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NCT01286077 · OUTCOME

Change From Baseline in Bone Mineral Density (BMD) in the Spine at End of Treatment (EOT)

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
g/mm2
Interval / dispersion
Standard Deviation
Time frame
at screening (i.e. between 14 and 1 days prior to start of treatment) and at end of treatment (EOT), i.e. 24 weeks after randomization or until start of alternative MMY therapy, if earlier

What was measured

Change from baseline in bone mineral density (BMD) will be assessed by dual energy x-ray absorptiometry scans at baseline and the EOT visit

Analysis population: ITT analysis:13 patients in the bortezomib group and 14 patients in the non-treated control group did not have values at the 2 timepoints to allow calculation of the parameter

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

GroupSource count
Bortezomib38
Non-treated Control39

Reported measurements

Source class 1
Values in g/mm2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bortezomib0.02140.0306Not reportedNot reportedNot reported
Non-treated Control0.01670.0301Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0306
        value
        0.0214
      2. group Id
        OG001
        spread
        0.0301
        value
        0.0167
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    2. group Id
      OG001
      value
      39
    units
    Participants
description
Change from baseline in bone mineral density (BMD) will be assessed by dual energy x-ray absorptiometry scans at baseline and the EOT visit
dispersion Type
Standard Deviation
groups
  1. 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
  2. description
    no treatment, observation only
    id
    OG001
    title
    Non-treated Control
param Type
MEAN
population Description
ITT analysis:13 patients in the bortezomib group and 14 patients in the non-treated control group did not have values at the 2 timepoints to allow calculation of the parameter
reporting Status
POSTED
time Frame
at screening (i.e. between 14 and 1 days prior to start of treatment) and at end of treatment (EOT), i.e. 24 weeks after randomization or until start of alternative MMY therapy, if earlier
title
Change From Baseline in Bone Mineral Density (BMD) in the Spine at End of Treatment (EOT)
type
PRIMARY
unit Of Measure
g/mm2

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

Preserved source evidence · Not medical advice