Effect of daily oral minodronate on vertebral fractures in Japanese postmenopausal women with established osteoporosis: a randomized placebo-controlled double-blind study.

Abstract

UNLABELLED:

SUMMARY; A randomized placebo-controlled trial was conducted to examine the effect of daily oral 1 mg minodronate on vertebral fractures in 704 postmenopausal women with established osteoporosis for 24 months. Minodronate treatment reduced vertebral fractures by 59% without serious adverse events. Minodronate is a safe and effective bisphosphonate for osteoporosis treatment.

INTRODUCTION:

Minodronate increases bone mineral density (BMD) in postmenopausal osteoporotic patients. However, its efficacy in reducing osteoporotic fractures has not been tested.

METHODS:

To examine anti-fracture efficacy and safety of daily oral minodronate in postmenopausal women with established osteoporosis, a randomized, double-blind, placebo-controlled trial was conducted in 704 postmenopausal women (55 to 80 years) with one to five vertebral fractures and low BMD. Subjects were randomly assigned to receive daily oral 1 mg minodronate (n = 359) or placebo (n = 345) for 24 months, with daily supplements of 600 mg calcium and 200 IU vitamin D(3).

RESULTS:

Daily 1 mg minodronate for 24 months reduced the risk of vertebral fractures by 59% (95% CI, 36.6-73.3%). Furthermore, when fractures during the first 6 months were eliminated, the risk of vertebral fractures from 6 to 24 months was reduced by 74% in minodronate-treated group. Minodronate treatment also reduced height loss. Bone turnover markers were suppressed by about 50% after 6 months of minodronate treatment and remained suppressed thereafter. The overall safety profile including gastrointestinal safety was similar between the two groups.

CONCLUSIONS:

Daily oral minodronate is safe, well-tolerated, and is effective in reducing vertebral fracture risk in postmenopausal women with established osteoporosis.

• Authors: T Matsumoto, H Hagino, M Shiraki, M Fukunaga, T Nakano, K Takaoka, H Morii, Y Ohashi, T Nakamura
• Journal: Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA (Osteoporos Int) Vol. 20 Issue 8 Pg. 1429-37 (Aug 2009) ISSN: 1433-2965 [Electronic] England
• PMID: 19101754 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Biomarkers
• Bone Density Conservation Agents
• Diphosphonates
• Imidazoles
• YM 529

Topics

• Administration, Oral
• Aged
• Aged, 80 and over
• Biomarkers (metabolism)
• Body Height (drug effects)
• Bone Density Conservation Agents (administration & dosage, adverse effects, therapeutic use)
• Bone Remodeling (drug effects)
• Diphosphonates (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Fractures, Bone (etiology, prevention & control)
• Humans
• Imidazoles (administration & dosage, adverse effects, therapeutic use)
• Middle Aged
• Osteoporosis, Postmenopausal (complications, drug therapy, physiopathology)
• Spinal Fractures (etiology, prevention & control)
• Treatment Outcome