NCT00104650 · OUTCOME

uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13

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: 13 weeks

What was measured

Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) \< 50 nmol/mmol at week 13.

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

Group	Source count
Bisphosphonate IV Q4W	35
Denosumab 180 mg Q12W	33
Denosumab 180 mg Q4W	36

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bisphosphonate IV Q4W	10	Not reported	Not reported	Not reported	Not reported
Denosumab 180 mg Q12W	21	Not reported	Not reported	Not reported	Not reported
Denosumab 180 mg Q4W	28	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
3.35
ci Pct Value
95
ci Upper Limit
45.03
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.001
param Type
Odds Ratio (OR)
param Value
12.28
statistical Comment
Adjusted for cancer type stratification factor
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
ci Lower Limit
1.74
ci Pct Value
95
ci Upper Limit
16.36
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.002
param Type
Odds Ratio (OR)
param Value
5.33
statistical Comment
Adjusted for cancer type stratification factor
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
ci Lower Limit
60.8
ci Pct Value
95
ci Upper Limit
89.9
group Ids
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Percentage of participants
param Value
77.8
tested Non Inferiority
false
ci Lower Limit
45.1
ci Pct Value
95
ci Upper Limit
79.6
group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Percentage of participants
param Value
63.6
tested Non Inferiority
false
ci Lower Limit
14.6
ci Pct Value
95
ci Upper Limit
46.3
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Percentage of participants
param Value
28.6
tested Non Inferiority
false

Complete source fields

analyses

ci Lower Limit
3.35
ci Pct Value
95
ci Upper Limit
45.03
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.001
param Type
Odds Ratio (OR)
param Value
12.28
statistical Comment
Adjusted for cancer type stratification factor
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
ci Lower Limit
1.74
ci Pct Value
95
ci Upper Limit
16.36
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.002
param Type
Odds Ratio (OR)
param Value
5.33
statistical Comment
Adjusted for cancer type stratification factor
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
ci Lower Limit
60.8
ci Pct Value
95
ci Upper Limit
89.9
group Ids
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Percentage of participants
param Value
77.8
tested Non Inferiority
false
ci Lower Limit
45.1
ci Pct Value
95
ci Upper Limit
79.6
group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Percentage of participants
param Value
63.6
tested Non Inferiority
false
ci Lower Limit
14.6
ci Pct Value
95
ci Upper Limit
46.3
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Percentage of participants
param Value
28.6
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
value
10
group Id
OG001
value
21
group Id
OG002
value
28

denoms

counts
group Id
OG000
value
35
group Id
OG001
value
33
group Id
OG002
value
36
units
Participants

description

Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) \< 50 nmol/mmol at week 13.

groups

description
Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
id
OG000
title
Bisphosphonate IV Q4W
description
Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
id
OG001
title
Denosumab 180 mg Q12W
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

13 weeks

title

uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13

type

PRIMARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice