Phase 4
N=85
Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
Giant Cell Tumor of Bone
Bottom Line
View on ClinicalTrials.gov: NCT03301857 ↗Enrolled (actual)
85
Serious AEs
9.4%
Results posted
May 2024
Primary outcome: Primary: Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI) — 3; 0; 6; 1 Count of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Denosumab (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI) |
3; 0; 6; 1; 2; 0 | — |
| SECONDARY Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) |
47; 8; 0; 9; 16; 14 | — |
| SECONDARY Number of Participants With Disease Progression or Recurrence of GCTB |
5; 3 | — |
| SECONDARY Number of Participants Receiving GCTB Interventions |
1; 3; 0; 2; 0; 0 | — |
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 safety follow up.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03301857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.