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

Updated: Sep 26, 2019
  • Author: Monique Bethel, MD; Chief Editor: Herbert S Diamond, MD  more...
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Answer

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. [168, 169, 170, 171]

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. [169, 171]

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. [172]


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