Clinical trial NCT02292316: Falls With Fracture : Role of Cognitive Disorders and Comparison With Bone Fragility
Official title: Falls With Fracture : Role of Cognitive Disorders and Comparison With Bone Fragility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Fractures
Keywords: middle-aged and aged adults
fall in the previous year
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2014-11-17
Enrollment: 218
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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)

Eligibility criteria: 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

Primary outcomes:
measure: Analysis of a global cognitive efficiency score Analysis of bone mineral density
timeFrame: on the inclusion day and two years after
Secondary outcomes:
measure: Age
timeFrame: on the inclusion day and over two years
measure: Cognitive scores
timeFrame: on the inclusion day and over two years
measure: Fracture features
timeFrame: on the inclusion day and over two years
measure: Balance and walking parameters
timeFrame: on the inclusion day and over two years
measure: handgrip force
timeFrame: on the inclusion day and over two years
measure: Daily life scales scores
timeFrame: on the inclusion day and over two years
measure: fear of falling
timeFrame: on the inclusion day and over two years
measure: functional restrictions score
timeFrame: on the inclusion day and over two years
measure: Degree of depression
timeFrame: on the inclusion day and over two years
measure: biological data
timeFrame: on the inclusion day and over two years
measure: Dual-energy X-ray absorptiometry
timeFrame: on the inclusion day and two years after
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital
city: Rouen
country: France
facility: Dr Alain Daragon
Study officials:
affiliation: CHU of Caen
name: Christian Marcelli, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langeard A, Pothier K, Chastan N, Marcelli C, Chavoix C, Bessot N. Reduced gait and postural stability under challenging conditions in fallers with upper limb fracture. Aging Clin Exp Res. 2019 Apr;31(4):483-489. doi: 10.1007/s40520-018-0992-z. Epub 2018 Jul 4.
citation: Langeard A, Pothier K, Morello R, Lelong-Boulouard V, Lescure P, Bocca ML, Marcelli C, Descatoire P, Chavoix C. Polypharmacy Cut-Off for Gait and Cognitive Impairments. Front Pharmacol. 2016 Aug 31;7:296. doi: 10.3389/fphar.2016.00296. eCollection 2016.