[A randomized double-blinded placebo-controlled clinical trial of minodronate tablet in postmenopausal Chinese women with osteoporosis].

Abstract

Objective: To verify the efficacy and safety of daily oral minodronate in postmenopausal women with established osteoporosis. Methods: In this randomized, double-blinded, placebo-controlled trial, 262 postmenopausal women were enrolled. Patients were randomized to receive daily oral minodronate 1 mg with supplements of 500 mg calcium and 200 U vitamin D3 (n=130) or placebo (n=132) with daily supplements of 500 mg calcium and 200 U vitamin D3, for 48 weeks. The primary endpoint was the average bone mineral density (BMD) change in the lumbar vertebrae 48 weeks post-treatment. Secondary outcome measures was the incidence of vertebral fractures. Safety assessments included the rate of adverse events. Results: At the end of 48 weeks treatment, the average BMD change rate from baseline were: full analysis set results: (3.52±4.82)% in the minodronate group and (2.00±5.74)% in the placebo group; per-protocol set results: (3.99±5.05)% in the minodronate group and (2.07±6.20)% in the placebo group; the differences were all significant (all P<0.05). Vertebral fracture occured in 3 patients (2.3%, 3/132) in the placebo group, and 1 case (0.8%, 1/130) in the minodronate group (P>0.05). The incidence of adverse events was 71.5% (93/130) in the minodronate group and 78.0% (103/132) in the placebo group (P>0.05). Conclusion: Minodronate is effective and safe in the treatment of postmenopausal osteoporosis without severe side effects.

• Authors: C Peng, R Tian, L Li, Y K Zhu, S Y Li, S D Ye, L He, J P Niu, Q Zhang, Y F Zhou
• Journal: Zhonghua fu chan ke za zhi (Zhonghua Fu Chan Ke Za Zhi) Vol. 57 Issue 5 Pg. 346-351 (May 25 2022) ISSN: 0529-567X [Print] China
• PMID: 35658325 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Bone Density Conservation Agents
• Diphosphonates
• Imidazoles
• Tablets
• YM 529
• Vitamin D
• Calcium

Topics

• Bone Density
• Bone Density Conservation Agents (adverse effects)
• Calcium (pharmacology, therapeutic use)
• China
• Diphosphonates
• Double-Blind Method
• Female
• Humans
• Imidazoles
• Osteoporosis (chemically induced, complications, drug therapy)
• Osteoporosis, Postmenopausal (chemically induced, complications, drug therapy)
• Postmenopause
• Spinal Fractures (complications, epidemiology, prevention & control)
• Tablets (pharmacology, therapeutic use)
• Treatment Outcome
• Vitamin D (pharmacology, therapeutic use)