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NCT00321464 · OUTCOME

Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority)

A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects. · Source last updated 2022-11-08

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 34 months

What was measured

Time to first on-study skeletal-related event (SRE) using a non-inferiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented.

Analysis population: Full Analysis Set, composed of all randomized participants.

Groups in this outcome

Zoledronic Acid

Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks

Denosumab

Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks

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

Analysis denominator · Participants

GroupSource count
Zoledronic Acid1020
Denosumab1026

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zoledronic Acid372Not reportedNot reportedNot reportedNot reported
Denosumab315Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.71
    ci Pct Value
    95
    ci Upper Limit
    0.95
    estimate Comment
    Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    A synthesis method was used for the non-inferiority test for the hypothesis that denosumab preserves at least 50% of the effect of zoledronic acid vs. placebo.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE_LEGACY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.82
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.71
    ci Pct Value
    95
    ci Upper Limit
    0.95
    estimate Comment
    Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    A synthesis method was used for the non-inferiority test for the hypothesis that denosumab preserves at least 50% of the effect of zoledronic acid vs. placebo.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE_LEGACY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.82
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        372
      2. group Id
        OG001
        value
        315
denoms
  1. counts
    1. group Id
      OG000
      value
      1020
    2. group Id
      OG001
      value
      1026
    units
    Participants
description
Time to first on-study skeletal-related event (SRE) using a non-inferiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented.
groups
  1. description
    Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
    id
    OG000
    title
    Zoledronic Acid
  2. description
    Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
    id
    OG001
    title
    Denosumab
param Type
NUMBER
population Description
Full Analysis Set, composed of all randomized participants.
reporting Status
POSTED
time Frame
Up to 34 months
title
Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice