Department of Orthopedics, People's Hospital of Rongchang District, Chongqing, China.
Second Clinical Medical College, Kunming Medical University, Kunming, China.
Menopause. 2019 Aug;26(8):929-939. doi: 10.1097/GME.0000000000001321.
The aim of this study was to assess the comparative effectiveness and safety of different pharmacological agents, including abaloparatide and romosozumab, for treatment of osteoporosis in postmenopausal women.
We searched PubMed, Embase, the Cochrane Central Register of Controlled Trials, and Google Scholar for relevant randomized controlled trials published up to July 16, 2018. After study selection according to the preplanned criteria, we performed data extraction and quality assessment. With statistical heterogeneity and inconsistency being examined, pairwise and network meta-analyses were conducted to synthesize risk ratio and 95% CI. Finally, we calculated the surface under the cumulative ranking curve to rank the interventions, and carried out three sensitivity analyses to assess the robustness of our main results.
Our searches yielded 2,584 records in total, of which 21 were finally included in quantitative synthesis and all of them were of high quality. Our 5 outcomes of interest involved a total of 13 interventions and 67,524 participants. For each outcome, the estimated τ values all were less than or equal to 0.0747, and the P values for test of consistency varied from 0.097 to 0.941, respectively, suggesting low heterogeneity and no inconsistency. Abaloparatide and teriparatide, without statistical difference between them, had a statistically lower risk of new vertebral or nonvertebral fractures than placebo, strontium ranelate, risedronate, raloxifene, lasofoxifene (0.25 mg/d), lasofoxifene (0.5 mg/d), denosumab, and alendronate. Zoledronic acid and romosozumab, without statistical difference between them, were significantly more efficacious than placebo, risedronate, and alendronate in preventing clinical fractures. Denosumab was statistically superior to placebo in preventing new vertebral and nonvertebral fractures, and to placebo, risedronate, and alendronate in preventing clinical fractures. For the outcomes of adverse events and serious adverse events, all of treatments were not statistically different from one another, except that zoledronic acid was statistically worse than placebo in terms of adverse events. Based on surface under the cumulative ranking curves, abaloparatide and teriparatide were two of the most effective treatments in preventing new vertebral and nonvertebral fractures; zoledronic acid and romosozumab were two of the most effective treatments in preventing clinical fractures, and denosumab and romosozumab were two of the best interventions for the outcome of adverse events. Three sensitivity analyses revealed the robustness of the main results.
Abaloparatide and teriparatide are most efficacious in preventing new vertebral and nonvertebral fractures in postmenopausal women with osteoporosis, whereas zoledronic acid and romosozumab are in preventing clinical fractures. Meanwhile, there is no statistical difference between abaloparatide, teriparatide or romosozumab, and placebo in terms of safety. Furthermore, in terms of adverse events, zoledronic acid is statistically worse than placebo, and two of the best interventions are denosumab and romosozumab, of which denosumab also reduces the risk of different kinds of fractures.
本研究旨在评估不同药物在绝经后骨质疏松症治疗中的疗效和安全性，包括abaloparatide 和 romosozumab。
我们在 PubMed、Embase、Cochrane 对照试验中心注册库和 Google Scholar 中检索了截至 2018 年 7 月 16 日发表的相关随机对照试验。根据预先制定的标准进行研究选择后，我们进行了数据提取和质量评估。检查了统计学异质性和不一致性后，我们进行了两两和网络荟萃分析，以综合风险比和 95%置信区间。最后，我们计算了累积排序曲线下的面积，以对干预措施进行排名，并进行了三次敏感性分析，以评估我们主要结果的稳健性。
我们的搜索共产生了 2584 条记录，其中 21 条最终纳入定量综合分析，且均为高质量研究。我们的 5 个感兴趣结局涉及 13 种干预措施和 67524 名参与者。对于每个结局，估计的τ值均小于或等于 0.0747，且一致性检验的 P 值在 0.097 至 0.941 之间不等，提示异质性低且不存在不一致性。abaloparatide 和 teriparatide 与安慰剂相比，新发椎体或非椎体骨折的风险统计学上较低，而 strontium ranelate、risedronate、raloxifene、lasofoxifene（0.25mg/d）、lasofoxifene（0.5mg/d）、denosumab 和 alendronate 则不然。zoledronic acid 和 romosozumab 与安慰剂相比，预防临床骨折的效果显著优于 placebo、risedronate 和 alendronate。与 placebo、risedronate 和 alendronate 相比，denosumab 预防新发椎体和非椎体骨折的效果统计学上更优，预防临床骨折的效果也统计学上更优。在不良事件和严重不良事件结局方面，除 zoledronic acid 的不良事件发生率高于 placebo 外，其他治疗方案之间无统计学差异。基于累积排序曲线下的面积，abaloparatide 和 teriparatide 是预防新发椎体和非椎体骨折最有效的两种治疗方法；zoledronic acid 和 romosozumab 是预防临床骨折最有效的两种治疗方法，而 denosumab 和 romosozumab 是预防不良事件最有效的两种干预措施。三次敏感性分析表明了主要结果的稳健性。
在绝经后骨质疏松症女性中，abaloparatide 和 teriparatide 在预防新发椎体和非椎体骨折方面最有效，而 zoledronic acid 和 romosozumab 则在预防临床骨折方面最有效。同时，abaloparatide、teriparatide 或 romosozumab 与安慰剂在安全性方面无统计学差异。此外，在不良事件方面，zoledronic acid 的不良事件发生率显著高于 placebo，而 denosumab 和 romosozumab 是两种最佳的干预措施，其中 denosumab 还降低了不同类型骨折的风险。
