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Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
Trial Status: complete
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.
Inclusion Criteria
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 Criteria
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03301857.
Locations matching your search criteria
United States
District of Columbia
Washington
MedStar Washington Hospital Center
Status: Active
Name Not Available
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer Center
Status: Active
Name Not Available
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. Collection of long-term safety information will
include adverse events of interest and all treatment-emergent adverse events and serious
