文献类型：期刊文献

英文题名：Sex differences in drug-induced osteoporosis: a pharmacovigilance study based on the FAERS database

作者：Liu, Lu[1];Song, Yongjia[1];Liu, Xiaoyu[1];Song, Bangguo[1];Song, Min[1]

第一作者：刘璐

通信作者：Song, M[1]

机构：[1]Gansu Univ Chinese Med, Clin Coll Tradit Chinese Med, Lanzhou, Peoples R China

第一机构：甘肃中医药大学中医临床学院

通信机构：[1]corresponding author), Gansu Univ Chinese Med, Clin Coll Tradit Chinese Med, Lanzhou, Peoples R China.|[10735ccd4a8840d96ab71]甘肃中医药大学中医临床学院;[10735]甘肃中医药大学;

年份：2025

卷号：13

外文期刊名：FRONTIERS IN PUBLIC HEALTH

收录：;Scopus(收录号：2-s2.0-105012606980);WOS:【SSCI(收录号:WOS:001545410700001)，SCI-EXPANDED(收录号:WOS:001545410700001)】；

基金：The author(s) declare that financial support was received for the research and/or publication of this article. The work was supported by 2024 Gansu Provincial university teachers' innovation fund (2024A-087); 2025 "Innovation and Entrepreneurship Fund" project for graduate students of Gansu University of Traditional Chinese Medicine (2025CXZX-915).

语种：英文

外文关键词：drug-induced osteoporosis; FAERS; sex-specific risk; mGPS; BCPNN; time-to-onset analysis; pharmacovigilance

摘要：Background Osteoporosis is a prevalent condition globally, often linked to a significant risk of fractures. Drug-induced osteoporosis (DIOP) is an increasingly recognized adverse effect of various medications, but the sex-specific risks and time-to-onset patterns remain inadequately understood. Addressing these gaps in knowledge is critical to improving patient safety and pharmacovigilance.Objective This study aimed to explore sex-related differences in DIOP, identify high-risk medications, and assess the onset patterns of osteoporosis-related adverse events by analyzing data from the FDA Adverse Event Reporting System (FAERS) and validating the findings using the Canada Vigilance Adverse Reaction Online Database (Canada Vigilance ADR).Methods We analyzed adverse event reports from the FAERS database covering the period from Q1 2004 to Q4 2024. Drugs were standardized using the RxNorm drug terminology system, and adverse events were matched to MedDRA 27.1. Disproportionality analysis was conducted using Reporting Odds Ratio (ROR), Multi-item Gamma Poisson Shrinker (MGPS), and Bayesian Confidence Propagation Neural Network (BCPNN) methods. To validate our findings, we performed external validation using the Canada Vigilance ADR database. Stratified analyses by sex were performed to assess differences in drug-osteoporosis associations.Results A total of 236,928 osteoporosis-related reports were identified, with 64.6% of the reports coming from females. We identified 68 drugs associated with DIOP, including 15 male-specific and 26 female-specific potential risk drugs. Notable drugs such as tenofovir disoproxil and esomeprazole were linked to both sexes. Drugs like upadacitinib exhibited early-onset failure patterns, while others like tenofovir demonstrated cumulative risk patterns over prolonged use. External validation with the Canada Vigilance ADR confirmed 32 drugs with potential osteoporosis risks.Conclusions This study highlights important sex-specific differences in the risk of drug-induced osteoporosis and underscores the need for targeted pharmacovigilance strategies. The findings contribute to a more personalized approach to drug safety, promoting more informed decision-making regarding medication use in osteoporosis-prone populations.