Nakamura T, Ito M, Hashimoto J, Shinomiya K, Asao Y, Katsumata K, Hagino H, Inoue T, Nakano T, Mizunuma H
National Center for Global Health and Medicine, Tokyo, Japan.
Center for Gender Equality, Nagasaki University, Nagasaki, Japan.
Osteoporos Int. 2015 Nov;26(11):2685-93. doi: 10.1007/s00198-015-3175-1. Epub 2015 May 23.
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.
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.
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.
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.
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.
MOVEST研究评估了每月口服伊班膦酸钠与日本获批的每月静脉注射伊班膦酸钠在骨质疏松症患者中的疗效和安全性。12个月后口服组的骨密度相对增加5.22%，静脉注射组为5.34%，表明口服伊班膦酸钠不劣于静脉注射伊班膦酸钠（主要终点）。未发现新的安全问题。
随机、3期、双盲的MOVEST（每月口服与静脉注射伊班膦酸钠）研究评估了每月口服伊班膦酸钠与日本获批的每月静脉注射伊班膦酸钠方案在日本骨质疏松症患者中的疗效和安全性。
年龄≥55岁的原发性骨质疏松门诊患者被随机分为接受每月口服100毫克伊班膦酸钠加每月静脉注射安慰剂，或每月静脉注射1毫克伊班膦酸钠加每月口服安慰剂。主要终点是治疗12个月后口服与静脉注射伊班膦酸钠在腰椎骨密度增加方面的非劣效性。
共纳入422例患者，符合方案集有372例患者（口服伊班膦酸钠组和静脉注射伊班膦酸钠组分别为183例和189例）。口服和静脉注射伊班膦酸钠组腰椎骨密度值相对于基线的相对变化分别为5.22%（95%置信区间[CI]4.65，5.80）和5.34%（95%CI 4.78，5.90）。两组的最小二乘均值差异为-0.23%（95%CI -0.97，0.51），表明口服伊班膦酸钠不劣于静脉注射伊班膦酸钠（非劣效界值=-1.60）。口服伊班膦酸钠组其他部位的骨密度值变化和骨转换标志物水平与静脉注射组相当。安全性与之前显示的相似；未发现新的安全问题。
本研究证明，在增加日本原发性骨质疏松症患者的腰椎骨密度方面，每月口服100毫克伊班膦酸钠不劣于每月静脉注射1毫克伊班膦酸钠（日本获批剂量）。
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