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Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Site details revised at 9 of 16 sitesv13
  2. Primary completion date: Jan 2026 to Jan 2027
    • Study completion date: Jan 2027 to Jan 2028
    • Site contacts updated at 14 of 16 sites
    v12
  3. Primary completion date: Jan 2025 to Jan 2026
    • Study sites: 17 to 16
    • Study completion date: Jan 2026 to Jan 2027
    • Collaborators: 15 to 17
    v11
  4. Primary completion date: Jan 2024 to Jan 2025
    • Study sites: 16 to 17
    • Study completion date: Jan 2025 to Jan 2026
    • Collaborators: 13 to 15
    v10
  5. Study sites: 13 to 16
    • Collaborators revised (13)
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 1 to 13
    • Collaborators: 12 to 13
    • Study description expanded, about 1 word
    v8
  2. Collaborators expanded, about 59 wordsv7
  3. Primary completion date: Jan 2022 to Jan 2024
    • Study completion date: Jan 2024 to Jan 2025
    v6
  4. Primary completion date: Jan 2021 to Jan 2022
    • Study completion date: Jan 2023 to Jan 2024
    v5
  5. Re-verified, no change to tracked fieldsv4
  6. Start date: Jan 15, 2018 to May 3, 2018v3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2018 to Jan 15, 2018
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of the clinical study is to investigate whether the local delivery of bisphosphonate as a surgical adjuvant can decrease the chance of a giant cell tumor of bone coming back to the same location. The hypothesis is that the local administration of bisphosphonate will decrease the rate of the tumor returning compared to traditional aggressive surgical removal of the tumor.
Trial Details
NCT Number NCT03295981
Lead Sponsor St. Louis University
Collaborators: Orthopedic Research and Education Foundation, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), University of Iowa, Johns Hopkins University, McGill University Health Centre/Research Institute of the McGill University Health Centre, The Cleveland Clinic, Wake Forest University, University of Kansas, Indiana University, University of Oklahoma, Beth Israel Deaconess Medical Center, Boston Children's Hospital, American Academy of Orthopaedic Surgeons, Massachusetts General Hospital, All India Institute of Medical Sciences, University of Washington, University of California
Conditions
(from sponsor)		 Giant Cell Tumor of Bone
Related terms Giant Cell Tumor of Bone
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov