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One year of romosozumab followed by two years of denosumab maintains fracture risk reductions: Results of the FRAME extension study

Journal of Bone and Mineral Research Mar 21, 2019

Lewiecki EM, et al. - Researchers report the outcomes of the FRAME (FRActure study in postmenopausal woMen with ostEoporosis) extension study, wherein, the eligible women from the FRAME study received denosumab for an additional 12 months after already being treated with subcutaneous placebo or romosozumab once monthly for 12 months, followed by open-label subcutaneous denosumab every 6 months for an additional 12 months. These women had a T-score of ≤ –2.5 at the total hip or femoral neck and they underwent efficacy assessments of new vertebral, clinical, and nonvertebral fracture; bone mineral density (BMD); and safety assessments through 36 months in the extension phase. The 36-month study was completed by 5743 (80%) women (2851 romosozumab-to-denosumab; 2892 placebo-to-denosumab). Twelve months of romosozumab when followed by 24 months of denosumab was found to be beneficial in terms of offering persistent fracture reduction and ongoing BMD gains. For the treatment of osteoporosis, romosozumab followed by denosumab may hold promise.
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