From Department of Family and Community Medicine, Mount Nittany Physician Group, Bellefonte, PA (KAT); Department of Medicine, Division of Cardiology, Penn State College of Medicine, Hershey (MN); Department of Medicine, Penn State College of Medicine, Hershey (EMM); Departments of Medicine and Public Health Sciences, Penn State College of Medicine, Hershey (AJF).
J Am Board Fam Med. 2023 Feb 8;36(1):175-185. doi: 10.3122/jabfm.2022.220099R1. Epub 2023 Jan 18.
There are multiple classes of pharmacologic agents approved for treatment of osteoporosis, but their costs vary widely, and systematic data on their efficacy compared with the traditional standard, bisphosphonates, for reducing fractures in postmenopausal women are lacking. The objective was to perform a systematic review and meta-analysis assessing the efficacy of denosumab compared with bisphosphonates.
Researchers selected randomized controlled trials (RCTs) comparing denosumab to bisphosphonates that included information on clinical and/or osteoporotic fracture events over the follow-up period. Each clinical outcome was meta-analyzed using a fixed-effects analysis, with clinical and osteoporotic fractures as the outcomes of interest. A meta-regression was performed using change in bone mineral density (BMD) as the moderator variable.
Seven RCTs were included. Denosumab was not associated with a reduction in clinical or osteoporotic fractures compared with bisphosphonates. There was no association between the change in BMD with denosumab and bisphosphonates and denosumab's effect on both osteoporotic and clinical fractures.
Existing data do not support the use of the more expensive denosumab as a first-line agent over bisphosphonates for reduction of fractures in postmenopausal women with osteoporosis. One limitation in this study was each RCT was not individually powered for fracture incidences.
有多种类别的药物被批准用于治疗骨质疏松症，但它们的成本差异很大，并且缺乏系统的数据来比较它们与传统标准药物——双磷酸盐类药物——在降低绝经后妇女骨折风险方面的疗效。本研究旨在进行一项系统评价和荟萃分析，评估地舒单抗与双磷酸盐类药物相比的疗效。
研究人员选择了比较地舒单抗与双磷酸盐类药物的随机对照试验（RCT），这些试验包括了随访期间的临床和/或骨质疏松性骨折事件的信息。每个临床结局都使用固定效应分析进行荟萃分析，以临床和骨质疏松性骨折为主要结局。使用骨密度（BMD）变化作为调节变量进行了荟萃回归分析。
共纳入了 7 项 RCT。与双磷酸盐类药物相比，地舒单抗并未降低临床或骨质疏松性骨折的发生率。地舒单抗与双磷酸盐类药物的 BMD 变化与地舒单抗对骨质疏松性和临床骨折的影响之间没有关联。
现有数据不支持将更昂贵的地舒单抗作为一线药物用于治疗绝经后骨质疏松症妇女的骨折风险，因为每个 RCT 都没有针对骨折发生率进行个体化的功率计算。
这项研究存在一定的局限性，因为每个 RCT 都没有针对骨折发生率进行个体化的功率计算。因此，需要更多的研究来进一步评估地舒单抗在治疗骨质疏松症中的疗效和安全性。
