<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/NCT02186171</url>
  </required_header>
  <id_info>
    <org_study_id>20110174</org_study_id>
    <secondary_id>2013-005551-32</secondary_id>
    <nct_id>NCT02186171</nct_id>
  </id_info>
  <brief_title>A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis</brief_title>
  <acronym>BRIDGE</acronym>
  <official_title>A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is designed to evaluate if treatment with romosozumab once a month for 12 months&#xD;
      compared with placebo is effective in increasing bone mineral density (BMD) at the lumbar&#xD;
      spine. Additionally, the study will assess the effect of treatment with romosozumab for 12&#xD;
      months compared with placebo on BMD at the femoral neck and total hip.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 16, 2014</start_date>
  <completion_date type="Actual">April 20, 2016</completion_date>
  <primary_completion_date type="Actual">February 15, 2016</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12</measure>
    <time_frame>Baseline and month 12</time_frame>
    <description>Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in BMD at the Total Hip at Month 12</measure>
    <time_frame>Baseline and month 12</time_frame>
    <description>Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in BMD at the Femoral Neck at Month 12</measure>
    <time_frame>Baseline and month 12</time_frame>
    <description>Femoral neck bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Lumbar Spine BMD at Month 6</measure>
    <time_frame>Baseline and month 6</time_frame>
    <description>Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in BMD at the Total Hip at Month 6</measure>
    <time_frame>Baseline and month 6</time_frame>
    <description>Bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in BMD at the Femoral Neck at Month 6</measure>
    <time_frame>Baseline and month 6</time_frame>
    <description>Bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">245</enrollment>
  <condition>Osteoporosis in Men</condition>
  <arm_group>
    <arm_group_label>Romosozumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received placebo subcutaneous injections once a month for 12 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Romosozumab</intervention_name>
    <description>Administered by subcutaneous injection once a month.</description>
    <arm_group_label>Romosozumab</arm_group_label>
    <other_name>AMG 785</other_name>
    <other_name>EVENITY™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered by subcutaneous injection once a month.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be ambulatory male subjects ≥ 55 years to ≤ 90 years of age&#xD;
&#xD;
          -  Must have a BMD T score ≤ -2.50 at the spine or hip, or BMD T score ≤ -1.50 at the&#xD;
             spine or hip and a history of fragility nonvertebral fracture or vertebral fracture.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A BMD T score ≤ -3.50 at the hip,&#xD;
&#xD;
          -  History of hip fracture&#xD;
&#xD;
          -  Severe metabolic bone diseases&#xD;
&#xD;
          -  Significant laboratory abnormalities&#xD;
&#xD;
          -  Recent treatment with agents affecting bone metabolism&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Liège</city>
        <zip>4020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Medellin</city>
        <state>Antioquia</state>
        <zip>050021</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bogota</city>
        <state>Cundinamarca</state>
        <zip>11001000</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ostrava-Trebovice</city>
        <zip>722 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Plzen</city>
        <zip>305 99</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Praha 11 - Chodov</city>
        <zip>148 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ballerup</city>
        <zip>2750</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mizunami-shi</city>
        <state>Gifu</state>
        <zip>509-6134</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yokohama-shi</city>
        <state>Kanagawa</state>
        <zip>223-0062</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bungoono-shi</city>
        <state>Oita</state>
        <zip>879-7125</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Takatsuki-shi</city>
        <state>Osaka</state>
        <zip>569-1123</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hachioji-shi</city>
        <state>Tokyo</state>
        <zip>192-0046</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shinagawa-ku</city>
        <state>Tokyo</state>
        <zip>140-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toshima-ku</city>
        <state>Tokyo</state>
        <zip>171-0033</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mexicali</city>
        <state>Baja California Norte</state>
        <zip>21100</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo León</state>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Culiacan</city>
        <state>Sinaloa</state>
        <zip>80000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lodz</city>
        <zip>90-558</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Swidnik</city>
        <zip>21-040</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Warszawa</city>
        <zip>01-192</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-088</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <zip>101990</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>190103</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150003</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zurich</city>
        <zip>8063</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Colombia</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Japan</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Switzerland</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <reference>
    <citation>Lewiecki EM, Blicharski T, Goemaere S, Lippuner K, Meisner PD, Miller PD, Miyauchi A, Maddox J, Chen L, Horlait S. A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3183-3193. doi: 10.1210/jc.2017-02163.</citation>
    <PMID>29931216</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>June 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <results_first_submitted>May 3, 2019</results_first_submitted>
  <results_first_submitted_qc>May 3, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 28, 2019</results_first_posted>
  <disposition_first_submitted>September 26, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>September 26, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">September 27, 2016</disposition_first_posted>
  <last_update_submitted>May 3, 2019</last_update_submitted>
  <last_update_submitted_qc>May 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Osteoporosis in men</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted at 31 centers in Europe, North America, Latin America, and Japan. Participants were enrolled from 16 June 2014 to 27 January 2015.</recruitment_details>
      <pre_assignment_details>Participants were randomized in a 2:1 ratio to receive 210 mg romosozumab or matched placebo in a blinded fashion for the duration of the 12-month treatment period. Randomization was stratified by geographic region (Europe, North America, Latin America, and Japan).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received placebo subcutaneous injections once a month (QM) for 12 months.</description>
        </group>
        <group group_id="P2">
          <title>Romosozumab 210 mg</title>
          <description>Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="82"/>
                <participants group_id="P2" count="163"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Treatment</title>
              <participants_list>
                <participants group_id="P1" count="81"/>
                <participants group_id="P2" count="163"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
                <participants group_id="P2" count="148"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol-specified Criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received placebo subcutaneous injections once a month (QM) for 12 months.</description>
        </group>
        <group group_id="B2">
          <title>Romosozumab 210 mg</title>
          <description>Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.</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="82"/>
            <count group_id="B2" value="163"/>
            <count group_id="B3" value="245"/>
          </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="71.5" spread="6.9"/>
                    <measurement group_id="B2" value="72.4" spread="7.4"/>
                    <measurement group_id="B3" value="72.1" spread="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>18 - 64 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>65 - 74 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
                <category>
                  <title>75 years and over</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="99"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="163"/>
                    <measurement group_id="B3" value="245"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="120"/>
                    <measurement group_id="B3" value="180"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Multiple</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Geographic Region</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Europe</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="108"/>
                    <measurement group_id="B3" value="162"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Japan</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Latin America</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>North America</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lumbar Spine Bone Mineral Density T-score</title>
          <description>The T-score is the bone mineral density (BMD) at the site when compared to that of a healthy thirty-year-old. Normal is a T-score of -1.0 or higher; Osteopenia is defined as between -1.0 and -2.5; Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and a half standard deviations below the mean of a thirty-year-old man/woman.</description>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="-2.33" spread="1.41"/>
                    <measurement group_id="B2" value="-2.22" spread="1.19"/>
                    <measurement group_id="B3" value="-2.26" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Hip BMD T-score</title>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="-1.92" spread="0.65"/>
                    <measurement group_id="B2" value="-1.92" spread="0.59"/>
                    <measurement group_id="B3" value="-1.92" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Femoral Neck BMD T-score</title>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="-2.30" spread="0.52"/>
                    <measurement group_id="B2" value="-2.34" spread="0.52"/>
                    <measurement group_id="B3" value="-2.33" spread="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12</title>
        <description>Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.</description>
        <time_frame>Baseline and month 12</time_frame>
        <population>Primary efficacy analysis subset, which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the lumbar spine; last observation carried forward (LOCF) imputation was used.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo subcutaneous injections once a month (QM) for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Romosozumab 210 mg</title>
            <description>Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12</title>
          <description>Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.</description>
          <population>Primary efficacy analysis subset, which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the lumbar spine; last observation carried forward (LOCF) imputation was used.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="157"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.5" lower_limit="0.5"/>
                    <measurement group_id="O2" value="12.1" spread="0.5" lower_limit="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>10.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.6</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.6</ci_lower_limit>
            <ci_upper_limit>12.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in BMD at the Total Hip at Month 12</title>
        <description>Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.</description>
        <time_frame>Baseline and month 12</time_frame>
        <population>Primary efficacy analysis subset, which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the total hip; LOCF imputation was used.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo subcutaneous injections once a month (QM) for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Romosozumab 210 mg</title>
            <description>Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in BMD at the Total Hip at Month 12</title>
          <description>Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.</description>
          <population>Primary efficacy analysis subset, which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the total hip; LOCF imputation was used.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="158"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="0.3" lower_limit="0.3"/>
                    <measurement group_id="O2" value="2.5" spread="0.2" lower_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 12 months in total hip and femoral neck to maintain the overall significance level at 0.05.</non_inferiority_desc>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>3.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.4</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.3</ci_lower_limit>
            <ci_upper_limit>3.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in BMD at the Femoral Neck at Month 12</title>
        <description>Femoral neck bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.</description>
        <time_frame>Baseline and month 12</time_frame>
        <population>Primary efficacy analysis subset, which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the femoral neck; LOCF imputation was used.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo subcutaneous injections once a month (QM) for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Romosozumab 210 mg</title>
            <description>Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in BMD at the Femoral Neck at Month 12</title>
          <description>Femoral neck bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.</description>
          <population>Primary efficacy analysis subset, which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the femoral neck; LOCF imputation was used.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="158"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="0.4" lower_limit="0.4"/>
                    <measurement group_id="O2" value="2.2" spread="0.4" lower_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 12 months in total hip and femoral neck to maintain the overall significance level at 0.05.</non_inferiority_desc>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>2.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.5</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.5</ci_lower_limit>
            <ci_upper_limit>3.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Lumbar Spine BMD at Month 6</title>
        <description>Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.</description>
        <time_frame>Baseline and month 6</time_frame>
        <population>Primary efficacy analysis subset with available data at baseline and month 6.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo subcutaneous injections once a month (QM) for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Romosozumab 210 mg</title>
            <description>Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Lumbar Spine BMD at Month 6</title>
          <description>Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.</description>
          <population>Primary efficacy analysis subset with available data at baseline and month 6.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="156"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.4" lower_limit="0.4"/>
                    <measurement group_id="O2" value="9.0" spread="0.4" lower_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.</non_inferiority_desc>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>8.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.5</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.6</ci_lower_limit>
            <ci_upper_limit>9.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in BMD at the Total Hip at Month 6</title>
        <description>Bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.</description>
        <time_frame>Baseline and month 6</time_frame>
        <population>Primary efficacy analysis subset with available data at baseline and month 6.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo subcutaneous injections once a month (QM) for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Romosozumab 210 mg</title>
            <description>Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in BMD at the Total Hip at Month 6</title>
          <description>Bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.</description>
          <population>Primary efficacy analysis subset with available data at baseline and month 6.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="157"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.2" lower_limit="0.2"/>
                    <measurement group_id="O2" value="1.6" spread="0.2" lower_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.</non_inferiority_desc>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>1.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.3</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.8</ci_lower_limit>
            <ci_upper_limit>2.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in BMD at the Femoral Neck at Month 6</title>
        <description>Bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.</description>
        <time_frame>Baseline and month 6</time_frame>
        <population>Primary efficacy analysis subset with available data at baseline and month 6.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo subcutaneous injections once a month (QM) for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Romosozumab 210 mg</title>
            <description>Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in BMD at the Femoral Neck at Month 6</title>
          <description>Bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.</description>
          <population>Primary efficacy analysis subset with available data at baseline and month 6.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="157"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.4" lower_limit="0.4"/>
                    <measurement group_id="O2" value="1.2" spread="0.3" lower_limit="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.</non_inferiority_desc>
            <p_value>= 0.0033</p_value>
            <p_value_desc>ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>1.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.4</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.4</ci_lower_limit>
            <ci_upper_limit>2.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>15 months</time_frame>
      <desc>Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received placebo subcutaneous injections once a month (QM) for 12 months.</description>
        </group>
        <group group_id="E2">
          <title>Romosozumab 210 mg</title>
          <description>Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Cardiac valve disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Wolff-Parkinson-White syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Intra-abdominal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Implant site haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Appendicitis perforated</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Escherichia sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Anaemia postoperative</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Oropharyngeal cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid arteriosclerosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Cerebral ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Dementia Alzheimer's type</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Lacunar infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Vascular encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Emphysema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.0</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="41" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="74" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="163"/>
              </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>The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Amgen Inc.</organization>
      <phone>866-572-6436</phone>
      <email>medinfo@amgen.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/NCT02186171
org study id: 20110174
secondary id: 2013-005551-32
nct id: NCT02186171
lead sponsor: 
has dmc: No
The study is designed to evaluate if treatment with romosozumab once a month for 12 months
      compared with placebo is effective in increasing bone mineral density (BMD) at the lumbar
      spine. Additionally, the study will assess the effect of treatment with romosozumab for 12
      months compared with placebo on BMD at the femoral neck and total hip.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12
time frame: Baseline and month 12
description: Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
measure: Percent Change From Baseline in BMD at the Total Hip at Month 12
time frame: Baseline and month 12
description: Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
measure: Percent Change From Baseline in BMD at the Femoral Neck at Month 12
time frame: Baseline and month 12
description: Femoral neck bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
measure: Percent Change From Baseline in Lumbar Spine BMD at Month 6
time frame: Baseline and month 6
description: Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
measure: Percent Change From Baseline in BMD at the Total Hip at Month 6
time frame: Baseline and month 6
description: Bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
measure: Percent Change From Baseline in BMD at the Femoral Neck at Month 6
time frame: Baseline and month 6
description: Bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
arm group label: Romosozumab
arm group type: Experimental
description: Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants received placebo subcutaneous injections once a month for 12 months.
intervention type: Biological
intervention name: Romosozumab
description: Administered by subcutaneous injection once a month.
arm group label: Romosozumab
other name: AMG 785
other name: EVENITY™
intervention type: Drug
intervention name: Placebo
description: Administered by subcutaneous injection once a month.
arm group label: Placebo
criteria: 
gender: Male
minimum age: 55 Years
maximum age: 90 Years
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
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country: Belgium
country: Colombia
country: Czechia
country: Denmark
country: Japan
country: Mexico
country: Poland
country: Russian Federation
country: Switzerland
country: United States
country: Czech Republic
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
citation: Lewiecki EM, Blicharski T, Goemaere S, Lippuner K, Meisner PD, Miller PD, Miyauchi A, Maddox J, Chen L, Horlait S. A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3183-3193. doi: 10.1210/jc.2017-02163.
PMID: 29931216
responsible party type: Sponsor
mesh term: Osteoporosis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 