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NCT00104650 · OUTCOME

uNTx (Corrected by Creatinine) < 50 Nmol/mmol at 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
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
25 weeks

What was measured

Urinary N-telopeptide (uNTX) corrected by creatinine \< 50 nmol/mmol at week 25.

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 Q4W35
Denosumab 180 mg Q12W33
Denosumab 180 mg Q4W36

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bisphosphonate IV Q4W13Not reportedNot reportedNot reportedNot reported
Denosumab 180 mg Q12W21Not reportedNot reportedNot reportedNot reported
Denosumab 180 mg Q4W23Not 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
    46.2
    ci Pct Value
    95
    ci Upper Limit
    79.2
    group Ids
    1. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Percentage of participants
    param Value
    63.9
    tested Non Inferiority
    false
  2. ci Lower Limit
    45.1
    ci Pct Value
    95
    ci Upper Limit
    79.6
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Percentage of participants
    param Value
    63.6
    tested Non Inferiority
    false
  3. ci Lower Limit
    21.5
    ci Pct Value
    95
    ci Upper Limit
    55.1
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Percentage of participants
    param Value
    37.1
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    46.2
    ci Pct Value
    95
    ci Upper Limit
    79.2
    group Ids
    1. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Percentage of participants
    param Value
    63.9
    tested Non Inferiority
    false
  2. ci Lower Limit
    45.1
    ci Pct Value
    95
    ci Upper Limit
    79.6
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Percentage of participants
    param Value
    63.6
    tested Non Inferiority
    false
  3. ci Lower Limit
    21.5
    ci Pct Value
    95
    ci Upper Limit
    55.1
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Percentage of participants
    param Value
    37.1
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        21
      3. group Id
        OG002
        value
        23
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    2. group Id
      OG001
      value
      33
    3. group Id
      OG002
      value
      36
    units
    Participants
description
Urinary N-telopeptide (uNTX) corrected by creatinine \< 50 nmol/mmol at week 25.
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
NUMBER
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
25 weeks
title
uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice