<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04470895</url>
  </required_header>
  <id_info>
    <org_study_id>MEDI-CHUTE</org_study_id>
    <nct_id>NCT04470895</nct_id>
  </id_info>
  <brief_title>Impact of Drugs on the Risk of Falls in the Fracture Department of the Paris Saint-Joseph Hospital Group</brief_title>
  <official_title>Impact of Drugs on the Risk of Falls in the Fracture Department of the Paris Saint-Joseph</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Falls of the elderly are a public health problem that have been neglected for too long. The&#xD;
      experience of a fall makes the elderly person vulnerable, even in the absence of traumatic&#xD;
      consequences, and can sometimes be a reason for institutionalization. These falls are&#xD;
      frequent and have many repercussions on the autonomy of seniors. According to data from the&#xD;
      National Institute for Prevention and Health Education (INPES), falls are the leading cause&#xD;
      of accidental death among people over 65 years of age. They cause approximately 8,500 deaths&#xD;
      per year. After the age of 65, one person in three falls at least once a year. They account&#xD;
      for 10% of the reasons for consultation and 12% of hospitalizations in geriatric settings&#xD;
      among the elderly. The risk increases with age because 80% of people over 85 years of age&#xD;
      fall at least once a year. 20 to 30% of people over 65 have a loss or decrease in autonomy&#xD;
      after a fall. The risk of another fall is twenty times higher after a first fall and the risk&#xD;
      of death increases especially in the year following the fall. This is of major importance&#xD;
      because falls are responsible for the majority of fractures in the elderly, especially&#xD;
      femoral neck fractures. The cost of falls among the elderly is significant and estimated at 2&#xD;
      billion euros for communities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The causes of falls are multiple and the imputability of medication is often mentioned. In&#xD;
      fact, physiological or pathological ageing, which often justifies an intensification of drug&#xD;
      use, leads to polymedication, which is recognised as a risk factor for falls in the elderly&#xD;
      and generates dosage regimens that are most often complex and which are a source of drug&#xD;
      over- or under-dosage. Thus, a large number of treatments increase the risk of drug&#xD;
      interactions, particularly of a pharmacokinetic nature, which may lead to drug overdoses,&#xD;
      while poor compliance with prescriptions may lead to underdoses. The main classes of drugs&#xD;
      currently attributed to the risk of falls are psychotropic drugs, sleeping pills and&#xD;
      tranquillizers, antidepressants, cardiovascular drugs, antiepileptics, hypoglycemic drugs and&#xD;
      drugs that cause orthostatic hypotension such as antihypertensives.&#xD;
&#xD;
      Screening for risk factors for falls is an important step in management. The recommendations&#xD;
      drawn up by the Société Française de Documentation et de Recherche en Médecine Générale&#xD;
      (SFDRMG), in partnership with the Haute Autorité de Santé (HAS), suggest specifying the&#xD;
      relevant interventions, both medicinal and non-pharmaceutical, to avoid an initial fall&#xD;
      (indications, necessary means, interactions between the interveners).&#xD;
&#xD;
      Osteoporosis is a diffuse skeletal disease characterized by low bone mass and deterioration&#xD;
      of the micro-architecture of bone tissue, responsible for an increased risk of fracture. The&#xD;
      prevention of osteoporotic fractures is essential and involves screening and treatment of&#xD;
      osteoporosis but also the prevention of falls. New care pathways have been developed in&#xD;
      recent years, in particular the Fractures Liaisons Services to improve the management of this&#xD;
      pathology.&#xD;
&#xD;
      Fracture Pathways (in English: Fractures Liaisons Services: FLS), so called because of the&#xD;
      need for a link between the services concerned by this pathology (emergency, orthopaedic&#xD;
      surgery, rheumatology, sometimes geriatrics), aim to identify, screen and, if necessary,&#xD;
      treat patients with osteoporosis.&#xD;
&#xD;
      Within the Paris Saint-Joseph Hospital Group (GhSPJ), the OPTIPOST study (OPTImisation de la&#xD;
      Prise en Charge de l'OSTéoporose chez des sujets de plus de 45 ans) highlighted the benefits&#xD;
      of &quot;reinforced&quot; management of patients with osteoporotic fractures of the upper end of the&#xD;
      femur (ESF) or the lower end of the radius (EIR) via a specific organisation coordinated by&#xD;
      an IDE between 2014 and 2015.&#xD;
&#xD;
      This is why, following these results, and in the continuity of OPTIPOST, a Fracture Track has&#xD;
      been set up at the GhPSJ. This is a new organisation dedicated to the management of fractured&#xD;
      osteoporosis, independent of OPTIPOST, based on the census and follow-up of patients aged 45&#xD;
      to 95 years old admitted to the emergency reception service (UAS) for any kind of&#xD;
      osteoporotic fracture. The main objective of this approach is the management of fractured&#xD;
      osteoporosis. Patients included in this line are counted by the nurse coordinator on D0 and&#xD;
      are questioned by telephone within 2 months following the fracture to ensure that the&#xD;
      osteoporosis is being managed.&#xD;
&#xD;
      Currently, the Fracture Track does not take into account the risk factors for falls in&#xD;
      osteoporotic fractured patients, in particular the risk of falls due to medication, hence the&#xD;
      aim of this work.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The PI chose not to start the study.&#xD;
  </why_stopped>
  <start_date type="Actual">September 24, 2021</start_date>
  <completion_date type="Actual">September 24, 2021</completion_date>
  <primary_completion_date type="Actual">September 24, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Impact of drugs on Fracture Track Patients</measure>
    <time_frame>July, 2020</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of falls on Fracture Track patients.</measure>
    <time_frame>July, 2020</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Fracture</condition>
  <condition>Fall</condition>
  <arm_group>
    <arm_group_label>Usual falling patients</arm_group_label>
    <description>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.&#xD;
These patients must answer positively the following question &quot;Have you fallen in the last 12 months, regardless of the current fracture&quot;?</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unusual falling patients</arm_group_label>
    <description>a group enrolling the patients who also completed the inclusive criteria, but are defined as &quot;unsual falling patients&quot;. These patients must answer negatively the following question: &quot;Have you fallen in the last 12 months, regardless of the current fracture&quot;?</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Failure Track patients analysis</intervention_name>
    <description>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.&#xD;
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.&#xD;
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.</description>
    <arm_group_label>Unusual falling patients</arm_group_label>
    <arm_group_label>Usual falling patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study involving patients aged between 45 and 95 years, who is affiliated to the fracture&#xD;
        track and has taken various types of medications after a fall that has occurred in the last&#xD;
        12 months&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged between 45 and 95&#xD;
&#xD;
          -  French-speaking&#xD;
&#xD;
          -  Patient included in the GhPSJ fracture track, taking at least one long-term&#xD;
             prescription medication and hospitalized in a GhPSJ department or in Léopold Bellan.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient objecting to participation in the study&#xD;
&#xD;
          -  Patient who has recently moved or medical nomadism making it impossible to reconcile&#xD;
             medication with a pharmacy&#xD;
&#xD;
          -  Patient not hospitalized or transferred to a hospital other than the GhPSJ or Léopold&#xD;
             Bellan at the time of the fracture&#xD;
&#xD;
          -  Patient under guardianship or curatorship&#xD;
&#xD;
          -  Patient deprived of liberty&#xD;
&#xD;
          -  Patient under the safeguard of justice.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>https://www.silvereco.fr/chute-de-la-personne-agee-causes-consequences-et-prevention/3187245</url>
    <description>Chute sur la personne âgée: causes, conséquences et prévention</description>
  </link>
  <link>
    <url>http://www.iugm.qc.ca/sante-aines/infochute/chute-corps/chute-corps-medicament.html</url>
    <description>Médicaments et chutes [Internet]</description>
  </link>
  <link>
    <url>https://www.has-sante.fr/portail/upload/docs/application/pdf/Prevention_chutes_recos.pdf</url>
    <description>Prévention_chutes_recos.pdf [Internet]</description>
  </link>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>January 18, 2022</last_update_submitted>
  <last_update_submitted_qc>January 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>elderly</keyword>
  <keyword>ageing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04470895
org study id: MEDI-CHUTE
nct id: NCT04470895
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Control
time perspective: Prospective
measure: Impact of drugs on Fracture Track Patients
time frame: July, 2020
description: 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.
measure: Frequency of falls on Fracture Track patients.
time frame: July, 2020
description: 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.
arm group label: Usual falling patients
description: 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"?
arm group label: Unusual falling patients
description: 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"?
intervention type: Diagnostic Test
intervention name: Failure Track patients analysis
description: 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.
arm group label: Unusual falling patients
arm group label: Usual falling patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: 95 Years
healthy volunteers: No
url: https://www.silvereco.fr/chute-de-la-personne-agee-causes-consequences-et-prevention/3187245
description: Chute sur la personne âgée: causes, conséquences et prévention
url: http://www.iugm.qc.ca/sante-aines/infochute/chute-corps/chute-corps-medicament.html
description: Médicaments et chutes [Internet]
url: https://www.has-sante.fr/portail/upload/docs/application/pdf/Prevention_chutes_recos.pdf
description: Prévention_chutes_recos.pdf [Internet]
responsible party type: Sponsor
mesh term: Fractures, Bone
sharing ipd: Undecided