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

Amgen

Status and phase: Completed; Phase 4

Conditions: Giant Cell Tumor of Bone

Treatments: Drug: Denosumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03301857

2017-001758-32 (EudraCT Number)

20140114

Details and patient eligibility

About

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.

Full 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

Enrollment: 85 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

Denosumab

Experimental group

Description:

Participants who are still being treated with denosumab when 20062004 completes: 120 mg administered subcutaneously (SC) every 4 weeks (Q4W). For participants undergoing retreatment with denosumab: 120 mg administered SC on Days 1, 8, 15 and 28 then every 4 weeks subsequently.

Treatment:

Drug: Denosumab

Safety Follow-up

No Intervention group

Description:

Participants who completed denosumab treatment and were in safety follow-up at the conclusion of 20062004 will have follow-up visits performed every 6 months via telephone or in-person clinic visit.