INSERM U1059, Rheumatology Department, University Hospital of Saint-Etienne, 42055, Saint-Etienne Cedex 2, France.
Osteoporos Int. 2013 Jan;24(1):263-9. doi: 10.1007/s00198-012-2060-4. Epub 2012 Jun 27.
This study aims to estimate bisphosphonate effectiveness by comparing fracture incidence over time on therapy in glucocorticoid-induced osteoporosis (GIO). From this observational study, alendronate and risedronate decreased clinical vertebral and nonvertebral fractures over time. The effectiveness of each bisphosphonate is consistent with their efficacies demonstrated on surrogate markers in randomized controlled trials (RCTs).
This study aims to estimate bisphosphonate effectiveness by comparing fracture incidence over time on therapy with fracture incidence during a short period after starting a therapy.
The study population was a subgroup of a larger cohort study comprising two cohorts of women aged ≥65 years, prescribed with alendronate or risedronate. Within the two study cohorts, 11,007 women were identified as having received glucocorticoids. Within each cohort, the baseline incidence of clinical fractures at nonvertebral and vertebral sites was defined by the initial 3-month period after starting therapy. Relative to these baseline data, we then compared the fracture incidence during the subsequent 12 months on therapy.
The baseline incidence of clinical nonvertebral and vertebral fractures was similar in the alendronate cohort (5.22 and 5.79/100 person-years, respectively) and in the risedronate cohort (5.51 and 5.68/100 person-years, respectively). Relative to the baseline incidence, fracture incidence was significantly lower in the subsequent 12 months in both cohorts of alendronate (33 % lower at nonvertebral sites and 59 % at vertebral sites) and risedronate (28 % lower at nonvertebral sites and 54 % at vertebral sites).
From this observational study not designed to compare drugs, both alendronate and risedronate decreased clinical vertebral and nonvertebral fractures over time. The reductions observed in fracture incidence, within each cohort, suggest that the effectiveness of each bisphosphonate in clinical practice is consistent with their efficacies demonstrated on surrogate markers in randomized controlled trials.
通过比较糖皮质激素诱导骨质疏松症（GIO）患者接受治疗后不同时间的骨折发生率，评估双膦酸盐的疗效。本观察性研究显示，阿仑膦酸钠和利塞膦酸钠可随时间推移降低临床椎体和非椎体骨折的发生率。每种双膦酸盐的疗效与随机对照试验（RCT）中替代终点所显示的疗效一致。
本研究旨在通过比较治疗期间的骨折发生率和治疗开始后短期的骨折发生率来评估双膦酸盐的疗效。
研究人群为一项较大队列研究的亚组，该研究包含两个年龄≥65 岁的女性队列，接受阿仑膦酸钠或利塞膦酸钠治疗。在这两个研究队列中，有 11007 名女性被诊断为使用过糖皮质激素。在每个队列中，治疗开始后最初 3 个月内非椎体和椎体部位的临床骨折的基线发生率通过定义。与这些基线数据相比，我们比较了随后 12 个月的治疗期间的骨折发生率。
阿仑膦酸钠队列（分别为 5.22 和 5.79/100 人年）和利塞膦酸钠队列（分别为 5.51 和 5.68/100 人年）的基线非椎体和椎体临床骨折发生率相似。与基线发生率相比，阿仑膦酸钠和利塞膦酸钠两个队列的骨折发生率在随后的 12 个月中均显著降低（非椎体部位降低 33%，椎体部位降低 59%）。
本观察性研究未设计用于比较药物，结果显示阿仑膦酸钠和利塞膦酸钠可随时间推移降低 GIO 患者的临床椎体和非椎体骨折的发生率。在每个队列中观察到的骨折发生率降低表明，每种双膦酸盐在临床实践中的有效性与其在 RCT 中替代终点所显示的疗效一致。
