FractureNCT04470895
Impact of Drugs on the Risk of Falls in the Fracture Department of the Paris Saint-Joseph Hospital Group
An observational study of Fracture and Fall, run by Fondation Hôpital Saint-Joseph.
Trial summary
Falls of the elderly are a public health problem that have been neglected for too long. The experience of a fall makes the elderly person vulnerable, even in the absence of traumatic consequences, and can sometimes be a reason for institutionalization. Read more about this study
- Who is it for?
- Ages 45 to 95 years
- What is being tested?
- Failure Track patients analysis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 24 Sep 2021to 24 Sep 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 45 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study involving patients aged between 45 and 95 years, who is affiliated to the fracture track and has taken various types of medications after a fall that has occurred in the last 12 months
Who may be able to join
- Patient aged between 45 and 95
- French-speaking
- Patient included in the GhPSJ fracture track, taking at least one long-term prescription medication and hospitalized in a GhPSJ department or in Léopold Bellan.
Who cannot join
- Patient objecting to participation in the study
- Patient who has recently moved or medical nomadism making it impossible to reconcile medication with a pharmacy
- Patient not hospitalized or transferred to a hospital other than the GhPSJ or Léopold Bellan at the time of the fracture
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under the safeguard of justice.
About this study
Official title: Impact of Drugs on the Risk of Falls in the Fracture Department of the Paris Saint-Joseph
Falls of the elderly are a public health problem that have been neglected for too long. The experience of a fall makes the elderly person vulnerable, even in the absence of traumatic consequences, and can sometimes be a reason for institutionalization. These falls are frequent and have many repercussions on the autonomy of seniors. According to data from the National Institute for Prevention and Health Education (INPES), falls are the leading cause of accidental death among people over 65 years of age. They cause approximately 8,500 deaths per year. After the age of 65, one person in three falls at least once a year. They account for 10% of the reasons for consultation and 12% of hospitalizations in geriatric settings among the elderly. The risk increases with age because 80% of people over 85 years of age fall at least once a year. 20 to 30% of people over 65 have a loss or decrease in autonomy after a fall. The risk of another fall is twenty times higher after a first fall and the risk of death increases especially in the year following the fall. This is of major importance because falls are responsible for the majority of fractures in the elderly, especially femoral neck fractures. The cost of falls among the elderly is significant and estimated at 2 billion euros for communities.
Read the detailed description
The causes of falls are multiple and the imputability of medication is often mentioned. In fact, physiological or pathological ageing, which often justifies an intensification of drug use, leads to polymedication, which is recognised as a risk factor for falls in the elderly and generates dosage regimens that are most often complex and which are a source of drug over- or under-dosage. Thus, a large number of treatments increase the risk of drug interactions, particularly of a pharmacokinetic nature, which may lead to drug overdoses, while poor compliance with prescriptions may lead to underdoses. The main classes of drugs currently attributed to the risk of falls are psychotropic drugs, sleeping pills and tranquillizers, antidepressants, cardiovascular drugs, antiepileptics, hypoglycemic drugs and drugs that cause orthostatic hypotension such as antihypertensives.
Screening for risk factors for falls is an important step in management. The recommendations drawn up by the Société Française de Documentation et de Recherche en Médecine Générale (SFDRMG), in partnership with the Haute Autorité de Santé (HAS), suggest specifying the relevant interventions, both medicinal and non-pharmaceutical, to avoid an initial fall (indications, necessary means, interactions between the interveners).
Osteoporosis is a diffuse skeletal disease characterized by low bone mass and deterioration of the micro-architecture of bone tissue, responsible for an increased risk of fracture. The prevention of osteoporotic fractures is essential and involves screening and treatment of osteoporosis but also the prevention of falls. New care pathways have been developed in recent years, in particular the Fractures Liaisons Services to improve the management of this pathology.
Fracture Pathways (in English: Fractures Liaisons Services: FLS), so called because of the need for a link between the services concerned by this pathology (emergency, orthopaedic surgery, rheumatology, sometimes geriatrics), aim to identify, screen and, if necessary, treat patients with osteoporosis.
Within the Paris Saint-Joseph Hospital Group (GhSPJ), the OPTIPOST study (OPTImisation de la Prise en Charge de l'OSTéoporose chez des sujets de plus de 45 ans) highlighted the benefits of "reinforced" management of patients with osteoporotic fractures of the upper end of the femur (ESF) or the lower end of the radius (EIR) via a specific organisation coordinated by an IDE between 2014 and 2015.
This is why, following these results, and in the continuity of OPTIPOST, a Fracture Track has been set up at the GhPSJ. This is a new organisation dedicated to the management of fractured osteoporosis, independent of OPTIPOST, based on the census and follow-up of patients aged 45 to 95 years old admitted to the emergency reception service (UAS) for any kind of osteoporotic fracture. The main objective of this approach is the management of fractured osteoporosis. Patients included in this line are counted by the nurse coordinator on D0 and are questioned by telephone within 2 months following the fracture to ensure that the osteoporosis is being managed.
Currently, the Fracture Track does not take into account the risk factors for falls in osteoporotic fractured patients, in particular the risk of falls due to medication, hence the aim of this work.
- Being tested
- Failure Track patients analysis
- Keywords
- elderly, ageing
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Failure Track patients analysisDiagnostic test
The nurse coordinator of the Fracture Track first comes to give the patient a written information note. She answers the patient's questions and obtains his or her non-opposition. The patient must be given sufficient time for reflection to make his decision in order to participate in the study. His non opposition will be traced in the computerized medical record. Each enrolling patient in the study can simultaneously participate in another research. There is no exclusion period in the protocol.
Once the patient is included, a semi-directed interview is conducted. The name of the patient's usual pharmacy will be collected. Data from the computerised medical record concerning the patient's stay are also analysed.
The patient's usual pharmacy or the nurse in charge of the patient will then be questioned in order to carry out a drug reconciliation interview.
| Study group | Role | What they receive |
|---|---|---|
| Usual falling patients | a group enrolling the patients who completed the inclusive criteria and have had at least one fall in the last 12 months in addition to the possible fall causing the index fracture.
These patients must answer positively the following question "Have you fallen in the last 12 months, regardless of the current fracture"? Receives: Diagnostic Test: Failure Track patients analysis | |
| Unusual falling patients | a group enrolling the patients who also completed the inclusive criteria, but are defined as "unsual falling patients". These patients must answer negatively the following question: "Have you fallen in the last 12 months, regardless of the current fracture"? Receives: Diagnostic Test: Failure Track patients analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of drugs on Fracture Track Patients
The research aims at determining the impact of drug intake (number and type of drugs) on the occurrence of falls in patients hospitalized for an osteoporotic fracture.
Measured: July, 2020
Secondary outcomes (1)
Frequency of falls on Fracture Track patients.
The research also aims at determining the frequency of fall in fracture Tracks patient and the frequency of self medication, as well as the possible therapeutics changes made by the caregivers following the occurrence of the fall on criteria such as the prescription changes, the drug addition/ deletions molecule changes... It will also evaluate the influence of age/ age range on medication use and the occurrence of falls and establish an algorithm for managing the drug risk of falling in the fracture track.
Measured: July, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start24 Sep 2021
- Primary completion24 Sep 2021
- Study completion24 Sep 2021
Why it stopped: The PI chose not to start the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470895
- Sponsor's protocol ID
- MEDI-CHUTE
- Status last verified
- Jan 2022
- First submitted
- 8 Jul 2020
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Drugs on the Risk of Falls in the Fracture Department of the Paris Saint-Joseph
- ClinicalTrials.gov ID
- NCT04470895
- Acronym / sponsor ID
- MEDI-CHUTE
- Keywords
- elderly, ageing
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The PI chose not to start the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 24 Sep 2021 (actual)
- Study completion
- 24 Sep 2021 (actual)
- First posted
- 14 Jul 2020 (actual)
- 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.
Falls of the elderly are a public health problem that have been neglected for too long. The experience of a fall makes the elderly person vulnerable, even in the absence of traumatic consequences, and can sometimes be a reason for institutionalization. These falls are frequent and have many repercussions on the autonomy of seniors. According to data from the National Institute for Prevention and Health Education (INPES), falls are the leading cause of accidental death among people over 65 years of age. They cause approximately 8,500 deaths per year. After the age of 65, one person in three falls at least once a year. They account for 10% of the reasons for consultation and 12% of hospitalizations in geriatric settings among the elderly. The risk increases with age because 80% of people over 85 years of age fall at least once a year. 20 to 30% of people over 65 have a loss or decrease in autonomy after a fall. The risk of another fall is twenty times higher after a first fall and the risk of death increases especially in the year following the fall. This is of major importance because falls are responsible for the majority of fractures in the elderly, especially femoral neck fractures. The cost of falls among the elderly is significant and estimated at 2 billion euros for communities.
Detailed description
The causes of falls are multiple and the imputability of medication is often mentioned. In fact, physiological or pathological ageing, which often justifies an intensification of drug use, leads to polymedication, which is recognised as a risk factor for falls in the elderly and generates dosage regimens that are most often complex and which are a source of drug over- or under-dosage. Thus, a large number of treatments increase the risk of drug interactions, particularly of a pharmacokinetic nature, which may lead to drug overdoses, while poor compliance with prescriptions may lead to underdoses. The main classes of drugs currently attributed to the risk of falls are psychotropic drugs, sleeping pills and tranquillizers, antidepressants, cardiovascular drugs, antiepileptics, hypoglycemic drugs and drugs that cause orthostatic hypotension such as antihypertensives.
Screening for risk factors for falls is an important step in management. The recommendations drawn up by the Société Française de Documentation et de Recherche en Médecine Générale (SFDRMG), in partnership with the Haute Autorité de Santé (HAS), suggest specifying the relevant interventions, both medicinal and non-pharmaceutical, to avoid an initial fall (indications, necessary means, interactions between the interveners).
Osteoporosis is a diffuse skeletal disease characterized by low bone mass and deterioration of the micro-architecture of bone tissue, responsible for an increased risk of fracture. The prevention of osteoporotic fractures is essential and involves screening and treatment of osteoporosis but also the prevention of falls. New care pathways have been developed in recent years, in particular the Fractures Liaisons Services to improve the management of this pathology.
Fracture Pathways (in English: Fractures Liaisons Services: FLS), so called because of the need for a link between the services concerned by this pathology (emergency, orthopaedic surgery, rheumatology, sometimes geriatrics), aim to identify, screen and, if necessary, treat patients with osteoporosis.
Within the Paris Saint-Joseph Hospital Group (GhSPJ), the OPTIPOST study (OPTImisation de la Prise en Charge de l'OSTéoporose chez des sujets de plus de 45 ans) highlighted the benefits of "reinforced" management of patients with osteoporotic fractures of the upper end of the femur (ESF) or the lower end of the radius (EIR) via a specific organisation coordinated by an IDE between 2014 and 2015.
This is why, following these results, and in the continuity of OPTIPOST, a Fracture Track has been set up at the GhPSJ. This is a new organisation dedicated to the management of fractured osteoporosis, independent of OPTIPOST, based on the census and follow-up of patients aged 45 to 95 years old admitted to the emergency reception service (UAS) for any kind of osteoporotic fracture. The main objective of this approach is the management of fractured osteoporosis. Patients included in this line are counted by the nurse coordinator on D0 and are questioned by telephone within 2 months following the fracture to ensure that the osteoporosis is being managed.
Currently, the Fracture Track does not take into account the risk factors for falls in osteoporotic fractured patients, in particular the risk of falls due to medication, hence the aim of this work.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual falling patients | – | Diagnostic Test: Failure Track patients analysisa group enrolling the patients who completed the inclusive criteria and have had at least one fall in the last 12 months in addition to the possible fall causing the index fracture. These patients must answer positively the following question "Have you fallen in the last 12 months, regardless of the current fracture"? |
| Unusual falling patients | – | Diagnostic Test: Failure Track patients analysisa group enrolling the patients who also completed the inclusive criteria, but are defined as "unsual falling patients". These patients must answer negatively the following question: "Have you fallen in the last 12 months, regardless of the current fracture"? |
Who may qualify
- Ages
- 45 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study involving patients aged between 45 and 95 years, who is affiliated to the fracture track and has taken various types of medications after a fall that has occurred in the last 12 months
Key inclusion criteria (3 listed)
- Patient aged between 45 and 95
- French-speaking
- Patient included in the GhPSJ fracture track, taking at least one long-term prescription medication and hospitalized in a GhPSJ department or in Léopold Bellan.
Key exclusion criteria (6 listed)
- Patient objecting to participation in the study
- Patient who has recently moved or medical nomadism making it impossible to reconcile medication with a pharmacy
- Patient not hospitalized or transferred to a hospital other than the GhPSJ or Léopold Bellan at the time of the fracture
- Patient under guardianship or curatorship
- Patient deprived of liberty
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 |
|---|---|---|
| Failure Track patients analysisThe nurse coordinator of the Fracture Track first comes to give the patient a written information note. She answers the patient's questions and obtains his or her non-opposition. The patient must be given sufficient time for reflection to make his decision in order to participate in the study. His non opposition will be traced in the computerized medical record. Each enrolling patient in the study can simultaneously participate in another research. There is no exclusion period in the protocol. Once the patient is included, a semi-directed interview is conducted. The name of the patient's usual pharmacy will be collected. Data from the computerised medical record concerning the patient's stay are also analysed. The patient's usual pharmacy or the nurse in charge of the patient will then be questioned in order to carry out a drug reconciliation interview. | Diagnostic test | Unusual falling patients, Usual falling patients |
Primary outcome
Impact of drugs on Fracture Track Patients
Time frame: July, 2020
The research aims at determining the impact of drug intake (number and type of drugs) on the occurrence of falls in patients hospitalized for an osteoporotic fracture.
1 secondary outcome
Frequency of falls on Fracture Track patients.
Time frame: July, 2020
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Chute sur la personne âgée: causes, conséquences et préventionLink provided by the sponsor.
- Médicaments et chutes \[Internet\]Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture and Fall, run by Fondation Hôpital Saint-Joseph.
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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.
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?
Impact of drugs on Fracture Track Patients (time frame: July, 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2022.