Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
Study Details
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.
Protocol Summary
Rate of Adverse Events of Interest in Participants With GCTB Treated With Denosumab
Timeframe: Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
Rate of Treatment-emergent Adverse Events for Participants who are Receiving Denosumab
Timeframe: Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
Rate of Serious Adverse Events for all Participants
Timeframe: Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
Rate of Disease Progression or Recurrence of GCTB for all Participants
Timeframe: Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
Rate of GCTB Interventions for all Participants
Timeframe: Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.