Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03301857
• Other study ID #: 20140114
• Secondary ID: 2017-001758-32
• Status: Completed
• Phase: Phase 4
• Start date: November 13, 2017
• Est. completion date: July 27, 2023

Study information

• Verified date: October 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. Collection of long-term safety information will include adverse events of interest and all treatment-emergent adverse events and serious adverse events

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bone Neoplasms
• Giant Cell Tumor of Bone
• Giant Cell Tumors

Intervention

Drug:
• Denosumab (Cohort A)
Cohort A: 120 mg administered subcutaneously (SC) every 4 weeks (Q4W).

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  France,  Italy,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

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.

External Links

•   AmgenTrials clinical trials website