From the Guidelines
Evenity (romosozumab) offers a significant advancement in osteoporosis treatment, allowing physicians to change the future management of postmenopausal osteoporosis patients by rapidly increasing bone mineral density and reducing fracture risk. This is based on the most recent and highest quality study from 2024, which highlights the importance of anabolic therapy in patients at very high risk of fracture 1. The study suggests that individuals eligible for treatment should be dichotomized into those at a ‘high risk’ and those at a ‘very high risk’ of fracture, with the latter being directed to more expensive but more efficacious anabolic therapy first. Key factors associated with a very high risk of fracture include older age, recent fracture, and glucocorticoid use. The use of romosozumab, as an anabolic agent, has been shown to have a greater and more rapid therapeutic effect than oral antiresorptives, making it a valuable tool in the management of postmenopausal osteoporosis patients. Some of the key benefits of Evenity include:
- Rapid increase in bone mineral density within a limited 12-month treatment course
- Significant reduction in fracture risk, particularly at the spine and hip
- Ability to build bone quickly in high-risk patients before transitioning them to antiresorptive therapy for maintenance
- Potential to change the trajectory of the disease and improve long-term outcomes for postmenopausal women with osteoporosis. As noted in the 2023 study, the benefits of romosozumab may outweigh the harms in a select population of postmenopausal females with osteoporosis and very high risk for fracture 1. Additionally, the 2023 guideline from the American College of Physicians recommends bisphosphonates as first-line treatment, but notes that romosozumab can be used in patients at very high risk of fracture 1. Overall, the evidence suggests that Evenity (romosozumab) is a valuable addition to the treatment options for postmenopausal osteoporosis patients, particularly those at very high risk of fracture.
From the FDA Drug Label
EVENITY is 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 statement "EVENITY offers physicians the opportunity to change the future management of their postmenopausal osteoporosis patients" likely refers to the fact that EVENITY provides a new treatment option for postmenopausal women with osteoporosis who are at high risk for fracture. This is because:
- EVENITY is a sclerostin inhibitor, which is a new class of medication for the treatment of osteoporosis.
- EVENITY has a unique mechanism of action, which can help to reduce the risk of fracture in postmenopausal women with osteoporosis.
- The use of EVENITY can be considered for patients who have failed or are intolerant to other available osteoporosis therapy, providing an alternative treatment option for these patients 2, 2, 2.
This can be seen as an opportunity for physicians to change the future management of their postmenopausal osteoporosis patients by offering a new and potentially effective treatment option.
From the Research
Relevance of Evenity in Postmenopausal Osteoporosis Management
The statement "Evenity offers physicians the opportunity to change the future management of their postmenopausal osteoporosis patients" is supported by several studies 3, 4, 5, 6, 7.
- Evenity (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 3.
- It has been approved for treating severe osteoporosis in postmenopausal women at high risk of fracture, and has been shown to significantly reduce vertebral and clinical fracture risk versus placebo and oral alendronate in pivotal phase III trials 3, 4.
- Romosozumab is the first anabolic medication that both increases bone formation and decreases bone resorption, making it a novel treatment option for postmenopausal women at high risk for osteoporotic fracture 4, 5.
- The treatment is administered once monthly in injection form for 12 consecutive months, and has been shown to increase bone mineral density and decrease fracture risk in clinical trials 5, 7.
Clinical Implications
- Evenity represents a major breakthrough in the treatment of osteoporosis, with a dual effect of increasing bone formation and reducing bone resorption 6.
- Its ideal use is as first-line treatment in postmenopausal women with a recent major fracture, and it should be followed by an anti-resorptive agent to maintain or further increase bone mineral density 6, 7.
- However, it is contraindicated in cases of hypocalcemia and personal history of stroke or myocardial infarction, and should not be considered for women with a history of or at high risk of cardiovascular disease 6, 7.