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

• Published in: Osteoporosis international Vol. 20; no. 8; pp. 1429 - 1437
• Main Authors: Matsumoto, T, Hagino, H, Shiraki, M, Fukunaga, M, Nakano, T, Takaoka, K, Morii, H, Ohashi, Y, Nakamura, T
• Format: Journal Article
• Language: English
• Published: London London : Springer-Verlag 01.08.2009; Springer-Verlag; Springer; Springer Nature B.V
• Subjects: Administration, Oral; Aged; Aged, 80 and over; Biological and medical sciences; Biomarkers - metabolism; Bisphosphonate; Body Height - drug effects; Bone density; Bone Density Conservation Agents - administration & dosage; Bone Density Conservation Agents - adverse effects; Bone Density Conservation Agents - therapeutic use; Bone Remodeling - drug effects; Bone turnover markers; Bones, joints and connective tissue. Antiinflammatory agents; Clinical trials; Diphosphonates - administration & dosage; Diphosphonates - adverse effects; Diphosphonates - therapeutic use; Diseases of the osteoarticular system; Double-Blind Method; Drug Administration Schedule; Drug therapy; Endocrinology; Female; Fracture prevention; Fractures; Fractures, Bone - etiology; Fractures, Bone - prevention & control; Height loss; Humans; Imidazoles - administration & dosage; Imidazoles - adverse effects; Imidazoles - therapeutic use; Injuries of the limb. Injuries of the spine; Medical sciences; Medicine; Medicine & Public Health; Menopause; Middle Aged; Minodronate; Older people; Original; Original Article; Orthopedics; Osteoporosis; Osteoporosis, Postmenopausal - complications; Osteoporosis, Postmenopausal - drug therapy; Osteoporosis, Postmenopausal - physiopathology; Osteoporosis. Osteomalacia. Paget disease; Pharmacology. Drug treatments; Rheumatology; Risk factors; Spinal Fractures - etiology; Spinal Fractures - prevention & control; Traumas. Diseases due to physical agents; Treatment Outcome; Women; Bisphosphonate; Minodronate; Height loss; Bone turnover markers; Fracture prevention; Human; Antiosteoporotic; Diseases of the osteoarticular system; Rheumatology; Oral administration; Minodronic acid; Vertebra; Corporal biometry; Fracture; Bone remodeling; Trauma; Bisphosphonates; Prevention; Osteoporosis; Antiosteoclastic agent; Body size; Double blind study; Postmenopause; Woman
• ISSN: 0937-941X; 1433-2965; 1433-2965
• DOI: 10.1007/s00198-008-0816-7

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 D₃. 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.