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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01600547
Other study ID # s20110162
Secondary ID
Status Completed
Phase N/A
First received May 8, 2012
Last updated December 5, 2014
Start date May 2012
Est. completion date December 2014

Study information

Verified date December 2014
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 322
Est. completion date December 2014
Est. primary completion date January 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 65 Years and older
Eligibility 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

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Odense University Hospital Geriatric department Odense C

Sponsors (2)

Lead Sponsor Collaborator
University of Southern Denmark Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bone mineral density using DXA of hip and spine regions (Hologic machine) baseline No
Primary Prevalence of vertebral fractures using instant vertebral assessment mode (IVA) of the DXA machine (Hologic machine) baseline No
Primary Bone mineral density of the phalanges using radiographic absorptiometry (Alara Metriscan machine) baseline No
Primary Broad band ultrasound attenuation of the heel using the heel ultrasound machine (Lunar Achilles machine) baseline No
Primary Fall incidences one year No
Primary Mental health state Meausered by Mini Mental State Examination (MMSE) one year No
Primary Health related quality of life Self Reporting Questionnaire will be used one year No
Primary Perceived need Self Reporting Questionnaire one year No
Primary Basis mobility Time up and go, Chair stand, Bergs balance scale, Avlunds scale, gait speed and dual-task will be used One year No
Primary Fear of falling The Falls Efficacy scale - international will be used One year No
Primary Muscle strength in upper and lower extremities A dynamometer will be used One year No
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