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临床试验/NCT04960033
NCT04960033已完成不适用

Central South University

Central South University1 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
264
试验地点
1
主要终点
Osteoporosis fracture

研究概览

简要总结

We evaluated fracture risk assessment tools (FRAXs) from different regions in Chinese postmenopausal women.

详细描述

This cross-sectional study recruited 264 postmenopausal women aged ≥50 years in September 2017. Basic information, general condition, history of illness, family history, and clinical risk factors were evaluated via a questionnaire. All subjects underwent a bone mineral density examination of the femur and lumbar spine and thoracolumbar spinal X-ray. The 10-year major osteoporotic fracture (MOF) and hip fracture (HF) risks were calculated using FRAXs from mainland China, Hong Kong, Taiwan, and Asia-America. All data were analyzed using SPSS 17.0. Sensitivity, specificity, and likelihood ratio were used to compare the effectiveness of each FRAX.

研究设计

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

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Postmenopausal women aged ≥50 years were randomly selected from community centers in Changsha City, Hunan Province, China in September
  • Menopause was defined as the absence of menstrual cycles for at least one year. All subjects were noninstitutionalized and in good health.

排除标准

  • The criteria for exclusion were morphological abnormalities or skeletal distortions that prohibited either clinical measurements or morphometric assessments of skeletal radiographs.

结局指标

主要结局

Osteoporosis fracture

时间窗: 2017years

The 10-year MOF probability and the 10-year HF probability were calculated using the FRAXs of different regions (mainland China, Hong Kong, Taiwan, and Asia-America). Subjects were deemed as high-risk for osteoporotic fracture if the 10-year probability of MOF was ≥20% or the 10-year probability of HF was ≥3%.

次要结局

未报告次要终点

研究者

发起方
Central South University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ChenRong

Central South University

Central South University

研究点 (1)

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