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

Completed · Phase 4

Conditions studied: Giant Cell Tumor of Bone

In brief

Study 20140114 will continue to follow participants 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.

Key facts

Study ID

NCT03301857

Run by

Amgen

People needed

85

Starts

2017-11-13

Expected to finish

2023-07-27

Last updated by the study team

2024-05-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant was previously enrolled in Study 20062004.
• Participant or participant's legally acceptable representative has provided informed consent/assent prior to initiation of any study-specific activities/procedures.

You may not qualify if…

• Participant 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 participant 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

Where it is running

• Sarcoma Oncology Research Center LLC — Santa Monica, California, United States
• Washington Cancer Institute at MedStar Washington Hospital — Washington D.C., District of Columbia, 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
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• Centre Leon Berard — Lyon, France
• Institut Gustave Roussy — Villejuif, France
• Istituti Ortopedici Rizzoli — Bologna, Italy
• Instytut Matki i Dziecka — Warsaw, Poland
• Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie â€" Panstwowy Instytut Badawczy — Warsaw, Poland
• Hospital Universitari Son Espases — Palma de Mallorca, Balearic Islands, Spain
• Skane Universitetssjukhus — Lund, Sweden
• Royal Orthopaedic Hospital — Birmingham, United Kingdom

Full record on ClinicalTrials.gov

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