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NCT00330759 · OUTCOME

Time to the First On-Study Skeletal-Related Event (Non-Inferiority)

Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma. · Source last updated 2022-11-07

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

Measure
MEDIAN
Unit
Days
Interval / dispersion
95% Confidence Interval
Time frame
up to 33 months

What was measured

Time to the first on-study skeletal-related event (SRE) using a non-inferiority analysis. Median was estimated using the Kaplan-Meier method.

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

Groups in this outcome

Zoledronic Acid

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

Denosumab

Denosumab 120 mg by subcutaneous injection with an 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 Acid890
Denosumab886

Reported measurements

Source class 1
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Zoledronic Acid496.0Not reported371.00589.00Not reported
Denosumab625.0Not reported456.00NAUpper limit could not be estimated due to the low number of events

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
    0.98
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    A synthesis approach was used for a non-inferiority test of 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
    0.0007
    param Type
    Hazard Ratio (HR)
    param Value
    0.84
    statistical Comment
    Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.71
    ci Pct Value
    95
    ci Upper Limit
    0.98
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    A synthesis approach was used for a non-inferiority test of 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
    0.0007
    param Type
    Hazard Ratio (HR)
    param Value
    0.84
    statistical Comment
    Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        371.00
        upper Limit
        589.00
        value
        496.0
      2. comment
        Upper limit could not be estimated due to the low number of events
        group Id
        OG001
        lower Limit
        456.00
        upper Limit
        NA
        value
        625.0
denoms
  1. counts
    1. group Id
      OG000
      value
      890
    2. group Id
      OG001
      value
      886
    units
    Participants
description
Time to the first on-study skeletal-related event (SRE) using a non-inferiority analysis. Median was estimated using the Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
    id
    OG000
    title
    Zoledronic Acid
  2. description
    Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
    id
    OG001
    title
    Denosumab
param Type
MEDIAN
population Description
Full Analysis Set, composed of all randomized participants.
reporting Status
POSTED
time Frame
up to 33 months
title
Time to the First On-Study Skeletal-Related Event (Non-Inferiority)
type
PRIMARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice