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NCT00079001 · FLOW

Participant flow

Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases · Source last updated 2020-05-12

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

groups
  1. description
    4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
    id
    FG000
    title
    Zoledronic Acid + Androgen Deprivation Therapy
  2. description
    Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
    id
    FG001
    title
    Placebo + Androgen Deprivation Therapy
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        323
      2. group Id
        FG001
        num Subjects
        322
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        323
      2. group Id
        FG001
        num Subjects
        322
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Between January 2004 and May 2012, 645 participants were registered and randomized.
Complete source fields
groups
  1. description
    4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
    id
    FG000
    title
    Zoledronic Acid + Androgen Deprivation Therapy
  2. description
    Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
    id
    FG001
    title
    Placebo + Androgen Deprivation Therapy
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        323
      2. group Id
        FG001
        num Subjects
        322
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        323
      2. group Id
        FG001
        num Subjects
        322
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Between January 2004 and May 2012, 645 participants were registered and randomized.

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

Preserved source evidence · Not medical advice