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DENO: Oral Care of Patients Treated With Anti-RANK-ligand Antibodies for a Giant Cell Tumour

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05542524
Collaborator
(none)
12
Enrollment
1
Location
12
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Giant cell tumors are mostly benign tomoral processes, most often responsible for areas of osteolysis in the metaphysoepiphyseal area of long bones, representing 5-6% of primary bone tumors. The bone weakening induced by these beaches leads to pain and risk of fracture, and this is what leads the patient to consult.

These tumors are found particularly in the young adult population between 20 and 40 years old, are locally aggressive, but malignant transformations and metastases (pulmonary) are quite rare.

In this study, the investigators wish to retrospectively study the oral care of patients who presented with a giant cell tumor and were treated with Denosumab at the University Hospital of Strasbourg and their associated oral follow-up

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    12 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Oral Care of Patients Treated With Anti-RANK-ligand Antibodies for a Giant Cell Tumour: Retrospective Study at the University Hospitals of Strasbourg
    Actual Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Number of Decayed, Missing, and Filled Permanent Teeth (DMFT) [Files analysed retrospectively from from January 01, 2014 to August 31, 2022 will be examined]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • Adult subject, having presented a giant cell tumor treated with adjuvant or neoadjuvant denosumab at the HUS from 01/01/2014 to 08/31/2022.

    • Subjects who have not expressed their opposition to the reuse of their data for scientific research purposes.

    Exclusion criteria:

    • Subject having expressed their opposition to the retrospective reuse of their data for scientific research purposes

    • Pathology finally labeled other than giant cell tumour.

    • Treatment with denosumab was not initiated because of death, change in treatment protocol, etc.

    • Absence of oral follow-up element.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Médecine et Chirurgie Bucco-Dentaires - CHU de Strasbourg - France Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT05542524
    Other Study ID Numbers:
    • 8699
    First Posted:
    Sep 15, 2022
    Last Update Posted:
    Sep 15, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Giant Cell Tumors
    Anti-RANK-ligand antibodies
    Additional relevant MeSH terms:
    Giant Cell Tumors

    Study Results

    No Results Posted as of Sep 15, 2022