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临床试验/NCT01600547
NCT01600547已完成不适用

Odense Fallers and Osteoporosis Study

University of Southern Denmark1 个研究点 分布在 1 个国家目标入组 322 人开始时间: 2012年5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
322
试验地点
1
主要终点
Bone mineral density using DXA of hip and spine regions (Hologic machine)

研究概览

简要总结

Osteoporosis and falls occur with increasing frequency among the elderly. Osteoporosis and fall increases the risk of fracture. Falls in the elderly are associated with a high morbidity and mortality with potentially life-threatening consequences of falls including fractures. Besides fracture fall may cause long term problems such as disability fear of falling and loss of independence. Today osteoporosis is diagnosed by bone scan of the hip and spine. The investigators want to investigate whether other more accessible and less expensive testing methods can be used to diagnose osteoporosis. Additionally, the investigators will examine the incidence of osteoporosis among the elderly in the municipality of Odense. Finally, the investigators would like to investigate the association between factors that can lead to falls and to investigate the performance of older and whether there are changes in functional ability over time.

详细描述

Study Objectives

  1. To define the prevalence of osteoporosis in a falls clinic population, and compare it with two aged matched control groups - fallers not attending the falls clinic and non-fallers.
  2. To evaluate the usefulness of peripheral bone scanning techniques in a falls clinic population.
  3. To determine the prevalence of vertebral fractures in a falls clinic population and compare it with two aged matched control groups - fallers not attending the falls clinic and non-fallers
  4. To investigate functioning, disability, health related quality of life and perceived need for rehabilitation in a falls clinic population including variation in a one year period, and compare it with two aged matched control groups - fallers not attending the falls clinic and non-fallers.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Women aged 65 years or over attending the falls clinic
  • *(There will be no upper age limit to recruitment).
  • Those capable of giving Informed consent.

排除标准

  • Patients under the age of 65 years.
  • Patients unwilling to give informed consent.
  • Cognitively impaired people who are not capable of giving consent.
  • Patients who are not mobile enough to be helped onto a DXA scan table with help

结局指标

主要结局

Bone mineral density using DXA of hip and spine regions (Hologic machine)

时间窗: baseline

Bone mineral density of the phalanges using radiographic absorptiometry (Alara Metriscan machine)

时间窗: baseline

Mental health state

时间窗: one year

Meausered by Mini Mental State Examination (MMSE)

Fall incidences

时间窗: one year

Prevalence of vertebral fractures using instant vertebral assessment mode (IVA) of the DXA machine (Hologic machine)

时间窗: baseline

Broad band ultrasound attenuation of the heel using the heel ultrasound machine (Lunar Achilles machine)

时间窗: baseline

Basis mobility

时间窗: One year

Time up and go, Chair stand, Bergs balance scale, Avlunds scale, gait speed and dual-task will be used

Fear of falling

时间窗: One year

The Falls Efficacy scale - international will be used

Muscle strength in upper and lower extremities

时间窗: One year

A dynamometer will be used

Health related quality of life

时间窗: one year

Self Reporting Questionnaire will be used

Perceived need

时间窗: one year

Self Reporting Questionnaire

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katja Thomsen

ph.d.student

University of Southern Denmark

研究点 (1)

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