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临床试验/NCT01324713
NCT01324713已完成不适用

Does Gender Play a Role in Bone-mineral Density Measurement Precision?

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
1
主要终点
DXA Bone Mineral Density precision

研究概览

简要总结

Bone mineral density (BMD) measurement using dual-energy x-ray absorptiometry (DXA) is the current gold standard for osteoporosis diagnosis and therapy monitoring. Like all quantitative tests, there is some variability in BMD results obtained when scanning a person more than once. As such, it is current clinical practice, based on the recommendation of the International Society for Clinical Densitometry, that each technologist perform a precision assessment. This approach consists of scanning 30 people twice; the data from which allow determination of what constitutes a real difference in BMD with 95% confidence. A precision assessment typically evaluates a specific clinic's population, using the age range and genders seen at that clinic. However men generally have larger, but often more arthritic, bones than women which may impact the precision results. Therefore, it is possible that gender-specific precision values should be used in clinical practice, however this issue has never been investigated.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 65 years
  • Able and willing to sign informed consent

排除标准

  • Inability to have DXA scans performed due to weight ≥ 450 pounds (exceeds densitometer table limit)
  • Metallic hardware in, or overlaying, any of the measured skeletal sites

结局指标

主要结局

DXA Bone Mineral Density precision

时间窗: 1 day

The primary analysis will compare DXA BMD precision (mean square error/variance) in males and females, pooled across technicians, using the two-sample F-test for equality of variances. Separate analyses will also be performed for each technician. In addition, due to the sensitivity of the F-test to the normality assumption, a secondary analysis will perform the same comparisons using Levene's test. A nominal two-sided p-value of 0.05 will be regarded as statistically significant.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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