From the Guidelines
Evenity (romosozumab) is a highly effective treatment for osteoporosis in postmenopausal women at high risk for fracture, with a recommended dosage of 210 mg administered as two separate subcutaneous injections once monthly for 12 months. After completing Evenity treatment, patients should transition to an antiresorptive therapy like alendronate or denosumab to maintain bone density gains, as suggested by the American College of Physicians 1. Evenity works by both increasing bone formation and decreasing bone resorption through its mechanism as a sclerostin inhibitor, making it particularly effective for rapidly increasing bone mineral density, with a recent network meta-analysis evaluating 73 osteoporosis trials reporting a protective effect of romosozumab for hip fractures compared with placebo 2. However, Evenity carries a boxed warning for increased risk of heart attack, stroke, and cardiovascular death, so it should not be used in patients with a history of heart attack or stroke within the previous year, as highlighted by the FDA safety warnings 3. Common side effects include joint pain, headache, and injection site reactions, and calcium and vitamin D supplementation should be maintained during treatment, with Evenity contraindicated in patients with hypocalcemia, which should be corrected before initiating therapy. Key considerations for treatment include:
- Patient selection: postmenopausal women at high risk for fracture
- Treatment duration: 12 months, with transition to antiresorptive therapy thereafter
- Monitoring: regular assessment of bone density and fracture risk
- Safety precautions: avoidance of use in patients with high risk for major cardiovascular events, and correction of hypocalcemia before initiating therapy, as recommended by the American College of Physicians 1 and the FDA safety warnings 3.
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. The main use of EVENITY (romosozumab) is for the treatment of osteoporosis in postmenopausal women at high risk for fracture.
- Key points: + Indications: Osteoporosis treatment in postmenopausal women. + Patient profile: High risk for fracture, history of osteoporotic fracture, or multiple risk factors for fracture. + Alternative use: For patients who have failed or are intolerant to other available osteoporosis therapy. 4
From the Research
Overview of Evenity
- Evenity, also known as romosozumab, is a humanized monoclonal antibody that promotes bone formation and inhibits bone resorption by inhibiting sclerostin, a protein involved in the regulation of bone formation 5.
- It is approved in several countries, including those of the EU and the USA, for treating severe osteoporosis in postmenopausal women at high risk of fracture 5, 6.
Efficacy of Evenity
- Studies have shown that romosozumab significantly reduces vertebral and clinical fracture risk versus placebo and oral alendronate in postmenopausal women with osteoporosis 5, 7.
- It also significantly increases bone mineral density (BMD) relative to placebo, alendronate, and subcutaneous teriparatide at 12 months, with these benefits maintained 12-24 months after patients transitioned from romosozumab to alendronate or denosumab 5, 7.
- Romosozumab is effective in postmenopausal women with osteoporosis and mild-to-moderate chronic kidney disease, with a similar safety profile across different levels of kidney function 8.
Safety of Evenity
- Romosozumab has a generally manageable tolerability profile, with common adverse events including arthralgia, headache, and injection site reactions 5, 9.
- However, major adverse cardiac events were observed in one clinical trial, and it is not recommended for women with a history of or at high risk of cardiovascular disease 9.
- The incidence of adverse events, including hypersensitivity and injection site reactions, was lower in the romosozumab arms compared to the alendronate and placebo arms 7.