What is the role of romosozumab in the treatment of osteoporosis?

Updated: Jan 20, 2021
  • Author: Rachel Elizabeth Whitaker Elam, MD, MSc; Chief Editor: Herbert S Diamond, MD  more...
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Romosozumab (Evenity) is a monoclonal antibody that binds with and inhibits sclerostin, and thus both increases bone formation and decreases bone resorption. It was approved by the FDA in 2019 for treatment of osteoporosis in postmenopausal women who are at high risk for fracture. It has been shown to reduce vertebral fracture rates in postmenopausal women with osteoporosis. [194, 195, 196]

In the Fracture Study in Postmenopausal Women With Osteoporosis (FRAME), a phase 3 randomized trial in 7180 postmenopausal women who had a T score of -2.5 to -3.5 at the total hip or femoral neck, 1 year of treatment with romosozumab reduced vertebral fracture rates by 73% compared with placebo. A further reduction in vertebral fracture risk occurred in the second year following transition to denosumab. [194, 196]

Romosozumab is also being investigated in men with osteoporosis. In the BRIDGE clinical trial, spine and hip BMD significantly improved following romosozumab for 12 months compared with placebo. [197]

In a randomized, controlled trial of 4093 postmenopausal women with osteoporosis and a fragility fracture, a higher rate of adjudicated serious cardiovascular events (a composite endpoint including cardiac ischemic events, cerebrovascular events, heart failure, death, noncoronary revascularization, and peripheral vascular ischemic event not requiring revascularization) was seen in the romosozumab group (2.5%) compared with the alendronate group (1.9%), although the increased risk only reached statistical significance for cardiac ischemic events (0.8% versus 0.3%; odds ratio 2.65 with 95% CI 1.03 to 6.77). [198]  

Romosozumab carries a black box warning regarding increased risk of myocardial infarction, stroke, and cardiovascualr death. Romosozumab should not be initaited in patients who have had a myocardial infarction or stroke within the preceding year, and cardiovascular risk profile must be considered before initiating romosozumab. In patients who experience a myocardial infarction or stroke during therapy, romosozumab should be discontinued.

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