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Completed

NCT Number: NCT05542524

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Médecine et Chirurgie Bucco-Dentaires - CHU de Strasbourg - France

Strasbourg, 67091, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of Decayed, Missing, and Filled Permanent Teeth (DMFT)

    Time frame: Files analysed retrospectively from from January 01, 2014 to August 31, 2022 will be examined

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Oral Care of Patients Treated With Anti-RANK-ligand Antibodies for a Giant Cell Tumour: Retrospective Study at the University Hospitals of Strasbourg

Acronym: DENO

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 15, 2022
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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