
Metabolic Disorders
Lower incidence of vertebral fracture with romosozumab vs placebo for osteoporosis
N Engl J Med. 2016 Oct 20;375(16):1532-15437180 postmenopausal women with osteoporosis were randomized to 12 months of treatment with either romosozumab or placebo, followed by a further 12 months of treatment with denosumab in both groups. The purpose of this study was to evaluate and compare vertebral fracture incidence, nonovertebral fracture incidence, and safety outcomes between groups after 6, 12, 18, and 24 months. Results after 12 months demonstrated a significantly lower vertebral fracture rate in the romosozumab group compared to the placebo group, though no significant difference in nonvertebral fracture rate was observed. Results after 24 months were consistent with those observed after 12 months. The incidence of adverse events leading to discontinuation was similar between groups.
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