the Center for Drug Evaluation and Research’s Division of Bone, Reproductive, and Urologic Products. This is why Evenity carries a “black box” warning from the FDA. Most people suffering from osteoporosis are older and therefore are aware of their increased risk of heart attack or stroke simply from advanced age- they don’t need a bone medication increasing their risk further.
- Evenity may cause severe jaw bone resorption, known as osteonecrosis of the jaw. This side effect of Evenity is also caused by bisphosphonates. Severe bone resorption causes osteonecrosis (“bone death”) of the jaw, which is associated with pain, infection, abscesses, and a bone starved of nutrients (maybe the calcium that is becoming deficint due to Evenity!).
- Evenity can cause unusual thigh bone fractures. Those with this type of fracture experience new or unusual pain in their hips, groin, or thighs.
- Evenity can cause serious allergic reactions. Inhibiting RANKL suppresses immune cell generation as a side effect of reducing osteoclast maturation.
Reason #4: Evenity May Cause Essential Micronutrient Deficiency.
Evenity reduces blood calcium levels, and should be given with adequate calcium (and until we know more, other key minerals as well). Other osteoporosis medications, such as bisphosphonates, also reduce blood calcium levels. The FDA is clear that if you are deficient in calcium, you should not start either drug. The real issue here is that doctors are prescribing these osteoporosis medications to nearly everyone with osteoporosis, yet more than 70 percent of people in the United States have been shown to have inadequate calcium intakes. Though we are still learning about how Evenity negatively competes for absorbtion with other minerals, we know that bisphosphonates bind to and reduce the absorption of minerals other than calcium such as magnesium, iron, copper, and zinc, hindering both the medication and minerals from being metabolized. Although we need more time and research to identify all the micronutrients that Evenity may deplete, any deficiencies in essential micronutirents puts your bone building ability at risk.
Support Bone Health Naturally
The bottom line is, no medication will address the underlying issues that caused your osteoporosis in the first place. And when you add in these medications not-so-appetizing side effects, we highly recommend considering a scientifically proven micronutrient-focused approach to rebuilding your bone that can actually deliver results. Our new book Rebuild Your Bones, The 12-Week Osteoporosis Protocol, is a step by step guide that will put you on the path towards beating your osteoporosis – preorder your copy today!
The choice us up to you can buy into Big Pharma’s feeble attempt to manipulate natural bone formation which can put you at risk for numerous adverse effects or you can empark on an alternative path that supplies your body with the essential micronutrients it needs to remodel bone naturally without any potential health risks. It seems to us that the choice is pretty clear. If you or a loved one is suffering from osteoporosis or osteopeina, or are interested in preventing it, and want to learn more about our new book Rebuild Your Bones, The 12-Week Osteoporosis Protocol, just CLICK HERE and let us know –we can’t wait to hear from you!