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

Caen University Hospital

Status: Completed

Conditions: Fractures; Accidental Falls

Treatments: Biological: blood sample; Behavioral: gait and cognitive assessments; Other: osteodensitometry

Study type: Interventional

Funder types: Other

Identifiers

NCT02292316

RCB 2011A00556-35

Details and patient eligibility

About

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.

Full 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)

Enrollment: 218 patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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218 participants in 2 patient groups

Fall with fracture

Experimental group

Description:

Fall with fracture in the last 6 months; Interventions : behavioral, biological and other; Behavioral intervention includes gait and cognitive assessments Blood sample Osteodensitometry

Treatment:

Behavioral: gait and cognitive assessments

Biological: blood sample

Other: osteodensitometry

controls

Sham Comparator group

Description:

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

Treatment:

Behavioral: gait and cognitive assessments

Biological: blood sample

Other: osteodensitometry