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NCT00869206 · OUTCOME

Percentage of Participants With at Least One Skeletal-related Event (SRE) Within 2 Years After Randomization

Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement · Source last updated 2018-11-07

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
2 years

What was measured

To determine whether every-12-week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma involving bone, as measured by the proportion of patients who would have experienced at least one skeletal related event within 24 months after randomization.

Analysis population: All patients that were eligible and completed treatment were analyzed.

Groups in this outcome

Arm I (Zoledronic Acid Every 4 Weeks)

Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Arm II (Zoledronic Acid Every 12 Weeks)

Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm I (Zoledronic Acid Every 4 Weeks)911
Arm II (Zoledronic Acid Every 12 Weeks)911

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Zoledronic Acid Every 4 Weeks)67.6Not reportedNot reportedNot reportedNot reported
Arm II (Zoledronic Acid Every 12 Weeks)67.9Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Based on the published data on the effect of a standard of dosing schedule of \> zoledronic acid compared to placebo, we choose ∆= 7%, πT= 42%, and πS= 35%. With a total of 1230 eligible patients (615 per arm), the probability of rejecting the null hypothesis using a one-sided test is at most 0.05 (Type I error α) when θ≥ 7% and the probability of rejecting the null hypothesis (the power) is at least 82% when θ≤0
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    p Value
    <=.05
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Based on the published data on the effect of a standard of dosing schedule of \> zoledronic acid compared to placebo, we choose ∆= 7%, πT= 42%, and πS= 35%. With a total of 1230 eligible patients (615 per arm), the probability of rejecting the null hypothesis using a one-sided test is at most 0.05 (Type I error α) when θ≥ 7% and the probability of rejecting the null hypothesis (the power) is at least 82% when θ≤0
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    p Value
    <=.05
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        67.6
      2. group Id
        OG001
        value
        67.9
denoms
  1. counts
    1. group Id
      OG000
      value
      911
    2. group Id
      OG001
      value
      911
    units
    Participants
description
To determine whether every-12-week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma involving bone, as measured by the proportion of patients who would have experienced at least one skeletal related event within 24 months after randomization.
groups
  1. description
    Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Arm I (Zoledronic Acid Every 4 Weeks)
  2. description
    Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Arm II (Zoledronic Acid Every 12 Weeks)
param Type
NUMBER
population Description
All patients that were eligible and completed treatment were analyzed.
reporting Status
POSTED
time Frame
2 years
title
Percentage of Participants With at Least One Skeletal-related Event (SRE) Within 2 Years After Randomization
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice