At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 85 enrolled
Drug / intervention
Denosumabdrug
Likely dose
Denosumab 120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
In Brief
A Phase 4 clinical trial evaluating Denosumab for Giant Cell Tumor of Bone. Completed, enrolled 85 participants across 14 sites in 8 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGiant Cell Tumor of Bone
CountriesAustralia, France, Italy, Poland, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedOct 2017
Enrollment StartNov 2017
Primary CompletionJul 2023
TodayJul 2026
First PostedOct 4, 2017
Enrollment StartNov 13, 2017
Primary CompletionJul 27, 2023
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 8.7 years ago
Interventions
Denosumabdrug
120 mg administered subcutaneously (SC) every 4 weeks (Q4W).