Odense Fallers and Osteoporosis Study

Completed

• Conditions: Osteoporosis; Accidental Falls; Disability

• Registration Number: NCT01600547
• Lead Sponsor: University of Southern Denmark

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-05-14
• Study First Posted: 2012-05-17
• Primary Completion: 2013-01
• Status Verified: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-05
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 322

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Odense University Hospital Geriatric department; 🇩🇰 Odense C, Denmark