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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02292316
Other study ID # RCB 2011A00556-35
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2011
Est. completion date December 31, 2018

Study information

Verified date March 2020
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Completed
Enrollment 218
Est. completion date December 31, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
gait and cognitive assessments
several tests are given in each domain
Biological:
blood sample
routine analyses in rheumatology such blood count and 25OH-D
Other:
osteodensitometry
Looking for osteoporosis

Locations

Country Name City State
France University Hospital Caen
France Dr Alain Daragon Rouen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

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