Analysis of clinical trials and progress of registered osteoporosis drugs in China
10.3760/cma.j.issn.0254-9026.2025.12.021
- VernacularTitle:中国注册骨质疏松症药物临床试验及进展分析
- Author:
Xuelin SUN
1
;
Xiaoli LIU
;
Xueying TAN
;
Xuejiao CUI
Author Information
1. 北京医院药学部 国家老年医学中心 中国医学科学院老年医学研究院，北京 100730
- Publication Type:Journal Article
- Keywords:
Osteoporosis;
Clinical trials;
Progress analysis
- From:
Chinese Journal of Geriatrics
2025;44(12):1766-1771
- CountryChina
- Language:Chinese
-
Abstract:
Objective:The aim of this study was to analyze the registration status of osteoporosis drug clinical trials in China, providing a reference for the research and development of therapeutic drugs for osteoporosis.Methods:Using the Drug Clinical Trial Registration and Information Publication Platform on the website of the State Drug Administration as the search platform, we retrieved the information on the public announcement of drug clinical trials with osteoporosis as an indication, and the search period was limited from 2013 to February 2025.Researchers extracted the key information and performed statistics.Results:A total of 182 registered osteoporosis drug clinical trial projects were collected.The main target indications were predominantly osteoporosis in postmenopausal women, and there were relatively few trials targeting the elderly subjects.56.0%(102/182)of the registered trials were bioequivalence studies, and 21.4%(39/182)were phase I clinical studies.Conclusions:The number of registered trials and the research and development process of domestic osteoporosis drug clinical trials in China have shown a stable trend in general, and the types of trials are mainly concentrated in bioequivalence studies and early clinical studies.In order to further meet the medication needs of domestic patients, China still needs to increase the research and development efforts of innovative osteoporosis drugs.
