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NCT00869206 · OUTCOME

Incidence of Osteonecrosis of the Jaw

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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
from baseline up to 2 years

What was measured

To compare the incidence of osteonecrosis of the jaw in 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 percentage of participants with osteonecrosis is reported here.

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 percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Zoledronic Acid Every 4 Weeks)2.0Not reportedNot reportedNot reportedNot reported
Arm II (Zoledronic Acid Every 12 Weeks)1.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2.0
      2. group Id
        OG001
        value
        1.0
denoms
  1. counts
    1. group Id
      OG000
      value
      882
    2. group Id
      OG001
      value
      884
    units
    Participants
description
To compare the incidence of osteonecrosis of the jaw in 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 percentage of participants with osteonecrosis is reported here.
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
NUMBER
population Description
1766 patients completed treatment and were analyzed.
reporting Status
POSTED
time Frame
from baseline up to 2 years
title
Incidence of Osteonecrosis of the Jaw
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice