deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT03301857

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

Sponsor: Amgen

Interventions Denosumab
Updated 23 times since 2017 Last updated: May 14, 2024 Started: Nov 13, 2017 Primary completion: Jul 27, 2023 Completion: Jul 27, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE4 trial investigates Giant Cell Tumor of Bone and is currently completed. Amgen leads this study, which shows 23 recorded versions since 2017 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

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

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

Status Flow

~Oct 2017 – ~Dec 2017 · 2 months · monthly snapshot~Dec 2017 – ~Jan 2018 · 31 days · monthly snapshot~Jan 2018 – ~Feb 2018 · 31 days · monthly snapshot~Feb 2018 – ~Mar 2018 · 28 days · monthly snapshot~Mar 2018 – ~May 2018 · 2 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Nov 2018 · 3 months · monthly snapshot~Nov 2018 – ~Jan 2019 · 2 months · monthly snapshot~Jan 2019 – ~Nov 2019 · 10 months · monthly snapshot~Nov 2019 – ~Jan 2021 · 14 months · monthly snapshot~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshot~Oct 2021 – ~Jan 2022 · 3 months · monthly snapshot~Jan 2022 – ~Jan 2023 · 12 months · monthly snapshot~Jan 2023 – ~Sep 2023 · 8 months · monthly snapshot~Sep 2023 – ~Nov 2023 · 2 months · monthly snapshot~Nov 2023 – ~Jun 2024 · 7 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 7 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot

Change History

23 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE4

  2. Sep 2025 — Present [monthly]

    Completed PHASE4

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE4

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  5. Jun 2024 — Jul 2024 [monthly]

    Completed PHASE4

Show 18 earlier versions
  1. Nov 2023 — Jun 2024 [monthly]

    Completed PHASE4

  2. Sep 2023 — Nov 2023 [monthly]

    Completed PHASE4

    Status: Active Not RecruitingCompleted

  3. Jan 2023 — Sep 2023 [monthly]

    Active Not Recruiting PHASE4

  4. Jan 2022 — Jan 2023 [monthly]

    Active Not Recruiting PHASE4

  5. Oct 2021 — Jan 2022 [monthly]

    Active Not Recruiting PHASE4

  6. Jan 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE4

  7. Nov 2019 — Jan 2021 [monthly]

    Active Not Recruiting PHASE4

  8. Jan 2019 — Nov 2019 [monthly]

    Active Not Recruiting PHASE4

  9. Nov 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE4

  10. Aug 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE4

    Status: RecruitingActive Not Recruiting

  11. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE4

  12. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE4

  13. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE4

  14. Mar 2018 — May 2018 [monthly]

    Recruiting PHASE4

  15. Feb 2018 — Mar 2018 [monthly]

    Recruiting PHASE4

  16. Jan 2018 — Feb 2018 [monthly]

    Recruiting PHASE4

  17. Dec 2017 — Jan 2018 [monthly]

    Recruiting PHASE4

    Status: Not Yet RecruitingRecruiting

  18. Oct 2017 — Dec 2017 [monthly]

    Not Yet Recruiting PHASE4

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Amgen
Data source: Amgen

For direct contact, visit the study record on ClinicalTrials.gov .