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Clinical Trials/NCT01600547
NCT01600547
Completed
Not Applicable

Odense Fallers and Osteoporosis Study

University of Southern Denmark1 site in 1 country322 target enrollmentMay 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Accidental Falls
Sponsor
University of Southern Denmark
Enrollment
322
Locations
1
Primary Endpoint
Bone mineral density using DXA of hip and spine regions (Hologic machine)
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
December 2014
Last Updated
11 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Katja Thomsen

ph.d.student

University of Southern Denmark

Eligibility Criteria

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.
  • 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

Outcomes

Primary Outcomes

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

Time Frame: baseline

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

Time Frame: baseline

Mental health state

Time Frame: one year

Meausered by Mini Mental State Examination (MMSE)

Fall incidences

Time Frame: one year

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

Time Frame: baseline

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

Time Frame: baseline

Basis mobility

Time Frame: One year

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

Fear of falling

Time Frame: One year

The Falls Efficacy scale - international will be used

Muscle strength in upper and lower extremities

Time Frame: One year

A dynamometer will be used

Health related quality of life

Time Frame: one year

Self Reporting Questionnaire will be used

Perceived need

Time Frame: one year

Self Reporting Questionnaire

Study Sites (1)

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