Status:
COMPLETED
Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
Lead Sponsor:
Amgen
Conditions:
Giant Cell Tumor of Bone
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
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 sa...
Detailed Description
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 sa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2023
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT03301857
Start Date
November 13 2017
End Date
July 27 2023
Last Update
May 20 2024
Active Locations (14)
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1
Sarcoma Oncology Research Center LLC
Santa Monica, California, United States, 90403
2
Washington Cancer Institute at MedStar Washington Hospital
Washington D.C., District of Columbia, United States, 20010
3
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States, 55455
4
Mount Sinai Beth Israel Downtown
New York, New York, United States, 10003