Comparative Effects of Minodronate and Alendronate on Low Back Pain in Postmenopausal Osteoporosis and Age Influence: A Head-to-Head, Randomized Clinical Trial.

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).