Falls With Fracture : Role of Cognitive Disorders and Comparison With Bone Fragility (CFC)

March 2, 2020 updated by: University Hospital, Caen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The fall is a major problem in the elderly. After 65 year old, falls represent 84% of daily living accidents and almost half of the post fall injuries are fractures (Ricard and Thélot, 2007). These falls with fracture lead to a loss of autonomy and a high health cost. Their prevention is a crucial focus of research.

Even if it is obvious that subjects with osteoporosis have a higher risk of fracture than those with a normal bone mineral density, recent studies have shown that most victims of fracture post-fall do not comply with the densitometric definition of osteoporosis.

It is well established that the presence of cognitive disorders, frequent in the elderly, is an important risk factor for falls; It might also be a risk factor for fracture after a fall with an unadapted postural or balance control.

The investigators will test this hypothesis on 150 victims of fracture (upper or lower limb) consecutive to a fall from standing height, recruited in the hospitals of Caen and Rouen (France) in the context of their medical follow-up (with blood and dual energy x-ray absorptiometry [DXA] exams). These patients will be matched to 150 control participants (victims of a fall with no fracture, submitted to the same exams).

All the participants are subjects to an in-depth study of cognitive functions, postural and walking tests and to various scales (daily life activities, depression, ...).

These exams will take half a day, with a two-year follow up (in which the participant will have to note new falls and new medical treatments)

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • University Hospital
      • Rouen, France, 76000
        • Dr Alain Daragon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Affiliation to the social security system
  • For subjects with fracture : victim of a low-energy fracture of the upper or lower limb that was consecutive to a fall from standing height, and who has accepted to realize a DXA exam in the context of the medical follow-up
  • For control subjects : victim of a fall from standing height, with no fracture, matched in terms of age, sex, socio-cultural level and living space with subjects with fracture.
  • Written informed consent

Exclusion Criteria:

  • Subject who is deprived of liberty, under supervision or legal guardianship
  • Pathology affecting balance (Parkinson's disease, after-effects of stroke, …)
  • Important visual impairment : age-related macular degeneration, …
  • Depressed state
  • Important consumption of alcohol (> 14 drinks per week for women / >21 for men)
  • Subject who is concurrently participating in another clinical study (unless prior notice of the principal investigator)
  • Fall has been caused by a third party (e.g. : pushing), is not from standing height (e.g. : fall from a ladder); fracture is not a low-energy one (e.g. : further a fall during running)

  • For subjects with fracture :

    • The fracture is not consecutive to a fall
    • The fracture is pathological, beyond osteoporosis (e.g. : bone metastases)
    • The last fall responsible for a fracture goes back more than 6 months

  • For control subjects :

    o The fall goes back more than 12 months

  • The fall has led to a medical consultation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fall with fracture
Fall with fracture in the last 6 months; Interventions : behavioral, biological and other; Behavioral intervention includes gait and cognitive assessments Blood sample Osteodensitometry
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
Sham Comparator: controls
Fall without fracture in the last 12 months; Interventions : behavioral, biological and other; Behavioral intervention includes gait and cognitive assessments Blood sample Osteodensitometry
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of a global cognitive efficiency score Analysis of bone mineral density
Time Frame: on the inclusion day and two years after
MMS, MoCA
on the inclusion day and two years after

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Christian Marcelli, Professor, CHU of Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2011

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

November 13, 2014

First Posted (Estimate)

November 17, 2014

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCB 2011A00556-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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