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NCT00396279 · FLOW

Participant flow

Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone · Source last updated 2022-11-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
    id
    FG000
    title
    Denosumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        26
      type
      Ongoing in study
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Disease progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        37
      type
      STARTED
    2. achievements
      1. comment
        Defined as participants with a complete resection
        group Id
        FG000
        num Subjects
        7
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        30
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
First patient enrolled 10 July 2006; Last patient enrolled 25 January 2008. Results data are reported as of the data cut-off date of 07 April 2008.
Complete source fields
groups
  1. description
    Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
    id
    FG000
    title
    Denosumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        26
      type
      Ongoing in study
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Disease progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        37
      type
      STARTED
    2. achievements
      1. comment
        Defined as participants with a complete resection
        group Id
        FG000
        num Subjects
        7
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        30
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
First patient enrolled 10 July 2006; Last patient enrolled 25 January 2008. Results data are reported as of the data cut-off date of 07 April 2008.

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Preserved source evidence · Not medical advice