A meta-analysis of the efficacy and safety of romosozumab in the treatment of osteoporosis

doi:10.3969/j.issn.1004-583X.2026.04.001

Abstract

Abstract:

Objective To evaluate the clinical efficacy and safety of romosozumab in patients with osteoporosis. Methods A systematic search was conducted in PubMed, Embase, Web of Science, Medline, the Cochrane Library, ClinicalTrials.gov, CNKI, Wanfang, VIP, and SinoMed for randomized controlled trials (RCTs) comparing romosozumab with placebo or other anti-osteoporotic drugs in the treatment of osteoporosis, from database inception to December 31, 2025. After data extraction and quality assessment of the eligible studies, meta-analysis was performed using RevMan 5.3. Results A total of 11 RCTs, including 15,719 patients, were included. The meta-analysis showed that, compared with placebo, romosozumab significantly increased lumbar spine bone mineral density (BMD) (MD=11.75, 95%CI[9.07, 14.42], P<0.01) and total hip bone mineral density (MD=3.31, 95%CI[1.19, 5.42], P=0.002), and reduced the incidence of new vertebral fractures (RR=0.25, 95%CI[0.16, 0.40], P<0.01). However, there was no statistically significant difference between groups in improving femoral neck bone mineral density. In terms of safety, the incidence of adverse events was significantly lower in the romosozumab group than in the placebo group (RR=0.97, 95%CI[0.96, 0.99], P=0.003). Compared with teriparatide, there was no statistically significant difference in the incidence of adverse events between the two groups (RR=1.11, 95%CI[1.00, 1.23], P=0.05). The incidence of adverse events was similar between the romosozumab and alendronate groups, with no statistically significant difference (RR=1.00, 95%CI[0.93, 1.08], P=0.95). The incidence of serious adverse events was similar between the romosozumab group and the placebo, teriparatide, and alendronate groups, with no statistically significant differences. Conclusion Romosozumab can significantly increase lumbar spine and total hip bone mineral density in patients with osteoporosis and reduce the incidence of new vertebral fractures. It has a favorable safety profile, with no increase in adverse event rates.

Key words: osteoporosis, bone mineral density, romosozumab, meta-analysis

CLC Number:

R681

Zhu Ruigang, Li Haoqiang, Wang Youkun, Guo Jidong, Wang Qiang. A meta-analysis of the efficacy and safety of romosozumab in the treatment of osteoporosis[J]. Clinical Focus, 2026, 41(4): 293-300.

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URL: https://www.lchc.cn/EN/10.3969/j.issn.1004-583X.2026.04.001

https://www.lchc.cn/EN/Y2026/V41/I4/293

Figures/Tables 15

Fig.1 Literature screening flowchart

Tab. 1 Baseline characteristics of the included studies

第一作者及发表年限	组别	例数	年龄(岁)	干预措施	疗程	结局指标
Lau^[4] 2020	试验组对照组	146 129	75.2±7.0 74.0±6.7	罗莫珠单抗210 mg 阿仑膦酸钠	12个月	⑤⑥
Bente^[5] 2022	试验组对照组	1 494 1 519	70.4±7.1 70.4±6.9	罗莫珠单抗210 mg 安慰剂	12个月	④⑤⑥
Cosman^[6] 2016	试验组对照组	3 589 3 591	70.9±7.0 70.8±6.9	罗莫珠单抗210 mg 安慰剂	12个月	①②③④⑤⑥
Baek^[7] 2021	试验组对照组	34 33	66.7±7.6 68.4±7.2	罗莫珠单抗210 mg 安慰剂	6个月	①②③⑤
Ishibashi^[8] 2017	试验组对照组	63 63	68.3±5.9 67.8±7.2	罗莫珠单抗210 mg 安慰剂	12个月	①②③⑤⑥
Mcclung^[9] 2014	试验组	52	66.3±6.5	罗莫珠单抗210 mg
		51	67.1±5.8	阿仑膦酸钠	12个月	①②③⑤⑥
		55	66.8±5.7	特立帕肽
	对照组	52	67.0±6.5	安慰剂
Padhi^[10] 2013	试验组对照组	36 12	58.6±8.7 59.1±5.6	罗莫珠单抗安慰剂	13个月	⑤⑥
Lewiecki^[11] 2018	试验组对照组	163 82	72.4±7.4 71.5±6.9	罗莫珠单抗210 mg 安慰剂	12个月	⑤⑥
Saag^[12] 2017	试验组对照组	2 046 2 047	74.4±7.5 74.2±7.5	罗莫珠单抗210 mg 阿仑磷酸盐70 mg	12个月	①②③⑤⑥
Padhi^[13] 2010	试验组对照组	12 14	50.2±4.0 52.8±4.8	罗莫珠单抗安慰剂	3个月	⑤⑥
Langdahl^[14] 2017	试验组对照组	218 218	71.8±7.4 71.2±7.7	罗莫珠单抗210 mg 特立帕肽	12个月	⑤⑥

Fig. 2 Risk-of-bias bar chart

Fig. 3 Risk-of-bias summary plot

Fig. 4 Meta-analysis of lumbar spine bone mineral density

Fig. 5 Meta-analysis of total hip bone mineral density

Fig. 6 Meta-analysis of femoral neck bone mineral density

Fig.7 Meta-analysis of the incidence of new vertebral fractures

Fig.8 Meta-analysis of adverse event incidence in the romosozumab and placebo groups

Fig. 9 Meta-analysis of adverse event incidence in the romosozumab and teriparatide groups

Fig.10 Meta-analysis of adverse event incidence in the romosozumab and alendronate groups

Fig.11 Meta-analysis of serious adverse event incidence in the romosozumab and placebo

Fig.12 Meta-analysis of serious adverse event incidence in the romosozumab and teriparatide groups

Fig.13 Meta-analysis of serious adverse event incidence in the romosozumab and alendronate groups

Tab. 2 Sensitivity analysis

结局指标	随机效应模型		固定效应模型		去除权重大的研究		去除权重小的研究
结局指标	$M D$ / $R R$ (95% $C I$ )	$P$ 值	$M D$ / $R R$ (95% $C I$ )	$P$ 值	$M D$ / $R R$ (95% $C I$ )	$P$ 值	$M D$ / $R R$ (95% $C I$ )	$P$ 值
腰椎骨密度	11.75[9.07, 14.42]	<0.01	9.47[9.11, 9.83]	<0.01	12.56[10.09, 15.03]	<0.01	10.71[8.45, 12.97]	<0.01
不良事件发生率	0.98[0.96, 0.99]	0.004	0.97[0.96, 0.99]	0.003	0.97[0.94, 0.99]	0.005	0.97[0.96, 0.99]	0.003

Tab. 2 Sensitivity analysis

结局指标	随机效应模型		固定效应模型		去除权重大的研究		去除权重小的研究
结局指标	$M D$ / $R R$ (95% $C I$ )	$P$ 值	$M D$ / $R R$ (95% $C I$ )	$P$ 值	$M D$ / $R R$ (95% $C I$ )	$P$ 值	$M D$ / $R R$ (95% $C I$ )	$P$ 值
腰椎骨密度	11.75[9.07, 14.42]	<0.01	9.47[9.11, 9.83]	<0.01	12.56[10.09, 15.03]	<0.01	10.71[8.45, 12.97]	<0.01
不良事件发生率	0.98[0.96, 0.99]	0.004	0.97[0.96, 0.99]	0.003	0.97[0.94, 0.99]	0.005	0.97[0.96, 0.99]	0.003

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