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已发表论文
米诺膦酸与阿仑膦酸对绝经后骨质疏松症患者腰痛的比较效果及年龄影响：一项头对头随机临床试验
Authors Wang H, Liu H, Huang J, Meng X, Wang W, Xiao W, Liu D , Tao L , Song C
Received 21 May 2025
Accepted for publication 5 November 2025
Published 27 November 2025 Volume 2025:20 Pages 2219—2230
DOI https://doi.org/10.2147/CIA.S541940
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Zhi-Ying Wu
Huan Wang,1 Hao Liu,1 Jie Huang,1 Xiuli Meng,2 Wei Wang,3 Wenhua Xiao,4 Dongyang Liu,5 Liyuan Tao,6 Chunli Song1
1Department of Orthopedics, Peking University Third Hospital, Beijing, People’s Republic of China; 2Pain Medicine Center, Peking University Third Hospital, Beijing, People’s Republic of China; 3Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing, People’s Republic of China; 4Department of Endocrinology and Metabolism, Center of Reproductive Medicine, Peking University Third Hospital, Beijing, People’s Republic of China; 5Drug Clinical Trial Center, Peking University Third Hospital, Beijing, People’s Republic of China; 6Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, People’s Republic of China
Correspondence: Chunli Song, Department of Orthopedics, Peking University Third Hospital, Beijing, China, 49# North Garden Road, Haidian District, Beijing, 100191, People’s Republic of China, Email schl@bjmu.edu.cn
Purpose: This study aimed to compare the analgesic efficacy of minodronate versus alendronate for postmenopausal osteoporosis-related low back pain and evaluate age-dependent treatment responses.
Methods: In this prospective, open-label randomized controlled trial, 72 postmenopausal women with osteoporosis were stratified by age (≥ 75 vs < 75 years) and allocated to 24-week treatment with daily minodronate (1 mg) or alendronate (10 mg). The primary endpoint was Visual Analogue Scale score changes from baseline to week 12. Secondary outcomes included age-stratified changes in lumbar spine and hip bone mineral density, along with serum bone turnover markers across different age groups (≥ 75 vs < 75 years).
Results: Both regimens demonstrated comparable analgesic efficacy, with significant within-group Visual Analogue Scale reductions (minodronate: 11.08± 1.52%; alendronate: 9.86± 1.29%; P< 0.01 for both) but no between-group difference (P=0.237). At week 24, comparable lumbar bone mineral density improvements were observed (minodronate: 2.42%, 95% CI 1.8– 3.1; alendronate: 4.84%, 95% CI 3.9– 5.7; P=0.103). Marked bone turnover markers suppression persisted in both arms (CTX: 46.14% vs 41.25%; P1NP: 44.82% vs 44.11%). Age-stratified analyses revealed comparable therapeutic responses across subgroups (P> 0.05). Safety profiles were similar, with adverse event rates of 29.7% (minodronate) versus 43.2% (alendronate) (P=0.10), predominantly mild upper gastrointestinal symptoms.
Conclusion: Both bisphosphonates demonstrated equivalent analgesic efficacy and comparable bone mineral density and biochemical effects, with age-independent responses. Safety profiles were similar, supporting clinical selection based on dosing convenience and gastrointestinal tolerance.
Trial Registration: ClinicalTrials.gov number: NCT05673980 (08/12/2022).
Plain Language Summary: This open-label trial demonstrated that minodronate and alendronate achieved comparable pain relief, bone mineral density improvement, and bone turnover markers suppression over 24 weeks, with similar safety profiles and age-independent efficacy. These findings support their equivalent analgesic and bone effects, guiding clinical selection based on dosing convenience and gastrointestinal tolerance.
Keywords: minodronate, alendronate, low back pain, bone mineral density, bone turnover markers, age
1Department of Orthopedics, Peking University Third Hospital, Beijing, People’s Republic of China; 2Pain Medicine Center, Peking University Third Hospital, Beijing, People’s Republic of China; 3Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing, People’s Republic of China; 4Department of Endocrinology and Metabolism, Center of Reproductive Medicine, Peking University Third Hospital, Beijing, People’s Republic of China; 5Drug Clinical Trial Center, Peking University Third Hospital, Beijing, People’s Republic of China; 6Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, People’s Republic of China
Correspondence: Chunli Song, Department of Orthopedics, Peking University Third Hospital, Beijing, China, 49# North Garden Road, Haidian District, Beijing, 100191, People’s Republic of China, Email schl@bjmu.edu.cn
Purpose: This study aimed to compare the analgesic efficacy of minodronate versus alendronate for postmenopausal osteoporosis-related low back pain and evaluate age-dependent treatment responses.
Methods: In this prospective, open-label randomized controlled trial, 72 postmenopausal women with osteoporosis were stratified by age (≥ 75 vs < 75 years) and allocated to 24-week treatment with daily minodronate (1 mg) or alendronate (10 mg). The primary endpoint was Visual Analogue Scale score changes from baseline to week 12. Secondary outcomes included age-stratified changes in lumbar spine and hip bone mineral density, along with serum bone turnover markers across different age groups (≥ 75 vs < 75 years).
Results: Both regimens demonstrated comparable analgesic efficacy, with significant within-group Visual Analogue Scale reductions (minodronate: 11.08± 1.52%; alendronate: 9.86± 1.29%; P< 0.01 for both) but no between-group difference (P=0.237). At week 24, comparable lumbar bone mineral density improvements were observed (minodronate: 2.42%, 95% CI 1.8– 3.1; alendronate: 4.84%, 95% CI 3.9– 5.7; P=0.103). Marked bone turnover markers suppression persisted in both arms (CTX: 46.14% vs 41.25%; P1NP: 44.82% vs 44.11%). Age-stratified analyses revealed comparable therapeutic responses across subgroups (P> 0.05). Safety profiles were similar, with adverse event rates of 29.7% (minodronate) versus 43.2% (alendronate) (P=0.10), predominantly mild upper gastrointestinal symptoms.
Conclusion: Both bisphosphonates demonstrated equivalent analgesic efficacy and comparable bone mineral density and biochemical effects, with age-independent responses. Safety profiles were similar, supporting clinical selection based on dosing convenience and gastrointestinal tolerance.
Trial Registration: ClinicalTrials.gov number: NCT05673980 (08/12/2022).
Plain Language Summary: This open-label trial demonstrated that minodronate and alendronate achieved comparable pain relief, bone mineral density improvement, and bone turnover markers suppression over 24 weeks, with similar safety profiles and age-independent efficacy. These findings support their equivalent analgesic and bone effects, guiding clinical selection based on dosing convenience and gastrointestinal tolerance.
Keywords: minodronate, alendronate, low back pain, bone mineral density, bone turnover markers, age