Clinical efficacy and safety of monthly oral ibandronate 100 mg versus monthly intravenous ibandronate 1 mg in Japanese patients with primary osteoporosis

• Published in: Osteoporosis international 2015-11, Vol.26 (11), p.2685-2693
• Main Authors: Nakamura, T., Ito, M., Hashimoto, J., Shinomiya, K., Asao, Y., Katsumata, K., Hagino, H., Inoue, T., Nakano, T., Mizunuma, H.
• Format: Article
• Language: English
• Subjects: Administration, Oral; Aged; Biomarkers - blood; Bone Density - drug effects; Bone Density Conservation Agents - administration & dosage; Bone Density Conservation Agents - adverse effects; Bone Density Conservation Agents - therapeutic use; Bone Remodeling - drug effects; Clinical trials; Diphosphonates - administration & dosage; Diphosphonates - adverse effects; Diphosphonates - therapeutic use; Double-Blind Method; Drug Administration Schedule; Endocrinology; Female; Humans; Infusions, Intravenous; Intravenous therapy; Male; Medicine; Medicine & Public Health; Middle Aged; Oral diseases; Original; Original Article; Orthopedics; Osteoporosis; Osteoporosis - drug therapy; Osteoporosis - physiopathology; Osteoporotic Fractures - prevention & control; Rheumatology
• ISSN: 0937-941X; 1433-2965
• DOI: 10.1007/s00198-015-3175-1

Summary The MOVEST study evaluated the efficacy and safety of monthly oral ibandronate versus licensed monthly IV ibandronate in Japanese osteoporotic patients. Relative BMD gains after 12 months were 5.22 % oral and 5.34 % IV, showing non-inferiority of oral to IV ibandronate (primary endpoint). No new safety concerns were identified. Introduction The randomized, phase 3, double-blind MOVEST (Monthly Oral VErsus intravenouS ibandronaTe) study evaluated the efficacy and safety of monthly oral ibandronate versus the licensed monthly intravenous (IV) ibandronate regimen in Japanese patients with osteoporosis. Methods Ambulatory patients aged ≥55 years with primary osteoporosis were randomized to receive oral ibandronate 100 mg/month plus monthly IV placebo, or IV ibandronate 1 mg/month plus monthly oral placebo. The primary endpoint was non-inferiority of oral versus IV ibandronate with respect to bone mineral density (BMD) gains at the lumbar spine after 12 months of treatment. Results Four hundred twenty-two patients were enrolled with 372 patients in the per-protocol set (183 and 189 in the oral and IV ibandronate groups, respectively). The relative change from baseline in lumbar spine BMD values for the oral and IV ibandronate groups, respectively, was 5.22 % (95 % confidence interval [CI] 4.65, 5.80) and 5.34 % (95 % CI 4.78, 5.90). The least squares mean difference between the two groups was −0.23 % (95 % CI −0.97, 0.51), showing non-inferiority of oral ibandronate to IV ibandronate (non-inferiority limit = −1.60). Changes in BMD values at other sites, and bone turnover marker levels in the oral ibandronate group, were comparable with those of the IV group. The safety profile was similar to that previously demonstrated; no new safety concerns were identified. Conclusions This study demonstrated the non-inferiority of oral ibandronate 100 mg/month to IV ibandronate 1 mg/month (licensed dose in Japan) in increasing lumbar spine BMD in Japanese patients with primary osteoporosis.