NCT03301857

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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. Collection of long-term safety information will include adverse events of interest and all treatment-emergent adverse events and serious adverse events

Conditions

• Giant Cell Tumor of Bone

Interventions

Type	Name	Description
DRUG	Denosumab	120 mg administered subcutaneously (SC) every 4 weeks (Q4W).

Timeline

• Start date: 2017-11-13
• Primary completion: 2023-07-27
• Completion: 2023-07-27
• First posted: 2017-10-04
• Last updated: 2024-05-20
• Results posted: 2024-05-20

Locations

14 sites across 8 countries: United States, Australia, France, Italy, Poland, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study