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Many of my clients use the osteoporosis medication EVENITY. It has been available since 2019 when the Food and Drug Administration (FDA) approved it as a treatment for osteoporosis.
EVENITY Review for Patients by a Leading Physician and Researcher
To help you better understand how EVENITY works, its long-term side effects, and when it’s used, I reached out to Dr. Janet Rubin, a practicing endocrinologist specializing in bone and mineral diseases at the University of North Carolina.
Dr. Rubin is the Sarah Graham Kenan Distinguished Professor and Vice Chair for Research in UNC’s Department of Medicine. She has spent her career studying bone remodeling, with a particular focus on how bone responds to mechanical forces like exercise.
In 2021, Dr. Rubin generously shared her experience treating patients with EVENITY. In late 2025, we revisited the topic to discuss what’s new for patients considering this medication.
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.
MelioGuide has no commercial relationship with Amgen.
What is EVENITY?
EVENITY is a medication for people with osteoporosis or those at high risk of fracture. Your physician may call it by its generic name, romosozumab. EVENITY is the trade name, and the medication is developed by the biotechnology company Amgen. It’s one of the newer osteoporosis treatments available, having received FDA approval in 2019.
EVENITY is a monoclonal antibody that is classified as an anabolic drug. An anabolic medication stimulates bone formation. As Dr. Rubin puts it, EVENITY kicks bone formation into high gear.
Is EVENITY a Bisphosphonate?
EVENITY is not a bisphosphonate.
Bisphosphonates (1) are a class of drugs that have been available since the 1990s to treat osteoporosis in both men and women. They work by inhibiting bone resorption and are classified as anti-resorptive agents. Prolia is another anti-resorptive drug.
Many of Dr. Rubin’s patients ask whether bone formation still occurs when using an anti-resorptive like a bisphosphonate or Prolia. The answer is yes. Bone is a living organ that constantly maintains and rebuilds itself. Anti-resorptive medications slow down bone breakdown, but formation continues naturally as part of the bone remodeling process.
EVENITY works differently. As an anabolic drug, it takes your body’s natural bone-forming activity and amplifies it, producing more bone than you would create organically on your own.
EVENITY Mechanism of Action
EVENITY is a monoclonal antibody with a unique mechanism of action. This monoclonal antibody binds to a specific molecule called sclerostin, a regulatory factor in bone metabolism.
According to the U.S. National Library of Medicine on MedlinePlus, sclerostin produces osteocytes, which are a type of bone cell. The main function of sclerostin is to stop (inhibit) bone formation. Inhibition of bone formation is necessary to ensure that bones are of the correct shape, size, and density. (2)
Sclerostin: A Protein That Inhibits Bone Formation
Sclerostin is produced naturally by osteocytes (the cells embedded within bone tissue) and acts as the body’s built-in brake on bone formation. It does this by binding to a receptor called LRP5/6 on the surface of osteoblasts, the cells responsible for building new bone. When sclerostin attaches to this receptor, it blocks a key signaling pathway known as Wnt/β-catenin, which is one of the primary drivers of osteoblast activity and bone production.
In other words, your body is constantly holding back its own bone-building capacity, and sclerostin is the mechanism it uses to do so.
EVENITY (romosozumab) is a monoclonal antibody that binds to sclerostin, preventing it from attaching to LRP5/6. With sclerostin out of the way, the Wnt/β-catenin pathway is free to function without interference, and osteoblasts can form bone more actively.
Releasing a Brake, Not Pressing the Accelerator
This distinction matters. EVENITY does not directly stimulate osteoblasts the way that Forteo (teriparatide) or Tymlos (abaloparatide) do. Those medications bind to the PTH receptor on osteoblasts and actively drive bone formation, increasing all of bone remodeling, both osteoblast and osteoclast activity, in the process.
EVENITY works differently. Rather than switching on a new process, it removes something that was holding an existing process back. In pharmacology, this is called disinhibition: the drug’s effect comes not from activating something, but from taking away what was suppressing it.
The practical consequence is significant. Because EVENITY does not ramp up osteoclast activity the way Forteo and Tymlos do, it avoids the early window of increased fracture vulnerability that can occur in the first few months of treatment with those medications. With Forteo and Tymlos, the simultaneous increase in both bone formation and bone resorption means there is a period at the start of treatment where the patient’s fracture protection has not yet caught up. EVENITY does not create this same early risk, though it does take some months before its full protective effect is established.
This is also why EVENITY’s effect on bone turnover markers looks different from the other anabolic agents. With Forteo and Tymlos, both P1NP (a marker of bone formation) and CTX (a marker of bone resorption) rise. With EVENITY, P1NP rises while CTx decreases, reflecting its unique dual action: promoting bone formation while simultaneously reducing resorption, without directly stimulating either side of the remodeling cycle.
A Bimodal Anabolic and Antiresorptive Agent
However, Dr. Rubin states that EVENITY does more than stimulate bone formation by suppressing sclerostin.
EVENITY (romosozumab) works in two ways.
- It’s primarily an anabolic agent that promotes bone formation by enhancing osteoblast activity.
- But it also acts as an antiresorptive agent, reducing bone breakdown by decreasing osteoclast activity.
This dual effect comes from how the medication works at a molecular level. As a monoclonal antibody, EVENITY binds to and inhibits sclerostin, a protein that normally suppresses bone formation while promoting resorption. By neutralizing sclerostin, romosozumab activates the Wnt/β-catenin signaling pathway, which boosts osteoblast function. At the same time, it lowers RANKL expression, curbing osteoclast differentiation and reducing bone breakdown. (3)
Source: https://www.evenityproliasa.com/starting-evenity/mechanism-of-action
How is EVENITY Administered?
According to Dr. Rubin, EVENITY is administered once a month by a nurse in her clinic. The treatment consists of two injections given one after the other during the same visit.
The injection site is either the abdomen, thigh, or upper arm. Patients return monthly for 12 consecutive months to complete the full course of treatment.
Dr. Rubin has not had a patient experience any problems with the double injection.
Can EVENITY be Self Administered?
I asked Dr. Rubin whether patients can self-administer EVENITY at home instead of coming into the clinic. She only offers the in-clinic option because she’s concerned about patients potentially doing the injections incorrectly.
However, Dr. Rubin recognizes that not everyone can easily access a clinic for monthly injections. Some patients travel two to four hours to reach her clinic, and making that trip every month is a significant barrier. Others may not be able to drive at all.
On the topic of self-injection, she believes almost anyone can learn to do it safely with proper training, guidance, and support. After all, diabetics have been self-injecting insulin since it was first purified in the 1930s.
Dr. Rubin acknowledges that medicine comes with many barriers, and every doctor needs to work closely with their patient to find solutions, figuring out what they can afford, what treatments they can access, and how they’ll manage their care going forward.
How Long Does EVENITY Stay in Your System?
When evaluating medications, doctors consider the half-life, how long it takes for half the drug to leave your system. For EVENITY, the half-life is about two weeks. After two weeks, half the medication is gone. After another two weeks, half of what remains is gone. The drug is essentially cleared from your system within about two months.
Because the effect begins to diminish as drug levels drop, the monthly dosing schedule ensures you maintain therapeutic levels throughout treatment.
When Does Protection from EVENITY Begin?
Most of EVENITY’s bone-building benefits occur in the first six months, followed by a period of bone consolidation.
Dr. Rubin wants patients to understand that protection isn’t immediate after the first injection. Data from bisphosphonate studies showed that fracture prevention benefits typically appeared around the six-month mark, that’s when researchers observed a decrease in new fractures.
It’s also important to have realistic expectations. No osteoporosis medication eliminates fracture risk entirely. Even people with osteopenia, not full osteoporosis, can experience spine fractures or broken hips. No doctor can guarantee you’re 100% protected.
How Long Can You Be On EVENITY?
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.
Is EVENITY Worth the Risk?
One serious concern with EVENITY is cardiovascular risk. This potential side effect was examined in two major studies of romosozumab: the ARCH study (4) and the FRAME study (5). The studies differed somewhat in their design and participant populations.
ARCH Study: Romosozumab
The ARCH study enrolled slightly older women who may have had more hypertension than participants in the FRAME study.
Over 4,000 individuals participated, split evenly between those receiving romosozumab for one year and those receiving weekly oral alendronate (a bisphosphonate). The bisphosphonate group experienced slightly fewer cardiovascular events than the romosozumab group.
It’s important to note that the difference was small, 38 cardiovascular events in the bisphosphonate group compared to 50 in the romosozumab group. This was also a long-term study in an age group where cardiovascular disease is common.
Still, the difference was enough to catch the FDA’s attention, and the manufacturer, Amgen, was required to place a warning on the EVENITY label.
FRAME Study: Romosozumab
The FRAME study enrolled younger participants than the ARCH study. The research team reported no difference in cardiovascular events between groups.
What Recent Research Shows
Dr. Rubin explains that the initial concern was whether blocking sclerostin might affect calcification in the vascular system. However, subsequent research has been reassuring. Three recent studies have addressed this question:
- The Stokar study in 2025 (6), published in JCEM, compared real-world cardiovascular event rates between patients taking EVENITY and those taking PTH analogs (which have no known cardiovascular association). The EVENITY group actually had fewer events, though Dr. Rubin cautions this doesn’t prove EVENITY is protective, it does suggest patients aren’t experiencing increased cardiovascular problems.
- A study in the JBMR+ (7) followed 847 women and found no signal for cardiovascular events.
- Another by Tominaga in JBMR (8) analysed data from 60,000 patients, 10,000 on EVENITY and 50,000 on bisphosphonates, and found no difference between groups.
Who Should Not Take EVENITY: Dr. Rubin’s Approach
Based on this evidence, Dr. Rubin now feels comfortable prescribing EVENITY to most patients. The black box warning remains, advising against use in people who’ve had a cardiovascular event in the past year. For other patients, she mentions that she’s not concerned about cardiovascular effects.
She does note some theoretical considerations for the future. Sclerostin, the molecule EVENITY blocks, is secreted by bone but may have effects elsewhere in the body, potentially in cartilage and the vascular system. Whether repeated courses of EVENITY over many years could raise concerns remains unknown.
However, as the drug is currently used, a single 12-month course, Dr. Rubin believes patients should feel confident that EVENITY will have positive effects without negative consequences. Her opinion on the cardiovascular risk has shifted considerably based on the recent evidence.
Long-Term Side Effects of Evenity
I asked Dr. Rubin about side effects she’s observed in her patients. In her experience, significant side effects have been rare. The most common issue is soreness at the injection site.
- One patient developed a fever after the first injection, but it was milder with the second dose and gone entirely by the third, the patient had forgotten it was ever a concern.
- Dr. Rubin has had to discontinue EVENITY in only one patient. This woman developed a rash after each injection, and the rash worsened each time. Whether the reaction was to the monoclonal antibody itself or to the carrier solution isn’t clear. However, because a worsening rash could potentially progress to an anaphylactic response, continuing the medication wasn’t worth the risk.
This type of reaction isn’t unique to EVENITY, it can happen with any medication. If you develop a rash from a drug, it’s generally best to stop taking it.
Overall, Dr. Rubin notes that patients may mention minor complaints, but if you look at any medication, you’ll find similar lists of minor side effects. In her practice, most patients complete the full year of treatment without significant issues.
EVENITY Side Effects: What Clinical Trials and Real-World Experience Tell Us
Understanding the potential side effects of EVENITY (romosozumab) is important when weighing it as a treatment option. Clinical trial data gives us a starting point, but the experiences of clinicians managing real patients day-to-day often add texture that trial averages alone can miss.
What the Clinical Trials Found
EVENITY’s safety profile was established through two large pivotal trials. The FRAME study enrolled 7,180 women and compared EVENITY with placebo, while the ARCH study included 4,093 women with severe osteoporosis and compared EVENITY with alendronate. In total, more than 5,000 women received EVENITY across these two trials.
The most commonly reported side effects were joint pain (8–13% of participants), headache (about 5–7%), and injection site reactions (approximately 5%). Rare but serious side effects included atypical femur fractures, osteonecrosis of the jaw, and severe allergic reactions.
EVENITY also carries an FDA boxed warning, the agency’s most serious safety label, regarding an increased risk of heart attack, stroke, and cardiovascular death. In the ARCH trial, major adverse cardiac events occurred in 2% of women receiving EVENITY compared to 1.1% of those on alendronate. EVENITY should not be started in patients who have had a heart attack or stroke within the past year.
What Clinicians Are Seeing in Practice
In our interview with Dr. Janet Rubin, she noted that her experience with EVENITY side effects has been relatively mild, mentioning only one patient who developed a rash.
Keith McCormick, author of The Whole Body Approach to Osteoporosis and Great Bones, offers a broader clinical perspective. Having treated 211 patients with EVENITY, his is one of the larger individual clinician caseloads reported, most practitioners will never prescribe EVENITY to anywhere near that number of patients. That said, 211 patients is still a small fraction of the 5,000+ who received EVENITY in the pivotal trials, and observations from a single clinical practice are subject to greater variability than large, controlled studies. Factors such as referral patterns, patient complexity, and how actively a clinician asks about symptoms can all influence reported side effect rates.
Observations of the McCormick Patient Group
With that context in mind, here is what McCormick has observed:
- Joint and musculoskeletal pain. Approximately 25% of his patients reported at least moderate low back, hip, or knee pain during treatment, notably higher than the 8–13% arthralgia rate from the clinical trials. Some of this difference may reflect how symptoms are captured: clinical trials use standardized adverse event reporting, while a clinician who routinely asks patients about pain may surface complaints that would otherwise go unreported. It may also reflect differences in the patient populations being treated. Nearly all of McCormick’s affected patients improved, though two were exceptions, one whose joint pain took about a year after stopping EVENITY to resolve, and another who continues to experience joint crepitus (a cracking or grinding sensation) in all joints more than a year after discontinuation, though without pain.
- Cardiac effects. Seven of his 211 patients (approximately 3%) developed tachycardia or arrhythmias. All resolved after discontinuing EVENITY, with one exception, a patient who continued to have cardiac issues even after stopping treatment. At seven cases out of 211, this is too small a number to draw firm statistical conclusions, but it is a clinical signal worth noting alongside the existing FDA boxed warning about cardiovascular risk.
- Skin reactions. Four patients experienced substantial rashes, consistent with the known, though uncommon, hypersensitivity reactions documented in clinical trials.
What This Means for You
The contrast between Dr. Rubin’s experience, McCormick’s observations, and the clinical trial data illustrates an important reality: side effect profiles can look quite different depending on sample size, patient population, and clinical setting. Large trials give us reliable averages across thousands of patients. A clinician’s experience with 211 patients, while substantial for an individual practice, carries wider statistical variability and may be shaped by the types of patients they tend to see. Neither perspective invalidates the other. Together, they offer a more complete picture than either one alone.
The EVENITY Decision: Symptoms and Risks
If you are considering EVENITY or are currently receiving it, keep these points in mind:
Talk openly with your prescribing clinician about any new symptoms, especially joint pain, heart palpitations, or skin changes. Most side effects observed in both the clinical trials and in clinical practice have been manageable and resolved after treatment ended. The cardiovascular warning is serious and should be part of every conversation about whether EVENITY is the right choice for your specific risk profile.
As with any osteoporosis medication, the decision to use EVENITY should be based on your individual fracture risk, medical history, and a thorough discussion with your healthcare provider about both the benefits and the risks.
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
I asked Dr. Rubin how EVENITY compares to other anabolic medications like Forteo and Tymlos.
Dr. Rubin explained that Forteo and Tymlos are parathyroid hormone (PTH) drugs — the other main anabolic options available.
In head-to-head studies, EVENITY showed impressive results. The first major comparison, published by McClung in 2014 in the New England Journal (9), found that after just one year, EVENITY increased spine bone density by 11%, compared to 7% with teriparatide (Forteo) and 4% with alendronate (a bisphosphonate). In animal experiments, EVENITY produces the most bone formation by a significant margin.
While EVENITY and the PTH drugs (Forteo and Tymlos) are all anabolic, they work in completely different ways. The key distinction is that EVENITY is a bimodal drug, it stimulates bone formation while also inhibiting resorption. The PTH drugs, on the other hand, stimulate both formation and resorption at the same time.
With EVENITY, you get bone building switched on and bone breakdown switched off. With PTH drugs, both processes are active simultaneously. This difference likely explains why EVENITY produces better results.
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.
Prolia vs EVENITY: How Do They Compare?
Both Prolia (denosumab) and EVENITY (romosozumab) are injectable monoclonal antibodies used to treat osteoporosis. However, they work through fundamentally different mechanisms and serve different roles in treatment.
How Prolia and EVENITY Work
EVENITY is a dual-action medication. It blocks sclerostin, which stimulates osteoblasts (bone-building cells) while also reducing osteoclast activity (bone-resorbing cells). This means it both builds new bone and slows bone breakdown simultaneously.
Prolia is purely anti-resorptive. It inhibits RANKL, a protein essential for osteoclast formation. By blocking RANKL, Prolia slows bone breakdown but doesn’t actively stimulate new bone formation.
Treatment Duration
EVENITY is a short-term treatment consisting of 12 monthly injections (two shots per visit) for one year only. After completing the course, patients must transition to another medication.
Prolia is a long-term maintenance therapy with no set end date. It’s administered once every six months and can be continued indefinitely, though stopping abruptly carries risks.
Effectiveness
In head-to-head studies, EVENITY showed superior bone density improvements. After 12 months, lumbar spine bone mineral density increased by 12.5% with EVENITY compared to 7.2% with Prolia. Similar advantages were seen at the hip and femoral neck.
In the FRAME study extension, patients who started on EVENITY and transitioned to maintenance therapy experienced a 75% reduction in vertebral fractures, with lumbar spine bone mineral density gains of 18.1%.
Who Can Use Them
EVENITY is FDA-approved only for postmenopausal women at high risk of fracture.
Prolia has broader approval. It can be used in postmenopausal women, men with osteoporosis, and patients with bone loss from glucocorticoid use or certain cancer treatments.
Safety Considerations
EVENITY carries a black box warning regarding cardiovascular risk. Dr. Rubin discusses this issue in detail in another part of this post.
Prolia doesn’t carry cardiovascular warnings but has its own concerns. Stopping Prolia abruptly can trigger rapid bone loss and increased fracture risk. Rare side effects include osteonecrosis of the jaw and atypical femoral fractures with long-term use.
Both medications can cause joint pain, headache, and injection site reactions.
Using EVENITY and Prolia Together
Clinical studies suggest that starting with EVENITY followed by transitioning to Prolia results in better long-term bone health outcomes compared to starting with Prolia alone. This sequential approach maximises bone density gains and maintains fracture protection over time.
As Dr. Rubin mentioned, she sometimes follows EVENITY with Prolia for patients with very low bone density because Prolia provides stronger ongoing bone density improvements than bisphosphonates.
EVENITY vs Prolia: Quick Comparison
EVENITY and Exercise
Exercise should be a critical part of your bone health program. Dr. Rubin recommends that all her clients follow a safe and effective exercise program.
What to Take After EVENITY
Is there a follow-up drug after EVENITY? Yes, but the situation isn’t as urgent as with Prolia, where stopping abruptly can cause problems.
The clinical studies of EVENITY always followed it with another medication. We don’t have good data on what happens if someone simply stops EVENITY without transitioning to something else. However, because the monoclonal antibody clears from your system within about two months (mostly within one month, which is why it’s dosed monthly), follow-up treatment is recommended.
The choice of follow-up medication is a clinical judgment based on individual circumstances.
For patients with very low bone mineral density, Dr. Rubin often follows EVENITY with Prolia (denosumab). This combination continues to build bone density because Prolia has a stronger effect on bone mineral density than bisphosphonates.
For patients whose bone density isn’t severely low but who received EVENITY because of a spine fracture, she may follow with a bisphosphonate instead. This puts patients on a standard long-term osteoporosis management path, potentially moving toward a drug holiday if appropriate.
The key takeaway: when you finish EVENITY, you should expect to transition to another medication to maintain the bone you’ve built.
Can You Take a Second Course of EVENITY?
Given the long lives that osteoporosis patients have ahead of them, the potential for using EVENITY a second time is an important consideration.
One thing to understand about EVENITY: bone formation increases for about the first six months, then tapers off. For the remainder of the treatment year, it functions primarily as an anti-resorptive drug. This raises the question of whether a six-month course might be sufficient, though pharmaceutical companies naturally prefer the full year of treatment.
Research on repeating EVENITY is encouraging. A 2018 study showed that if you waited a year after completing treatment and then restarted EVENITY, you would see bone formation increase again. At least two studies published in the Journal of Bone and Mineral Research this year confirm that the drug can be reused effectively.
Dr. Rubin expects this will become more common. After completing EVENITY, patients transition to another medication, and at some point their doctor may decide another course of EVENITY could boost bone density further. This isn’t yet standard of care, but she believes it’s coming.
Can You Take EVENITY After Prolia or a Bisphosphonate?
The sequencing of osteoporosis medications matters. Research suggests that EVENITY works better after bisphosphonates than after Prolia (denosumab).
The issue with transitioning from Prolia to EVENITY is that stopping Prolia triggers a surge in bone resorption. Even though EVENITY stimulates new bone formation, it may not be enough to offset the bone loss occurring simultaneously. Emerging data supports this concern.
In her own practice, Dr. Rubin sometimes takes an unconventional approach. For patients who’ve been on standard medications for years without much improvement, particularly those who aren’t exercising as recommended, she may suggest a one-year drug holiday before starting EVENITY.
Her reasoning is twofold. First, the break allows the bone metabolism to reset, clearing out any lingering effects from previous medications (bisphosphonates, for instance, may slightly inhibit bone formation). Second, data on drug holidays lasting at least a year suggests that adverse effects from long-term use are reduced during this time.
Dr. Rubin emphasises that she’s risk-averse. It’s worth remembering that because EVENITY also works as an anti-resorptive, it carries the same rare risk of atypical femoral fractures associated with that drug class.
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 (10).
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.
EVENITY Cost and Insurance Coverage
While EVENITY is highly effective, Dr. Rubin notes that it’s an expensive medication, costing as much as $3,300 USD per month without insurance coverage.
However, how the drug is billed can make a significant difference. Because Dr. Rubin’s clinic administers EVENITY on-site, it’s billed as part of the medical benefit rather than the pharmacy benefit. This means that once patients meet their deductible, the medication is generally covered.
The PTH drugs (Forteo and Tymlos) work differently from a billing perspective. They’re processed as a pharmacy benefit, so even when insurance approves coverage, patients take the medication home and face a copay. That copay is often substantial because the drugs themselves are expensive.
In Dr. Rubin’s practice, they’ve been successful getting EVENITY covered by insurance. This has made it their first-choice medication, not only because studies show it’s more effective, but because patients actually receive and complete the treatment.
Amgen SupportPlus Co-Pay Program for EVENITY
A reader contacted me to share information she found about assistance in paying for EVENITY. She believes that this assistance is not dependent on income, although she recommends that you verify that you qualify beforehand.
EVENITY’s list price is approximately $2,628 to $3,300 per month without insurance. Eligible patients with commercial insurance may use the Amgen SupportPlus Co-Pay Program for EVENITY to lower out-of-pocket costs to as little as $0–$25 per dose.
Scroll to the bottom of this post to read A Guide to Amgen Safety Net Foundation and Amgen SupportPlus Program.
EVENITY Treatment 3 Months May Be Enough
A new study from Harvard Medical School, published in The Lancet Diabetes & Endocrinology (11), suggests that the standard EVENITY treatment duration of 12 months may not be necessary—3 months could be just as effective.
This could have a significant effect on the treatment duration period for EVENITY.
Why EVENITY Treatment Duration Matters
EVENITY is remarkably effective. A 12-month course followed by antiresorptive therapy (like Prolia or a bisphosphonate) has been shown to increase bone mineral density more than any other monotherapy and reduce fracture risk more effectively than alendronate, the most commonly used osteoporosis medication.
But here’s something that bone specialists like Dr. Rubin have known for years: EVENITY’s bone-building effects are transient. While the drug both stimulates bone formation and inhibits bone breakdown, the bone-building (anabolic) effects peak within days of starting treatment and return to baseline after just 2–3 months.
The antiresorptive effects, the part that slows bone breakdown, continue throughout the year. But when it comes to actually building new bone, most of the action happens early.
This raises an important question: if the bone-building benefits occur in the first few months, why do we need a full 12 months of a drug that’s expensive, requires monthly clinic visits, and carries cardiovascular warnings?
Making matters more challenging, discontinuation rates for EVENITY in the United States exceed 50% by the end of the treatment course. Many patients simply don’t complete the full regimen due to cost, inconvenience, or concerns about side effects.
What the New Study Found
The trial, conducted at Massachusetts General Hospital, tested whether 3 months of EVENITY followed by 9 months of Prolia (denosumab) would be just as effective as the standard 12 months of EVENITY.
The study enrolled 50 postmenopausal women at high risk of fracture, either because they had a previous fragility fracture or because their bone density T-score was –2.5 or lower. The average age was around 70, and about half had already experienced a fragility fracture.
After 12 months, both groups showed nearly identical improvements in bone density.
The short-course regimen met the study’s “non-inferiority” threshold, meaning it was statistically just as good as the full 12-month course.
Why It Works: The Science Behind It
The bone marker data from the study helps explain why both regimens performed similarly.
P1NP, a marker of bone formation, increased substantially in both groups during the first 3 months (from about 60 to 90 ng/mL). This confirms that EVENITY was doing its bone-building work. After 3 months, when the short-course group switched to Prolia, their P1NP dropped dramatically, but by then, the bone formation boost had already done its job.
Meanwhile, CTX (a marker of bone breakdown) showed a huge decrease in the group that switched to Prolia at 3 months. This makes sense because Prolia is a more potent antiresorptive than EVENITY. So while those patients got less time with EVENITY’s bone-building effects, they got stronger protection against bone breakdown for the remaining 9 months.
Will It Prevent Fractures Just as Well?
This study measured bone density changes, not fractures directly, the sample size was too small for that. But there’s growing evidence that changes in bone mineral density, particularly at the total hip, serve as a reliable predictor of fracture risk reduction.
In Dr. Rubin’s assessment: “I don’t see why not” when it comes to fracture protection. The bone density gains were virtually identical between groups, and we have solid data showing that hip BMD improvements translate to fewer fractures.
What a Shorter EVENITY Treatment Duration Means for Patients
If these findings hold up in larger studies, the implications are significant:
- Cost savings: Three months of EVENITY instead of twelve could reduce drug costs by 75%.
- Fewer clinic visits: Nine fewer monthly injections means less time away from work or other obligations.
- Reduced cardiovascular exposure: Although the cardiovascular risk with EVENITY remains debated, less time on the medication would theoretically reduce any potential risk.
- Better adherence: A shorter, more manageable regimen might help more patients actually complete their treatment.
A Word of Caution
This was a small study, just 50 patients at a single center. It wasn’t designed to prove fracture reduction directly.
But it’s important research that challenges how we think about EVENITY treatment. The standard 12-month regimen was established before we fully understood how quickly the drug’s bone-building effects fade.
Dr. Rubin believes that this is an important development that may change everything we do. We will want to keep tracking this.
The Bottom Line
If you’re currently taking EVENITY or considering it, this doesn’t mean you should change your treatment plan on your own. Continue to follow your physician’s recommendations.
But this research opens an important conversation. Ask your doctor about the trial findings. If cost, inconvenience, or cardiovascular concerns are barriers for you, this study suggests there may be room for a more personalized approach.
We’ll continue to follow this research and update you as more data becomes available.
Is EVENITY Right For You? Clinical Decision Making
Dr. Rubin most commonly prescribes EVENITY for patients who present with a new spine fracture.
Why Spine Fractures Are Serious
Spine fractures are often underestimated. While hip fractures get more attention, Dr. Rubin finds that many of her patients, particularly younger women, recover well from hip fractures. Spine fractures, however, can be devastating.
A spine fracture carries a high risk of chronic pain. It changes how you stand, how you balance, and how your entire upper body moves. The thoracic spine has many degrees of freedom for movement, and a fracture disrupts all of it.
The statistics are sobering: after a spine fracture, your risk of having another one within the next year is approximately 20%, one in five. With 26 vertebrae that could potentially fracture, preventing that next fracture is critical.
EVENITY’s Advantage for Spine Fractures
Alendronate (a bisphosphonate) reduces spine fracture risk by about half, which is genuinely good. But EVENITY can reduce it by about three-quarters. For Dr. Rubin, every spine fracture prevented matters.
This is why high-risk osteoporosis studies typically enrol women who’ve already had a vertebral fracture, researchers are looking to see whether the next one occurs. EVENITY consistently performs best at preventing subsequent spine fractures.
For non-spine fractures, the picture is different. Alendronate performs nearly as well as EVENITY for preventing fractures elsewhere in the body.
Bottom line: if you arrive at Dr. Rubin’s clinic with a spine fracture, you’ll likely be offered EVENITY if it’s appropriate for you.
What About Very Low Bone Density Without Fractures?
Patients sometimes present with extremely low bone mineral density, T-scores of -3.5 or even -4, but no fractures. Should they automatically receive EVENITY?
Dr. Rubin doesn’t believe every patient with very low bone density needs EVENITY, though she acknowledges many colleagues disagree. Her reasoning: EVENITY is expensive, and bisphosphonates are highly effective medications.
What would change her mind? Long-term data. If research showed that patients with T-scores of -4 who received EVENITY had significantly fewer fractures ten years later, that would be compelling. That data doesn’t yet exist.
She notes that younger endocrinologists may be more aggressive in prescribing EVENITY for very low bone density. If you see an endocrinologist in the coming years with this presentation, many will recommend EVENITY, and that’s not wrong. But if your doctor prefers a different approach, they’re not a bad doctor.
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.
Questions For Your Doctor About EVENITY
What should you ask if your physician recommends EVENITY?
Dr. Rubin believes this conversation is essential with any medication, particularly as drugs become more expensive. In the United States especially, where healthcare costs are a significant burden, access to newer medications may become increasingly limited.
She often sees patients upset when they can’t access what they perceive as the “best” drug available. But the question worth asking is: do you actually need the most expensive option?
Is a Bisphosphonate and Alternative to EVENITY?
Bisphosphonates have been available since the 1990s. They’re excellent, proven medications, and they’re hugely underused. So the key questions to ask your doctor are:
- Why do you want me on EVENITY rather than a tried-and-true medication?
- What additional benefit will I get from this expensive drug compared to a cheaper one?
These are difficult questions for both doctors and patients to navigate. If a patient asks Dr. Rubin directly, her answer is straightforward: “You had a spine fracture, and I don’t want you to have another one.”
But she acknowledges the broader challenge. Across medicine, we’re not very good at articulating when expensive drugs are truly necessary versus when established, affordable options work just as well.
The Role of Exercise
Dr. Rubin raises an important point that brings the conversation back to what you can control: exercise.
If a patient asked her whether dedicated core exercises or EVENITY would be better for preventing spine fractures, she’d point to the fundamentals first. Standing up straight, avoiding risky movements, and addressing biomechanics, that’s a significant starting point. In some cases, it may even be the answer.
A Guide to Amgen Safety Net Foundation and Amgen SupportPlus Program
If your doctor has prescribed EVENITY® (romosozumab-aqqg) for osteoporosis, one of the first things you may be wondering is how to manage the cost. The Amgen Safety Net Foundation offers a comprehensive patient support program called Amgen SupportPlus for EVENITY. The program is designed to help patients access the medication regardless of their insurance situation or financial circumstances.
Amgen Safety Net Foundation
The Amgen Safety Net Foundation (ASNF) is a separate nonprofit organization, though it was established in 2001 and is sponsored by Amgen. It was designed specifically to assist patients who have a financial need and are either uninsured, or whose insurance plan excludes the Amgen medicine. Because it is structured as an independent nonprofit, it operates under its own eligibility criteria and governance — separate from Amgen’s commercial programs.
To qualify for ASNF, patients generally must have lived in the U.S. or its territories for six months or longer and must satisfy income eligibility requirements, which vary by product.
What Is Amgen SupportPlus?
Amgen SupportPlus is Amgen’s dedicated patient and healthcare provider support program. For EVENITY patients, it provides personalized financial assistance resources, insurance navigation support, and guidance on where to receive treatment. The program recognizes that every patient’s situation is different and tailors its support accordingly.
Amgen SupportPlus handles insurance verification, prior authorizations, co-pay assistance for commercially insured patients, provider resources, and acts as the central hub for navigating financial support.
You can reach the program directly by calling (866) 264-2778, Monday through Friday, 8:30 am to 8:00 pm ET.
If You Have Commercial (Private) Insurance
Commercially insured patients, those with employer-sponsored plans, PPOs, HMOs, or COBRA coverage, may be eligible for the Amgen SupportPlus Co-Pay Program. This program can reduce your out-of-pocket costs significantly, with eligible patients potentially paying as little as $25 per dose of EVENITY. The program can be applied to your deductible, co-insurance, and co-payment.
To enroll:
- Create an online account at AmgenSupportPlus.com, or call (866) 264-2778 to enroll over the phone.
- Have your health insurance information ready when you begin enrollment.
- Review the full terms and conditions at AmgenSupportPlus.com/copay, as eligibility criteria and program maximums apply.
The Co-Pay Card Program is not valid for patients whose EVENITY prescription is paid for in whole or in part by Medicare, Medicaid, or any other federal or state healthcare program.
If You Have Government Insurance (Medicare or Medicaid)
Medicare and Medicaid patients have a separate pathway for financial support. The Amgen SupportPlus team can walk you through the options available under your specific plan, including information on Medicare Part B coverage for EVENITY (which is typically administered in a clinical setting) and whether supplemental or Medigap coverage may help offset costs.
A helpful resource, the “Understanding Medicare Options” guide, is available as a free download through the Amgen SupportPlus website.
If You Are Uninsured
Even without insurance, you are not without options. The Amgen Safety Net Foundation (ASNF) is a nonprofit patient assistance program that can provide EVENITY at no cost to patients who meet financial need criteria. This program is entirely free, the Foundation does not charge patients for its services.
How to Get Started
The simplest first step is to have a conversation with your prescribing physician or their office staff. Healthcare providers can also work directly with Amgen SupportPlus — including submitting insurance verification requests and co-pay claims on your behalf.
If you prefer to reach out directly as a patient, calling (866) 264-2778 is the most efficient route. Representatives are available Monday through Friday and can assess your specific situation, walk you through eligibility requirements, and help you enroll in the right program.
Note: This information reflects program details as currently published by Amgen. Program terms, eligibility criteria, and benefit amounts are subject to change. Always confirm current details directly with Amgen SupportPlus before making healthcare decisions.
EVENITY for Osteoporosis Summary
Conclusion and 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.
My original interview from 2021 with Dr. Rubin can be found here.
Margaret Martin
Further Readings
References
- Kavitha Ganesan; Amandeep Goyal; Douglas Roane. Bisphosphonate. StatPearls [Internet]. 2025 Jan
- SOST gene (sclerostin). https://medlineplus.gov/genetics/gene/sost/
- EVENITY® is the first and only bone builder that works differently with a dual effect https://www.evenityproliasa.com/starting-evenity/mechanism-of-action.
- Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis (ARCH). https://clinicaltrials.gov/ct2/show/NCT01631214
- Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (FRAME). https://clinicaltrials.gov/ct2/show/NCT01575834
Stokar J, Szalat A. Response to Letter to the Editor From Kawaguchi: “Cardiovascular Safety of Romosozumab vs PTH Analogs for Osteoporosis Treatment: A Propensity Score Matched Cohort Study”. J Clin Endocrinol Metab. 2024 Sep 16;109(10):e1978-e1979. doi: 10.1210/clinem/dgae348. PMID: 38767110.
Tsur A, Cahn A, Levy L, Pollack R. Cardiovascular outcomes of romosozumab treatment-real-world data analysis. JBMR Plus. 2024 Dec 10;9(1):ziae146. doi: 10.1093/jbmrpl/ziae146. PMID: 39687784; PMCID: PMC11647516.
Tominaga R, Ikenoue T, Ishii R, Niihata K, Aita T, Okuda T, Shimizu S, Taguri M, Kurita N. Comparative cardiovascular safety of romosozumab versus bisphosphonates in Japanese patients with osteoporosis: a new-user, active comparator design with instrumental variable analyses. J Bone Miner Res. 2025 Jan 17:zjaf010. doi: 10.1093/jbmr/zjaf010. Epub ahead of print. Erratum in: J Bone Miner Res. 2025 Jun 25;40(7):906. doi: 10.1093/jbmr/zjaf074. PMID: 39823291.
- McClung MR, Grauer A, Boonen S, Bolognese MA, Brown JP, Diez-Perez A, Langdahl BL, Reginster JY, Zanchetta JR, Wasserman SM, Katz L, Maddox J, Yang YC, Libanati C, Bone HG. Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med. 2014 Jan 30;370(5):412-20. doi: 10.1056/NEJMoa1305224. Epub 2014 Jan 1. PMID: 24382002.
- 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.
- Leder BZ, Ramchand SK, Jordan M, et al. 3 months vs 12 months of romosozumab for postmenopausal osteoporosis (LIDA): an open-label, non-inferiority, randomised controlled trial. Lancet Diabetes Endocrinol. Published online January 29, 2026. doi:10.1016/S2213-8587(25)00319-5
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