Effect of monitoring bone turnover markers on persistence with risedronate treatment of postmenopausal osteoporosis
Effect of monitoring bone turnover markers on persistence with risedronate treatment of postmenopausal osteoporosis
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DOI：
10.1210/jc.2006-1526
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发表时间：
2007-04-01
影响因子：
5.8
通讯作者：
Watts, Nelson B.
中科院分区：
文献类型：
--
作者：
Delmas, Pierre D.;Vrijens, Bernard;Watts, Nelson B.
内容：骨质疏松症治疗的持续性较差，但对最大获益很重要。目的：本研究的目的是评估使用骨转换标志物（BTM）的医师强化对利塞膦酸盐治疗持续性的影响。设计和设置：这是一项在21个国家的171个骨质疏松症中心进行的为期1年的多国前瞻性、开放标签、盲法研究。患者：共有2382名绝经后妇女（65-80岁）脊柱/髋关节T评分为-2.5或更低或T评分为-1.0或更低，伴有低创伤骨折。干预：干预包括钙500 mg/d，维生素D 400 IU/d，利塞膦酸钠5 mg/d，持续1年。中心被随机分配至强化（RE+）或无强化（RE-）。在第13和25周，根据尿I型胶原蛋白N端肽较基线的变化，采用以下反应类别向RE+患者提供强化治疗：良好（下降> 30%），稳定（-30%至+30%变化）或较差（增加> 30%）。主要结果测量：用电子药物监测器评估持续性。在总体疗效人群（n = 2302）中，持续性出乎意料地高，两组相似（RE-，77%; RE+，80%; P = 0.160）。观察到消息类型和持久性之间存在显著关系（P = 0.017）。与RE-相比，基于良好BTM反应的干预与持续性的显著改善相关[风险比（HR）0.71; 95%置信区间（CI）0.53-0.95]。当强化分别基于稳定或较差的BTM应答时，持续性不变（HR 1.02; 95% CI 0.74-1.40）或更低（HR 2.22; 95% CI 1.27-3.89）。加固与新的放射学确定的椎骨骨折的发生率较低（比值比0.4; 95%CI，0.2-1.0）。结论：使用BTM加固影响绝经后骨质疏松症妇女治疗的持久性，这取决于观察到的BTM反应。
Context: Persistence with osteoporosis treatment is poor but is important for maximum benefit.Objective: The objective of the study was to assess the impact of physician reinforcement using bone turnover markers (BTMs) on persistence with risedronate treatment.Design and Setting: This was a 1-yr multinational prospective, open-label, blinded study in 171 osteoporosis centers in 21 countries.Patients: A total of 2382 postmenopausal women (65-80 yr old) with spine/hip T-score -2.5 or less or T-score -1.0 or less with a low-trauma fracture.Intervention: Intervention included calcium 500 mg/d, vitamin D 400 IU/d, and risedronate 5 mg/d for 1 yr. Centers were randomized to reinforcement (RE+) or no reinforcement (RE-). At 13 and 25 wk, reinforcement based on urinary N-telopeptide of type I collagen change from baseline was provided to the RE+ patients using the following response categories: good (> 30% decrease), stable (-30% to +30% change), or poor (> 30% increase).Main Outcome Measures: Persistence assessed with electronic drug monitors was measured.Results: In the overall efficacy population (n = 2302), persistence was unexpectedly high and was similar for both groups (RE-, 77%; RE+, 80%; P = 0.160). A significant relationship between the type of message and persistence was observed (P = 0.017). Compared with RE-, intervention based on a good BTM response was associated with a significant improvement in persistence [hazard ratio (HR) 0.71; 95% confidence interval (CI) 0.53-0.95]. Persistence was unchanged ( HR 1.02; 95% CI 0.74-1.40) or lower (HR 2.22; 95% CI 1.27-3.89) when reinforcement was based on a stable or poor BTM response, respectively. Reinforcement was associated with a lower incidence of new radiologically determined vertebral fractures (odds ratio 0.4; 95% CI, 0.2-1.0).Conclusions: Reinforcement using BTMs influences persistence with treatment in postmenopausal women with osteoporosis, depending on the BTM response observed.