Giant Cell Tumor of Bone Clinical Trial
Official title:
Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
Verified date | October 2023 |
Source | Amgen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study 20140114 will continue to follow subjects with GCTB who were treated in Study 20062004 and remained on the study at the completion of Study 20062004 for an additional 5 years on long-term safety follow up.
Status | Completed |
Enrollment | 85 |
Est. completion date | July 27, 2023 |
Est. primary completion date | July 27, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Subject was previously enrolled in Study 20062004. - Subject or subject's legally acceptable representative has provided informed consent/assent prior to initiation of any study-specific activities/procedures. Exclusion Criteria: - Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge. - Females of childbearing potential on denosumab and not willing to continue to use 1 highly effective method of contraception during treatment and for 5 months after the end of treatment |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
France | Centre Leon Berard | Lyon CEDEX 08 | |
France | Institut Gustave Roussy | Villejuif | |
Italy | Istituti Ortopedici Rizzoli | Bologna | |
Poland | Instytut Matki i Dziecka | Warszawa | |
Poland | Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie â€" Panstwowy Instytut Badawczy | Warszawa | |
Spain | Hospital Universitari Son Espases | Palma de Mallorca | Baleares |
Sweden | Skane Universitetssjukhus | Lund | |
United Kingdom | Royal Orthopaedic Hospital | Birmingham | |
United States | University of Minnesota Medical Center Fairview | Minneapolis | Minnesota |
United States | Mount Sinai Beth Israel Downtown | New York | New York |
United States | Abramson Cancer Center at Pennsylvania Hospital | Philadelphia | Pennsylvania |
United States | Sarcoma Oncology Research Center LLC | Santa Monica | California |
United States | Washington Cancer Institute at MedStar Washington Hospital | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Amgen |
United States, Australia, France, Italy, Poland, Spain, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of adverse events of interest in subjects with GCTB treated with denosumab | Evaluate adverse events of interest in subjects with GCTB treated with denosumab. | Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up. | |
Secondary | Rate of treatment-emergent adverse events for subjects who are receiving denosumab. | Evaluate treatment-emergent adverse events for subjects who are receiving denosumab. | Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up. | |
Secondary | Rate of serious adverse events for all subjects. | Evaluate serious adverse events for all subjects. | Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up. | |
Secondary | Rate of disease progression or recurrence of GCTB for all subjects. | Summarize the rate of disease progression or recurrence of GCTB for all subjects. | Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up. | |
Secondary | Rate of GCTB interventions for all subjects. | Summarize the use of GCTB interventions for all subjects. | Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up. |
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