Racewicz Artur J, Schofield Pamela J, Cahall David L, Cline Gary A, Burgio David E
NZOZ Centrum Medyczne, BiaBystok, Poland.
Curr Med Res Opin. 2007 Dec;23(12):3079-89. doi: 10.1185/030079907X242665.
Risedronate 5 mg daily significantly reduces the incidence of vertebral and non-vertebral osteoporotic fractures in postmenopausal women. We compared the efficacy and tolerability of risedronate 50 mg administered on 3 consecutive days per month, with and without a loading dose, with those of risedronate 5 mg daily in a randomized, double-blind study.
Subjects were postmenopausal women 65-80 years old with low bone mineral density (BMD) (T-score < or = -2). Subjects received risedronate 5 mg daily for 6 months (n = 48), risedronate 150 mg (50-mg doses on 3 consecutive days) monthly for 6 months (n = 50), or a loading dose of risedronate 15 mg daily for 1 month followed by 150 mg (50-mg doses on 3 consecutive days) monthly for 5 months (n = 52).
Within 1 week, statistically significant reductions in urine N-telopeptide, the primary efficacy measure, were observed in all three groups. After 6 months, the least squares (LS) mean differences (95% confidence intervals [CI]) from the change in the 5 mg daily group (-39.88) were -3.54% (-15.71; 8.64) for the 150 mg monthly and -2.02% (-14.13;10.10) for the loading dose + 150 mg monthly groups. Mean percent changes in serum alpha-C-telopeptide, bone-specific alkaline phosphatase, and BMD, secondary efficacy measures, after 6 months were also similar for the three groups. The LS mean differences (95% CI) from the mean percent change in BMD in the 5 mg daily group (3.22%) were 0.20 (-1.15; 1.55) for the 150 mg monthly and -0.58 (-1.93; 0.76) for the loading dose + 150 mg monthly groups. The safety profile of the monthly regimens was similar to that of the 5 mg daily regimen and consistent with product labeling.
A monthly regimen of risedronate 50 mg on 3 consecutive days per month was similar to risedronate 5 mg daily with respect to its effect in suppressing bone turnover and increasing BMD and its safety profile in women with postmenopausal osteoporosis. This study was not powered to be a confirmatory trial for non-inferiority; therefore, additional study is needed.
每日服用5毫克利塞膦酸盐可显著降低绝经后妇女椎骨和非椎骨骨质疏松性骨折的发生率。在一项随机双盲研究中，我们比较了每月连续3天服用50毫克利塞膦酸盐（有无负荷剂量）与每日服用5毫克利塞膦酸盐的疗效和耐受性。
研究对象为65 - 80岁、骨矿物质密度（BMD）较低（T值≤ -2）的绝经后妇女。受试者分别接受以下治疗：每日服用5毫克利塞膦酸盐，持续6个月（n = 48）；每月服用150毫克利塞膦酸盐（连续3天每日服用50毫克），持续6个月（n = 50）；或先每日服用15毫克利塞膦酸盐负荷剂量1个月，随后每月服用150毫克（连续3天每日服用50毫克），持续5个月（n = 52）。
在1周内，所有三组均观察到作为主要疗效指标的尿N - 端肽有统计学意义的下降。6个月后，每月服用150毫克组与每日服用5毫克组变化值（-39.88）的最小二乘（LS）均值差异（95%置信区间[CI]）为-3.54%（-15.71；8.64），负荷剂量 + 每月服用150毫克组为-2.02%（-14.13；10.10）。作为次要疗效指标的血清α - C - 端肽、骨特异性碱性磷酸酶和BMD在6个月后的平均百分比变化，三组也相似。每月服用150毫克组与每日服用5毫克组BMD平均百分比变化值（3.22%）的LS均值差异（95% CI）为0.20（-1.15；1.55），负荷剂量 + 每月服用150毫克组为-0.58（-1.93；0.76）。每月用药方案的安全性与每日服用5毫克方案相似，且与产品标签一致。
每月连续3天服用50毫克利塞膦酸盐的方案在抑制骨转换和增加骨密度方面的效果及其在绝经后骨质疏松症女性中的安全性与每日服用5毫克利塞膦酸盐相似。本研究无足够效力作为非劣效性的确证性试验；因此，需要进一步研究。
