NCT01286077 · OUTCOME

Change From Baseline in Biochemical Bone Markers:Carboxyterminal Telopeptide of Type I Collagen (ICTP), Osteocalcin, Bone-specific Alkaline Phosphatase (BAP)

Velcade Consolidation Bone Study · Source last updated 2016-05-30

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

Measure: MEAN
Unit: Microgram per liter
Interval / dispersion: Standard Deviation
Time frame: Baseline up to end of study (approximately 4 years 7 months)

What was measured

Bone markers (carboxyterminal telopeptide of type I collagen (ICTP), osteocalcin (Oc) and bone-specific alkaline phosphatase (BAP) was measured on serum samples.

Analysis population: FAS was used for analysis. "N" (number of subjects analyzed) signifies the subjects evaluable this measure and n=number pf participants analysed for this outcome measure at specific time point. Missing data was imputed by last observation carried forward (LOCF) method.

Groups in this outcome

Bortezomib

bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles

Non-treated Control

no treatment, observation only

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
Bortezomib	46
Non-treated Control	47

Reported measurements

ICTP (n= 44, 42)

Values in Microgram per liter · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bortezomib	-4.11	4.36	Not reported	Not reported	Not reported
Non-treated Control	-3.51	3.81	Not reported	Not reported	Not reported

Osteocalcin (44, 42)

Values in Microgram per liter · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bortezomib	20.15	28.79	Not reported	Not reported	Not reported
Non-treated Control	14.59	5.57	Not reported	Not reported	Not reported

BAP (42, 40)

Values in Microgram per liter · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bortezomib	-0.48	6.08	Not reported	Not reported	Not reported
Non-treated Control	-2.11	4.80	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
4.36
value
-4.11
group Id
OG001
spread
3.81
value
-3.51
title
ICTP (n= 44, 42)
categories
measurements
group Id
OG000
spread
28.79
value
20.15
group Id
OG001
spread
5.57
value
14.59
title
Osteocalcin (44, 42)
categories
measurements
group Id
OG000
spread
6.08
value
-0.48
group Id
OG001
spread
4.80
value
-2.11
title
BAP (42, 40)

denoms

counts
group Id
OG000
value
46
group Id
OG001
value
47
units
Participants

description

Bone markers (carboxyterminal telopeptide of type I collagen (ICTP), osteocalcin (Oc) and bone-specific alkaline phosphatase (BAP) was measured on serum samples.

dispersion Type

Standard Deviation

groups

description
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
id
OG000
title
Bortezomib
description
no treatment, observation only
id
OG001
title
Non-treated Control

param Type

MEAN

population Description

FAS was used for analysis. "N" (number of subjects analyzed) signifies the subjects evaluable this measure and n=number pf participants analysed for this outcome measure at specific time point. Missing data was imputed by last observation carried forward (LOCF) method.

reporting Status

POSTED

time Frame

Baseline up to end of study (approximately 4 years 7 months)

title

Change From Baseline in Biochemical Bone Markers:Carboxyterminal Telopeptide of Type I Collagen (ICTP), Osteocalcin, Bone-specific Alkaline Phosphatase (BAP)

type

SECONDARY

unit Of Measure

Microgram per liter

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

Preserved source evidence · Not medical advice