Odense Fallers and Osteoporosis Study (OFOS)
5. december 2014 opdateret af: Katja Thomsen, University of Southern Denmark
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Study Objectives
- 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.
- To evaluate the usefulness of peripheral bone scanning techniques in a falls clinic population.
- 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
- 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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
322
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Odense C, Danmark, 5000
- Odense University Hospital Geriatric department
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
65 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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fall clinic population
women, aged + 65 years
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control fallers
randomly selected community aged matched female controls with a fall episode
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control non fallers
randomly selected community aged matched female controls, with out fall episodes
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Bone mineral density using DXA of hip and spine regions (Hologic machine)
Tidsramme: baseline
|
baseline
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Prevalence of vertebral fractures using instant vertebral assessment mode (IVA) of the DXA machine (Hologic machine)
Tidsramme: baseline
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baseline
|
|
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Bone mineral density of the phalanges using radiographic absorptiometry (Alara Metriscan machine)
Tidsramme: baseline
|
baseline
|
|
|
Broad band ultrasound attenuation of the heel using the heel ultrasound machine (Lunar Achilles machine)
Tidsramme: baseline
|
baseline
|
|
|
Fall incidences
Tidsramme: one year
|
one year
|
|
|
Mental health state
Tidsramme: one year
|
Meausered by Mini Mental State Examination (MMSE)
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one year
|
|
Health related quality of life
Tidsramme: one year
|
Self Reporting Questionnaire will be used
|
one year
|
|
Perceived need
Tidsramme: one year
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Self Reporting Questionnaire
|
one year
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Basis mobility
Tidsramme: One year
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Time up and go, Chair stand, Bergs balance scale, Avlunds scale, gait speed and dual-task will be used
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One year
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Fear of falling
Tidsramme: One year
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The Falls Efficacy scale - international will be used
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One year
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Muscle strength in upper and lower extremities
Tidsramme: One year
|
A dynamometer will be used
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One year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Katja Thomsen, MD, University of Southern Denmark
- Ledende efterforsker: Lisbeth Rosenbek Minet, ph.d., Odense University Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2012
Primær færdiggørelse (Faktiske)
1. januar 2013
Studieafslutning (Faktiske)
1. december 2014
Datoer for studieregistrering
Først indsendt
8. maj 2012
Først indsendt, der opfyldte QC-kriterier
14. maj 2012
Først opslået (Skøn)
17. maj 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. december 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. december 2014
Sidst verificeret
1. december 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- s20110162
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .