<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/NCT02194660</url>
  </required_header>
  <id_info>
    <org_study_id>201311048RINC</org_study_id>
    <nct_id>NCT02194660</nct_id>
  </id_info>
  <brief_title>Fragility Fracture Liaison Service Project</brief_title>
  <official_title>Fragility Fracture Liaison Service Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aims: to Establish the FLS services at the National Taiwan University Hospital (NTUH) and its&#xD;
      Beihu Branch (BB).&#xD;
&#xD;
      Method: From Jan., 2014, two related fracture liaison services (FLSs) following the 13&#xD;
      'Capture the Fracture Best Practice Standards' were implemented at the National Taiwan&#xD;
      University Hospital (NTUH) health care system. The main hospital (MH) program enrolled&#xD;
      patient with 1) new hip fracture 2) newly identified radiographic vertebral fractures or 3)&#xD;
      clinical vertebral fractures from both inpatients and outpatients. The Beihu branch (BB)&#xD;
      program enrolled only the later two types of patients from outpatients. During the whole&#xD;
      study period, two programs planed to enroll 600 fracture patients. Each patient would be&#xD;
      assessed at baseline, and every 4 month for at least one year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:The Asia Fracture Gap Taiwan Study (AFGTS) showed that among fragility fracture&#xD;
      sufferers, only 1/4 of them underwent bone mineral density (BMD) tests and 1/3 of them&#xD;
      received treatments for osteoporosis. Secondary fragility fracture prevention services are&#xD;
      needed to improve the care gaps&#xD;
&#xD;
      . Aims: to Establish the FLS services at the National Taiwan University Hospital (NTUH) and&#xD;
      its Beihu Branch (BB).&#xD;
&#xD;
      Method: The FLS was designed following the 13 'Capture the Fracture Best Practice Standards'.&#xD;
      The National Taiwan University Hospital (NTUH) institutional review board approved the study&#xD;
      in Jan., 2014. Patients were eligible to be enrolled into the main hospital (MH) service if&#xD;
      they had&#xD;
&#xD;
        1. new hip fracture in orthopedic ward&#xD;
&#xD;
        2. newly identified radiographic vertebral fractures from plan films in geriatric ward or&#xD;
&#xD;
        3. clinical vertebral fractures in outpatient clinics.&#xD;
&#xD;
      Patients in outpatient clinics of BB were eligible to be enrolled if they had (1) clinical&#xD;
      vertebral fractures or (2) newly identified asymtomatic radiological vertebral fractures by a&#xD;
      routine weekly review of every plan film of thoracic or lumbar spine regardless of the reason&#xD;
      for it.They were excluded from the service if they had life expectancy shorter than 2 years&#xD;
      of life or not be able to complete study assessments for communication or cognitive problems.&#xD;
&#xD;
      Osteoporosis-related assessments, treatments, consultations on diet, medications, exercise,&#xD;
      fall prevention were given mainly by care managers. A system is set up to remind patients to&#xD;
      take their medications at home or to return to clinic for regular injections of medications.&#xD;
      Follow up assessments included adherence to education instructions, medications, fall and&#xD;
      fracture incidences. During the whole study period, we planed to enroll 600 fracture&#xD;
      patients. Each patient would be assessed at baseline, and every 4 months last for two years.&#xD;
&#xD;
      Anticipated results:&#xD;
&#xD;
      Establish domestic FLS model and database Publish preliminary results at the 2014 the IOF 5th&#xD;
      Regionals Asia Pacific Meeting in Taipei in November.&#xD;
&#xD;
      Participating physicians and care managers will learn new skills in managing osteoporosis&#xD;
      patients.&#xD;
&#xD;
      Application for Best Practice Recognition for the IOF Capture the Fracture Campaign&#xD;
&#xD;
      Preliminary results:&#xD;
&#xD;
      We have enrolled 371 eligible patients into FLS services. From the NTUH program, BMD tests&#xD;
      were completed within 8 weeks for over 90% of participants. Also, anti-osteoporosis&#xD;
      medication (AOMs) were prescribed to about 90% of participants eligible for National Health&#xD;
      Insurance reimbursements.&#xD;
&#xD;
      In 2014, National Taiwan University Hospital (NTUH) and its BeiHu Branch (BB) were awarded&#xD;
      the gold medal and silver medal accredited best practice programs from the 'Capture the&#xD;
      Fracture' campaign from International Osteoporosis Foundation, respectively.&#xD;
&#xD;
      Our preliminary results were presented at annual scientific meeting of the Taiwanese&#xD;
      Osteoporosis Association, at Madrid, Spain, and the IOF 5th Regionals Asia Pacific Meeting in&#xD;
      Taipei, Taiwan, and the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal&#xD;
      Diseases, at Milan, Italy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">May 2026</completion_date>
  <primary_completion_date type="Actual">December 28, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>24 Months</target_duration>
  <primary_outcome>
    <measure>Bone Mineral Density test within 8 weeks of enrollments</measure>
    <time_frame>8 weeks</time_frame>
    <description>Capture the fracture campaign provide 13 best practice standards. The above mentioned index is the limiting factor for many osteoporosis related managements after fracture. We decided to use this as the primary outcome</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Osteoporosis</condition>
  <condition>Fracture</condition>
  <arm_group>
    <arm_group_label>M- main hospital</arm_group_label>
    <description>Patient enrolled in the main hospital</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B- Beihu branch</arm_group_label>
    <description>Patients enrolled in the Beihu branch</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        new fragility fracture&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: (Main hospital)&#xD;
&#xD;
          -  age &gt;=50 years and&#xD;
&#xD;
          -  new hip fracture in orthopedic ward&#xD;
&#xD;
          -  newly identified radiographic vertebral fractures from plan films in geriatric ward&#xD;
&#xD;
          -  clinical vertebral fractures in outpatient clinics Inclusion criteria (Beihu branch,&#xD;
             only outpatients)&#xD;
&#xD;
          -  age &gt;=50 years and&#xD;
&#xD;
          -  newly identified radiographic vertebral fractures from plan films&#xD;
&#xD;
          -  clinical vertebral fractures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  fracture is sufer from trauma or cancer&#xD;
&#xD;
          -  atypical fractures&#xD;
&#xD;
          -  Life expectancy less than 2 years or can't be assessed for communication or cognitive&#xD;
             problems&#xD;
&#xD;
          -  patient in other medication clinical trials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ding-Cheng Chan Chan, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital Chu-Tung Branch</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>March 10, 2021</last_update_submitted>
  <last_update_submitted_qc>March 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fractures Liaison Service</keyword>
  <keyword>Osteoporosis</keyword>
  <keyword>Fracture</keyword>
  <keyword>Medication adherence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Fractures, Bone</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/NCT02194660
org study id: 201311048RINC
nct id: NCT02194660
lead sponsor: 
has dmc: No
Aims: to Establish the FLS services at the National Taiwan University Hospital (NTUH) and its
      Beihu Branch (BB).

      Method: From Jan., 2014, two related fracture liaison services (FLSs) following the 13
      'Capture the Fracture Best Practice Standards' were implemented at the National Taiwan
      University Hospital (NTUH) health care system. The main hospital (MH) program enrolled
      patient with 1) new hip fracture 2) newly identified radiographic vertebral fractures or 3)
      clinical vertebral fractures from both inpatients and outpatients. The Beihu branch (BB)
      program enrolled only the later two types of patients from outpatients. During the whole
      study period, two programs planed to enroll 600 fracture patients. Each patient would be
      assessed at baseline, and every 4 month for at least one year.
Background:The Asia Fracture Gap Taiwan Study (AFGTS) showed that among fragility fracture
      sufferers, only 1/4 of them underwent bone mineral density (BMD) tests and 1/3 of them
      received treatments for osteoporosis. Secondary fragility fracture prevention services are
      needed to improve the care gaps

      . Aims: to Establish the FLS services at the National Taiwan University Hospital (NTUH) and
      its Beihu Branch (BB).

      Method: The FLS was designed following the 13 'Capture the Fracture Best Practice Standards'.
      The National Taiwan University Hospital (NTUH) institutional review board approved the study
      in Jan., 2014. Patients were eligible to be enrolled into the main hospital (MH) service if
      they had

        1. new hip fracture in orthopedic ward

        2. newly identified radiographic vertebral fractures from plan films in geriatric ward or

        3. clinical vertebral fractures in outpatient clinics.

      Patients in outpatient clinics of BB were eligible to be enrolled if they had (1) clinical
      vertebral fractures or (2) newly identified asymtomatic radiological vertebral fractures by a
      routine weekly review of every plan film of thoracic or lumbar spine regardless of the reason
      for it.They were excluded from the service if they had life expectancy shorter than 2 years
      of life or not be able to complete study assessments for communication or cognitive problems.

      Osteoporosis-related assessments, treatments, consultations on diet, medications, exercise,
      fall prevention were given mainly by care managers. A system is set up to remind patients to
      take their medications at home or to return to clinic for regular injections of medications.
      Follow up assessments included adherence to education instructions, medications, fall and
      fracture incidences. During the whole study period, we planed to enroll 600 fracture
      patients. Each patient would be assessed at baseline, and every 4 months last for two years.

      Anticipated results:

      Establish domestic FLS model and database Publish preliminary results at the 2014 the IOF 5th
      Regionals Asia Pacific Meeting in Taipei in November.

      Participating physicians and care managers will learn new skills in managing osteoporosis
      patients.

      Application for Best Practice Recognition for the IOF Capture the Fracture Campaign

      Preliminary results:

      We have enrolled 371 eligible patients into FLS services. From the NTUH program, BMD tests
      were completed within 8 weeks for over 90% of participants. Also, anti-osteoporosis
      medication (AOMs) were prescribed to about 90% of participants eligible for National Health
      Insurance reimbursements.

      In 2014, National Taiwan University Hospital (NTUH) and its BeiHu Branch (BB) were awarded
      the gold medal and silver medal accredited best practice programs from the 'Capture the
      Fracture' campaign from International Osteoporosis Foundation, respectively.

      Our preliminary results were presented at annual scientific meeting of the Taiwanese
      Osteoporosis Association, at Madrid, Spain, and the IOF 5th Regionals Asia Pacific Meeting in
      Taipei, Taiwan, and the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal
      Diseases, at Milan, Italy.
observational model: Case-Only
time perspective: Prospective
measure: Bone Mineral Density test within 8 weeks of enrollments
time frame: 8 weeks
description: Capture the fracture campaign provide 13 best practice standards. The above mentioned index is the limiting factor for many osteoporosis related managements after fracture. We decided to use this as the primary outcome
arm group label: M- main hospital
description: Patient enrolled in the main hospital
arm group label: B- Beihu branch
description: Patients enrolled in the Beihu branch
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Ding-Cheng Chan Chan, MD, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital Chu-Tung Branch
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Osteoporosis
mesh term: Fractures, Bone
sharing ipd: No