Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fall with fracture | Experimental | Fall with fracture in the last 6 months; Interventions : behavioral, biological and other; Behavioral intervention includes gait and cognitive assessments Blood sample Osteodensitometry |
|
| controls | Sham Comparator | Fall without fracture in the last 12 months; Interventions : behavioral, biological and other; Behavioral intervention includes gait and cognitive assessments Blood sample Osteodensitometry |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gait and cognitive assessments | Behavioral | several tests are given in each domain |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
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 :
For control subjects :
o The fall goes back more than 12 months
The fall has led to a medical consultation
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christian Marcelli, Professor | CHU of Caen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Caen | 14000 | France | |||
| Dr Alain Daragon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29974390 | Derived | 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. | |
| 27630572 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D005684 | Gait |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D016138 | Walking |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| blood sample | Biological | routine analyses in rheumatology such blood count and 25OH-D |
|
| osteodensitometry | Other | Looking for osteoporosis |
|
| 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 |
| Rouen |
| 76000 |
| France |
| D008124 |
| Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |