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NCT00104650 · OUTCOME

Percent Change of uNTx (Corrected by Creatinne) From Baseline to Week 25

Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates · Source last updated 2011-01-24

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

Measure
MEAN
Unit
Percent change
Interval / dispersion
Standard Deviation
Time frame
Baseline, week 25

What was measured

Percent change from baseline to week 25 urinary N-telopeptide (uNTX) calculated using ((week 25 value - baseline value) / baseline value ) x 100.

Analysis population: All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.

Groups in this outcome

Bisphosphonate IV Q4W

Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)

Denosumab 180 mg Q12W

Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)

Denosumab 180 mg Q4W

Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)

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

Analysis denominator · Participants

GroupSource count
Bisphosphonate IV Q4W23
Denosumab 180 mg Q12W25
Denosumab 180 mg Q4W26

Reported measurements

Source class 1
Values in Percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bisphosphonate IV Q4W-32.9165.91Not reportedNot reportedNot reported
Denosumab 180 mg Q12W-69.0929.97Not reportedNot reportedNot reported
Denosumab 180 mg Q4W-41.68118.32Not 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
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.388
    statistical Comment
    Adjusted for the stratum to which participants were originally assigned by the Interactive Voice Response System (IVRS)
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.388
    statistical Comment
    Adjusted for the stratum to which participants were originally assigned by the Interactive Voice Response System (IVRS)
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        65.91
        value
        -32.91
      2. group Id
        OG001
        spread
        29.97
        value
        -69.09
      3. group Id
        OG002
        spread
        118.32
        value
        -41.68
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      25
    3. group Id
      OG002
      value
      26
    units
    Participants
description
Percent change from baseline to week 25 urinary N-telopeptide (uNTX) calculated using ((week 25 value - baseline value) / baseline value ) x 100.
dispersion Type
Standard Deviation
groups
  1. description
    Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
    id
    OG000
    title
    Bisphosphonate IV Q4W
  2. description
    Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
    id
    OG001
    title
    Denosumab 180 mg Q12W
  3. description
    Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
    id
    OG002
    title
    Denosumab 180 mg Q4W
param Type
MEAN
population Description
All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.
reporting Status
POSTED
time Frame
Baseline, week 25
title
Percent Change of uNTx (Corrected by Creatinne) From Baseline to Week 25
type
SECONDARY
unit Of Measure
Percent change

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice