Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
NCT ID: NCT03301857
Last Updated: 2024-05-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
85 participants
INTERVENTIONAL
2017-11-13
2023-07-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Safety Follow-up
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.
No interventions assigned to this group
Denosumab
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.
Denosumab
120 mg administered subcutaneously (SC) every 4 weeks (Q4W).
Interventions
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Denosumab
120 mg administered subcutaneously (SC) every 4 weeks (Q4W).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant or participant's legally acceptable representative has provided informed consent/assent prior to initiation of any study-specific activities/procedures.
Exclusion Criteria
* 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
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Sarcoma Oncology Research Center LLC
Santa Monica, California, United States
Washington Cancer Institute at MedStar Washington Hospital
Washington D.C., District of Columbia, United States
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States
Mount Sinai Beth Israel Downtown
New York, New York, United States
Abramson Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Centre Leon Berard
Lyon, , France
Institut Gustave Roussy
Villejuif, , France
Istituti Ortopedici Rizzoli
Bologna, , Italy
Instytut Matki i Dziecka
Warsaw, , Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie â€" Panstwowy Instytut Badawczy
Warsaw, , Poland
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain
Skane Universitetssjukhus
Lund, , Sweden
Royal Orthopaedic Hospital
Birmingham, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2017-001758-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20140114
Identifier Type: -
Identifier Source: org_study_id
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