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

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

Clinical Phase

NA

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-15

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Accidental Falls Fractures

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

gait and cognitive assessments

Intervention Type BEHAVIORAL

several tests are given in each domain

blood sample

Intervention Type BIOLOGICAL

routine analyses in rheumatology such blood count and 25OH-D

osteodensitometry

Intervention Type OTHER

Looking for osteoporosis

controls

Fall without fracture in the last 12 months; Interventions : behavioral, biological and other; Behavioral intervention includes gait and cognitive assessments Blood sample Osteodensitometry

Group Type SHAM_COMPARATOR

gait and cognitive assessments

Intervention Type BEHAVIORAL

several tests are given in each domain

blood sample

Intervention Type BIOLOGICAL

routine analyses in rheumatology such blood count and 25OH-D

osteodensitometry

Intervention Type OTHER

Looking for osteoporosis

Interventions

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gait and cognitive assessments

several tests are given in each domain

Intervention Type BEHAVIORAL

blood sample

routine analyses in rheumatology such blood count and 25OH-D

Intervention Type BIOLOGICAL

osteodensitometry

Looking for osteoporosis

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes