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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05542524
Other study ID # 8699
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date August 31, 2023

Study information

Verified date December 2023
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date August 31, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Service de Médecine et Chirurgie Bucco-Dentaires - CHU de Strasbourg - France Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Decayed, Missing, and Filled Permanent Teeth (DMFT) Files analysed retrospectively from from January 01, 2014 to August 31, 2022 will be examined
See also
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Completed NCT06331104 - Network Pharmacology Prediction: Mechanism Study of Puerarin in the Treatment of Giant Cell Tumors of Bone