Phase 4
Completed N=85
Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
Source: ClinicalTrials.gov NCT03301857 ↗Enrolled (actual)
85
Serious AEs
9.4%
Results posted
May 2024
Primary outcomePrimary: Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI) — 3; 0; 6; 1 Count of Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.