Accidental FallsCFCNCT02292316
Falls With Fracture : Role of Cognitive Disorders and Comparison With Bone Fragility
A study testing gait and cognitive assessments, blood sample and osteodensitometry in people with Accidental Falls and Fractures, run by University Hospital, Caen at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls, Fractures
- What is being tested?
- gait and cognitive assessments, blood sample and osteodensitometry
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Nov 2011to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the detailed 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)
- Conditions
- Accidental Falls, Fractures
- Being tested
- gait and cognitive assessments, blood sample, osteodensitometry
- Keywords
- middle-aged and aged adults, fall in the previous year
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait and cognitive assessmentsBehavioural
several tests are given in each domain
blood sampleBiological
routine analyses in rheumatology such blood count and 25OH-D
osteodensitometryOther
Looking for osteoporosis
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: gait and cognitive assessments; Biological: blood sample; Other: osteodensitometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of a global cognitive efficiency score Analysis of bone mineral density
MMS, MoCA
Measured: on the inclusion day and two years after
Secondary outcomes (11)
Age
Measured: on the inclusion day and over two years
Cognitive scores
Mainly tests of memory, attention and executive functions
Measured: on the inclusion day and over two years
Fracture features
Location and severity
Measured: on the inclusion day and over two years
Balance and walking parameters
Tinetti scale, TUG and dual-tasks
Measured: on the inclusion day and over two years
handgrip force
using a dynamometer
Measured: on the inclusion day and over two years
Daily life scales scores
Mainly IADL
Measured: on the inclusion day and over two years
fear of falling
ABC-scale
Measured: on the inclusion day and over two years
functional restrictions score
Lequesne score
Measured: on the inclusion day and over two years
Degree of depression
MADRS
Measured: on the inclusion day and over two years
biological data
25OHD
Measured: on the inclusion day and over two years
Dual-energy X-ray absorptiometry
bone mineral densitometry
Measured: on the inclusion day and two years after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study start15 Nov 2011
- Primary completion31 Dec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Marcelli, Professor, Principal investigator, CHU of Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292316
- Sponsor's protocol ID
- RCB 2011A00556-35
- Acronym
- CFC
- Status last verified
- Mar 2020
- First submitted
- 26 Sep 2014
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29974390Langeard 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.
PubMed 27630572
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Falls With Fracture : Role of Cognitive Disorders and Comparison With Bone Fragility
- ClinicalTrials.gov ID
- NCT02292316
- Acronym / sponsor ID
- CFC / RCB 2011A00556-35
- Conditions
- Accidental Falls, Fractures
- Keywords
- middle-aged and aged adults, fall in the previous year
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 15 Nov 2011 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 17 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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)
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fall with fracture | Experimental | Behavioral: gait and cognitive assessments, Biological: blood sample, Other: osteodensitometryFall 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 | Behavioral: gait and cognitive assessments, Biological: blood sample, Other: osteodensitometryFall without fracture in the last 12 months; Interventions : behavioral, biological and other; Behavioral intervention includes gait and cognitive assessments Blood sample Osteodensitometry |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gait and cognitive assessmentsseveral tests are given in each domain | Behavioural | Fall with fracture, controls |
| blood sampleroutine analyses in rheumatology such blood count and 25OH-D | Biological | Fall with fracture, controls |
| osteodensitometryLooking for osteoporosis | Other | Fall with fracture, controls |
Primary outcome
Analysis of a global cognitive efficiency score Analysis of bone mineral density
Time frame: on the inclusion day and two years after
MMS, MoCA
11 secondary outcomes
Age
Time frame: on the inclusion day and over two years
Cognitive scores
Time frame: on the inclusion day and over two years
Fracture features
Time frame: on the inclusion day and over two years
Balance and walking parameters
Time frame: on the inclusion day and over two years
handgrip force
Time frame: on the inclusion day and over two years
Daily life scales scores
Time frame: on the inclusion day and over two years
fear of falling
Time frame: on the inclusion day and over two years
functional restrictions score
Time frame: on the inclusion day and over two years
Degree of depression
Time frame: on the inclusion day and over two years
biological data
Time frame: on the inclusion day and over two years
Dual-energy X-ray absorptiometry
Time frame: on the inclusion day and two years after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Derived from this study: PubMed 29974390Langeard 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.
- Derived from this study: PubMed 27630572Langeard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Marcelli, Professor principal investigator
CHU of Caen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gait and cognitive assessments, blood sample and osteodensitometry in people with Accidental Falls and Fractures, run by University Hospital, Caen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of a global cognitive efficiency score Analysis of bone mineral density (time frame: on the inclusion day and two years after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02292316, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.