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

NCT02292316 | Completed

• 1 other identifier: RCB 2011A00556-35
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 2

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.

Conditions

Accidental Falls; Fractures

Keywords

middle-aged and aged adults; fall in the previous year

Outcome Measures

Primary Outcomes (1)

• Analysis of a global cognitive efficiency score Analysis of bone mineral density

  MMS, MoCA

  on the inclusion day and two years after

Secondary Outcomes (11)

• Age

  on the inclusion day and over two years

• Cognitive scores

  on the inclusion day and over two years

• Fracture features

  on the inclusion day and over two years

• Balance and walking parameters

  on the inclusion day and over two years

• handgrip force

  on the inclusion day and over two years

Study Arms (2)

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

Behavioral: gait and cognitive assessments; Biological: blood sample; Other: 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

Behavioral: gait and cognitive assessments; Biological: blood sample; Other: osteodensitometry

Interventions

gait and cognitive assessments BEHAVIORAL

several tests are given in each domain

Fall with fracture; controls

blood sample BIOLOGICAL

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

Fall with fracture; controls

osteodensitometry OTHER

Looking for osteoporosis

Fall with fracture; controls

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (2)

University Hospital

Caen, 14000, France

Location

Dr Alain Daragon

Rouen, 76000, France

Location

Related Publications (2)

• 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.

  PMID: 29974390 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.

  PMID: 27630572 DERIVED

MeSH Terms

Conditions

Fractures, Bone

Interventions

Gait; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christian Marcelli, Professor

  CHU of Caen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: November 17, 2014
• Study Start: November 15, 2011
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

FR (2)