Research & Evaluation incorporating ASERNIP-S, Royal Australasian College of Surgeons, 24 King William Street, Kent Town, South Australia, 5067, Australia.
Health Technology Assessment Section, Health Insurance Benefits Division, Health and Accident Insurance Directorate, Federal Office of Public Health (FOPH), Bern, Switzerland.
Calcif Tissue Int. 2023 Jun;112(6):631-646. doi: 10.1007/s00223-023-01078-z. Epub 2023 Apr 5.
To assess the effectiveness and safety of denosumab (Prolia®) compared to bisphosphonates (alendronate, ibandronate, risedronate, zoledronate), selective estrogen receptor modulators (SERMs; bazedoxifene, raloxifene) or placebo, for the treatment of osteoporosis in postmenopausal women (PMW). Systematic searches were run in PubMed, Embase & Cochrane Library on 27-April-2022. Randomized controlled trials (RCTs) that included osteoporotic PMW allocated to denosumab, SERMs, bisphosphonates, or placebo were eligible for inclusion. RCTs were appraised using Cochrane Risk of Bias 2.0. Bayesian network and/or pairwise meta-analyses were conducted on predetermined outcomes (i.e. vertebral/nonvertebral fractures, bone mineral density [BMD], mortality, adverse events [AEs], serious AEs (SAEs), withdrawals due to AEs, AEs caused by denosumab discontinuation). A total of 12 RCTs (k = 22 publications; n = 25,879 participants) were included in the analyses. Denosumab, reported a statistically significant increase in lumbar spine (LS) and total hip (TH) BMD, compared to placebo. Similarly, denosumab also resulted in a statistically significant increase in TH BMD compared to the raloxifene and bazedoxifene. However, relative to denosumab, alendronate, ibandronate and risedronate resulted in significant improvements in both femoral neck (FN) and LS BMD. With regards to vertebral fractures and all safety outcomes, there were no statistically significant differences between denosumab and any of the comparator. Relative to placebo, denosumab was associated with significant benefits in both LS and TH BMD. Additionally, denosumab (compared to placebo) was not associated with reductions in vertebral and nonvertebral fractures. Finally, denosumab was not associated with improvement in safety outcomes, compared to placebo. These findings should be interpreted with caution as some analyses suffered from statistical imprecision.
评估地舒单抗（Prolia®）与双膦酸盐（阿仑膦酸钠、伊班膦酸钠、利塞膦酸钠、唑来膦酸）、选择性雌激素受体调节剂（SERMs；巴多昔芬、雷洛昔芬）或安慰剂相比，治疗绝经后妇女（PMW）骨质疏松症的有效性和安全性。于 2022 年 4 月 27 日在 PubMed、Embase 和 Cochrane Library 进行了系统检索。符合纳入标准的研究为纳入骨质疏松症 PMW 并随机分配至地舒单抗、SERMs、双膦酸盐或安慰剂的随机对照试验（RCT）。使用 Cochrane 偏倚风险 2.0 对 RCT 进行评估。对预先确定的结局（即椎体/非椎体骨折、骨密度 [BMD]、死亡率、不良事件 [AE]、严重不良事件 [SAE]、因 AE 退出、因停用地舒单抗导致的 AE）进行贝叶斯网络和/或成对荟萃分析。共纳入 12 项 RCT（k=22 篇文献；n=25879 名参与者）进行分析。与安慰剂相比，地舒单抗报告称腰椎（LS）和全髋关节（TH）BMD 有统计学意义的增加。同样，与雷洛昔芬和巴多昔芬相比，地舒单抗也导致 TH BMD 有统计学意义的增加。然而，与地舒单抗相比，阿仑膦酸钠、伊班膦酸钠和利塞膦酸钠使股骨颈（FN）和 LS BMD 有显著改善。关于椎体骨折和所有安全性结局，地舒单抗与任何比较药物之间均无统计学差异。与安慰剂相比，地舒单抗在 LS 和 TH BMD 方面均有显著获益。此外，与安慰剂相比，地舒单抗并未导致椎体和非椎体骨折减少。最后，与安慰剂相比，地舒单抗并未改善安全性结局。由于一些分析存在统计学不精确性，因此应谨慎解释这些发现。
