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Romosozumab for the treatment of postmenopausal women at high risk of fracture.

INTRODUCTION: Romosozumab is a monoclonal antibody that binds to sclerostin (an inhibitor of the Wingless-related integration site (Wnt) signaling pathway). It is a new osteoanabolic drug, that simultaneously increases bone formation and decreases bone resorption. It has recently been approved by the US and EU authorities in postmenopausal women with a very high risk of fractures.

AREAS COVERED: The literature on romosozumab in preclinical and in phase II and III clinical studies has been reviewed about the effect on bone, bone markers, and fracture reduction and its safety.

EXPERT OPINION: Compared to antiresorptive (AR) agents, its unique mechanism of action results in a quicker and greater increase in low bone mineral density, it repairs and restores trabecular and cortical bone microarchitecture, and reduces fracture risk more rapidly and more effectively than the AR alendronate, with persisting effects for at least two years after transition to ARs. This finding has introduced the concept that, in patients at very high risk of fractures, the optimal sequence of treatment is to start with an osteoanabolic agent, followed by a potent AR drug. Recent national and international guidelines recommend the use of romosozumab as initial treatment in patients at very high fracture risk without a history of stroke or myocardial infarction.

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