<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT01666106</url>
  </required_header>
  <id_info>
    <org_study_id>20101102</org_study_id>
    <nct_id>NCT01666106</nct_id>
  </id_info>
  <brief_title>Osteonecrosis of the Jaw (ONJ) Case Registry</brief_title>
  <official_title>Osteonecrosis of the Jaw (ONJ) Case Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Osteonecrosis of the Jaw (ONJ) Case Registry&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the ONJ case registry is to describe the natural history of&#xD;
      positively-adjudicated ONJ in subjects with cancer with an observation period of 5 years.&#xD;
      Most of these subjects are expected to have received bone antiresorptive agents such as&#xD;
      bisphosphonates or denosumab together with cancer-specific therapies (eg, chemotherapy,&#xD;
      steroids, or anti-angiogenics). It is also possible that the registry will include subjects&#xD;
      with cancer who developed ONJ without exposure to any antiresorptive therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2012</start_date>
  <completion_date type="Actual">December 16, 2020</completion_date>
  <primary_completion_date type="Actual">December 16, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Resolution rate and time to ONJ resolution</measure>
    <time_frame>5 years</time_frame>
    <description>Resolution: complete coverage of the exposed bone by mucosa in the absence of clinical symptoms&#xD;
Improvement: a decrease in the stage or severity of the lesion&#xD;
Progression: an increase in the stage or severity of the lesion&#xD;
Stable: not resolved, improved, or progressed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The clinical features of ONJ, including severity and staging at enrollment</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The frequency of risk factors for incident ONJ</measure>
    <time_frame>5 years</time_frame>
    <description>Characterize the frequency of risk factors for incident ONJ such as a history of inflammatory dental disease (periodontal and dental abscesses), dentoalveolar procedures, smoking, use of antiangiogenic agents, and duration/dosing regimens of antiresorptive medications prior to the development of ONJ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic treatment patterns for ONJ</measure>
    <time_frame>5 years</time_frame>
    <description>Characterize treatment patterns of antiresorptive medications subsequent to incident ONJ such as the proportion of subjects who continue to be treated with antiresorptive medications by specific agents and ONJ severity and stage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment patterns of antiresorptive agents subsequent to incident ONJ</measure>
    <time_frame>5 years</time_frame>
    <description>Characterize subsequent treatment patterns for ONJ including antimicrobial oral rinses, antibiotics, and surgery</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">327</enrollment>
  <condition>Osteonecrosis of the Jaw</condition>
  <arm_group>
    <arm_group_label>Subjects with cancer and ONJ</arm_group_label>
    <description>Subjects with cancer and positively adjudicated ONJ</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with cancer and ONJ&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (≥18 years of age) with diagnosis of cancer&#xD;
&#xD;
          -  Newly diagnosed, positively-adjudicated ONJ&#xD;
&#xD;
          -  ECOG &lt;=2 and expected survival ≥3 months&#xD;
&#xD;
          -  Willing to provide access to previous and future medical and dental information&#xD;
&#xD;
          -  Subject or subject's legally acceptable representative has provided written informed&#xD;
             consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of radiation to the jaws administered for the treatment of cancer&#xD;
&#xD;
          -  Subject will not be available for protocol required study visits, to the best of the&#xD;
             subject and investigator's knowledge.&#xD;
&#xD;
          -  Subject has any kind of disorder that, in the opinion of the investigator, may&#xD;
             compromise the ability of the subject to give written informed consent and/or to&#xD;
             comply with all required study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</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>Research Site</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
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      <name>Research Site</name>
      <address>
        <city>Farmington</city>
        <state>Connecticut</state>
        <zip>06030</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
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      <name>Research Site</name>
      <address>
        <city>Stratford</city>
        <state>Connecticut</state>
        <zip>06615</zip>
        <country>United States</country>
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  </location>
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        <state>District of Columbia</state>
        <zip>20010</zip>
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  </location>
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  </location>
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  </location>
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  </location>
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  </location>
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      <name>Research Site</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2SJ</zip>
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    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>Spain</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>
  <reference>
    <citation>Schiodt M, Vadhan-Raj S, Chambers MS, Nicolatou-Galitis O, Politis C, Coropciuc R, Fedele S, Jandial D, Zhang J, Ma H, Saunders DP. A multicenter case registry study on medication-related osteonecrosis of the jaw in patients with advanced cancer. Support Care Cancer. 2018 Jun;26(6):1905-1915. doi: 10.1007/s00520-017-4003-2. Epub 2017 Dec 23.</citation>
    <PMID>29275525</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>December 18, 2020</last_update_submitted>
  <last_update_submitted_qc>December 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2020</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>Osteonecrosis</mesh_term>
  </condition_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/NCT01666106
org study id: 20101102
nct id: NCT01666106
lead sponsor: 
has dmc: No
Osteonecrosis of the Jaw (ONJ) Case Registry
The purpose of the ONJ case registry is to describe the natural history of
      positively-adjudicated ONJ in subjects with cancer with an observation period of 5 years.
      Most of these subjects are expected to have received bone antiresorptive agents such as
      bisphosphonates or denosumab together with cancer-specific therapies (eg, chemotherapy,
      steroids, or anti-angiogenics). It is also possible that the registry will include subjects
      with cancer who developed ONJ without exposure to any antiresorptive therapy.
observational model: Case-Only
time perspective: Prospective
measure: Resolution rate and time to ONJ resolution
time frame: 5 years
description: Resolution: complete coverage of the exposed bone by mucosa in the absence of clinical symptoms
Improvement: a decrease in the stage or severity of the lesion
Progression: an increase in the stage or severity of the lesion
Stable: not resolved, improved, or progressed
measure: The clinical features of ONJ, including severity and staging at enrollment
time frame: 5 years
measure: The frequency of risk factors for incident ONJ
time frame: 5 years
description: Characterize the frequency of risk factors for incident ONJ such as a history of inflammatory dental disease (periodontal and dental abscesses), dentoalveolar procedures, smoking, use of antiangiogenic agents, and duration/dosing regimens of antiresorptive medications prior to the development of ONJ
measure: Therapeutic treatment patterns for ONJ
time frame: 5 years
description: Characterize treatment patterns of antiresorptive medications subsequent to incident ONJ such as the proportion of subjects who continue to be treated with antiresorptive medications by specific agents and ONJ severity and stage
measure: Treatment patterns of antiresorptive agents subsequent to incident ONJ
time frame: 5 years
description: Characterize subsequent treatment patterns for ONJ including antimicrobial oral rinses, antibiotics, and surgery
arm group label: Subjects with cancer and ONJ
description: Subjects with cancer and positively adjudicated ONJ
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
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country: Belgium
country: Canada
country: Denmark
country: Finland
country: France
country: Germany
country: Greece
country: Italy
country: Spain
country: United Kingdom
country: United States
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
citation: Schiodt M, Vadhan-Raj S, Chambers MS, Nicolatou-Galitis O, Politis C, Coropciuc R, Fedele S, Jandial D, Zhang J, Ma H, Saunders DP. A multicenter case registry study on medication-related osteonecrosis of the jaw in patients with advanced cancer. Support Care Cancer. 2018 Jun;26(6):1905-1915. doi: 10.1007/s00520-017-4003-2. Epub 2017 Dec 23.
PMID: 29275525
responsible party type: Sponsor
mesh term: Osteonecrosis
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