<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/NCT03808285</url>
  </required_header>
  <id_info>
    <org_study_id>18-334</org_study_id>
    <nct_id>NCT03808285</nct_id>
  </id_info>
  <brief_title>Denosumab Related Osteonecrossi of the Jaw : : an Emergent and Potentially Complex Bone and Joint Infection</brief_title>
  <official_title>Denosumab Related Osteonecrossi of the Jaw : : an Emergent and Potentially Complex Bone and Joint Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to adescription of mandibular osteomylitis in patients having had a&#xD;
      treatment by DENOSUMAB. Indeed, one of the adverse effect ot this molecule is to induce&#xD;
      mandibular infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of mandibular osteomyelitis</measure>
    <time_frame>Entire description can be made at the outcome which is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption</time_frame>
    <description>description of mandibular osteomyelitis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of antibiotics</measure>
    <time_frame>Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption</time_frame>
    <description>Description of the duration and strategies of antibiotic treatments used (double-agent therapy, monotherapy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Treatment Failure</measure>
    <time_frame>Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption</time_frame>
    <description>Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin. Analyse of risk factor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>management of mandibular osteomyelitis by medical team</measure>
    <time_frame>all data are available at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption</time_frame>
    <description>description of medical and surgical strategies : data availables in consultation report</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">13</enrollment>
  <condition>Bone and Joint Infection</condition>
  <condition>Osteomyelitis</condition>
  <condition>Adverse Drug Event</condition>
  <arm_group>
    <arm_group_label>mandibular osteomylitis</arm_group_label>
    <description>description of mandibular osteomylitis due to denosumab</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>mandibular osteomylitis</intervention_name>
    <arm_group_label>mandibular osteomylitis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients having a mandibular osteomylelitis due to DENOSUMAB betwwen 01/01/2013 and&#xD;
        31/12/2018 and managed at the Lyon Bone and joint infection refence Center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients having a mandibular osteomylelitis due to DENOSUMAB&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>TRISTAN FERRY, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospices Civils de Lyon</investigator_affiliation>
    <investigator_full_name>Eugénie MABRUT</investigator_full_name>
    <investigator_title>Clinical Research Assistant</investigator_title>
  </responsible_party>
  <keyword>bone and joint infection</keyword>
  <keyword>osteomyelitis</keyword>
  <keyword>mandibular</keyword>
  <keyword>denosumab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Arthritis, Infectious</mesh_term>
    <mesh_term>Osteomyelitis</mesh_term>
    <mesh_term>Drug-Related Side Effects and Adverse Reactions</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03808285
org study id: 18-334
nct id: NCT03808285
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to adescription of mandibular osteomylitis in patients having had a
      treatment by DENOSUMAB. Indeed, one of the adverse effect ot this molecule is to induce
      mandibular infection.
observational model: Cohort
time perspective: Retrospective
measure: Rate of mandibular osteomyelitis
time frame: Entire description can be made at the outcome which is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
description: description of mandibular osteomyelitis
measure: Duration of antibiotics
time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
description: Description of the duration and strategies of antibiotic treatments used (double-agent therapy, monotherapy)
measure: Rate of Treatment Failure
time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
description: Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin. Analyse of risk factor.
measure: management of mandibular osteomyelitis by medical team
time frame: all data are available at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
description: description of medical and surgical strategies : data availables in consultation report
arm group label: mandibular osteomylitis
description: description of mandibular osteomylitis due to denosumab
intervention type: Other
intervention name: mandibular osteomylitis
arm group label: mandibular osteomylitis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: TRISTAN FERRY, MD,PhD
role: Principal Investigator
affiliation: Hospices Civils de Lyon
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Hospices Civils de Lyon
investigator full name: Eugénie MABRUT
investigator title: Clinical Research Assistant
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Arthritis, Infectious
mesh term: Osteomyelitis
mesh term: Drug-Related Side Effects and Adverse Reactions
sharing ipd: Undecided