Odense Fallers and Osteoporosis Study

NCT ID: NCT01600547

Last Updated: 2014-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

322 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Accidental Falls Osteoporosis Disability

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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fall clinic population

women, aged + 65 years

No interventions assigned to this group

control fallers

randomly selected community aged matched female controls with a fall episode

No interventions assigned to this group

control non fallers

randomly selected community aged matched female controls, with out fall episodes

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Odense University Hospital

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Katja Thomsen

ph.d.student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katja Thomsen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Lisbeth Rosenbek Minet, ph.d.

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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Odense University Hospital Geriatric department

Odense C, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 25441734 (View on PubMed)

Other Identifiers

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s20110162

Identifier Type: -

Identifier Source: org_study_id