Odense Fallers and Osteoporosis Study


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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2013

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.

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Bone mineral density using DXA of hip and spine regions (Hologic machine)
    • Time Frame: baseline
  • Prevalence of vertebral fractures using instant vertebral assessment mode (IVA) of the DXA machine (Hologic machine)
    • Time Frame: baseline
  • Bone mineral density of the phalanges using radiographic absorptiometry (Alara Metriscan machine)
    • Time Frame: baseline
  • Broad band ultrasound attenuation of the heel using the heel ultrasound machine (Lunar Achilles machine)
    • Time Frame: baseline
  • Fall incidences
    • Time Frame: one year
  • Mental health state
    • Time Frame: one year
    • Meausered by Mini Mental State Examination (MMSE)
  • Health related quality of life
    • Time Frame: one year
    • Self Reporting Questionnaire will be used
  • Perceived need
    • Time Frame: one year
    • Self Reporting Questionnaire
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Southern Denmark
  • Collaborator
    • Odense University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Katja Thomsen, ph.d.student – University of Southern Denmark
  • Overall Official(s)
    • Katja Thomsen, MD, Principal Investigator, University of Southern Denmark
    • Lisbeth Rosenbek Minet, ph.d., Principal Investigator, Odense University Hospital

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