NCT00869206 · OUTCOME

Skeletal Morbidity Rate

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: SRE's per year
Interval / dispersion: Standard Deviation
Time frame: from baseline up to 2 years

What was measured

To compare the skeletal morbidity rate, defined as the number of skeletal-related events per year, of patients receiving every 12 week dosing to those receiving every 4 week dosing.

Analysis population: 1766 patients were treated and 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

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

Reported measurements

Source class 1

Values in SRE's per year · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm I (Zoledronic Acid Every 4 Weeks)	.4	1.0	Not reported	Not reported	Not reported
Arm II (Zoledronic Acid Every 12 Weeks)	.4	1.1	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
1.0
value
.4
group Id
OG001
spread
1.1
value
.4

denoms

counts
group Id
OG000
value
882
group Id
OG001
value
884
units
Participants

description

To compare the skeletal morbidity rate, defined as the number of skeletal-related events per year, of patients receiving every 12 week dosing to those receiving every 4 week dosing.

dispersion Type

Standard Deviation

groups

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)
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 were treated and analyzed.

reporting Status

POSTED

time Frame

from baseline up to 2 years

title

Skeletal Morbidity Rate

type

SECONDARY

unit Of Measure

SRE's per year

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

Preserved source evidence · Not medical advice