Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00680992 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      268
    2. group Id
      BG001
      value
      252
    3. group Id
      BG002
      value
      12
    4. group Id
      BG003
      value
      532
    units
    Participants
groups
  1. description
    Participants with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) were enrolled into cohort 1 and received denosumab 120 mg SC once 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
    BG000
    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
    BG001
    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
    BG002
    title
    Cohort 3 (Denosumab 120 mg Q4W)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          28
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          238
        2. group Id
          BG001
          value
          231
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          481
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          23
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.6
          value
          36.4
        2. group Id
          BG001
          spread
          13.5
          value
          35.1
        3. group Id
          BG002
          spread
          14.9
          value
          36.1
        4. group Id
          BG003
          spread
          14.1
          value
          35.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          154
        2. group Id
          BG001
          value
          142
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          301
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          114
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          231
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          221
        2. group Id
          BG001
          value
          208
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          440
      title
      White or Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          30
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          27
      title
      Hispanic or Latino
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          25
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Native Hawaiian or Other Pacific Islander
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          9
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          167
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          167
      title
      Primary resectable
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          93
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          95
      title
      Primary unresectable
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          85
      title
      Recurrent resectable
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          175
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          185
      title
      Recurrent unresectable
    param Type
    NUMBER
    title
    GCTB Disease Type
    unit Of Measure
    Participants
population Description
The overall baseline population consisted of the 532 participants enrolled into the treatment phase of the study.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      268
    2. group Id
      BG001
      value
      252
    3. group Id
      BG002
      value
      12
    4. group Id
      BG003
      value
      532
    units
    Participants
groups
  1. description
    Participants with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) were enrolled into cohort 1 and received denosumab 120 mg SC once 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
    BG000
    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
    BG001
    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
    BG002
    title
    Cohort 3 (Denosumab 120 mg Q4W)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          28
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          238
        2. group Id
          BG001
          value
          231
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          481
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          23
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.6
          value
          36.4
        2. group Id
          BG001
          spread
          13.5
          value
          35.1
        3. group Id
          BG002
          spread
          14.9
          value
          36.1
        4. group Id
          BG003
          spread
          14.1
          value
          35.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          154
        2. group Id
          BG001
          value
          142
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          301
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          114
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          231
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          221
        2. group Id
          BG001
          value
          208
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          440
      title
      White or Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          30
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          27
      title
      Hispanic or Latino
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          25
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Native Hawaiian or Other Pacific Islander
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          9
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          167
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          167
      title
      Primary resectable
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          93
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          95
      title
      Primary unresectable
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          85
      title
      Recurrent resectable
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          175
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          185
      title
      Recurrent unresectable
    param Type
    NUMBER
    title
    GCTB Disease Type
    unit Of Measure
    Participants
population Description
The overall baseline population consisted of the 532 participants enrolled into the treatment phase of the study.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice