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NCT00869206 · OUTCOME

Average Pain Intensity Score as Assessed by the Brief Pain Inventory (BPI) Questionnaire

Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement · Source last updated 2018-11-07

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

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Error
Time frame
from baseline up to 2 years

What was measured

To compare pain scores (Brief Pain Inventory) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The change scores were evaluated in a general linear model with repeated measures for treatment effect and the time trend with patient-specific characteristics being adjusted for the mean interference score. Specifically the difference in score change per 4 weeks for Arm I using Arm II as the reference is reported. The score of the BPI questionnaire ranges from 0 being no pain to 10 being the most pain. The average score is reported for each arm below.

Analysis population: 1766 patients completed treatment and were analyzed.

Groups in this outcome

Arm I (Zoledronic Acid Every 4 Weeks)

Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Arm II (Zoledronic Acid Every 12 Weeks)

Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Arm I (Zoledronic Acid Every 4 Weeks)882
Arm II (Zoledronic Acid Every 12 Weeks)884

Reported measurements

Source class 1
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Zoledronic Acid Every 4 Weeks)2.060.14Not reportedNot reportedNot reported
Arm II (Zoledronic Acid Every 12 Weeks)2.090.14Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    0.009620
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.68
    param Type
    Slope
    param Value
    -0.00394
    statistical Comment
    Model is adjusted for tumor type, baseline creatinine, prior SREs, prior bisphosphonates, age, gender, race, BSA, and baseline performance status
    statistical Method
    Mixed Models Analysis
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    0.009620
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.68
    param Type
    Slope
    param Value
    -0.00394
    statistical Comment
    Model is adjusted for tumor type, baseline creatinine, prior SREs, prior bisphosphonates, age, gender, race, BSA, and baseline performance status
    statistical Method
    Mixed Models Analysis
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.14
        value
        2.06
      2. group Id
        OG001
        spread
        0.14
        value
        2.09
denoms
  1. counts
    1. group Id
      OG000
      value
      882
    2. group Id
      OG001
      value
      884
    units
    Participants
description
To compare pain scores (Brief Pain Inventory) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The change scores were evaluated in a general linear model with repeated measures for treatment effect and the time trend with patient-specific characteristics being adjusted for the mean interference score. Specifically the difference in score change per 4 weeks for Arm I using Arm II as the reference is reported. The score of the BPI questionnaire ranges from 0 being no pain to 10 being the most pain. The average score is reported for each arm below.
dispersion Type
Standard Error
groups
  1. description
    Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Arm I (Zoledronic Acid Every 4 Weeks)
  2. description
    Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Arm II (Zoledronic Acid Every 12 Weeks)
param Type
MEAN
population Description
1766 patients completed treatment and were analyzed.
reporting Status
POSTED
time Frame
from baseline up to 2 years
title
Average Pain Intensity Score as Assessed by the Brief Pain Inventory (BPI) Questionnaire
type
SECONDARY
unit Of Measure
score on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice