[{"@context":"https:\/\/schema.org\/","@type":"Article","@id":"https:\/\/betterbones.com\/bone-drugs\/a-look-at-the-latest-bone-drug-evenity\/#Article","mainEntityOfPage":"https:\/\/betterbones.com\/bone-drugs\/a-look-at-the-latest-bone-drug-evenity\/","headline":"A look at the latest bone drug, Evenity","name":"A look at the latest bone drug, Evenity","description":"Print PDF eBook Facebook Twitter Gmail 2 LinkedIn Pinterest In April 2019, the FDA approved romosozumab (Evenity), a new osteoporosis drug targeted at postmenopausal women with high risk for fracture. I looked at the data used by the FDA in granting approval for the drug — and it’s far from confirming the runaway success of […]","datePublished":"2019-09-29","dateModified":"2026-04-06","author":{"@type":"Person","@id":"https:\/\/betterbones.com\/author\/brownbetterbonesgmail-com\/#Person","name":"Dr. Susan E. Brown, PhD","url":"https:\/\/betterbones.com\/author\/brownbetterbonesgmail-com\/","identifier":72,"image":{"@type":"ImageObject","@id":"https:\/\/secure.gravatar.com\/avatar\/8e08d87bd45250c6616e1752933a6576aba077f335d97ee337a0cde5e435cbd3?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/8e08d87bd45250c6616e1752933a6576aba077f335d97ee337a0cde5e435cbd3?s=96&d=mm&r=g","height":96,"width":96}},"publisher":{"@type":"Organization","name":"Center for Better Bones","logo":{"@type":"ImageObject","@id":"https:\/\/betterbones.com\/wp-content\/uploads\/2018\/12\/Better-Bones-AMP.png","url":"https:\/\/betterbones.com\/wp-content\/uploads\/2018\/12\/Better-Bones-AMP.png","width":150,"height":60}},"image":{"@type":"ImageObject","@id":"https:\/\/betterbones.com\/wp-content\/uploads\/2019\/09\/the-truth-about-the-bone-drug-evenity.png","url":"https:\/\/betterbones.com\/wp-content\/uploads\/2019\/09\/the-truth-about-the-bone-drug-evenity.png","height":512,"width":1024},"url":"https:\/\/betterbones.com\/bone-drugs\/a-look-at-the-latest-bone-drug-evenity\/","video":{"@context":"http:\/\/schema.org\/","@type":"VideoObject","@id":"https:\/\/www.youtube.com\/watch?v=Y922zcjwUoA#VideoObject","contentUrl":"https:\/\/www.youtube.com\/watch?v=Y922zcjwUoA","name":"New Bone Drug Evenity- Hype & Concerns","description":"Dr. Susan Brown discusses a new bone drug, Evenity and its hype and concerns. \n\nLearn more about bone health: www.betterbones.com\nCheck us out on facebook: https:\/\/www.facebook.com\/betterbonesbetterbody\/\nExercise for bone health: patreon.com\/betterbones\n\nTranscription:\nhi everyone I welcome everyone in the\nbetter bones community this afternoon\nwe're gonna have a little fun my office\nmy staff we've been really busy\npreparing a report for you on this new\nbone drug that's just come out you might\nhave seen the report yesterday in the\nNew York Times reporting that most\nosteoporosis drugs don't build bone but\nthis one does and it's a whole fanfare\nabout a new drug a new drug that they're\ncalling a vanity the technical name is\nreally compliment complicated remote so\nzoo mob no wonder they call it a vanity\nto make it simple this drug is a very\ninteresting new type of drug it has a\nreally peculiar history and it is held\nto build bone but what I'm going to show\nyou is that it really doesn't reduce\nfracture very much and that's the most\nimportant thing so if you are interested\nin this analysis of this new drug if you\nwant to know what you need to know when\nyour doctor tells you you should think\nabout this drug stay tuned and also we'd\nlike you to share this little discussion\nwith your group so that many women\naround the world can learn about this\nnew drug like I say it's been very\ninteresting looking into this drug so\nthe first thing is you might wonder what\nabout this drug so this drug has just\nbeen released and actually it has the\nblack black box warning and a black box\nwarning on a drug means there's very\nserious possible side effects in this\nparticular case this black box warning\nis that there's an increased risk of\nheart attack stroke and cardiovascular\ndisease these are the major problems\nthat can happen even though they may be\nrare they've had to put a black box\nwarning at it and then there's some\nother additional side effects that are\nthings like possible necrosis of the jaw\npossible unwarranted fractures several\nother adverse reactions that they've\nreported in the studies minor reactions\nfrom allergic responses to low blood\ncalcium to necrosis of the jaw to\natypical fractures many of these side\neffects we've heard before with some of\nthe other bone drugs that halted bone\nbreakdown\nthis is a new drug it's held to build\nbone formation and it has its own\nserious bunch of side effects the most\ndistinctive ones are the heart attack\nand stroke but you say you might say so\nwhat is this new drug what it is it's an\nantibody to a natural factor that the\nbody produces the body produces a skull\nRosten which actually is a natural turn\noff switch to bone growth so the body\nproduces you know we produce all kinds\nof factors that stimulate bone growth\nall kinds of factors that slow down bone\ngrowth and through a most peculiar\nhistory I'm gonna tell you about and as\nan anthropologist it's a fascinating\nstory they found out that this\nparticular turnoff switch to bone growth\noccurred in certain areas of the world\nand people developed really strong bones\nalthough there was some problems with\nthat as you're gonna see in a second so\nthen they said let's develop a drug that\ncan stop this turn off switch so that\nbone just keeps growing and growing and\ngrowing this is a new drug event at E\njust to show you a little illustration\nof how it works you might be able to see\nthis slide it talks about sclerostin and\nhow it really works - it works to\ninhibit bone formation so the bone\nformation doesn't get run away the body\nhas so many checks and balances so they\ndiscovered this one checks and balances\nthe disk Lauriston is produced by the\nbone cells and it's a way to quiet down\nbone formation now how did they ever get\nthis idea well they got this idea of\ndeveloping a drug that halted the action\nof sclerostin because there's a\npopulation in South Africa\nsome Dutch immigrants went there\nsometime ago and there was one single\nmutation a mutation that actually caused\nthis skull rust and not to be effective\nand you got overgrowth of bone these\nthere were 66 people they've identified\nnow that have this all from one single\nfounder that have this mutation and they\ndevelop things like progressive skeletal\novergrowth they develop in large skull\nand\nmandible often with facial palsy they\ndevelop high intracranial pressure from\nthe crane from the cranium developing\nsuch big bone and they often develop\ndeafness so when they discovered this\npopulation they said wow maybe we could\ndo a drug that that took off the breaks\non bone growth and we could build more\nnew bone so they actually did that and\nthe drug that you've seen is the one\nthat came out today that everyone is\nreally raving about that it can build\nbone those of you that followed the work\nat the Center for better bones know that\nwhat we care about is actually the\nendpoint is fracture reduction how much...","thumbnailUrl":["https:\/\/i.ytimg.com\/vi\/Y922zcjwUoA\/default.jpg","https:\/\/i.ytimg.com\/vi\/Y922zcjwUoA\/mqdefault.jpg","https:\/\/i.ytimg.com\/vi\/Y922zcjwUoA\/hqdefault.jpg","https:\/\/i.ytimg.com\/vi\/Y922zcjwUoA\/sddefault.jpg","https:\/\/i.ytimg.com\/vi\/Y922zcjwUoA\/maxresdefault.jpg"],"uploadDate":"2019-04-12T17:21:01+00:00","duration":"PT10M36S","embedUrl":"https:\/\/www.youtube.com\/embed\/Y922zcjwUoA","publisher":{"@type":"Organization","@id":"https:\/\/www.youtube.com\/channel\/UCm6Zry9uGdrZpm05sQLIxMw#Organization","url":"https:\/\/www.youtube.com\/channel\/UCm6Zry9uGdrZpm05sQLIxMw","name":"Dr. Susan E. Brown","description":"Dr. Susan E. Brown, PhD, is a medical anthropologist, a New York State Certified Nutritionist, and the author of Better Bones, Better Body -- the first comprehensive look at natural bone health. Dr. Brown specializes in osteoporosis, osteopenia, bone health regeneration, and auto-immune disease. She is also famous for her natural approach to bone health; check out her Better Bones programs and products.","logo":{"url":"https:\/\/yt3.ggpht.com\/ytc\/AIdro_m0l08uY9k8RO1FbN8-VsYIOa8fiq9BtocNNM_k3xw7a7s=s800-c-k-c0x00ffffff-no-rj","width":800,"height":800,"@type":"ImageObject","@id":"https:\/\/www.youtube.com\/watch?v=Y922zcjwUoA#VideoObject_publisher_logo_ImageObject"}},"potentialAction":{"@type":"SeekToAction","@id":"https:\/\/www.youtube.com\/watch?v=Y922zcjwUoA#VideoObject_potentialAction","target":"https:\/\/www.youtube.com\/watch?v=Y922zcjwUoA&t={seek_to_second_number}","startOffset-input":"required name=seek_to_second_number"},"interactionStatistic":[[{"@type":"InteractionCounter","@id":"https:\/\/www.youtube.com\/watch?v=Y922zcjwUoA#VideoObject_interactionStatistic_WatchAction","interactionType":{"@type":"WatchAction"},"userInteractionCount":16945}],{"@type":"InteractionCounter","@id":"https:\/\/www.youtube.com\/watch?v=Y922zcjwUoA#VideoObject_interactionStatistic_LikeAction","interactionType":{"@type":"LikeAction"},"userInteractionCount":318}]},"about":["Bone Drugs"],"wordCount":1274,"articleBody":" Print PDF eBook\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tFacebook\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tTwitter\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tGmail\t\t\t\t\t\t2\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tLinkedIn\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tPinterest\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tIn April 2019, the FDA approved romosozumab (Evenity), a new osteoporosis drug targeted at postmenopausal women with high risk for fracture. I looked at the data used by the FDA in granting approval for the drug — and it’s far from confirming the runaway success of Evenity that Big Pharma would lead us to believe. So before you fill that prescription, here’s some information I think you should know.Table of ContentsToggle     6 Minutes ReadNew bone drug Evenity — how does it work?What did the studies show?Did Evenity really make a big difference?Taking drawbacks into accountNew bone drug Evenity — how does it work?Evenity is a monoclonal antibody that suppresses a protein called sclerostin, which also regulates bone formation.\u00a0In people who have a rare genetic disorder called sclerosteosis, sclerostin is very low, which allows osteoblasts to build bone at will. People who are born with sclerosteosis or a milder form called Van Buchem Disease have enhanced bone formation and denser, stronger bones than average \u2014 typically, Z-scores in the spine of as much as +7.7\u2013+14.4. This might sound great to someone with osteoporosis, but the truth is, unimpeded bone building with nothing stopping it eventually causes serious harm, including entrapped nerves and enlargement of the skull, which puts pressure on the brain \u2014 and most people with sclerosteosis don\u2019t live past their 30s.\u00a0Knowing this, researchers looked for a way to inhibit sclerostin in women with low bone mass to see if it would cause them to develop greater bone density. And it does \u2014 although this shouldn\u2019t surprise anyone. The principle of \u201cuse the body\u2019s own mechanisms to build bone\u201d is a fairly sound idea on the face of it. Where it runs into problems \u2014 and Evenity is no exception \u2014 is when you put normal bodily mechanisms on overdrive, as most of these medications do.\u00a0What did the studies show?The data used for the drug\u2019s approval comes from two trials: The FRAME study (FRActure study in postmenopausal woMen with ostEoporosis) and the ARCH study, both of which looked at postmenopausal women at high risk for fracture.The FRAME study enrolled 7180 postmenopausal women with a T-score of \u20132.5 to \u20133.5 at the total hip or femoral neck \u2014 so, definitely in the bone loss zone that defines osteoporosis. Half of these women were given Evenity, while the other half got a placebo. All of the participants also got at least 500 mg calcium and 600 international units (IU) of vitamin D supplementation daily, and anyone in either group who had serum 25-hydroxyvitamin D concentrations of 40 ng\/mL or less (which was a whopping 77% of participants!) was given a loading dose of 50,000 to 60,000 international units of vitamin D within one week of randomization. After 12 months on Evenity, all of the participants were switch to Prolia for 12 months.\u00a0The ARCH study was similar, except instead of following the year of Evenity or placebo with a year of Prolia, participants received alendronate (Fosamax). And as in the other study, the 4093 participants were all given 500 mg of calcium and 600 IU of vitamin D, and 74% had the same vitamin D loading dose as in the FRAME study.So, how did the patients taking the drug fare? When you read the FRAME researchers\u2019 publication in the Journal of Bone & Mineral Research, the numbers are staggering: \u201cafter 12 months of romosozumab, at the lumbar spine, 96% of patients achieved gains \u22653% from baseline, 89% of patients achieved gains \u22656%, and 68% of patients achieved gains \u226510%, compared with 22%, 6%, and 1% of patients receiving placebo\u201d \u2014 amazing numbers!\u00a0Are they too good to be true? You bet they are.Did Evenity really make a big difference?Let\u2019s go back for a minute and consider the protocols used in the FRAME and ARCH studies. Each of the women enrolled had osteoporosis \u2014 it was a prerequisite for participating. All of them got vitamin D tested, and well over two-thirds in both studies were identified as being deficient and given a therapeutic dose of vitamin D. (It\u2019s also interesting to see that the cutoff point for vitamin D deficit was set at 40 ng\/mL, higher than the usual 30 ng\/mL).\u00a0While the results from the drug arm of the FRAME study are astonishing, what\u2019s really interesting are the results from the placebo group in the FRAME study, where 29% of the participants had a 3\u201310% improvement in bone density just from the added vitamin D and calcium. Meanwhile, 47% had a decrease in bone density. The remainder (24%) saw no significant change.What this means is that the vitamin D therapy alone enabled more than half (53%) of the women in the placebo group to halt their bone loss and, for some, start building bone. It\u2019s problematic for the findings because this \u201cplacebo\u201d arm did not actually use a placebo \u2014 what it did was identify a common cause of bone loss and treat it using nutrition (sound familiar?). How much more improvement would this groups have seen if they had also used weight-bearing exercise and the remaining key nutrients as part of its \u201cplacebo\u201d?Taking drawbacks into accountThe findings from the FRAME trial\u2019s placebo arm also imply something else: that nearly 2000 of the women who were given Evenity could have halted their bone loss and perhaps started to build bone even without the drug, just by improving their vitamin D status.\u00a0However, they built even more bone with the drug, and that\u2019s good, right? Well, if that were all the drug did, it certainly would be. But the bone drug Evenity comes with a black box warning of increased risk of heart attack, stroke, and death. One has to wonder if the risk of a heart attack is really worth it for the thousands of\u00a0women who took this drug without realizing that the \u201csupportive\u201d treatment \u2014 vitamin D therapy \u2014 might be responsible for at least some of the bone-building effects.\u00a0The news from the ARCH trial is no different: It found reductions in fracture incidence (which you\u2019d expect) but increased cardiovascular events, as well as a few instances of the atypical fractures and osteonecrosis of the jaw \u2014 problems that have been associated with bisphosphonates in the past.Not to mention, the reason these studies were constructed with only 1 year of Evenity followed by 1 year of a different drug is that Evenity stops working after 1 year. It\u2019s a pity that the researchers didn\u2019t follow a year of Evenity with a year of just nutritional support to see whether the gains seen in the women who took the bone drug Evenity were maintained. (Maybe they didn\u2019t want to know the answer\u2026) [av_toggle_container initial=’0′ mode=’accordion’ sort=” styling=” colors=” font_color=” background_color=” border_color=” av_uid=’av-zftmqdcj’ custom_class=”][av_toggle title=’References’ tags=” av_uid=’av-nezd6gib’]Appelman-Dijkstra N, Van Lierop A, Papapoulos S. SOST-related sclerosing bone dysplasias. In: Adam MP, Ardinger HH, Pagon RA, et al., editors. GeneReviews (Internet). Seattle (WA): University of Washington, Seattle; 1993-2019.Cosman F, Crittenden DB, Adachi JD, et al. Romosozumab treatment in postmenopausal women with osteoporosis. N Engl J Med. 2016;375:1532\u201343.Lewiecki EM. Role of sclerostin in bone and cartilage and its potential as a therapeutic target in bone disease. Ther Adv Musculoskelet Dis 2014;6(2):48-57.Saag KG, Petersen J, Brandi ML, et al. Romosozumab or alendronate for fracture prevention in women with osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427.Sancar F. Caution with new osteoporosis drug. JAMA 2019;321(19):1862.[\/av_toggle][\/av_toggle_container] Explore our in-depth resource on rebuilding bone density naturally.For natural support alongside any treatment, read our complete guide to bone health nutrition as a natural foundation."},{"@context":"https:\/\/schema.org\/","@type":"BreadcrumbList","itemListElement":[{"@type":"ListItem","position":1,"name":"Bone Drugs","item":"https:\/\/betterbones.com\/bone-drugs\/#breadcrumbitem"},{"@type":"ListItem","position":2,"name":"A look at the latest bone drug, Evenity","item":"https:\/\/betterbones.com\/bone-drugs\/a-look-at-the-latest-bone-drug-evenity\/#breadcrumbitem"}]}]