<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/NCT01724489</url>
  </required_header>
  <id_info>
    <org_study_id>2012P002276</org_study_id>
    <nct_id>NCT01724489</nct_id>
  </id_info>
  <brief_title>Study of Growth Hormone and Bone in Obesity</brief_title>
  <official_title>Skeletal Physiology Dysregulation in Obesity: The Role of Growth Hormone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obesity is an important risk factor for osteoporosis and fractures. With the growing&#xD;
      prevalence of obesity in the U.S., understanding the pathophysiology of bone loss in this&#xD;
      population is of importance to public health. Growth hormone (GH) is a critical mediator of&#xD;
      bone homeostasis and is markedly reduced in obesity. Our preliminary data suggest an&#xD;
      important role for the GH/insulin-like growth factor 1 (IGF-1) system in the pathogenesis of&#xD;
      bone loss in obesity. The development of novel imaging techniques provides an opportunity to&#xD;
      investigate the effects of GH on skeletal structure and strength, which will provide insights&#xD;
      into the pathogenesis of obesity related bone loss. Understanding the pathophysiology of bone&#xD;
      loss in obesity may help identify new treatment targets for this important complication. The&#xD;
      investigator hypothesizes that low-dose GH administration for 18 months will improve skeletal&#xD;
      health.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">April 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 15, 2018</primary_completion_date>
  <phase>N/A</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>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bone Mineral Density</measure>
    <time_frame>baseline and 18 months</time_frame>
    <description>Change in BMD over 18 months in the GH vs placebo group</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Obesity</condition>
  <condition>Osteopenia</condition>
  <arm_group>
    <arm_group_label>Growth Hormone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Growth Hormone is Genotropin, provided by Pfizer Inc. It is self administered daily for 18 months using a 5 mg injection pen device. Dose will be titrated based on IGF-1 levels.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo will be provided by Pfizer Inc. It will appear identical to active growth hormone and will be administered in the same manner.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Growth hormone</intervention_name>
    <arm_group_label>Growth Hormone</arm_group_label>
    <other_name>Genotropin (Pfizer Inc.)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 18-65 and generally healthy&#xD;
&#xD;
          -  BMI ≥ 25 kg/m2&#xD;
&#xD;
          -  Bone mineral density (BMD) T score ≤ -1.0 and &gt; -2.5 (as measured by DXA)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For women: amenorrhea for 3 months, pregnancy or breastfeeding, polycystic ovary&#xD;
             syndrome&#xD;
&#xD;
          -  History of diabetes mellitus, cancer or other serious chronic disease&#xD;
&#xD;
          -  Use of osteoporosis medications&#xD;
&#xD;
          -  Anemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen Miller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Miriam Bredella, 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>December 2019</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <results_first_submitted>November 15, 2019</results_first_submitted>
  <results_first_submitted_qc>December 4, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 17, 2019</results_first_posted>
  <last_update_submitted>December 4, 2019</last_update_submitted>
  <last_update_submitted_qc>December 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 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>Chief, Neuroendocrine Unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Diseases, Metabolic</mesh_term>
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hormones</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 7, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT01724489/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 7, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT01724489/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from August 2013 to April 2017. Recruitment techniques included posting advertisements on the internet (i.e. Facebook and Craigslist) and on the Massachusetts General Hospital's clinical trial recruitment website.</recruitment_details>
      <pre_assignment_details>Of the 253 people who signed a consent form, 165 were unable to participate due to various reasons including meeting ineligibility criteria. The 88 subjects remaining were randomized to one of two arms. Of these 88 subjects, a total of 77 subjects had baseline measurements collected.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Growth Hormone</title>
          <description>Growth Hormone (GH) is Genotropin, provided by Pfizer Inc. It is a self-administered sub-cutaneous daily injection using an injection pen device. It was administered up to 18 months. The dose was titrated based on IGF-1 hormone levels with the goal of maintaining an IGF-1 level in the upper-quartile of the normal range.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo was provided by Pfizer Inc. It appeared identical to active growth hormone and was administered in the same manner; self administered sub-cutaneous daily for 18 months using an injection pen device. Dose was titrated in a way to maintain the double-blind.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Surgery, medication</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Growth Hormone</title>
          <description>Growth Hormone is Genotropin, provided by Pfizer Inc. It is self administered daily for 18 months using a 5 mg injection pen device. Dose will be titrated based on IGF-1 levels.&#xD;
Growth hormone</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo will be provided by Pfizer Inc. It will appear identical to active growth hormone and will be administered in the same manner.&#xD;
Placebo</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="39"/>
            <count group_id="B2" value="38"/>
            <count group_id="B3" value="77"/>
          </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="47" spread="13"/>
                    <measurement group_id="B2" value="49" spread="12"/>
                    <measurement group_id="B3" value="48" spread="12"/>
                  </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="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="41"/>
                  </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="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="71"/>
                  </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_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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Bone Mineral Density</title>
        <description>Change in BMD over 18 months in the GH vs placebo group</description>
        <time_frame>baseline and 18 months</time_frame>
        <population>Two subjects from the growth hormone arm were not analyzed due to large amount of weight loss, which has a well-documented effect of decreasing BMD. AP spine bone density in one study subject in the placebo group was excluded because the scan was technically poor.&#xD;
These data were excluded before the study was unblinded.</population>
        <group_list>
          <group group_id="O1">
            <title>Growth Hormone</title>
            <description>Growth Hormone (GH) is Genotropin, provided by Pfizer Inc. It is a self-administered sub-cutaneous daily injection using an injection pen device. It was administered up to 18 months. The dose was titrated based on IGF-1 hormone levels with the goal of maintaining an IGF-1 level in the upper-quartile of the normal range.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo was provided by Pfizer Inc. It appeared identical to active growth hormone and was administered in the same manner; self administered sub-cutaneous daily for 18 months using an injection pen device. Dose was titrated in a way to maintain the double-blind.</description>
          </group>
        </group_list>
        <measure>
          <title>Bone Mineral Density</title>
          <description>Change in BMD over 18 months in the GH vs placebo group</description>
          <population>Two subjects from the growth hormone arm were not analyzed due to large amount of weight loss, which has a well-documented effect of decreasing BMD. AP spine bone density in one study subject in the placebo group was excluded because the scan was technically poor.&#xD;
These data were excluded before the study was unblinded.</population>
          <units>grams/cm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.015" spread="0.033"/>
                    <measurement group_id="O2" value="-0.008" spread="0.034"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>18 months</time_frame>
      <desc>Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by &quot;expected&quot; (eg listed in the medication package insert) and &quot;unexpected&quot; (not listed in the medication package insert).&#xD;
# of events = # of subjects that experienced the side effect at any point during the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Growth Hormone</title>
          <description>Growth Hormone is Genotropin, provided by Pfizer Inc. It is self administered daily for 18 months using a 5 mg injection pen device. Dose will be titrated based on IGF-1 levels.&#xD;
Growth hormone</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo will be provided by Pfizer Inc. It will appear identical to active growth hormone and will be administered in the same manner.&#xD;
Placebo</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>prolonged inpatient psychiatric hospitalization</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="29" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>edema (swelling) in the hands and/or feet</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="39"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>elevated blood sugar</sub_title>
                <description>elevated fasting glucose or HbA1c</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="39"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>pain and/or stiffness in the hands and/or feet</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>joint pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>myalgia (muscle aches)</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="39"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>joint stiffness (not in the hands and/or feet)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>tingling</sub_title>
                <counts group_id="E1" events="16" subjects_affected="13" subjects_at_risk="39"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>injection site discomfort</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>injection site bruising</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </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>
    <limitations_and_caveats>Study medication was discontinued at 18 months. Subjects were followed for an additional 6 months off of study medication. The data reported here are for the primary 18-month trial.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Karen K. Miller</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>617-726-3870</phone>
      <email>kkmiller@mgh.harvard.edu</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/NCT01724489
org study id: 2012P002276
nct id: NCT01724489
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Obesity is an important risk factor for osteoporosis and fractures. With the growing
      prevalence of obesity in the U.S., understanding the pathophysiology of bone loss in this
      population is of importance to public health. Growth hormone (GH) is a critical mediator of
      bone homeostasis and is markedly reduced in obesity. Our preliminary data suggest an
      important role for the GH/insulin-like growth factor 1 (IGF-1) system in the pathogenesis of
      bone loss in obesity. The development of novel imaging techniques provides an opportunity to
      investigate the effects of GH on skeletal structure and strength, which will provide insights
      into the pathogenesis of obesity related bone loss. Understanding the pathophysiology of bone
      loss in obesity may help identify new treatment targets for this important complication. The
      investigator hypothesizes that low-dose GH administration for 18 months will improve skeletal
      health.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Bone Mineral Density
time frame: baseline and 18 months
description: Change in BMD over 18 months in the GH vs placebo group
arm group label: Growth Hormone
arm group type: Active Comparator
description: Growth Hormone is Genotropin, provided by Pfizer Inc. It is self administered daily for 18 months using a 5 mg injection pen device. Dose will be titrated based on IGF-1 levels.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo will be provided by Pfizer Inc. It will appear identical to active growth hormone and will be administered in the same manner.
intervention type: Drug
intervention name: Growth hormone
arm group label: Growth Hormone
other name: Genotropin (Pfizer Inc.)
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Karen Miller, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Miriam Bredella, 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: Chief, Neuroendocrine Unit
mesh term: Bone Diseases, Metabolic
mesh term: Obesity
mesh term: Hormones
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study medication was discontinued at 18 months. Subjects were followed for an additional 6 months off of study medication. The data reported here are for the primary 18-month trial.
point of contact: 