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

Authors :
Peng C
Tian R
Li L
Zhu YK
Li SY
Ye SD
He L
Niu JP
Zhang Q
Zhou YF
Source :
Zhonghua fu chan ke za zhi [Zhonghua Fu Chan Ke Za Zhi] 2022 May 25; Vol. 57 (5), pp. 346-351.
Publication Year :
2022

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 D <subscript>3</subscript> ( n =130) or placebo ( n =132) with daily supplements of 500 mg calcium and 200 U vitamin D <subscript>3</subscript> , 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.

Details

Language :
Chinese
ISSN :
0529-567X
Volume :
57
Issue :
5
Database :
MEDLINE
Journal :
Zhonghua fu chan ke za zhi
Publication Type :
Academic Journal
Accession number :
35658325
Full Text :
https://doi.org/10.3760/cma.j.cn112141-20220220-00108