Comparative Effects of Minodronate and Alendronate on Low Back Pain in Postmenopausal Osteoporosis and Age Influence: A Head-to-Head, Randomized Clinical Trial
Abstract
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%; P0.05). 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).
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 72 participants or records.
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