xml: <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/NCT06024148</url>
    </required_header>
    <id_info>
      <org_study_id>38RC23.0179</org_study_id>
      <nct_id>NCT06024148</nct_id>
    </id_info>
    <brief_title>Continuation of Anti-osteoporotic Treatment 1 Year After Initial Administration</brief_title>
    <acronym>POUROSTEO</acronym>
    <official_title>Evaluation of the Continuation of Anti-osteoporotic Treatment 1 Year After Initial Administration Following Severe Osteoporotic Fracture in Patients Aged 75 and Over, Hospitalized at the Rocheplane Medical Center</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Grenoble</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Grenoble</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>
        The aim of this observational study is to assess the obstacles and levers to the continuation&#xD;
        of anti-osteoporotic treatment, and to identify those where action could be taken to improve&#xD;
        the quality of care for fractured patients.&#xD;
  &#xD;
        The individual and collective stakes are high. Fracture is the most feared complication of&#xD;
        osteoporosis. The current under-diagnosis and under-treatment of this chronic pathology&#xD;
        exposes patients to a high risk of early re-fracture, with the associated morbidity and&#xD;
        mortality.&#xD;
  &#xD;
        General practitioners have a major role to play in monitoring and coordinating patients'&#xD;
        healthcare pathways. The aim of this study is to assess ways of improving osteoporosis&#xD;
        management in order to improve quality of life and disability-free life expectancy for&#xD;
        individual patients. The public health and economic stakes are equally high. It is by&#xD;
        identifying the obstacles that prospective work on the key elements to be implemented could&#xD;
        help optimize osteoporosis management.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Selection of patients hospitalized at the Rocheplane Medical Center between June 2021 and May&#xD;
        2022, following a severe osteoporotic fracture and having received a first dose of&#xD;
        antiosteoporotic treatment during their overall stay (initial admission department + CMR).&#xD;
  &#xD;
        Sending of an information letter and request for non-objection from patients or their trusted&#xD;
        support person, with a 1-month cooling-off period to express opposition.&#xD;
  &#xD;
        Collection of variables of interest from CMR patients' medical records, followed by&#xD;
        administration of a telephone hetero-questionnaire (transferred to Excel) to patients or&#xD;
        their families 1 year after fracture occurrence.&#xD;
  &#xD;
        If the patient or family did not answer the questionnaire, or if it was incomplete (missing&#xD;
        data), the information could be sought by telephone from the attending physician.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluate the rate of continuation of anti-osteoporotic treatment at 1 year after initial administration following a severe osteoporotic fracture in patients aged 75 and over.</measure>
      <time_frame>Telephone data collection one year after Geriatric Rehabilitation Department stay</time_frame>
      <description>Percentage of patients for whom anti-osteoporosis treatment was renewed 1 year after initial administration (between fracture occurrence and discharge from the geriatric department)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Determine the rate of introduction of anti-osteoporotic treatment during the patient's overall stay</measure>
      <time_frame>Medical records collected one year after Geriatric Rehabilitation Department stay</time_frame>
      <description>Percentage of patients who received anti-osteoporosis treatment during their overall stay</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Identify patient-related obstacles and levers to treatment renewal at 1 year after fracture</measure>
      <time_frame>Telephone data collection one year after Geriatric Rehabilitation Department stay</time_frame>
      <description>Percentage of patients presenting: a contraindication to treatment, intolerance to treatment, refusal of treatment, non-adherence to treatment, failure to consult their GP, forgetfulness, death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine the obstacles and levers to the continuation of treatment at 1 year after a fracture, in relation to the treating physician.</measure>
      <time_frame>Telephone data collection one year after Geriatric Rehabilitation Department stay</time_frame>
      <description>Percentage of GPs reporting: unfamiliarity with the introduction of treatment at the time of fracture, unfamiliarity with how to prescribe treatment, unfamiliarity with &quot;osteoporosis&quot; recommendations, non-prescribing for fear of adverse effects (iatrogenicity), non-prescribing based on a judgement of an unfavourable benefit/risk balance, feeling of incompetence regarding the management of osteoporosis, lack of time, proposing therapeutic alternatives, forgetfulness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine the obstacles and levers to the continuation of treatment at 1 year for fractures related to the healthcare system</measure>
      <time_frame>Telephone data collection one year after Geriatric Rehabilitation Department stay</time_frame>
      <description>Absence of clear follow-up instructions on upstream department reports (quality of inter-professional communication), Absence of consultation with a rheumatologist, Absence of consultation with a geriatrician, Difficulty accessing a dental consultation, Absence of BMD, Cost of medication, Existence of a doctor-pharmacist link, GP cooperation with a network of well-identified specialists.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the professional practices of general practitioners concerning the management of osteoporosis.</measure>
      <time_frame>Telephone data collection one year after Geriatric Rehabilitation Department stay of their patient</time_frame>
      <description>Analysis of the results of the professional practice assessment questionnaire</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Osteoporosis Fracture</condition>
    <arm_group>
      <arm_group_label>patients hospitalized in the Geriatric Rehabilitation Department</arm_group_label>
      <description>patients aged 75 and over, admitted with a severe osteoporotic post-fracture, having received a first dose of antiosteoporotic treatment between the day of fracture and discharge from Geriatric Rehabilitation Department</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>phone survey</intervention_name>
      <description>patients complete a 10-minute telephone questionnaire on their osteoporosis management</description>
      <arm_group_label>patients hospitalized in the Geriatric Rehabilitation Department</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          We will include the number of patients corresponding to the &quot;patient flow&quot; admitted to&#xD;
          CMR's units of interest over one year, and, corresponding to the inclusion criteria (CMR&#xD;
          welcomes 250 patients aged 75 and over to its geriatric units each year, all types of&#xD;
          fractures combined; ¾ of patients are admitted for severe fractures).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Hospitalization in CMR's Geriatric Rehabilitation Department between 01/06/2021 and&#xD;
               31/05/2022&#xD;
  &#xD;
            -  Age: 75 and over&#xD;
  &#xD;
            -  Admitted with severe post-fracture osteoporosis&#xD;
  &#xD;
            -  Having received a first dose of antiosteoporotic treatment between the day the&#xD;
               fracture occurred and discharge from CMR (either in an inpatient unit prior to CMR, or&#xD;
               at CMR)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having objected to the use of his/her data for research purposes&#xD;
  &#xD;
            -  Subject under guardianship or deprived of liberty.&#xD;
  &#xD;
            -  Pathological fracture&#xD;
  &#xD;
            -  Anti-osteoporotic treatment prior to fracture&#xD;
  &#xD;
            -  1-year follow-up made impossible by lack of contact with patient, family or attending&#xD;
               physician.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>75 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sabine DREVET, Dr</last_name>
      <phone>04 76 76 66 06</phone>
      <email>sdrevet@chu-grenoble.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Magali ABADIE</last_name>
      <email>mabadie@chu-grenoble.fr</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>antiosteoporotic treatment</keyword>
    <keyword>professional practice assessment</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoporosis</mesh_term>
      <mesh_term>Osteoporotic Fractures</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024148
  org study id: 38RC23.0179
  nct id: NCT06024148
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this observational study is to assess the obstacles and levers to the continuation
        of anti-osteoporotic treatment, and to identify those where action could be taken to improve
        the quality of care for fractured patients.
  
        The individual and collective stakes are high. Fracture is the most feared complication of
        osteoporosis. The current under-diagnosis and under-treatment of this chronic pathology
        exposes patients to a high risk of early re-fracture, with the associated morbidity and
        mortality.
  
        General practitioners have a major role to play in monitoring and coordinating patients'
        healthcare pathways. The aim of this study is to assess ways of improving osteoporosis
        management in order to improve quality of life and disability-free life expectancy for
        individual patients. The public health and economic stakes are equally high. It is by
        identifying the obstacles that prospective work on the key elements to be implemented could
        help optimize osteoporosis management.
  Selection of patients hospitalized at the Rocheplane Medical Center between June 2021 and May
        2022, following a severe osteoporotic fracture and having received a first dose of
        antiosteoporotic treatment during their overall stay (initial admission department + CMR).
  
        Sending of an information letter and request for non-objection from patients or their trusted
        support person, with a 1-month cooling-off period to express opposition.
  
        Collection of variables of interest from CMR patients' medical records, followed by
        administration of a telephone hetero-questionnaire (transferred to Excel) to patients or
        their families 1 year after fracture occurrence.
  
        If the patient or family did not answer the questionnaire, or if it was incomplete (missing
        data), the information could be sought by telephone from the attending physician.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Evaluate the rate of continuation of anti-osteoporotic treatment at 1 year after initial administration following a severe osteoporotic fracture in patients aged 75 and over.
  time frame: Telephone data collection one year after Geriatric Rehabilitation Department stay
  description: Percentage of patients for whom anti-osteoporosis treatment was renewed 1 year after initial administration (between fracture occurrence and discharge from the geriatric department)
  measure: Determine the rate of introduction of anti-osteoporotic treatment during the patient's overall stay
  time frame: Medical records collected one year after Geriatric Rehabilitation Department stay
  description: Percentage of patients who received anti-osteoporosis treatment during their overall stay
  measure: Identify patient-related obstacles and levers to treatment renewal at 1 year after fracture
  time frame: Telephone data collection one year after Geriatric Rehabilitation Department stay
  description: Percentage of patients presenting: a contraindication to treatment, intolerance to treatment, refusal of treatment, non-adherence to treatment, failure to consult their GP, forgetfulness, death.
  measure: Determine the obstacles and levers to the continuation of treatment at 1 year after a fracture, in relation to the treating physician.
  time frame: Telephone data collection one year after Geriatric Rehabilitation Department stay
  description: Percentage of GPs reporting: unfamiliarity with the introduction of treatment at the time of fracture, unfamiliarity with how to prescribe treatment, unfamiliarity with "osteoporosis" recommendations, non-prescribing for fear of adverse effects (iatrogenicity), non-prescribing based on a judgement of an unfavourable benefit/risk balance, feeling of incompetence regarding the management of osteoporosis, lack of time, proposing therapeutic alternatives, forgetfulness.
  measure: Determine the obstacles and levers to the continuation of treatment at 1 year for fractures related to the healthcare system
  time frame: Telephone data collection one year after Geriatric Rehabilitation Department stay
  description: Absence of clear follow-up instructions on upstream department reports (quality of inter-professional communication), Absence of consultation with a rheumatologist, Absence of consultation with a geriatrician, Difficulty accessing a dental consultation, Absence of BMD, Cost of medication, Existence of a doctor-pharmacist link, GP cooperation with a network of well-identified specialists.
  measure: Evaluation of the professional practices of general practitioners concerning the management of osteoporosis.
  time frame: Telephone data collection one year after Geriatric Rehabilitation Department stay of their patient
  description: Analysis of the results of the professional practice assessment questionnaire
  arm group label: patients hospitalized in the Geriatric Rehabilitation Department
  description: patients aged 75 and over, admitted with a severe osteoporotic post-fracture, having received a first dose of antiosteoporotic treatment between the day of fracture and discharge from Geriatric Rehabilitation Department
  intervention type: Other
  intervention name: phone survey
  description: patients complete a 10-minute telephone questionnaire on their osteoporosis management
  arm group label: patients hospitalized in the Geriatric Rehabilitation Department
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 75 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sabine DREVET, Dr
  phone: 04 76 76 66 06
  email: sdrevet@chu-grenoble.fr
  last name: Magali ABADIE
  email: mabadie@chu-grenoble.fr
  responsible party type: Sponsor
  mesh term: Osteoporosis
  mesh term: Osteoporotic Fractures