Philipps-University of Marburg, Marburg, Germany.
Osteoporos Int. 2012 Feb;23(2):625-33. doi: 10.1007/s00198-011-1583-4. Epub 2011 Mar 26.
The ROSE study compared a once-yearly intravenous dose of zoledronic acid with a once-weekly oral dose of alendronate in postmenopausal women. Once-yearly zoledronic acid showed a greater and faster reduction in the levels of two markers of bone turnover and may be an effective option for the treatment of osteoporosis.
The open-label Rapid Onset and Sustained Efficacy (ROSE) study was designed to compare a once-yearly intravenous (iv) dose of zoledronic acid with a once-weekly oral dose of alendronate with respect to markers of bone turnover in approximately 600 postmenopausal women in Germany.
Levels of N-telopeptide of collagen type I (NTx) and procollagen 1 C terminal extension peptide (P1NP) were assessed during the study. The primary objective was to assess if zoledronic acid was superior to alendronate in reducing serum NTx levels after 12 months' treatment.
A significantly greater reduction in NTx levels from baseline to month 12 (as determined by the area under the curve) was observed in patients treated with zoledronic acid (n = 408) versus those receiving alendronate (n = 196; 0.282 ng/mL vs. 0.270 ng/mL; P = 0.012). The reduction in levels of P1NP after 1 year was also significantly greater in patients treated with zoledronic acid compared with those receiving alendronate (28.21 vs. 25.53 ng/mL; P = 0.0024). The overall incidence of adverse events was similar between groups; both treatments were generally well tolerated. Although post-dose symptoms, including the incidence of influenza-like symptoms, were higher with zoledronic acid than alendronate initially, the incidence was similar between groups from days 4-360. Gastrointestinal symptoms were more frequent with alendronate than zoledronic acid throughout the study.
In this study, once-yearly iv zoledronic acid provided a greater and faster reduction in the levels of NTx and P1NP versus once-weekly oral alendronate.
ROSE 研究比较了绝经后妇女每年一次静脉注射唑来膦酸与每周一次口服阿仑膦酸钠的疗效。每年一次唑来膦酸可更快速、更大程度地降低两种骨转换标志物的水平，可能是骨质疏松症治疗的有效选择。
开放性 Rapid Onset and Sustained Efficacy（ROSE）研究旨在比较每年一次静脉（IV）注射唑来膦酸与每周一次口服阿仑膦酸钠对约 600 名德国绝经后妇女骨转换标志物的影响。
在研究期间评估了 I 型胶原 N 末端肽（NTx）和前胶原 1 C 端延长肽（P1NP）的水平。主要目的是评估唑来膦酸在治疗 12 个月后降低血清 NTx 水平方面是否优于阿仑膦酸钠。
与接受阿仑膦酸钠治疗的患者（n=196）相比，接受唑来膦酸治疗的患者（n=408）在 12 个月时从基线至第 12 个月的 NTx 水平（通过曲线下面积确定）下降更明显（0.282ng/mL vs. 0.270ng/mL；P=0.012）。与接受阿仑膦酸钠治疗的患者相比，接受唑来膦酸治疗的患者在 1 年后 P1NP 水平的降低也更显著（28.21 vs. 25.53ng/mL；P=0.0024）。两组的不良反应总发生率相似；两种治疗方法均普遍耐受良好。尽管最初接受唑来膦酸治疗的患者比接受阿仑膦酸钠治疗的患者发生更多的治疗后症状，包括流感样症状的发生率，但在第 4-360 天期间两组之间的发生率相似。在整个研究期间，胃肠道症状在阿仑膦酸钠组比唑来膦酸组更频繁。
在这项研究中，与每周一次口服阿仑膦酸钠相比，每年一次静脉注射唑来膦酸可更快速、更大程度地降低 NTx 和 P1NP 的水平。
