Clinical efficacy and safety of monthly oral ibandronate 100 mg versus monthly intravenous ibandronate 1 mg in Japanese patients with primary osteoporosis.
Clinical efficacy and safety of monthly oral ibandronate 100 mg versus monthly intravenous ibandronate 1 mg in Japanese patients with primary osteoporosis.
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日本原发性骨质疏松症患者的每月口服i灯膦酸100毫克与静脉注射1 mg的临床功效和安全性。
DOI：
10.1007/s00198-015-3175-1
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发表时间：
2015-11
期刊：
影响因子：
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通讯作者：
MOVEST Study Group
中科院分区：
文献类型：
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作者：
Nakamura T;Ito M;Hashimoto J;Shinomiya K;Asao Y;Katsumata K;Hagino H;Inoue T;Nakano T;Mizunuma H;MOVEST Study Group
MOVEST 研究评估了日本骨质疏松患者每月口服伊班膦酸钠与每月静脉注射伊班膦酸钠的疗效和安全性。 12 个月后相对 BMD 增益为口服治疗的 5.22% 和静脉注射治疗的 5.34%，显示口服伊班膦酸钠不劣于静脉注射伊班膦酸钠（主要终点）。没有发现新的安全问题。随机、3 期、双盲 MOVEST（每月口服伊班膦酸钠与静脉注射伊班膦酸钠）研究评估了日本骨质疏松症患者每月口服伊班膦酸钠与许可的每月静脉注射 (IV) 伊班膦酸钠方案的疗效和安全性。年龄≥55岁的原发性骨质疏松症门诊患者被随机分配接受口服伊班膦酸钠100毫克/月加每月静脉注射安慰剂，或静脉注射伊班膦酸钠1毫克/月加每月口服安慰剂。主要终点是治疗 12 个月后，口服伊班膦酸钠与静脉注射伊班膦酸钠在腰椎骨矿物质密度 (BMD) 增加方面的非劣效性。共有 422 名患者入组，其中符合方案组有 372 名患者（口服和静脉注射伊班膦酸盐组分别为 183 名和 189 名）。口服和静脉注射伊班膦酸钠组的腰椎 BMD 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）。两组之间的最小二乘平均差异为-0.23%（95%CI-0.97，0.51），显示口服伊班膦酸钠与静脉注射伊班膦酸钠的非劣效性（非劣效限 = -1.60）。口服伊班膦酸钠组其他部位 BMD 值的变化以及骨转换标志物水平与静脉注射组相当。安全性与之前证明的相似；没有发现新的安全问题。这项研究证明，在日本原发性骨质疏松症患者中，口服伊班膦酸钠 100 毫克/月与静脉注射伊班膦酸钠 1 毫克/月（日本许可剂量）在增加腰椎 BMD 方面并不逊色。本文的在线版本 (doi:10.1007/s00198-015-3175-1) 包含补充材料，可供授权用户使用。
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. The online version of this article (doi:10.1007/s00198-015-3175-1) contains supplementary material, which is available to authorized users.