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Odense Fallers and Osteoporosis Study (OFOS)

2014年12月5日更新者：Katja Thomsen、University of Southern Denmark

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.

研究概览

地位

完全的

条件

详细说明

Study Objectives

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.
To evaluate the usefulness of peripheral bone scanning techniques in a falls clinic population.
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
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.

研究类型

观察性的

注册 (实际的)

322

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

丹麦
- - Odense C、丹麦、5000
    - Odense University Hospital Geriatric department

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年及以上 (年长者)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

概率样本

研究人群

Consecutive patients attending the Odense University hospital falls clinic will be recruited to the study Two control groups will be recruited. A questionnaire will be sent to randomly selected community aged matched female controls.

描述

Inclusion Criteria:

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.

Exclusion Criteria:

Patients under the age of 65 years.
Men.
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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
fall clinic population women, aged + 65 years
control fallers randomly selected community aged matched female controls with a fall episode
control non fallers randomly selected community aged matched female controls, with out fall episodes

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Bone mineral density using DXA of hip and spine regions (Hologic machine) 大体时间：baseline		baseline
Prevalence of vertebral fractures using instant vertebral assessment mode (IVA) of the DXA machine (Hologic machine) 大体时间：baseline		baseline
Bone mineral density of the phalanges using radiographic absorptiometry (Alara Metriscan machine) 大体时间：baseline		baseline
Broad band ultrasound attenuation of the heel using the heel ultrasound machine (Lunar Achilles machine) 大体时间：baseline		baseline
Fall incidences 大体时间：one year		one year
Mental health state 大体时间：one year	Meausered by Mini Mental State Examination (MMSE)	one year
Health related quality of life 大体时间：one year	Self Reporting Questionnaire will be used	one year
Perceived need 大体时间：one year	Self Reporting Questionnaire	one year
Basis mobility 大体时间：One year	Time up and go, Chair stand, Bergs balance scale, Avlunds scale, gait speed and dual-task will be used	One year
Fear of falling 大体时间：One year	The Falls Efficacy scale - international will be used	One year
Muscle strength in upper and lower extremities 大体时间：One year	A dynamometer will be used	One year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Southern Denmark

合作者

Odense University Hospital

调查人员

首席研究员：Katja Thomsen, MD、University of Southern Denmark
首席研究员：Lisbeth Rosenbek Minet, ph.d.、Odense University Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

Thomsen K, Ryg J, Matzen L, Hermann AP, Masud T. Choice of osteoporosis guideline has important implications for the treatment decision in elderly women referred to a fall clinic. Dan Med J. 2014 Dec;61(12):A4980.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年5月1日

初级完成 (实际的)

2013年1月1日

研究完成 (实际的)

2014年12月1日

研究注册日期

首次提交

2012年5月8日

首先提交符合 QC 标准的

2012年5月14日

首次发布 (估计)

2012年5月17日

研究记录更新

最后更新发布 (估计)

2014年12月8日

上次提交的符合 QC 标准的更新

2014年12月5日

最后验证