Summary

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• This summary is based on the review of 14 systematic review(s)/meta-analysis(es). ^[1-14]
• Romosozumab significantly increased bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck compared to placebo, control, and teriparatide at 12 months (mean difference (MD) = 4.42; 95% confidence interval (CI) 3.03-5.80) for lumbar spine = 12.69, 95% CI 11.10-14.29; MD for total hip = 4.42, 95% CI 3.03-5.80; MD for femoral neck = 3.99, 95% CI 2.42-5.57).
• Romosozumab reduced the risk of new vertebral fractures at 12 months compared to control (odds ratio (OR) = 0.42, 95% CI 0.20-0.89) and at 24 months with sequential treatment (OR = 0.36, 95% CI 0.18-0.71).
• Major osteoporotic fractures were significantly reduced with romosozumab compared to placebo (relative risk (RR) = 0.37, 95% CI 0.25-0.54), and the risk of falls was also lower (RR = 0.80, 95% CI 0.68-0.93).
• Romosozumab was more effective than alendronate and teriparatide in increasing BMD and preventing fractures across multiple studies.
• No significant difference was observed in serious or fatal adverse events between romosozumab and control groups, though injection-site reactions were more frequent with romosozumab (RR = 1.83; 95% CI 1.46-2.30).
• Cardiovascular safety outcomes showed no significant difference in cardiovascular mortality or major cardiovascular events between romosozumab and placebo, and no significant difference in serious cardiovascular events was found in the Asian population (OR 1.09; 95% CI 0.40-2.96).
• Most studies focused on postmenopausal women with osteoporosis, where romosozumab was effective in increasing BMD and reducing fractures; one study showed significant BMD improvement in men with osteoporosis, and no significant difference in serious cardiovascular events was observed in an Asian population.