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Osteoporosis-Related Randomized Clinical Trials With Middle-Aged and Older Adults Registered on the International Clinical Trials Registry Platform.
Frontiers in Endocrinology ( IF 5.2 ) Pub Date : 2021-08-31 , DOI: 10.3389/fendo.2021.702261
Fenghua Lai 1 , Ling Pei 1 , Xinwen Chen 1 , Jin Li 2
Affiliation  

Background A better understanding of the current features of osteoporosis-related randomized clinical trials (RCTs) is important for improving clinical trial designs and promoting the translatability of results into benefits for patients. However, there is a lack of thorough evaluation of osteoporosis-related RCTs in middle-aged and older populations. Therefore, this study aimed to investigate the characteristics of registered RCTs on osteoporosis among middle-aged and older adults on the International Clinical Trials Registry Platform (ICTRP). Methods Osteoporosis-related RCTs registered on the ICTRP were searched on December 31, 2020. The main features of eligible RCTs were assessed. We searched PubMed, Google scholar, Medline, and Embase databases for the publication status of completed RCTs. Results A total of 537 osteoporosis-related RCTs were identified for analysis. The number of registered RCTs increased rapidly in 2005 (N = 47). Of these, 346 (64.4%) RCTs involved only women and 275 (51.2%) were retrospectively registered. Most RCTs were of open-label design (61.3%). The most common primary purpose of osteoporosis-related RCTs was treatment (72.3%). Intervention investigated was mainly focused on medication (62.8%), followed by lifestyle or education (19.0%), and dietary supplement (10.4%). After trial completion, the results of only 140 (35.5%) RCTs were available on the ICTRP, and the publication rate after trial completion was 30.5%. Conclusions RCTs on osteoporosis among middle-aged and older adults were dominated by retrospectively registered and open-label trials. Most trials lacked available results and associated publications. More awareness of prospective registration and blinding design in osteoporosis-related RCTs is needed. Further, publication and dissemination of RCTs results should be promoted.

中文翻译:

在国际临床试验注册平台上注册的中老年人骨质疏松症相关随机临床试验。

背景 更好地了解骨质疏松症相关随机临床试验 (RCT) 的当前特征对于改进临床试验设计和促进将结果转化为对患者的益处具有重要意义。然而,缺乏对中老年人群骨质疏松症相关 RCT 的全面评估。因此,本研究旨在调查国际临床试验注册平台(ICTRP)上注册的中老年人骨质疏松症随机对照试验的特征。方法 检索 2020 年 12 月 31 日在 ICTRP 注册的骨质疏松症相关 RCT,评估符合条件的 RCT 的主要特征。我们搜索了 PubMed、谷歌学者、Medline 和 Embase 数据库,了解已完成 RCT 的发表状态。结果共筛选出537篇与骨质疏松症相关的RCT进行分析。2005 年注册的 RCT 数量迅速增加(N = 47)。其中,346 项(64.4%)RCT 仅涉及女性,275 项(51.2%)是回顾性登记的。大多数 RCT 采用开放标签设计(61.3%)。骨质疏松症相关 RCT 最常见的主要目的是治疗(72.3%)。调查的干预主要集中在药物治疗(62.8%),其次是生活方式或教育(19.0%)和膳食补充剂(10.4%)。试验完成后,ICTRP上仅有140项(35.5%)RCT的结果,试验完成后发表率为30.5%。结论 中老年人骨质疏松症的随机对照试验以回顾性注册和开放标签试验为主。大多数试验缺乏可用的结果和相关出版物。需要更多地了解骨质疏松症相关 RCT 中的前瞻性注册和盲法设计。此外,应促进 RCT 结果的发表和传播。
更新日期:2021-08-31
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