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

Study Overview
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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.

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)

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

Conditions
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Accidental Falls, Fractures

Intervention / Treatment
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* Behavioral: gait and cognitive assessments
* Biological: blood sample
* Other: osteodensitometry


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fall with fracture<br>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<br>* several tests are given in each domain<br>Biological: blood sample<br>* routine analyses in rheumatology such blood count and 25OH-D<br>Other: osteodensitometry<br>* Looking for osteoporosis<br>|
| Sham Comparator: controls<br>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<br>* several tests are given in each domain<br>Biological: blood sample<br>* routine analyses in rheumatology such blood count and 25OH-D<br>Other: osteodensitometry<br>* Looking for osteoporosis<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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middle-aged and aged adults, fall in the previous year