University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093, USA.
Contemp Clin Trials. 2010 Jul;31(4):336-44. doi: 10.1016/j.cct.2010.03.012. Epub 2010 Apr 8.
POROS evaluates a 3-step fracture risk screening program in women 50-64 not previously diagnosed with osteoporosis. This report details the research design and baseline characteristics.
Recruiting from 6 primary care sites, baseline characteristics, including fracture risk factors, were assessed via self-administered questionnaires (SAQs). Subjects with >or=1 risk factor were randomized to Intervention or Non-Intervention. Those without any risk factors were placed in the No Risk Factors group. Bone turnover was measured in the Intervention group via urine N-telopeptide (NTx) testing. Subjects with NTx>50 had central hip and spine Dual-energy X-ray Absorptiometry (dxa). All groups were followed for 24 months, completing SAQs on osteoporosis management and fractures. At baseline, comparisons were made on demographics, health status, and prevalence of fracture risk factors.
2839 women were enrolled and included in baseline analyses (1464 Intervention, 372 Non-Intervention, and 1003 No Risk Factors). The mean age was 56.1 and 81.1% were postmenopausal. As expected by randomization, the Intervention and Non-Intervention groups had similar baseline characteristics. The most commonly reported fracture risk factors were body mass index <24 kg/m(2) and needing to use arms to stand from a chair. Subjects in the No Risk Factors group were more likely to be younger, heavier, Hispanic, in good health, a non-smoker, and to drink less alcohol.
A stepwise screening program, utilizing data on fracture risk factors and high bone turnover prior to obtaining central bone density, can contribute significantly to fracture risk assessment in perimenopausal and younger postmenopausal women.
POROS 评估了一个针对此前未被诊断为骨质疏松症的 50-64 岁女性的 3 步骨折风险筛查计划。本报告详细介绍了研究设计和基线特征。
在 6 个初级保健点招募参与者，通过自我管理问卷（SAQ）评估基线特征，包括骨折风险因素。有>或=1 个风险因素的患者被随机分配到干预组或非干预组。没有任何风险因素的患者被置于无风险因素组。通过尿液 N-端肽（NTx）检测，对干预组的骨转换进行测量。NTx>50 的患者进行中央髋部和脊柱双能 X 线吸收法（dxa）检查。所有组均随访 24 个月，完成骨质疏松症管理和骨折的 SAQ。在基线时，对人口统计学、健康状况和骨折风险因素的患病率进行了比较。
共纳入 2839 名女性进行基线分析（干预组 1464 人，非干预组 372 人，无风险因素组 1003 人）。平均年龄为 56.1 岁，81.1%绝经后。按随机分组，干预组和非干预组的基线特征相似。报告最多的骨折风险因素是体重指数<24 kg/m（2）和需要用手臂从椅子上站起来。无风险因素组的患者更年轻、体重更重、西班牙裔、健康状况更好、不吸烟、饮酒更少。
一个逐步的筛查计划，利用骨折风险因素和高骨转换的数据，在获得中央骨密度之前，可显著有助于围绝经期和年轻绝经后妇女的骨折风险评估。
