J Popul Ther Clin Pharmacol. 2020 Jan 6;27(1):e25-e31. doi: 10.15586/jptcp.v27i1.655.
Romosozumab (ROMO) is a recently approved monoclonal antibody (approved by the U.S. Food and Drug Administration [FDA] in April 2019 and Health Canada in June 2019) for the treatment of osteoporosis in postmenopausal women. ROMO works by selectively inhibiting sclerostin-a glycoprotein that inhibits osteoblasts and further promotes bone resorption. The authors reviewed three phase III clinical trials (Fracture Study in Postmenopausal Women with Osteoporosis [FRAME], Active-Controlled Fracture Study in Postmenopausal Women with Osteoporosis at High Risk [ARCH], and STudy evaluating the effect of RomosozUmab Compared with Teriparatide in postmenopaUsal women with osteoporosis at high risk for fracture pReviously treated with bisphosphonatE therapy [STRUCTURE]) that demonstrated ROMO’s ability to increase bone mineral density (BMD) at the lumbar spine and hip and the risk of vertebral and clinical fractures. Additionally, clinical trials demonstrated the risk for serious cardiovascular events among patients that received ROMO, and these severe adverse reactions deserve 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.