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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02292316
Acronym
CFC
Enrollment
218
Registered
2014-11-17
Start date
2011-11-15
Completion date
2018-12-31
Last updated
2020-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Falls, Fractures

Keywords

middle-aged and aged adults, fall in the previous year

Brief 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.

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)

Interventions

BEHAVIORALgait and cognitive assessments

several tests are given in each domain

BIOLOGICALblood sample

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

Looking for osteoporosis

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Analysis of a global cognitive efficiency score Analysis of bone mineral densityon the inclusion day and two years afterMMS, MoCA

Secondary

MeasureTime frameDescription
Cognitive scoreson the inclusion day and over two yearsMainly tests of memory, attention and executive functions
Fracture featureson the inclusion day and over two yearsLocation and severity
Balance and walking parameterson the inclusion day and over two yearsTinetti scale, TUG and dual-tasks
handgrip forceon the inclusion day and over two yearsusing a dynamometer
Daily life scales scoreson the inclusion day and over two yearsMainly IADL
Ageon the inclusion day and over two years
functional restrictions scoreon the inclusion day and over two yearsLequesne score
Degree of depressionon the inclusion day and over two yearsMADRS
biological dataon the inclusion day and over two years25OHD
Dual-energy X-ray absorptiometryon the inclusion day and two years afterbone mineral densitometry
fear of fallingon the inclusion day and over two yearsABC-scale

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026