Odense Fallers and Osteoporosis Study (OFOS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of Southern Denmark.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Katja Thomsen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01600547
First received: May 8, 2012
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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.


Condition
Accidental Falls
Osteoporosis
Disability

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Odense Fallers and Osteoporosis Study

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Bone mineral density using DXA of hip and spine regions (Hologic machine) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Prevalence of vertebral fractures using instant vertebral assessment mode (IVA) of the DXA machine (Hologic machine) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Bone mineral density of the phalanges using radiographic absorptiometry (Alara Metriscan machine) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Broad band ultrasound attenuation of the heel using the heel ultrasound machine (Lunar Achilles machine) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Fall incidences [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Mental health state [ Time Frame: one year ] [ Designated as safety issue: No ]
    Meausered by Mini Mental State Examination (MMSE)

  • Health related quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
    Self Reporting Questionnaire will be used

  • Perceived need [ Time Frame: one year ] [ Designated as safety issue: No ]
    Self Reporting Questionnaire

  • Basis mobility [ Time Frame: One year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The Falls Efficacy scale - international will be used

  • Muscle strength in upper and lower extremities [ Time Frame: One year ] [ Designated as safety issue: No ]
    A dynamometer will be used


Estimated Enrollment: 300
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/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

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.
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Consecutive patients attending the Odense University hospital falls clinic will be recruited to the study Two control groups will be recruited. A questionnaire will be sent to randomly selected community aged matched female controls.

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.
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600547

Contacts
Contact: Katja Thomsen, MD +45 65413497 katja.thomsen@ouh.regionsyddanmark.dk
Contact: Lisbeth Rosenbek Minet, ph.d. +45 24459307 Lisbeth.minet@ouh.regionsyddanmark.dk

Locations
Denmark
Odense University Hospital Geriatric department Recruiting
Odense C, Denmark, 5000
Contact: Katja Thomsen, MD    +45 65 41 34 97    katja.thomsen@ouh.regionsyddanmark.dk   
Contact: LIsbeth Rosenbek Minet, ph.d.    +45 24 45 93 07    Lisbeth.Minet@ouh.regionsyddanmark.dk   
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Investigators
Principal Investigator: Katja Thomsen, MD University of Southern Denmark
Principal Investigator: Lisbeth Rosenbek Minet, ph.d. Odense University Hospital
  More Information

No publications provided

Responsible Party: Katja Thomsen, ph.d.student, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01600547     History of Changes
Other Study ID Numbers: s20110162
Study First Received: May 8, 2012
Last Updated: May 14, 2012
Health Authority: Denmark: National Board of Health

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 16, 2014