<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/NCT01675297</url>
  </required_header>
  <id_info>
    <org_study_id>HL_RSNP_401</org_study_id>
    <nct_id>NCT01675297</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis</brief_title>
  <official_title>For 12months, the Multi Center, Randomized, Open-label, Active Controlled Comparative Clinical Study to Assess the Efficacy and the Safety of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hanlim Pharm. Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hanlim Pharm. Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and the safety of Risedronate,&#xD;
      cholecalciferol combination tablet in patients with Osteoporosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate the efficacy and the safety of Risedronate with and&#xD;
      without cholecalciferol on vitamin D status, Bone Mineral Density (BMD) and bone markers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 4, 2011</start_date>
  <completion_date type="Actual">April 15, 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Change of Bone Mineral Density (BMD) Value</measure>
    <time_frame>baseline and 12 months</time_frame>
    <description>Higher Bone Mineral Density(BMD) value mean a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Change of 25OHD(25-hydroxyvitamin D)</measure>
    <time_frame>baseline, 6months, 12months</time_frame>
    <description>range of 25OHD: 4.80~52.80 Higher 25OHD scores mean a better outcome.&#xD;
If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTH(Parathyroid Hormone Value)</measure>
    <time_frame>baseline, 6months, 12months</time_frame>
    <description>range of PTH: 13~54 Higher PTH scores mean a worse outcome.&#xD;
If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1053</enrollment>
  <condition>Osteoporosis</condition>
  <arm_group>
    <arm_group_label>Risendronate/Cholecalciferol combination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Risedronate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sedron tablet: one tablet once a week for 12months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Risedronate/Cholecalciferol combination</intervention_name>
    <description>Risendronate/Cholecalciferol combination once a week</description>
    <arm_group_label>Risendronate/Cholecalciferol combination</arm_group_label>
    <other_name>RisenexPlus tablet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Risedronate</intervention_name>
    <description>Risedronate once a week</description>
    <arm_group_label>Risedronate</arm_group_label>
    <other_name>Sedron 35mg tablet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male osteoporosis patients over 19 years of age&#xD;
&#xD;
          2. Female osteoporosis patients with menopause&#xD;
&#xD;
               -  Definition of osteoporosis&#xD;
&#xD;
                    -  They had a BMD T-score -2.5 or less at mean Lumbar spine(L1-L4), Femoral&#xD;
                       neck or total. Or evidence of at least one vertebral fracture&#xD;
&#xD;
               -  Definition of menopause(can be one of three condition)&#xD;
&#xD;
                    -  For 12months spontaneous amenorrhea&#xD;
&#xD;
                    -  For 6months spontaneous amenorrhea with serum FSH(Follicle stimulating&#xD;
                       hormone) is 40mlU/mL and over&#xD;
&#xD;
                    -  6weeks after bilateral ovariectomy whether hysterectomy or not.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with esophagus disorder (i.e:esophagostenosis)&#xD;
&#xD;
          2. Patients administered with osteoporosis therapy(except calcium, Vit.D&#xD;
             medication)within the previous 3 Months&#xD;
&#xD;
          3. Patients with serum calcium concentrations 8.0mg under&#xD;
&#xD;
          4. Patients with severe nephropathy (CCr 30mL/min less)&#xD;
&#xD;
          5. Patients with unable to sit upright or stand for 30minutes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyoung-Moo Park, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chung-Ang University Hosptial, Chung-Ang University College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chung-ang university hospital</name>
      <address>
        <city>Seoul</city>
        <zip>156-755</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <results_first_submitted>August 15, 2018</results_first_submitted>
  <results_first_submitted_qc>June 23, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 5, 2019</results_first_posted>
  <last_update_submitted>June 23, 2019</last_update_submitted>
  <last_update_submitted_qc>June 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Risedronate, cholecalciferol, BMD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Risedronic Acid</mesh_term>
    <mesh_term>Etidronic Acid</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>medical clinic</recruitment_details>
      <pre_assignment_details>wash out 7~14days</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Risendronate/Cholecalciferol Combination</title>
          <description>Experimental: Administer Risendronate/Cholecalciferol combination one tablet once a week for 12months.&#xD;
Risedronate/Cholecalciferol combination: once a week</description>
        </group>
        <group group_id="P2">
          <title>Risedronate</title>
          <description>Active comparator: Administer Risendronate one tablet once a week for 12months.&#xD;
Risedronate: once a week</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="806"/>
                <participants group_id="P2" count="247"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="642"/>
                <participants group_id="P2" count="199"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="164"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Risendronate/Cholecalciferol Combination</title>
          <description>Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months&#xD;
Risedronate/Cholecalciferol combination: Risendronate/Cholecalciferol combination once a week</description>
        </group>
        <group group_id="B2">
          <title>Risedronate</title>
          <description>Sedron tablet: one tablet once a week for 12months&#xD;
Risedronate: Risedronate once a week</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="806"/>
            <count group_id="B2" value="247"/>
            <count group_id="B3" value="1053"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.77" spread="7.87"/>
                    <measurement group_id="B2" value="65.51" spread="8.59"/>
                    <measurement group_id="B3" value="65.71" spread="8.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="754"/>
                    <measurement group_id="B2" value="236"/>
                    <measurement group_id="B3" value="990"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.40" spread="3.32"/>
                    <measurement group_id="B2" value="23.00" spread="3.00"/>
                    <measurement group_id="B3" value="23.31" spread="3.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Osteoporosis disease period</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.90" spread="37.49"/>
                    <measurement group_id="B2" value="27.07" spread="40.44"/>
                    <measurement group_id="B3" value="24.65" spread="38.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Change of Bone Mineral Density (BMD) Value</title>
        <description>Higher Bone Mineral Density(BMD) value mean a better outcome.</description>
        <time_frame>baseline and 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Risendronate/Cholecalciferol Combination</title>
            <description>Experimental: Administer Risendronate/Cholecalciferol combination one tablet once a week for 12months.&#xD;
Risedronate/Cholecalciferol combination: once a week</description>
          </group>
          <group group_id="O2">
            <title>Risedronate</title>
            <description>Active comparator: Administer Risendronate one tablet once a week for 12months.&#xD;
Risedronate: once a week</description>
          </group>
        </group_list>
        <measure>
          <title>The Change of Bone Mineral Density (BMD) Value</title>
          <description>Higher Bone Mineral Density(BMD) value mean a better outcome.</description>
          <units>g/cm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="642"/>
                <count group_id="O2" value="199"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.77" spread="0.11"/>
                    <measurement group_id="O2" value="0.77" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.81" spread="0.12"/>
                    <measurement group_id="O2" value="0.80" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>change(12months-baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.05"/>
                    <measurement group_id="O2" value="0.03" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Change of 25OHD(25-hydroxyvitamin D)</title>
        <description>range of 25OHD: 4.80~52.80 Higher 25OHD scores mean a better outcome.&#xD;
If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.</description>
        <time_frame>baseline, 6months, 12months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Risendronate/Cholecalciferol Combination</title>
            <description>Experimental: Administer Risendronate/Cholecalciferol combination one tablet once a week for 12months.&#xD;
Risedronate/Cholecalciferol combination: once a week</description>
          </group>
          <group group_id="O2">
            <title>Risedronate</title>
            <description>Active comparator: Administer Risendronate one tablet once a week for 12months.&#xD;
Risedronate: once a week</description>
          </group>
        </group_list>
        <measure>
          <title>The Change of 25OHD(25-hydroxyvitamin D)</title>
          <description>range of 25OHD: 4.80~52.80 Higher 25OHD scores mean a better outcome.&#xD;
If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.</description>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="642"/>
                <count group_id="O2" value="199"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>25OHD(baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.23" spread="11.59"/>
                    <measurement group_id="O2" value="17.83" spread="10.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25OHD(6months)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.93" spread="11.16"/>
                    <measurement group_id="O2" value="19.47" spread="12.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25OHD(12months)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.57" spread="11.89"/>
                    <measurement group_id="O2" value="18.35" spread="11.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25OHD change(6months-baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.74" spread="11.53"/>
                    <measurement group_id="O2" value="1.68" spread="9.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25OHD change(12months-baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.33" spread="13.33"/>
                    <measurement group_id="O2" value="0.53" spread="12.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PTH(Parathyroid Hormone Value)</title>
        <description>range of PTH: 13~54 Higher PTH scores mean a worse outcome.&#xD;
If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.</description>
        <time_frame>baseline, 6months, 12months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Risendronate/Cholecalciferol Combination</title>
            <description>Experimental: Administer Risendronate/Cholecalciferol combination one tablet once a week for 12months.&#xD;
Risedronate/Cholecalciferol combination: once a week</description>
          </group>
          <group group_id="O2">
            <title>Risedronate</title>
            <description>Active comparator: Administer Risendronate one tablet once a week for 12months.&#xD;
Risedronate: once a week</description>
          </group>
        </group_list>
        <measure>
          <title>PTH(Parathyroid Hormone Value)</title>
          <description>range of PTH: 13~54 Higher PTH scores mean a worse outcome.&#xD;
If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.</description>
          <units>pg/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="642"/>
                <count group_id="O2" value="199"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PTH(baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.48" spread="30.95"/>
                    <measurement group_id="O2" value="39.17" spread="34.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PTH(6months)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.34" spread="23.82"/>
                    <measurement group_id="O2" value="42.40" spread="27.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PTH(12months)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.17" spread="19.37"/>
                    <measurement group_id="O2" value="45.27" spread="23.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PTH change(6months-baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.78" spread="23.36"/>
                    <measurement group_id="O2" value="3.39" spread="35.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PTH change(12months-baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.34" spread="27.31"/>
                    <measurement group_id="O2" value="6.16" spread="33.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12months</time_frame>
      <desc>The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.</desc>
      <group_list>
        <group group_id="E1">
          <title>Risendronate/Cholecalciferol Combination</title>
          <description>Experimental: Administer Risendronate/Cholecalciferol combination one tablet once a week for 12months.&#xD;
Risedronate/Cholecalciferol combination: once a week</description>
        </group>
        <group group_id="E2">
          <title>Risedronate</title>
          <description>Active comparator: Administer Risendronate one tablet once a week for 12months.&#xD;
Risedronate: once a week</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (18.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="806"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="61" subjects_at_risk="806"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Prinzmetal angina</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="806"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Distal intestinal obstruction syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Gastric polyps</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Rectal prolapse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="806"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Chronic sinusitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="806"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Infectious pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="806"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="806"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="806"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="806"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Incisional hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="806"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Ligament rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Subdural haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Ketoacidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Foot deformity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="806"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Intervertebral disc disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="806"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="806"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Still's disease adult onset</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="806"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Gallbladder cancer stage IV</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Plasma cell myeloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Pyogenic granuloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Thyroid neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Tonsil cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="806"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Hydrocephalus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Completed suicide</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Obstructive airways disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Bronchitis chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="806"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Emphysema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Elderly</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA (18.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="61" subjects_at_risk="806"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="21" subjects_affected="20" subjects_at_risk="806"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="22" subjects_affected="19" subjects_at_risk="806"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="806"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="247"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="806"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="247"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Multiple centers proceded clinical study do not use the same measuring instrument.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Clinical Trial Unit</name_or_title>
      <organization>Hanlim Pharma</organization>
      <phone>82-2-3489-6297</phone>
      <email>yrsong@hanlim.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01675297
org study id: HL_RSNP_401
nct id: NCT01675297
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the efficacy and the safety of Risedronate,
      cholecalciferol combination tablet in patients with Osteoporosis.
The purpose of this study is to evaluate the efficacy and the safety of Risedronate with and
      without cholecalciferol on vitamin D status, Bone Mineral Density (BMD) and bone markers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Change of Bone Mineral Density (BMD) Value
time frame: baseline and 12 months
description: Higher Bone Mineral Density(BMD) value mean a better outcome.
measure: The Change of 25OHD(25-hydroxyvitamin D)
time frame: baseline, 6months, 12months
description: range of 25OHD: 4.80~52.80 Higher 25OHD scores mean a better outcome.
If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.
measure: PTH(Parathyroid Hormone Value)
time frame: baseline, 6months, 12months
description: range of PTH: 13~54 Higher PTH scores mean a worse outcome.
If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.
arm group label: Risendronate/Cholecalciferol combination
arm group type: Experimental
description: Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months
arm group label: Risedronate
arm group type: Active Comparator
description: Sedron tablet: one tablet once a week for 12months
intervention type: Drug
intervention name: Risedronate/Cholecalciferol combination
description: Risendronate/Cholecalciferol combination once a week
arm group label: Risendronate/Cholecalciferol combination
other name: RisenexPlus tablet
intervention type: Drug
intervention name: Risedronate
description: Risedronate once a week
arm group label: Risedronate
other name: Sedron 35mg tablet
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Hyoung-Moo Park, MD
role: Principal Investigator
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Osteoporosis
mesh term: Cholecalciferol
mesh term: Vitamin D
mesh term: Risedronic Acid
mesh term: Etidronic Acid
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Multiple centers proceded clinical study do not use the same measuring instrument.
point of contact: 