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

Accidental Falls Clinical Trial

— CFC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02292316
• Other study ID #: RCB 2011A00556-35
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Accidental Falls
• Cognition Disorders
• Fractures
• Fractures, Bone

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