Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00556374 · FLOW

Participant flow

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.

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
    FG000
    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
    FG001
    title
    Denosumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        235
      2. group Id
        FG001
        num Subjects
        205
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        158
      2. group Id
        FG001
        num Subjects
        127
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        17
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        50
      2. group Id
        FG001
        num Subjects
        0
      type
      Continuing into Zoledronic Acid Substudy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1709
      2. group Id
        FG001
        num Subjects
        1711
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1699
      2. group Id
        FG001
        num Subjects
        1700
      type
      Received Study Drug in the Double-blind Phase
    3. achievements
      1. group Id
        FG000
        num Subjects
        268
      2. group Id
        FG001
        num Subjects
        3
      type
      Continued Into the Open-Label Phase
    4. achievements
      1. comment
        The safety analysis set was summarized based on the actual treatment received in the double-blind phase. Participants who received at least 1 dose of denosumab in the double-blind phase were summarized in the denosumab group regardless of the randomized treatment.
        group Id
        FG000
        num Subjects
        1690
      2. comment
        The safety analysis set was summarized based on the actual treatment received in the double-blind phase. Participants who received at least 1 dose of denosumab in the double-blind phase were summarized in the denosumab group regardless of the randomized treatment.
        group Id
        FG001
        num Subjects
        1709
      type
      Safety Analysis Set
    5. achievements
      1. group Id
        FG000
        num Subjects
        1242
      2. group Id
        FG001
        num Subjects
        1362
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        467
      2. group Id
        FG001
        num Subjects
        349
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants were randomized in a 1:1 ratio to receive either denosumab or placebo in the double-blind phase. Randomization was stratified by type of hospital (major academic centers or other centers), prior aromatase inhibitor usage (Yes/No) and total lumbar spine bone mineral density (BMD) score at baseline (T-score \< -1.0 or ≥ -1.0). Willing and eligible participants continued into the open-label phase and receive denosumab for a maximum of 7 doses once Q6M.
recruitment Details
Participants were enrolled at 58 centers in Austria and Sweden from December 2006 to August 2020. Data collected during the exploratory ZA substudy were not used for the final analysis of the main study.
Complete source fields
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
    FG000
    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
    FG001
    title
    Denosumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        235
      2. group Id
        FG001
        num Subjects
        205
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        158
      2. group Id
        FG001
        num Subjects
        127
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        17
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        50
      2. group Id
        FG001
        num Subjects
        0
      type
      Continuing into Zoledronic Acid Substudy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1709
      2. group Id
        FG001
        num Subjects
        1711
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1699
      2. group Id
        FG001
        num Subjects
        1700
      type
      Received Study Drug in the Double-blind Phase
    3. achievements
      1. group Id
        FG000
        num Subjects
        268
      2. group Id
        FG001
        num Subjects
        3
      type
      Continued Into the Open-Label Phase
    4. achievements
      1. comment
        The safety analysis set was summarized based on the actual treatment received in the double-blind phase. Participants who received at least 1 dose of denosumab in the double-blind phase were summarized in the denosumab group regardless of the randomized treatment.
        group Id
        FG000
        num Subjects
        1690
      2. comment
        The safety analysis set was summarized based on the actual treatment received in the double-blind phase. Participants who received at least 1 dose of denosumab in the double-blind phase were summarized in the denosumab group regardless of the randomized treatment.
        group Id
        FG001
        num Subjects
        1709
      type
      Safety Analysis Set
    5. achievements
      1. group Id
        FG000
        num Subjects
        1242
      2. group Id
        FG001
        num Subjects
        1362
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        467
      2. group Id
        FG001
        num Subjects
        349
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants were randomized in a 1:1 ratio to receive either denosumab or placebo in the double-blind phase. Randomization was stratified by type of hospital (major academic centers or other centers), prior aromatase inhibitor usage (Yes/No) and total lumbar spine bone mineral density (BMD) score at baseline (T-score \< -1.0 or ≥ -1.0). Willing and eligible participants continued into the open-label phase and receive denosumab for a maximum of 7 doses once Q6M.
recruitment Details
Participants were enrolled at 58 centers in Austria and Sweden from December 2006 to August 2020. Data collected during the exploratory ZA substudy were not used for the final analysis of the main study.

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

Preserved source evidence · Not medical advice