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临床试验/NCT03798444
NCT03798444已完成不适用

An Observational and Cross-sectional Study on Prevalence of Vertebral Fractures in Postmenopausal Women Living in Chinese Communities

Central South University1 个研究点 分布在 1 个国家目标入组 255 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
255
试验地点
1
主要终点
Wall-occiput distance

研究概览

简要总结

This is an observational and cross-sectional study on the height loss, kyphosis indicators, bone mineral density and vertebral fractures in Chinese postmenopausal women

详细描述

Postmenopausal women (N=255) aged ≥50 years were randomly selected from community centers in Changsha City, Hunan Province, China in September 2017. Menopause was defined as the absence of menstrual cycles for at least one year. All subjects were noninstitutionalized and in good health.The criteria for exclusion were morphological abnormalities or skeletal distortions that prohibited either clinical measurements or morphometric assessments of skeletal radiographs All participants were interviewed using a standard questionnaire. Body weight and height were measured to the closest 0.1 kg and 0.5 cm, respectively, with subjects wearing light clothing and no shoes. Current height was measured using a wall-mounted stadiometer, with a horizontal plate pressed on the head, and hair flattened. All subjects provided basic information, including current age, age at the start of menopause, years since menopause (YSM), weight, and their tallest recalled height. The current measured height subtracted from the tallest recalled height was subjects' HHL.The RPD, which was the vertical distance between the lowest margin of the ribs and the superior surface of the iliac crest along the mid-axillary line, was measured twice by a physician who stood behind the subject. For the kyphosis assessment, subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. The wall-occiput distance was defined as the horizontal distance between the wall and the back of the head. The distance between the prominence of the 7th cervical vertebra and the wall was defined as 7th cervical vertebra-wall distance (C7WD) , and wall-tragus-distance (WTD) was defined as the horizontal distance from the participant's tragus to the wall . All RPD and anthropometric indicators of kyphosis were measured in increments of 0.1 cm by two trained physicians.BMD of the lumbar spine, left femoral neck, and total hip were measured using dual energy X-ray absorptiometry. VFs were assessed using lateral spine imaging from T4 to L4 on X-ray.

研究设计

研究类型
Observational
观察模型
Case Control
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 (Menopause was defined as the absence of menstrual cycles for at least one year)

排除标准

  • Morphological abnormalities or skeletal distortions

结局指标

主要结局

Wall-occiput distance

时间窗: 4 weeks

Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. The wall-occiput distance was defined as the horizontal distance between the wall and the back of the head. Measured in increments of 0.1 cm by two trained physicians.

7th cervical vertebra-wall distance

时间窗: 4 weeks

Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. The distance between the prominence of the 7th cervical vertebra and the wall was defined as 7th cervical vertebra-wall distance. Measured in increments of 0.1 cm by two trained physicians.

Wall-tragus-distance

时间窗: 4 weeks

Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown.Wall-tragus-distance was defined as the horizontal distance from the participant's tragus to the wall. Measured in increments of 0.1 cm by two trained physicians.

Weight

时间窗: 4 weeks

Body weight was measured with subjects wearing light clothing and no shoes

Rib to pelvis distance

时间窗: 4 weeks

The rib to pelvis distance, which was the vertical distance between the lowest margin of the ribs and the superior surface of the iliac crest along the mid-axillary line, was measured twice by a physician who stood behind the subject. Measured in increments of 0.1 cm by two trained physicians.

Height

时间窗: 4 weeks

Subjects wearing light clothing and no shoes. Current height was measured using a wall-mounted stadiometer, with a horizontal plate pressed on the head, and hair flattened. Height were measured to the closest 0.5 cm,

Historical height loss

时间窗: 4 weeks

The current measured height subtracted from the tallest recalled height was subjects' historical height loss

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

Principal Investigator

Central South University

研究点 (1)

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