Abstract：
BACKGROUND: We aimed to comprehensively compile placebo-controlled trials on the efficacy and safety of romosozumab (210 mg, subcutaneously, once monthly) in postmenopausal women and men with osteoporosis.
METHODS: PubMed, Google Scholar, and ClinicalTrials.gov were searched for relevant placebo-controlled trials (as of January 1, 2024). Percent change in bone mineral density (BMD), falls, fractures, and adverse events (AEs) after drug administration were collected. Risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) were calculated.
RESULTS: Six trials (7990 patients; follow-up period, 6-12 months) were included. Compared with placebo, romosozumab significantly increased lumbar spine BMD (MD = 12.69; 95% CI 11.10-14.29), total hip BMD (MD = 4.42; 95% CI 3.03-5.80), and femoral neck BMD (MD = 3.99; 95% CI 2.42-5.57) at 12 months. Romosozumab significantly decreased falls (RR = 0.80; 95% CI 0.68-0.93) and major osteoporotic fractures (RR = 0.37; 95% CI 0.25-0.54), but increased injection-site reactions (RR = 1.83; 95% CI 1.46-2.30) within 12 months. No significant differences were observed in other AEs (including cardiovascular AEs) within 12 months.
CONCLUSIONS: Romosozumab treatment resulted in a significant BMD gain, reduced falls and major osteoporotic fractures. It was generally well-tolerated, including the cardiovascular aspects. However, clinicians should consider the occurrence of minor AEs (e.g., injection-site reactions).
METHODS: PubMed, Google Scholar, and ClinicalTrials.gov were searched for relevant placebo-controlled trials (as of January 1, 2024). Percent change in bone mineral density (BMD), falls, fractures, and adverse events (AEs) after drug administration were collected. Risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) were calculated.
RESULTS: Six trials (7990 patients; follow-up period, 6-12 months) were included. Compared with placebo, romosozumab significantly increased lumbar spine BMD (MD = 12.69; 95% CI 11.10-14.29), total hip BMD (MD = 4.42; 95% CI 3.03-5.80), and femoral neck BMD (MD = 3.99; 95% CI 2.42-5.57) at 12 months. Romosozumab significantly decreased falls (RR = 0.80; 95% CI 0.68-0.93) and major osteoporotic fractures (RR = 0.37; 95% CI 0.25-0.54), but increased injection-site reactions (RR = 1.83; 95% CI 1.46-2.30) within 12 months. No significant differences were observed in other AEs (including cardiovascular AEs) within 12 months.
CONCLUSIONS: Romosozumab treatment resulted in a significant BMD gain, reduced falls and major osteoporotic fractures. It was generally well-tolerated, including the cardiovascular aspects. However, clinicians should consider the occurrence of minor AEs (e.g., injection-site reactions).
摘要：
背景：我们旨在全面汇编有关romosozumab的疗效和安全性的安慰剂对照试验（210mg，皮下,每月一次）绝经后女性和患有骨质疏松症的男性。
方法：PubMed，谷歌学者，和ClinicalTrials.gov进行了相关的安慰剂对照试验（截至2024年1月1日）。骨矿物质密度（BMD）的百分比变化，falls,骨折,收集给药后的不良事件（AE）。计算风险比（RR）和平均差异（MD）以及95％置信区间（CI）。
结果：六项试验（7990例；随访期，包括6-12个月）。与安慰剂相比，romosozumab显着增加腰椎BMD（MD=12.69；95％CI11.10-14.29），全髋部BMD（MD=4.42；95%CI3.03-5.80），12个月时股骨颈骨密度（MD=3.99；95%CI2.42-5.57）。Romosozumab显著降低了跌倒(RR=0.80;95%CI0.68-0.93)和严重骨质疏松性骨折(RR=0.37;95%CI0.25-0.54),但12个月内注射部位反应增加（RR=1.83；95%CI1.46-2.30）。其他不良事件（包括心血管不良事件）在12个月内没有观察到显著差异。
结论：Romosozumab治疗导致BMD显著增加，减少跌倒和严重的骨质疏松性骨折。它通常耐受性良好，包括心血管方面。然而,临床医生应考虑轻微AE的发生(例如，注射部位反应)。
方法：PubMed，谷歌学者，和ClinicalTrials.gov进行了相关的安慰剂对照试验（截至2024年1月1日）。骨矿物质密度（BMD）的百分比变化，falls,骨折,收集给药后的不良事件（AE）。计算风险比（RR）和平均差异（MD）以及95％置信区间（CI）。
结果：六项试验（7990例；随访期，包括6-12个月）。与安慰剂相比，romosozumab显着增加腰椎BMD（MD=12.69；95％CI11.10-14.29），全髋部BMD（MD=4.42；95%CI3.03-5.80），12个月时股骨颈骨密度（MD=3.99；95%CI2.42-5.57）。Romosozumab显著降低了跌倒(RR=0.80;95%CI0.68-0.93)和严重骨质疏松性骨折(RR=0.37;95%CI0.25-0.54),但12个月内注射部位反应增加（RR=1.83；95%CI1.46-2.30）。其他不良事件（包括心血管不良事件）在12个月内没有观察到显著差异。
结论：Romosozumab治疗导致BMD显著增加，减少跌倒和严重的骨质疏松性骨折。它通常耐受性良好，包括心血管方面。然而,临床医生应考虑轻微AE的发生(例如，注射部位反应)。
