Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
Giant Cell Tumor of Bone
About this trial
This is an interventional supportive care trial for Giant Cell Tumor of Bone
Eligibility Criteria
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
Sites / Locations
- Sarcoma Oncology Research Center LLC
- Washington Cancer Institute at MedStar Washington Hospital
- University of Minnesota Medical Center Fairview
- Mount Sinai Beth Israel Downtown
- Abramson Cancer Center at Pennsylvania Hospital
- Royal Prince Alfred Hospital
- Centre Leon Berard
- Institut Gustave Roussy
- Istituti Ortopedici Rizzoli
- Instytut Matki i Dziecka
- Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie â€" Panstwowy Instytut Badawczy
- Hospital Universitari Son Espases
- Skane Universitetssjukhus
- Royal Orthopaedic Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Denosumab
Safety Follow up
Cohort A (subjects who are still being treated with denosumab when 20062004 completes): 120 mg administered subcutaneously (SC) every 4 weeks (Q4W). For subjects undergoing retreatment with denosumab: 120 mg administered SC on Days 1, 8, 15 and 28 then every 4 weeks subsequently.
Subjects still receiving treatment will have follow-up study visits in the clinic every 6 months while receiving denosumab (Cohort A). Subjects who completed denosumab treatment and were in safety follow-up at the conclusion of 20062004 will have follow-up visits performed every 6 months via telephone or in-person clinic visit (Cohort B).