<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/NCT02194647</url>
  </required_header>
  <id_info>
    <org_study_id>201406077RINA</org_study_id>
    <nct_id>NCT02194647</nct_id>
  </id_info>
  <brief_title>Anti-osteoporosis Medication Monitoring and Management Service</brief_title>
  <official_title>Anti-osteoporosis Medication Monitoring and Management Service</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>
      BACKGROUND:&#xD;
&#xD;
      One-year adherence to oral anti-osteoporosis medication (AOMs) was only about 30%. In recent&#xD;
      years, efforts have been made to change the delivery of these medications from oral form to&#xD;
      injection form every, 3, 6 or 12 months to increase adherence. However, both patients and&#xD;
      providers are sometimes confused about the multiple choices. Also, patients may receive extra&#xD;
      medications if providers did not keep tract of their previous AOM uses or patients may&#xD;
      changes providers. There were urgent needs to provide AOM monitoring and management services&#xD;
      to improve cares.&#xD;
&#xD;
      OBJECTIVES:&#xD;
&#xD;
      To establish a anti-osteoporosis medication management service at National Taiwan University&#xD;
      Hospital and its BeiHu Branch.&#xD;
&#xD;
      METHODS:&#xD;
&#xD;
      Participating physicians will select those eligible for services and refer to study&#xD;
      coordinators. Study coordinators will conduct baseline assessments on osteoporosis/fracture&#xD;
      risks, record medical conditions, AOMs, provide educations on osteoporosis, fracture,&#xD;
      sarcopenia, fall, medications, nutrition, and exercise. They also arrange return clinic&#xD;
      visit, telephone reminder and follow up for patients, and communicate with providers on&#xD;
      regular bases. the investigators plan to enroll 500 patients with 18-month follow up for&#xD;
      each.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 1, 2026</completion_date>
  <primary_completion_date type="Actual">August 22, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>medication adherence</measure>
    <time_frame>18 months</time_frame>
    <description>Medication adherence will be assessed at 4, 8, 12, 18 months after enrollments. Final results will be reported at 18 month. If the patient changes medication, all AOMs adherence will be combined.&#xD;
Specific formula is as below:&#xD;
for oral medications, adherence is defined as # medication taken/ #medication prescribed within past 3 months for injection medications, adherence is defined as # of injection/ # of due injection since baseline or last follow up phone call.&#xD;
Statistics: Simple counts of adherence % among all participants.</description>
  </primary_outcome>
  <enrollment type="Actual">500</enrollment>
  <condition>Osteoporosis</condition>
  <condition>Fracture</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adults treated with anti-osteoporosis medicines (AOMs)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;=50 and one of the below&#xD;
&#xD;
          -  Newly prescribed with AOMs&#xD;
&#xD;
          -  Recent change of AOMs&#xD;
&#xD;
          -  Poor adherence to AOMs&#xD;
&#xD;
          -  Participating physicians feel that the service will benefit the patient in overall&#xD;
             osteoporosis and medication managements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life expectancy less than 2 years or can't be assessed for communication problems&#xD;
&#xD;
          -  patient in our fracture liaison service or 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, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</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>July 2023</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>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Osteoporosis</keyword>
  <keyword>Medication Monitoring</keyword>
  <keyword>Education</keyword>
  <keyword>Adherence</keyword>
  <keyword>Management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02194647
org study id: 201406077RINA
nct id: NCT02194647
lead sponsor: 
has dmc: No
BACKGROUND:

      One-year adherence to oral anti-osteoporosis medication (AOMs) was only about 30%. In recent
      years, efforts have been made to change the delivery of these medications from oral form to
      injection form every, 3, 6 or 12 months to increase adherence. However, both patients and
      providers are sometimes confused about the multiple choices. Also, patients may receive extra
      medications if providers did not keep tract of their previous AOM uses or patients may
      changes providers. There were urgent needs to provide AOM monitoring and management services
      to improve cares.

      OBJECTIVES:

      To establish a anti-osteoporosis medication management service at National Taiwan University
      Hospital and its BeiHu Branch.

      METHODS:

      Participating physicians will select those eligible for services and refer to study
      coordinators. Study coordinators will conduct baseline assessments on osteoporosis/fracture
      risks, record medical conditions, AOMs, provide educations on osteoporosis, fracture,
      sarcopenia, fall, medications, nutrition, and exercise. They also arrange return clinic
      visit, telephone reminder and follow up for patients, and communicate with providers on
      regular bases. the investigators plan to enroll 500 patients with 18-month follow up for
      each.
observational model: Case-Only
time perspective: Other
measure: medication adherence
time frame: 18 months
description: Medication adherence will be assessed at 4, 8, 12, 18 months after enrollments. Final results will be reported at 18 month. If the patient changes medication, all AOMs adherence will be combined.
Specific formula is as below:
for oral medications, adherence is defined as # medication taken/ #medication prescribed within past 3 months for injection medications, adherence is defined as # of injection/ # of due injection since baseline or last follow up phone call.
Statistics: Simple counts of adherence % among all participants.
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, MD, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Osteoporosis