Overview

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

Status:
Active, not recruiting
Trial end date:
2023-07-25
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
Treatments:
Denosumab
Immunoglobulin G
Immunoglobulins
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