<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/NCT03044015</url>
  </required_header>
  <id_info>
    <org_study_id>PDMRAL-16</org_study_id>
    <nct_id>NCT03044015</nct_id>
  </id_info>
  <brief_title>Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures</brief_title>
  <acronym>APROP</acronym>
  <official_title>a Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Department of Health, Generalitat de Catalunya</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</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>
      BACKGROUND Recent evidence has been published about the effectiveness for the secondary&#xD;
      prevention of osteoporotic fractures (OF) of the hospital-based fracture liaison services.&#xD;
&#xD;
      AIM To assess the effectiveness of a primary care based intervention in the secondary&#xD;
      prevention of OF.&#xD;
&#xD;
      METHODOLOGY Prospective study of random clusters, defined at the primary-care trust (PCT)&#xD;
      level. Total study follow-up 3 years. Sample size 1800 patients.&#xD;
&#xD;
      DESCRIPTION To launch a defined strategy for the identification of OF. To carry out a primary&#xD;
      care based intervention about lifestyle, diet and drug prescription, if needed, with an&#xD;
      intensive follow-up in the intervention PCT vs treatment as usual in the control branch.&#xD;
&#xD;
      ANALYSIS As the outcome are the new OF, a survival analysis will be done. Risk factors will&#xD;
      be analyzed through Cox proportional hazard regression model stratified by age groups.&#xD;
&#xD;
      Outcomes :&#xD;
&#xD;
        -  new OF ratio in intervention vs control areas.&#xD;
&#xD;
        -  maintenance of the adherence to the pharmacological and non pharmacological&#xD;
           interventions proposed&#xD;
&#xD;
        -  assessment of cost-effectivity of the intervention&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with osteoporotic fractures</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>economic cost</measure>
    <time_frame>24 months</time_frame>
    <description>We will consider time spent by physicians and nurses, cost of treatment (hospital admissions, drug therapy, rehabilitation)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1800</enrollment>
  <condition>Osteoporotic Fractures</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>a defined strategy for the identification of OF. To carry out a primary care based intervention about lifestyle, diet and drug prescription, if needed, with an intensive follow-up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>community based integrated strategy for secondary prevention of OF</intervention_name>
    <description>Educational programme on pharmacological treatment, diet recommendations, physical activity programme on OF prevention in primary care</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>as usual</intervention_name>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major OF (distal forearm, vertebral, hip, pelvis and humerus&#xD;
&#xD;
          -  Caused by a low impact mechanism&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  High impact mechanism of impact or secondary to other diseases (cancer, Paget disease&#xD;
             ...)&#xD;
&#xD;
          -  Patients not residing in the area of the targeted primary care practices&#xD;
&#xD;
          -  Patients with an invalidating disease (dementia ...)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>IDIAP Jordi Gol</name>
      <address>
        <city>Barcelona</city>
        <zip>08007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Pueyo, MD</last_name>
      <phone>+34 93 556 62 13</phone>
      <email>mjpueyo@gencat.cat</email>
    </contact>
    <investigator>
      <last_name>Bonaventura Bolibar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>August 24, 2020</last_update_submitted>
  <last_update_submitted_qc>August 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Osteoporotic Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03044015
org study id: PDMRAL-16
nct id: NCT03044015
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
BACKGROUND Recent evidence has been published about the effectiveness for the secondary
      prevention of osteoporotic fractures (OF) of the hospital-based fracture liaison services.

      AIM To assess the effectiveness of a primary care based intervention in the secondary
      prevention of OF.

      METHODOLOGY Prospective study of random clusters, defined at the primary-care trust (PCT)
      level. Total study follow-up 3 years. Sample size 1800 patients.

      DESCRIPTION To launch a defined strategy for the identification of OF. To carry out a primary
      care based intervention about lifestyle, diet and drug prescription, if needed, with an
      intensive follow-up in the intervention PCT vs treatment as usual in the control branch.

      ANALYSIS As the outcome are the new OF, a survival analysis will be done. Risk factors will
      be analyzed through Cox proportional hazard regression model stratified by age groups.

      Outcomes :

        -  new OF ratio in intervention vs control areas.

        -  maintenance of the adherence to the pharmacological and non pharmacological
           interventions proposed

        -  assessment of cost-effectivity of the intervention
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of patients with osteoporotic fractures
time frame: 24 months
measure: economic cost
time frame: 24 months
description: We will consider time spent by physicians and nurses, cost of treatment (hospital admissions, drug therapy, rehabilitation)
arm group label: Intervention
arm group type: Experimental
description: a defined strategy for the identification of OF. To carry out a primary care based intervention about lifestyle, diet and drug prescription, if needed, with an intensive follow-up
arm group label: Control
arm group type: Active Comparator
description: Intervention as usual
intervention type: Behavioral
intervention name: community based integrated strategy for secondary prevention of OF
description: Educational programme on pharmacological treatment, diet recommendations, physical activity programme on OF prevention in primary care
arm group label: Intervention
intervention type: Behavioral
intervention name: as usual
arm group label: Control
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: Spain
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Osteoporotic Fractures
sharing ipd: No