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NCT03301857 · ClinicalTrials.gov registry record · Phase 4
Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
A Phase 4 study of Giant Cell Tumor of Bone, sponsored by Amgen.
- Completed
- Registry status
- Phase 4
- Development phase
- 85
- Enrollment target
- 14
- Study locations
NCT03301857: Completed Phase 4 study of Giant Cell Tumor of Bone, sponsored by Amgen.
NCT03301857 is a Phase 4 study of Giant Cell Tumor of Bone that has completed, run by Amgen. The registered enrollment target is 85 participants, below the 317-participant average among 3 other Giant Cell Tumor of Bone trials with a reported enrollment target (73% lower). The trial reports 14 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03301857, a Phase 4 study of Giant Cell Tumor of Bone, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 85 participants
- Enrollment target
- 14
- Study locations
Study 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.
Primary Outcome
EOIs assessed in the study were signs and symptoms of osteonecrosis of the jaw (ONJ), malignancy (including malignancy in GCTB), atypical femoral fracture (AFF), hypocalcemia, hypercalcemia after treatment discontinuation, pregnancy and lactation (if occurring during treatment or within 5 months of the last dose of denosumab). Hypocalcemia includes events that occurred after 30 days following the last dose of IP and includes TEAEs only. Other EOIs encompass all events from signing the informed c
Conditions Studied
Interventions
- DRUG Denosumab
Study Locations (14)
Other
- Centre Leon Berard - Lyon
- Institut Gustave Roussy - Villejuif
- Istituti Ortopedici Rizzoli - Bologna
- Instytut Matki i Dziecka - Warsaw
- Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie â€" Panstwowy Instytut Badawczy - Warsaw
- Skane Universitetssjukhus - Lund
- Royal Orthopaedic Hospital - Birmingham
California
- Sarcoma Oncology Research Center LLC - Santa Monica
District of Columbia
- Washington Cancer Institute at MedStar Washington Hospital - Washington D.C.
Minnesota
- University of Minnesota Medical Center Fairview - Minneapolis
New York
- Mount Sinai Beth Israel Downtown - New York
Pennsylvania
- Abramson Cancer Center at Pennsylvania Hospital - Philadelphia
New South Wales
- Royal Prince Alfred Hospital - Camperdown
Balearic Islands
- Hospital Universitari Son Espases - Palma de Mallorca
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2017-11-13 |
| Est. Completion | 2023-07-27 |
| Phase | Phase 4 |
What the finished NCT03301857 record still lists
NCT03301857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 317-participant average among 3 other Giant Cell Tumor of Bone trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Giant Cell Tumor of Bone appearing as the primary indexed condition, and to 1 intervention - of which Denosumab is the first listed.
NCT03301857 lists 14 locations in 8 states (Other, California, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT03301857 about?
NCT03301857 is a clinical study titled "Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004". 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.
What is the current status of trial NCT03301857?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 85 participants. The study started on 2017-11-13. Estimated completion is 2023-07-27.
What conditions does trial NCT03301857 study?
This clinical trial studies the following conditions: Giant Cell Tumor of Bone.
What interventions are being tested in trial NCT03301857?
The interventions under investigation include: Denosumab (DRUG).
Who is sponsoring clinical trial NCT03301857?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03301857 being conducted?
This trial has 14 study locations across California, District of Columbia, Minnesota, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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