<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/NCT03301857</url>
  </required_header>
  <id_info>
    <org_study_id>20140114</org_study_id>
    <secondary_id>2017-001758-32</secondary_id>
    <nct_id>NCT03301857</nct_id>
  </id_info>
  <brief_title>Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004</brief_title>
  <official_title>Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study 20140114 will continue to follow subjects with GCTB who were treated in Study 20062004&#xD;
      and remained on the study at the completion of Study 20062004 for an additional 5 years on&#xD;
      long-term safety follow up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study 20140114 will continue to follow subjects with GCTB who were treated in Study 20062004&#xD;
      and remained on the study at the completion of Study 20062004 for an additional 5 years on&#xD;
      long-term safety follow up. Collection of long-term safety information will include adverse&#xD;
      events of interest and all treatment-emergent adverse events and serious adverse events&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2017</start_date>
  <completion_date type="Actual">July 27, 2023</completion_date>
  <primary_completion_date type="Actual">July 27, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of adverse events of interest in subjects with GCTB treated with denosumab</measure>
    <time_frame>Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.</time_frame>
    <description>Evaluate adverse events of interest in subjects with GCTB treated with denosumab.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of treatment-emergent adverse events for subjects who are receiving denosumab.</measure>
    <time_frame>Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.</time_frame>
    <description>Evaluate treatment-emergent adverse events for subjects who are receiving denosumab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of serious adverse events for all subjects.</measure>
    <time_frame>Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.</time_frame>
    <description>Evaluate serious adverse events for all subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of disease progression or recurrence of GCTB for all subjects.</measure>
    <time_frame>Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.</time_frame>
    <description>Summarize the rate of disease progression or recurrence of GCTB for all subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of GCTB interventions for all subjects.</measure>
    <time_frame>Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.</time_frame>
    <description>Summarize the use of GCTB interventions for all subjects.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Giant Cell Tumor of Bone</condition>
  <arm_group>
    <arm_group_label>Denosumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort A (subjects who are still being treated with denosumab when 20062004 completes): 120 mg administered subcutaneously (SC) every 4 weeks (Q4W).&#xD;
For subjects undergoing retreatment with denosumab: 120 mg administered SC on Days 1, 8, 15 and 28 then every 4 weeks subsequently.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Safety Follow up</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects still receiving treatment will have follow-up study visits in the clinic every 6 months while receiving denosumab (Cohort A).&#xD;
Subjects who completed denosumab treatment and were in safety follow-up at the conclusion of 20062004 will have follow-up visits performed every 6 months via telephone or in-person clinic visit (Cohort B).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Denosumab (Cohort A)</intervention_name>
    <description>Cohort A: 120 mg administered subcutaneously (SC) every 4 weeks (Q4W).</description>
    <arm_group_label>Denosumab</arm_group_label>
    <other_name>AMG 162, Immunoglobulin G2 human monoclonal antibody to RANK ligand</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject was previously enrolled in Study 20062004.&#xD;
&#xD;
          -  Subject or subject's legally acceptable representative has provided informed&#xD;
             consent/assent prior to initiation of any study-specific activities/procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject likely to not be available to complete all protocol-required study visits or&#xD;
             procedures, and/or to comply with all required study procedures to the best of the&#xD;
             subject and investigator's knowledge.&#xD;
&#xD;
          -  Females of childbearing potential on denosumab and not willing to continue to use 1&#xD;
             highly effective method of contraception during treatment and for 5 months after the&#xD;
             end of treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</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>Sarcoma Oncology Research Center LLC</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Cancer Institute at MedStar Washington Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota Medical Center Fairview</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Beth Israel Downtown</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abramson Cancer Center at Pennsylvania Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Prince Alfred Hospital</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Leon Berard</name>
      <address>
        <city>Lyon CEDEX 08</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituti Ortopedici Rizzoli</name>
      <address>
        <city>Bologna</city>
        <zip>40136</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instytut Matki i Dziecka</name>
      <address>
        <city>Warszawa</city>
        <zip>01-211</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie â€&quot; Panstwowy Instytut Badawczy</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Son Espases</name>
      <address>
        <city>Palma de Mallorca</city>
        <state>Baleares</state>
        <zip>07010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skane Universitetssjukhus</name>
      <address>
        <city>Lund</city>
        <zip>221 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Orthopaedic Hospital</name>
      <address>
        <city>Birmingham</city>
        <zip>B31 2AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>France</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>July 31, 2023</last_update_submitted>
  <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Giant Cell Tumors</mesh_term>
    <mesh_term>Bone Neoplasms</mesh_term>
    <mesh_term>Giant Cell Tumor of Bone</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Denosumab</mesh_term>
    <mesh_term>Immunoglobulins</mesh_term>
    <mesh_term>Immunoglobulin G</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.</ipd_access_criteria>
    <ipd_url>https://www.amgen.com/datasharing</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03301857
org study id: 20140114
secondary id: 2017-001758-32
nct id: NCT03301857
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Study 20140114 will continue to follow subjects with GCTB who were treated in Study 20062004
      and remained on the study at the completion of Study 20062004 for an additional 5 years on
      long-term safety follow up.
Study 20140114 will continue to follow subjects with GCTB who were treated in Study 20062004
      and remained on the study at the completion of Study 20062004 for an additional 5 years on
      long-term safety follow up. Collection of long-term safety information will include adverse
      events of interest and all treatment-emergent adverse events and serious adverse events
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Rate of adverse events of interest in subjects with GCTB treated with denosumab
time frame: Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
description: Evaluate adverse events of interest in subjects with GCTB treated with denosumab.
measure: Rate of treatment-emergent adverse events for subjects who are receiving denosumab.
time frame: Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
description: Evaluate treatment-emergent adverse events for subjects who are receiving denosumab.
measure: Rate of serious adverse events for all subjects.
time frame: Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
description: Evaluate serious adverse events for all subjects.
measure: Rate of disease progression or recurrence of GCTB for all subjects.
time frame: Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
description: Summarize the rate of disease progression or recurrence of GCTB for all subjects.
measure: Rate of GCTB interventions for all subjects.
time frame: Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
description: Summarize the use of GCTB interventions for all subjects.
arm group label: Denosumab
arm group type: Experimental
description: Cohort A (subjects who are still being treated with denosumab when 20062004 completes): 120 mg administered subcutaneously (SC) every 4 weeks (Q4W).
For subjects undergoing retreatment with denosumab: 120 mg administered SC on Days 1, 8, 15 and 28 then every 4 weeks subsequently.
arm group label: Safety Follow up
arm group type: No Intervention
description: Subjects still receiving treatment will have follow-up study visits in the clinic every 6 months while receiving denosumab (Cohort A).
Subjects who completed denosumab treatment and were in safety follow-up at the conclusion of 20062004 will have follow-up visits performed every 6 months via telephone or in-person clinic visit (Cohort B).
intervention type: Drug
intervention name: Denosumab (Cohort A)
description: Cohort A: 120 mg administered subcutaneously (SC) every 4 weeks (Q4W).
arm group label: Denosumab
other name: AMG 162, Immunoglobulin G2 human monoclonal antibody to RANK ligand
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: France
country: Italy
country: Poland
country: Spain
country: Sweden
country: United Kingdom
country: United States
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Giant Cell Tumors
mesh term: Bone Neoplasms
mesh term: Giant Cell Tumor of Bone
mesh term: Denosumab
mesh term: Immunoglobulins
mesh term: Immunoglobulin G
sharing ipd: Yes
ipd description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
ipd access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
ipd url: https://www.amgen.com/datasharing