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osteoporosis, romosozumab, sclerostin, review
Romosozumab (ROMO) (Brand name: EVENITY™), is a recently approved monoclonal antibody (U.S. FDA April 2019 and Health Canada June 2019) for the treatment of osteoporosis in postmenopausal women. ROMO works by selectively inhibiting sclerostin – a glycoprotein that inhibits osteoclasts and further promotes bone resorption. The authors reviewed three phase III clinical trials (FRAME, ARC, and STRUCTURE) that demonstrated ROMO’s ability to increase bone mineral density (BMD) at the lumbar spine and hip and reduces the risk of vertebral and clinical fractures. Additionally, clinical trials demonstrated the risk for serious cardiovascular events amongst patients that received ROMO and awaits further investigation. Although ROMO presents as a potentially exciting therapeutic with serious clinical implications, the authors recommend further analysis using real-world evidence (RWE) studies to fully elucidate the cardiovascular event risk associated with ROMO administration.
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