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NCT00556374 · BASELINE

Baseline characteristics

Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy · Source last updated 2023-07-27

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
      1709
    2. group Id
      BG001
      value
      1711
    3. group Id
      BG002
      value
      3420
    units
    Participants
groups
  1. description
    Participants randomized to receive the matching placebo subcutaneously (SC) once every 6 months (Q6M) in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
    id
    BG000
    title
    Placebo
  2. description
    Participants randomized to receive 60 mg denosumab SC once Q6M in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
    id
    BG001
    title
    Denosumab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.0
          value
          64.6
        2. group Id
          BG001
          spread
          7.9
          value
          64.0
        3. group Id
          BG002
          spread
          8.0
          value
          64.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1709
        2. group Id
          BG001
          value
          1711
        3. group Id
          BG002
          value
          3420
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1700
        2. group Id
          BG001
          value
          1702
        3. group Id
          BG002
          value
          3402
        title
        White/Caucasian
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        Hispanic/Latino
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Black/Afro-Caribbean
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          632
        2. group Id
          BG001
          value
          633
        3. group Id
          BG002
          value
          1265
      title
      Major Academic Center
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1077
        2. group Id
          BG001
          value
          1078
        3. group Id
          BG002
          value
          2155
      title
      Other Center
    param Type
    NUMBER
    title
    Stratification Factor: Type of Hospital
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          269
        2. group Id
          BG001
          value
          270
        3. group Id
          BG002
          value
          539
        title
        No
      2. measurements
        1. group Id
          BG000
          value
          1440
        2. group Id
          BG001
          value
          1441
        3. group Id
          BG002
          value
          2881
        title
        Yes
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor: Prior Aromatase inhibitor Use
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          775
        2. group Id
          BG001
          value
          773
        3. group Id
          BG002
          value
          1548
        title
        T-score < -1.0
      2. measurements
        1. group Id
          BG000
          value
          934
        2. group Id
          BG001
          value
          938
        3. group Id
          BG002
          value
          1872
        title
        T-score ≥ -1.0
    description
    T-scores are standardized scores that reflect the standard deviations (SDs) above/below the normal mean for young adults. T-score ≥ -1.0: BMD is considered normal. T-score \< -1.0: Low BMD.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor: Total Lumbar Spine BMD T-score
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1709
    2. group Id
      BG001
      value
      1711
    3. group Id
      BG002
      value
      3420
    units
    Participants
groups
  1. description
    Participants randomized to receive the matching placebo subcutaneously (SC) once every 6 months (Q6M) in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
    id
    BG000
    title
    Placebo
  2. description
    Participants randomized to receive 60 mg denosumab SC once Q6M in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
    id
    BG001
    title
    Denosumab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.0
          value
          64.6
        2. group Id
          BG001
          spread
          7.9
          value
          64.0
        3. group Id
          BG002
          spread
          8.0
          value
          64.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1709
        2. group Id
          BG001
          value
          1711
        3. group Id
          BG002
          value
          3420
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1700
        2. group Id
          BG001
          value
          1702
        3. group Id
          BG002
          value
          3402
        title
        White/Caucasian
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        Hispanic/Latino
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Black/Afro-Caribbean
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          632
        2. group Id
          BG001
          value
          633
        3. group Id
          BG002
          value
          1265
      title
      Major Academic Center
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1077
        2. group Id
          BG001
          value
          1078
        3. group Id
          BG002
          value
          2155
      title
      Other Center
    param Type
    NUMBER
    title
    Stratification Factor: Type of Hospital
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          269
        2. group Id
          BG001
          value
          270
        3. group Id
          BG002
          value
          539
        title
        No
      2. measurements
        1. group Id
          BG000
          value
          1440
        2. group Id
          BG001
          value
          1441
        3. group Id
          BG002
          value
          2881
        title
        Yes
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor: Prior Aromatase inhibitor Use
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          775
        2. group Id
          BG001
          value
          773
        3. group Id
          BG002
          value
          1548
        title
        T-score < -1.0
      2. measurements
        1. group Id
          BG000
          value
          934
        2. group Id
          BG001
          value
          938
        3. group Id
          BG002
          value
          1872
        title
        T-score ≥ -1.0
    description
    T-scores are standardized scores that reflect the standard deviations (SDs) above/below the normal mean for young adults. T-score ≥ -1.0: BMD is considered normal. T-score \< -1.0: Low BMD.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor: Total Lumbar Spine BMD T-score
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice