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

Study Overview
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Brief Summary
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Study 20140114 will continue to follow subjects 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
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Study 20140114 will continue to follow subjects 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

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

Conditions
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Giant Cell Tumor of Bone

Intervention / Treatment
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* Drug: Denosumab (Cohort A)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject was previously enrolled in Study 20062004. Subject or subject's legally acceptable representative has provided informed consent/assent prior to initiation of any study-specific activities/procedures. Exclusion Criteria: Subject 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 subject 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Denosumab<br>Cohort A (subjects who are still being treated with denosumab when 20062004 completes): 120 mg administered subcutaneously (SC) every 4 weeks (Q4W). For subjects undergoing retreatment with denosumab: 120 mg administered SC on Days 1, 8, 15 and 28 then every 4 weeks subsequently. | Drug: Denosumab (Cohort A)<br>* Cohort A: 120 mg administered subcutaneously (SC) every 4 weeks (Q4W).<br>* Other names: AMG 162, Immunoglobulin G2 human monoclonal antibody to RANK ligand;|
| No Intervention: Safety Follow up<br>Subjects still receiving treatment will have follow-up study visits in the clinic every 6 months while receiving denosumab (Cohort A). Subjects 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 (Cohort B). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events of interest in subjects with GCTB treated with denosumab | Evaluate adverse events of interest in subjects with GCTB treated with denosumab. | Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of treatment-emergent adverse events for subjects who are receiving denosumab. | Evaluate treatment-emergent adverse events for subjects who are receiving denosumab. | 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 subjects. | Evaluate serious adverse events for all subjects. | 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 subjects. | Summarize the rate of disease progression or recurrence of GCTB for all subjects. | 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 subjects. | Summarize the use of GCTB interventions for all subjects. | Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up. |