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Completed

NCT Number: NCT02292316

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

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Caen, France

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About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gait and cognitive assessments

Behavioral

several tests are given in each domain

Blood sample

Biological

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

osteodensitometry

Other

Looking for osteoporosis

Primary outcomes

  1. Analysis of a global cognitive efficiency score Analysis of bone mineral density

    Time frame: on the inclusion day and two years after

    MMS, MoCA

Secondary outcomes

  1. Age

    Time frame: on the inclusion day and over two years

  2. Cognitive scores

    Time frame: on the inclusion day and over two years

    Mainly tests of memory, attention and executive functions

  3. Fracture features

    Time frame: on the inclusion day and over two years

    Location and severity

  4. Balance and walking parameters

    Time frame: on the inclusion day and over two years

    Tinetti scale, TUG and dual-tasks

  5. handgrip force

    Time frame: on the inclusion day and over two years

    using a dynamometer

  6. Daily life scales scores

    Time frame: on the inclusion day and over two years

    Mainly IADL

  7. fear of falling

    Time frame: on the inclusion day and over two years

    ABC-scale

  8. functional restrictions score

    Time frame: on the inclusion day and over two years

    Lequesne score

  9. Degree of depression

    Time frame: on the inclusion day and over two years

    MADRS

  10. biological data

    Time frame: on the inclusion day and over two years

    25OHD

  11. Dual-energy X-ray absorptiometry

    Time frame: on the inclusion day and two years after

    bone mineral densitometry

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: CFC

Important dates

Study start
2011
Primary completion
2017
Study completion
2018
First posted
Nov 17, 2014
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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