From the Guidelines
Romosozumab should only be considered for females with primary osteoporosis at very high risk of fracture, due to its potential to increase the risk of cardiovascular events, as evidenced by a hazard ratio of 1.9 for cardiovascular events compared to alendronate 1.
Key Points to Consider
- The American College of Physicians recommends bisphosphonates as the initial pharmacologic treatment for primary osteoporosis to reduce the risk of fractures, with romosozumab considered for those at very high risk of fracture 1.
- Romosozumab works by inhibiting sclerostin, increasing bone formation and decreasing bone resorption, with a standard dosing regimen of 210 mg administered monthly for 12 months 1.
- After completing the 12-month romosozumab treatment course, patients should transition to an antiresorptive therapy like alendronate or denosumab to maintain bone density gains 1.
- The medication carries a boxed warning for increased risk of cardiovascular events, including heart attack and stroke, and should not be used in patients with a history of myocardial infarction or stroke within the previous year 1.
Important Considerations
- Common side effects include joint pain, headache, and injection site reactions, and patients should have their calcium levels checked and any deficiency corrected before starting treatment 1.
- Clinical trials have shown approximately 73% reduction in vertebral fractures compared to placebo, making romosozumab a valuable option for patients with severe osteoporosis who have failed or cannot tolerate other treatments 1.
- However, the use of romosozumab should be limited to 12 monthly doses, as the anabolic effect wanes after 12 monthly doses, and patients with high risk for major cardiovascular events should avoid its use 1.
From the FDA Drug Label
EVENITY is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Limitations of Use: Limit duration of use to 12 monthly doses If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered.
The main use of romosozumab is for the treatment of osteoporosis in postmenopausal women at high risk for fracture. The limitation of use is 12 monthly doses, after which continued therapy with an anti-resorptive agent should be considered if osteoporosis therapy remains warranted 2.
Key points:
- Indication: Osteoporosis treatment in postmenopausal women at high risk for fracture
- Limitation of use: 12 monthly doses
- Post-treatment therapy: Consider continued therapy with an anti-resorptive agent 2
From the Research
Overview of Romosozumab
- Romosozumab, also known by its brand name Evenity, is a humanized monoclonal antibody used for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture 3, 4.
- It works by promoting bone formation and inhibiting bone resorption through the inhibition of sclerostin, a protein involved in the regulation of bone formation 4.
Efficacy of Romosozumab
- Studies have shown that romosozumab significantly reduces the risk of vertebral and clinical fractures in postmenopausal women with osteoporosis compared to placebo and active comparators like alendronate 4, 5.
- Romosozumab has also been shown to increase bone mineral density (BMD) compared to placebo, alendronate, and teriparatide, with these benefits maintained after transitioning to other osteoporosis therapies 4.
- The efficacy of romosozumab in reducing the risk of non-vertebral fractures has also been demonstrated, particularly in patients with more severe osteoporosis 6.
Safety and Cardiovascular Risk
- Romosozumab has a generally manageable tolerability profile, but there have been reports of adverse events including hyperostosis, cardiovascular events, osteoarthritis, and cancer 5.
- A boxed warning on the romosozumab label recommends careful consideration of the cardiovascular risk profile in individual women who may receive this agent, due to an imbalance in serious cardiovascular adverse events between romosozumab and alendronate in clinical trials 7, 6.
- Numerical increases in cardiovascular events have been observed with romosozumab use, particularly in patients with a history of cardiovascular disease or those at high cardiovascular risk, suggesting that romosozumab should be used cautiously in these populations 6.