Hagino Hiroshi, Nishizawa Yoshiki, Sone Teruki, Morii Hirotoshi, Taketani Yuji, Nakamura Toshitaka, Itabashi Akira, Mizunuma Hideaki, Ohashi Yasuo, Shiraki Masataka, Minamide Toshiomi, Matsumoto Toshio
Rehabilitation Division and School of Health Science, Tottori University, Yonago, Tottori 683-8504, Japan.
Bone. 2009 Jun;44(6):1078-84. doi: 10.1016/j.bone.2009.02.016. Epub 2009 Mar 2.
In a randomized, active-controlled, double-blinded, multicenter study, the efficacy and safety of minodronate were examined and compared to that of alendronate.
A total of 270 postmenopausal osteoporotic women >or=45 years of age were randomized into the minodronate group (n=135) or alendronate group (n=135). Each subject received 1 mg minodronate or 5 mg alendronate once a day for 12 months.
Both treatment groups showed similar changes in BMD after 12 months. After 1 year of treatment, the lumbar spine BMD increased by 5.86% and 6.29% in the minodronate and alendronate groups, respectively, and the total hip BMD increased by 3.47% and 3.27%, respectively. Bone turnover markers were rapidly reduced within 1 month in both treatment groups. Urine DPD was significantly lower in the minodronate group than in the alendronate group at 6 months, and urine NTX was significantly lower in the minodronate group than in the alendronate group at 1 and 9 months. Both completion rates for the 12-month study and the overall incidence of clinical adverse events, including gastrointestinal events, were similar between the two groups.
The effects on lumbar and hip BMD and the safety profile of minodronate are comparable to those of alendronate. Minodronate is a promising new potent bisphosphonate for the treatment of osteoporosis.
在一项随机、活性药物对照、双盲、多中心研究中，对米诺膦酸盐的疗效和安全性进行了研究，并与阿仑膦酸盐进行了比较。
总共270名年龄≥45岁的绝经后骨质疏松症女性被随机分为米诺膦酸盐组（n = 135）或阿仑膦酸盐组（n = 135）。每位受试者每天服用1毫克米诺膦酸盐或5毫克阿仑膦酸盐，持续12个月。
12个月后，两个治疗组的骨密度变化相似。治疗1年后，米诺膦酸盐组和阿仑膦酸盐组的腰椎骨密度分别增加了5.86%和6.29%，全髋骨密度分别增加了3.47%和3.27%。两个治疗组的骨转换标志物在1个月内迅速降低。在6个月时，米诺膦酸盐组的尿DPD显著低于阿仑膦酸盐组，在1个月和9个月时，米诺膦酸盐组的尿NTX显著低于阿仑膦酸盐组。两组12个月研究的完成率以及包括胃肠道事件在内的临床不良事件的总发生率相似。
米诺膦酸盐对腰椎和髋部骨密度的影响以及安全性与阿仑膦酸盐相当。米诺膦酸盐是一种有前途的新型强效双膦酸盐，可用于治疗骨质疏松症。
