Establishing a Reference Interval for Bone Turnover Markers in 637 Healthy, Young, Premenopausal Women From the United Kingdom, France, Belgium, and the United States
Establishing a Reference Interval for Bone Turnover Markers in 637 Healthy, Young, Premenopausal Women From the United Kingdom, France, Belgium, and the United States
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DOI：
10.1359/jbmr.080703
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发表时间：
2009-03-01
影响因子：
6.2
通讯作者：
Eastell, Richard
中科院分区：
文献类型：
--
作者：
Glover, Sarah J.;Gall, Martin;Eastell, Richard
在大型 III 期骨折试验中，需要稳健的参考区间来解释骨转换标志物。该研究的目的是（1）估计健康年轻绝经前女性血清骨碱性磷酸酶（骨 ALP）、血清 1 型 N 型前胶原前肽（PINP）、血清 β 型 I 型胶原交联 C 端肽（S-β CTX）和尿 I 型胶原交联 N 端肽（UNTX）的参考区间； (2) 检查骨转换标志物的地理差异，(3) 评估已知影响骨转换的因素并测试这些因素是否解释了任何区域差异。我们研究了来自四个国家（英国、法国、比利时、美国）参与 Horizon-PFT 研究的 637 名符合条件的女性。女性年龄30-39岁（平均34.6岁），月经周期规律。受试者完成了医疗和生活方式调查问卷。使用国际临床化学联合会提出的方法，根据转换值估计两侧 95% 参考区间并转换回原始范围。通过方差分析，法国 4 的 S-beta CTX 显着高于英国 (p = 0.01)，法国 (p < 0.001) 和比利时 (p = 0.02) 的 PINP 相对于英国较高，法国相对于美国 (p < 0.01) 显着较高。总体而言，人们可以将低骨转换标志物与不吸烟、使用避孕药、锻炼、接近排卵时间以及高 25-羟基维生素 D 水平联系起来。各国的这些特征各不相同，一旦统计模型考虑在内，任何国家差异都会减弱或消除。
Robust reference intervals are needed for the interpretation of bone turnover markers in large phase III fracture trials. The objectives of the study were to (1) estimate reference intervals for serum bone alkaline phosphatase (bone ALP), serum procollagen type 1 N propeptide (PINP), serum beta cross-linked C-telopeptides of type I collagen (S-beta CTX), and urinary cross-linked N-telopeptides of type I collagen (UNTX) in healthy young premenopausal women; (2) examine geographical differences on bone turnover markers and (3) assess factors known to influence bone turnover and test whether these explain any regional differences. We studied 637 eligible women from four countries that participated in the Horizon-PFT study (United Kingdom, France, Belgium, United States). The women were 30-39 yr of age (mean, 34.6 yr), with regular cyclic menses. Subjects completed a medical and lifestyle questionnaire. Two-sided 95% reference intervals were estimated on transformed values and transformed back to the original scale using the proposed methodology of the International Federation of Clinical Chemistry. S-beta CTX was significantly higher in France 4, relative to the United Kingdom (p = 0.01), and PINP was higher in France (p < 0.001) and Belgium (p = 0.02) relative to the United Kingdom and significantly higher in France relative to the United States (p < 0.01) by ANOVA. Overall, one could associate low bone turnover markers with nonsmoking, use of a contraceptive pill, exercise, being close to the time of ovulation, and having high 25-hydroxyvitamin D levels. Countries differed by these characteristics, and once allowed for in the statistical model, any country differences were attenuated or removed.