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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02292316
Other study ID # RCB 2011A00556-35
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2011
Est. completion date December 31, 2018

Study information

Verified date March 2020
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether cognitive disorders are a risk factor for a fracture after a fall independently of a bone fragility.


Description:

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Study Design


Intervention

Behavioral:
gait and cognitive assessments
several tests are given in each domain
Biological:
blood sample
routine analyses in rheumatology such blood count and 25OH-D
Other:
osteodensitometry
Looking for osteoporosis

Locations

Country Name City State
France University Hospital Caen
France Dr Alain Daragon Rouen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Analysis of a global cognitive efficiency score Analysis of bone mineral density MMS, MoCA on the inclusion day and two years after
Secondary Age on the inclusion day and over two years
Secondary Cognitive scores Mainly tests of memory, attention and executive functions on the inclusion day and over two years
Secondary Fracture features Location and severity on the inclusion day and over two years
Secondary Balance and walking parameters Tinetti scale, TUG and dual-tasks on the inclusion day and over two years
Secondary handgrip force using a dynamometer on the inclusion day and over two years
Secondary Daily life scales scores Mainly IADL on the inclusion day and over two years
Secondary fear of falling ABC-scale on the inclusion day and over two years
Secondary functional restrictions score Lequesne score on the inclusion day and over two years
Secondary Degree of depression MADRS on the inclusion day and over two years
Secondary biological data 25OHD on the inclusion day and over two years
Secondary Dual-energy X-ray absorptiometry bone mineral densitometry on the inclusion day and two years after
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