<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/NCT01732406</url>
  </required_header>
  <id_info>
    <org_study_id>2012P001556</org_study_id>
    <nct_id>NCT01732406</nct_id>
  </id_info>
  <brief_title>Acromegaly Treatment Quality of Life Study</brief_title>
  <official_title>Effect of Growth Hormone Receptor Antagonism and Somatostatin Analog Administration on Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that treatment of acromegaly will be associated with an&#xD;
      improvement in quality of life compared to active acromegaly. At the same time, they will&#xD;
      also be studying the effects of different acromegaly treatments on the quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">December 19, 2016</completion_date>
  <primary_completion_date type="Actual">December 19, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Acromegaly Quality of Life (ACROQoL) Global Score</measure>
    <time_frame>Cross-sectional at baseline</time_frame>
    <description>The Global Score of the Acromegaly Quality of Life (ACROQoL) Survey measures quality of life in patients with acromegaly. Higher scores indicate better QOL. The range is 22-110 units on a scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Gastrointestinal Quality of Life Index (GIQLI) Total Score</measure>
    <time_frame>Cross-sectional at baseline</time_frame>
    <description>The total score for the Gastrointestinal Quality of Life Index (GIQLI) measures quality of life with specific attention to gastrointestinal symptoms. The score ranges from 0-144 points on a scale. Higher scores indicating better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36-Item Short Form Survey Instrument (SF-36) Physical Health</measure>
    <time_frame>Cross-sectional at baseline</time_frame>
    <description>The Physical Health Summary Score of the SF-36 is a quality of life measure of physical health. It ranges from 0 to 100 points on a scale. Higher scores indicate better quality of life. This survey is scored as demonstrated at https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html. The Physical Health Summary Score (Physical Component Summary) is calculated as the mean average of the physically relevant questions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36-Item Short Form Survey (SF-36) Mental Health Summary Score</measure>
    <time_frame>Cross-sectional at baseline</time_frame>
    <description>The Mental Health Summary Score of the SF-36 measures quality of life with a focus on mental health. It ranges from 0 to 100 points on a scale. Higher scores indicate better quality of life. This survey is scored as demonstrated at https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html. The Mental Health Summary Score (Mental Component Summary) is calculated as the mean average of the emotionally relevant questions.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">126</enrollment>
  <condition>Acromegaly</condition>
  <arm_group>
    <arm_group_label>Acomegaly with Pegvisomant</arm_group_label>
    <description>Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acromegaly with somatostatin analog</arm_group_label>
    <description>Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Acromegaly</arm_group_label>
    <description>Patients not on drugs for treatment of acromegaly</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma and blood serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        There will be 3 groups/cohorts: 1) Patients with active acromegaly (n=35), 2) patients&#xD;
        receiving pegvisomant monotherapy to treat acromegaly (n=31), and 3) patients receiving&#xD;
        somatostatin analog monotherapy to treat acromegaly (n=60)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-90&#xD;
&#xD;
          -  Active acromegaly or receiving pegvisomant monotherapy or receiving somatostatin&#xD;
             analog monotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Untreated thyroid or adrenal insufficiency. Subjects on replacement therapy must be&#xD;
             stable for at least 3 months prior to entry into the study&#xD;
&#xD;
          -  Initiation or discontinuation of testosterone or estrogen within 3 months of entry&#xD;
&#xD;
          -  Pregnant and nursing women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen Miller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <results_first_submitted>November 2, 2017</results_first_submitted>
  <results_first_submitted_qc>January 25, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 29, 2019</results_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Karen Klahr Miller, MD</investigator_full_name>
    <investigator_title>Assistant Physician in Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acromegaly</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Acomegaly With Pegvisomant</title>
          <description>Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.</description>
        </group>
        <group group_id="P2">
          <title>Acromegaly With Somatostatin Analog</title>
          <description>Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly</description>
        </group>
        <group group_id="P3">
          <title>Active Acromegaly</title>
          <description>Patients not on drugs for treatment of acromegaly</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="60"/>
                <participants group_id="P3" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="60"/>
                <participants group_id="P3" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Subjects with IGF-1 levels not consistent with assigned group were excluded.</population>
      <group_list>
        <group group_id="B1">
          <title>Acomegaly With Pegvisomant</title>
          <description>Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.</description>
        </group>
        <group group_id="B2">
          <title>Acromegaly With Somatostatin Analog</title>
          <description>Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly</description>
        </group>
        <group group_id="B3">
          <title>Active Acromegaly</title>
          <description>Patients not on drugs for treatment of acromegaly</description>
        </group>
        <group group_id="B4">
          <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="29"/>
            <count group_id="B2" value="55"/>
            <count group_id="B3" value="32"/>
            <count group_id="B4" value="116"/>
          </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="51" spread="16"/>
                    <measurement group_id="B2" value="52" spread="13"/>
                    <measurement group_id="B3" value="50" spread="15"/>
                    <measurement group_id="B4" value="51" spread="15"/>
                  </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="21"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="103"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>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="30" spread="6"/>
                    <measurement group_id="B2" value="30" spread="7"/>
                    <measurement group_id="B3" value="30" spread="5"/>
                    <measurement group_id="B4" value="30" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>IGF-1 Level</title>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="176" spread="58"/>
                    <measurement group_id="B2" value="174" spread="51"/>
                    <measurement group_id="B3" value="678" spread="221"/>
                    <measurement group_id="B4" value="343" spread="277"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Acromegaly Quality of Life (ACROQoL) Global Score</title>
        <description>The Global Score of the Acromegaly Quality of Life (ACROQoL) Survey measures quality of life in patients with acromegaly. Higher scores indicate better QOL. The range is 22-110 units on a scale.</description>
        <time_frame>Cross-sectional at baseline</time_frame>
        <population>Patients receiving either no treatment (active acromegaly), pegvisomant monotherapy or somatostatin analog monotherapy from own doctor to treat acromegaly.</population>
        <group_list>
          <group group_id="O1">
            <title>Acromegaly With Pegvisomant</title>
            <description>No adverse events were experienced in this study.</description>
          </group>
          <group group_id="O2">
            <title>Acromegaly With Somatostatin Analog</title>
            <description>No adverse events were experienced in this study.</description>
          </group>
          <group group_id="O3">
            <title>Active Acromegaly</title>
            <description>No adverse events were experienced in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Acromegaly Quality of Life (ACROQoL) Global Score</title>
          <description>The Global Score of the Acromegaly Quality of Life (ACROQoL) Survey measures quality of life in patients with acromegaly. Higher scores indicate better QOL. The range is 22-110 units on a scale.</description>
          <population>Patients receiving either no treatment (active acromegaly), pegvisomant monotherapy or somatostatin analog monotherapy from own doctor to treat acromegaly.</population>
          <units>points on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57" spread="19"/>
                    <measurement group_id="O2" value="60" spread="21"/>
                    <measurement group_id="O3" value="54" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Gastrointestinal Quality of Life Index (GIQLI) Total Score</title>
        <description>The total score for the Gastrointestinal Quality of Life Index (GIQLI) measures quality of life with specific attention to gastrointestinal symptoms. The score ranges from 0-144 points on a scale. Higher scores indicating better quality of life.</description>
        <time_frame>Cross-sectional at baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Acomegaly With Pegvisomant</title>
            <description>Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.</description>
          </group>
          <group group_id="O2">
            <title>Acromegaly With Somatostatin Analog</title>
            <description>Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly</description>
          </group>
          <group group_id="O3">
            <title>Active Acromegaly</title>
            <description>Patients not on drugs for treatment of acromegaly</description>
          </group>
        </group_list>
        <measure>
          <title>The Gastrointestinal Quality of Life Index (GIQLI) Total Score</title>
          <description>The total score for the Gastrointestinal Quality of Life Index (GIQLI) measures quality of life with specific attention to gastrointestinal symptoms. The score ranges from 0-144 points on a scale. Higher scores indicating better quality of life.</description>
          <units>points on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" spread="21"/>
                    <measurement group_id="O2" value="107" spread="24"/>
                    <measurement group_id="O3" value="102" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>36-Item Short Form Survey Instrument (SF-36) Physical Health</title>
        <description>The Physical Health Summary Score of the SF-36 is a quality of life measure of physical health. It ranges from 0 to 100 points on a scale. Higher scores indicate better quality of life. This survey is scored as demonstrated at https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html. The Physical Health Summary Score (Physical Component Summary) is calculated as the mean average of the physically relevant questions.</description>
        <time_frame>Cross-sectional at baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Acromegaly With Pegvisomant</title>
            <description>Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.</description>
          </group>
          <group group_id="O2">
            <title>Acromegaly With Somatostatin Analog</title>
            <description>Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly</description>
          </group>
          <group group_id="O3">
            <title>Active Acromegaly</title>
            <description>Patients not on drugs for treatment of acromegaly</description>
          </group>
        </group_list>
        <measure>
          <title>36-Item Short Form Survey Instrument (SF-36) Physical Health</title>
          <description>The Physical Health Summary Score of the SF-36 is a quality of life measure of physical health. It ranges from 0 to 100 points on a scale. Higher scores indicate better quality of life. This survey is scored as demonstrated at https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html. The Physical Health Summary Score (Physical Component Summary) is calculated as the mean average of the physically relevant questions.</description>
          <units>points on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" spread="28"/>
                    <measurement group_id="O2" value="64" spread="28"/>
                    <measurement group_id="O3" value="63" spread="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>36-Item Short Form Survey (SF-36) Mental Health Summary Score</title>
        <description>The Mental Health Summary Score of the SF-36 measures quality of life with a focus on mental health. It ranges from 0 to 100 points on a scale. Higher scores indicate better quality of life. This survey is scored as demonstrated at https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html. The Mental Health Summary Score (Mental Component Summary) is calculated as the mean average of the emotionally relevant questions.</description>
        <time_frame>Cross-sectional at baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Acromegaly With Pegvisomant</title>
            <description>Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.</description>
          </group>
          <group group_id="O2">
            <title>Acromegaly With Somatostatin Analog</title>
            <description>Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly</description>
          </group>
          <group group_id="O3">
            <title>Active Acromegaly</title>
            <description>Patients not on drugs for treatment of acromegaly</description>
          </group>
        </group_list>
        <measure>
          <title>36-Item Short Form Survey (SF-36) Mental Health Summary Score</title>
          <description>The Mental Health Summary Score of the SF-36 measures quality of life with a focus on mental health. It ranges from 0 to 100 points on a scale. Higher scores indicate better quality of life. This survey is scored as demonstrated at https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html. The Mental Health Summary Score (Mental Component Summary) is calculated as the mean average of the emotionally relevant questions.</description>
          <units>points on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58" spread="23"/>
                    <measurement group_id="O2" value="64" spread="25"/>
                    <measurement group_id="O3" value="58" spread="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>This was a cross-sectional study. Adverse events were collected at the baseline cross-sectional visit for each subject.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Acromegaly on Pegvisomant</title>
          <description>Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.</description>
        </group>
        <group group_id="E2">
          <title>Acromegaly on Somatostatin Analog</title>
          <description>Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly.</description>
        </group>
        <group group_id="E3">
          <title>Active Acromegaly</title>
          <description>Patients receiving no medications to treat active acromegaly.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="35"/>
              </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 NOT 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>
    <point_of_contact>
      <name_or_title>Dr. Karen Miller</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>617-726-3870</phone>
      <email>kkmiller@partners.org</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/NCT01732406
org study id: 2012P001556
nct id: NCT01732406
lead sponsor: 
collaborator: 
has dmc: No
The investigators hypothesize that treatment of acromegaly will be associated with an
      improvement in quality of life compared to active acromegaly. At the same time, they will
      also be studying the effects of different acromegaly treatments on the quality of life.
observational model: Cohort
time perspective: Prospective
measure: Acromegaly Quality of Life (ACROQoL) Global Score
time frame: Cross-sectional at baseline
description: The Global Score of the Acromegaly Quality of Life (ACROQoL) Survey measures quality of life in patients with acromegaly. Higher scores indicate better QOL. The range is 22-110 units on a scale.
measure: The Gastrointestinal Quality of Life Index (GIQLI) Total Score
time frame: Cross-sectional at baseline
description: The total score for the Gastrointestinal Quality of Life Index (GIQLI) measures quality of life with specific attention to gastrointestinal symptoms. The score ranges from 0-144 points on a scale. Higher scores indicating better quality of life.
measure: 36-Item Short Form Survey Instrument (SF-36) Physical Health
time frame: Cross-sectional at baseline
description: The Physical Health Summary Score of the SF-36 is a quality of life measure of physical health. It ranges from 0 to 100 points on a scale. Higher scores indicate better quality of life. This survey is scored as demonstrated at https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html. The Physical Health Summary Score (Physical Component Summary) is calculated as the mean average of the physically relevant questions.
measure: 36-Item Short Form Survey (SF-36) Mental Health Summary Score
time frame: Cross-sectional at baseline
description: The Mental Health Summary Score of the SF-36 measures quality of life with a focus on mental health. It ranges from 0 to 100 points on a scale. Higher scores indicate better quality of life. This survey is scored as demonstrated at https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html. The Mental Health Summary Score (Mental Component Summary) is calculated as the mean average of the emotionally relevant questions.
arm group label: Acomegaly with Pegvisomant
description: Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.
arm group label: Acromegaly with somatostatin analog
description: Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly
arm group label: Active Acromegaly
description: Patients not on drugs for treatment of acromegaly
Plasma and blood serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Karen Miller, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Karen Klahr Miller, MD
investigator title: Assistant Physician in Medicine
mesh term: Acromegaly
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 