History of Changes for Study: NCT01600547

Odense Fallers and Osteoporosis Study (OFOS)

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Study Record Versions

Version	A	B	Submitted Date	Changes
1			May 14, 2012	None (earliest Version on record)
2			December 5, 2014	Recruitment Status, Study Status, Contacts/Locations and Study Design

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Study Identification


Unique Protocol ID:	s20110162
Brief Title:	Odense Fallers and Osteoporosis Study (OFOS)
Official Title:	Odense Fallers and Osteoporosis Study
Secondary IDs:

Study Status


Record Verification:	May 2012
Overall Status:	Recruiting
Study Start:	May 2012
Primary Completion:	May 2014 [Anticipated]
Study Completion:	May 2014 [Anticipated]

First Submitted:	May 8, 2012
First Submitted that Met QC Criteria:	May 14, 2012
First Posted:	May 17, 2012 [Estimate]

Last Update Submitted that Met QC Criteria:	May 14, 2012
Last Update Posted:	May 17, 2012 [Estimate]

Sponsor/Collaborators


Sponsor:	University of Southern Denmark
Responsible Party:	Principal Investigator Investigator: Katja Thomsen Official Title: ph.d.student Affiliation: University of Southern Denmark
Collaborators:	Odense University Hospital

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	Yes

Study Description

Brief Summary:

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:

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.

Conditions


Conditions:	Accidental Falls Osteoporosis Disability
Keywords:

Study Design


Study Type:	Observational
Observational Study Model:	Case-Control
Time Perspective:	Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment:	300 [Anticipated]
Number of Groups/Cohorts	3

Groups and Interventions

Groups/Cohorts	Interventions
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

Outcome Measures


Primary Outcome Measures:
1.	Bone mineral density using DXA of hip and spine regions (Hologic machine) [ Time Frame: baseline ]
2.	Prevalence of vertebral fractures using instant vertebral assessment mode (IVA) of the DXA machine (Hologic machine) [ Time Frame: baseline ]
3.	Bone mineral density of the phalanges using radiographic absorptiometry (Alara Metriscan machine) [ Time Frame: baseline ]
4.	Broad band ultrasound attenuation of the heel using the heel ultrasound machine (Lunar Achilles machine) [ Time Frame: baseline ]
5.	Fall incidences [ Time Frame: one year ]
6.	Mental health state [ Time Frame: one year ] Meausered by Mini Mental State Examination (MMSE)
7.	Health related quality of life [ Time Frame: one year ] Self Reporting Questionnaire will be used
8.	Perceived need [ Time Frame: one year ] Self Reporting Questionnaire
9.	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
10.	Fear of falling [ Time Frame: One year ] The Falls Efficacy scale - international will be used
11.	Muscle strength in upper and lower extremities [ Time Frame: One year ] A dynamometer will be used

Eligibility


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.
Sampling Method:	Probability Sample
Minimum Age:	65 Years
Maximum Age:
Sex:	Female
Gender Based:
Accepts Healthy Volunteers:	Yes
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/Locations


Central Contact Person:	Katja Thomsen, MD Telephone: +45 65413497 Email: katja.thomsen@ouh.regionsyddanmark.dk
Central Contact Backup:	Lisbeth Rosenbek Minet, ph.d. Telephone: +45 24459307 Email: Lisbeth.minet@ouh.regionsyddanmark.dk
Study Officials:	Katja Thomsen, MD Principal Investigator University of Southern Denmark
	Lisbeth Rosenbek Minet, ph.d. Principal Investigator Odense University Hospital
Locations:	Denmark
	Odense University Hospital Geriatric department [Recruiting] Odense C, Denmark, 5000 Contact:Contact: Katja Thomsen, MD +45 65 41 34 97 katja.thomsen@ouh.regionsyddanmark.dk Contact:Contact: LIsbeth Rosenbek Minet, ph.d. +45 24 45 93 07 Lisbeth.Minet@ouh.regionsyddanmark.dk

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