Odense Fallers and Osteoporosis Study

Osteoporosis Clinical Trial

— OFOS  

Official title:

Odense Fallers and Osteoporosis Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600547
• Other study ID #: s20110162
• 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

• Accidental Falls
• Disability
• Osteoporosis

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