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NCT00680992 · FLOW

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Study of Denosumab in Subjects With Giant Cell Tumor of Bone · Source last updated 2022-09-22

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

groups
  1. description
    Participants with surgically unsalvageable disease (eg, sacral, spinal giant cell tumor of bone (GCTB), or multiple lesions including pulmonary metastases) were enrolled into cohort 1 and received denosumab 120 milligrams (mg) subcutaneously (SC) once every 4 weeks (Q4W), starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
    id
    FG000
    title
    Cohort 1 (Denosumab 120 mg Q4W)
  2. description
    Participants with surgically salvageable disease whose planned initial on-study surgery was associated with severe morbidity (eg, joint resection, limb amputation, or hemipelvectomy) were enrolled into cohort 2 and received denosumab 120 mg SC Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
    id
    FG001
    title
    Cohort 2 (Denosumab 120 mg Q4W)
  3. description
    Participants who participated in study 20040215 and were eligible to enroll in the current study (20062004) for continuation of treatment were enrolled into cohort 3 and received denosumab 120 mg SC Q4W, starting on study day 1. Participants in cohort 3 did not receive loading doses of denosumab on days 8 and 15 in the first month of treatment.
    id
    FG002
    title
    Cohort 3 (Denosumab 120 mg Q4W)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        25
      2. group Id
        FG001
        num Subjects
        121
      3. group Id
        FG002
        num Subjects
        0
      type
      Complete Resection (as per protocol)
    2. reasons
      1. group Id
        FG000
        num Subjects
        83
      2. group Id
        FG001
        num Subjects
        42
      3. group Id
        FG002
        num Subjects
        5
      type
      Administrative Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        3
      type
      End of Trial
    4. reasons
      1. group Id
        FG000
        num Subjects
        33
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        1
      type
      Other
    7. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease Progression
    8. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    9. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      type
      Noncompliance
    10. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Requirement for Alternative Therapy
    11. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Pregnancy
    12. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        268
      2. group Id
        FG001
        num Subjects
        252
      3. group Id
        FG002
        num Subjects
        12
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        265
      2. group Id
        FG001
        num Subjects
        249
      3. group Id
        FG002
        num Subjects
        12
      comment
      Received ≥1 dose of denosumab
      type
      Safety Analysis Set
    3. achievements
      1. group Id
        FG000
        num Subjects
        260
      2. group Id
        FG001
        num Subjects
        242
      3. group Id
        FG002
        num Subjects
        11
      comment
      Eligible for study and received ≥1 dose of denosumab
      type
      Efficacy Analysis Set
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      comment
      Completed the initial treatment phase
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        268
      2. group Id
        FG001
        num Subjects
        252
      3. group Id
        FG002
        num Subjects
        12
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
3 participants from study 20040215 (NCT00396279) were enrolled directly into safety follow-up phase without retreatment. They were excluded from all defined analysis sets and results are reported for the 532 participants enrolled into the treatment phase. Non-completion reasons are summarized for the on-study period (ie, initial treatment phase).
recruitment Details
Adults and skeletally mature adolescents (≥12 years of age) were enrolled in this open-label single-arm study. The study was conducted at 30 centers in North America, Europe, and Australia from 09 Sep 2008 to study completion on 17 May 2018. The planned study duration for each participant was at least 60 months (following protocol amendment 7).
Complete source fields
groups
  1. description
    Participants with surgically unsalvageable disease (eg, sacral, spinal giant cell tumor of bone (GCTB), or multiple lesions including pulmonary metastases) were enrolled into cohort 1 and received denosumab 120 milligrams (mg) subcutaneously (SC) once every 4 weeks (Q4W), starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
    id
    FG000
    title
    Cohort 1 (Denosumab 120 mg Q4W)
  2. description
    Participants with surgically salvageable disease whose planned initial on-study surgery was associated with severe morbidity (eg, joint resection, limb amputation, or hemipelvectomy) were enrolled into cohort 2 and received denosumab 120 mg SC Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
    id
    FG001
    title
    Cohort 2 (Denosumab 120 mg Q4W)
  3. description
    Participants who participated in study 20040215 and were eligible to enroll in the current study (20062004) for continuation of treatment were enrolled into cohort 3 and received denosumab 120 mg SC Q4W, starting on study day 1. Participants in cohort 3 did not receive loading doses of denosumab on days 8 and 15 in the first month of treatment.
    id
    FG002
    title
    Cohort 3 (Denosumab 120 mg Q4W)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        25
      2. group Id
        FG001
        num Subjects
        121
      3. group Id
        FG002
        num Subjects
        0
      type
      Complete Resection (as per protocol)
    2. reasons
      1. group Id
        FG000
        num Subjects
        83
      2. group Id
        FG001
        num Subjects
        42
      3. group Id
        FG002
        num Subjects
        5
      type
      Administrative Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        3
      type
      End of Trial
    4. reasons
      1. group Id
        FG000
        num Subjects
        33
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        1
      type
      Other
    7. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease Progression
    8. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    9. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      type
      Noncompliance
    10. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Requirement for Alternative Therapy
    11. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Pregnancy
    12. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        268
      2. group Id
        FG001
        num Subjects
        252
      3. group Id
        FG002
        num Subjects
        12
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        265
      2. group Id
        FG001
        num Subjects
        249
      3. group Id
        FG002
        num Subjects
        12
      comment
      Received ≥1 dose of denosumab
      type
      Safety Analysis Set
    3. achievements
      1. group Id
        FG000
        num Subjects
        260
      2. group Id
        FG001
        num Subjects
        242
      3. group Id
        FG002
        num Subjects
        11
      comment
      Eligible for study and received ≥1 dose of denosumab
      type
      Efficacy Analysis Set
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      comment
      Completed the initial treatment phase
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        268
      2. group Id
        FG001
        num Subjects
        252
      3. group Id
        FG002
        num Subjects
        12
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
3 participants from study 20040215 (NCT00396279) were enrolled directly into safety follow-up phase without retreatment. They were excluded from all defined analysis sets and results are reported for the 532 participants enrolled into the treatment phase. Non-completion reasons are summarized for the on-study period (ie, initial treatment phase).
recruitment Details
Adults and skeletally mature adolescents (≥12 years of age) were enrolled in this open-label single-arm study. The study was conducted at 30 centers in North America, Europe, and Australia from 09 Sep 2008 to study completion on 17 May 2018. The planned study duration for each participant was at least 60 months (following protocol amendment 7).

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Preserved source evidence · Not medical advice