Odense Fallers and Osteoporosis Study (OFOS)

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 Overview

• Status: Completed
• Conditions: Osteoporosis; Disability; Accidental Falls

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 Type: Observational
• Enrollment (Actual): 322

Contacts and Locations

Study Locations

• Denmark
  • Odense C, Denmark, 5000
    • Odense University Hospital Geriatric department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Odense University Hospital
• Investigators: Principal Investigator: Katja Thomsen, MD, University of Southern Denmark; Principal Investigator: Lisbeth Rosenbek Minet, ph.d., Odense University Hospital

Publications and helpful links

General Publications

• Thomsen K, Ryg J, Matzen L, Hermann AP, Masud T. Choice of osteoporosis guideline has important implications for the treatment decision in elderly women referred to a fall clinic. Dan Med J. 2014 Dec;61(12):A4980.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: May 8, 2012
• First Submitted That Met QC Criteria: May 14, 2012
• First Posted (Estimate): May 17, 2012

Study Record Updates

• Last Update Posted (Estimate): December 8, 2014
• Last Update Submitted That Met QC Criteria: December 5, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: s20110162