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NCT00869206 · OUTCOME

Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Breast Cancer)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
from baseline up to 2 years

What was measured

To compare the suppression of serum markers of bone resorption 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 number of patients with high \& low CTX values by arm will be reported here.

Analysis population: 266 breast cancer patients who were treated and included in this portion of the substudy.

Groups in this outcome

Breast Cancer 4 Weeks

Patients with Breast Cancer 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.

Breast Cancer 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
Breast Cancer 4 Weeks137
Breast Cancer 12 Weeks129

Reported measurements

Low CTX (<0.415ng/ml)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Breast Cancer 4 Weeks83Not reportedNot reportedNot reportedNot reported
Breast Cancer 12 Weeks75Not reportedNot reportedNot reportedNot reported
High CTX (>0.415ng/ml)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Breast Cancer 4 Weeks54Not reportedNot reportedNot reportedNot reported
Breast Cancer 12 Weeks54Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        83
      2. group Id
        OG001
        value
        75
    title
    Low CTX (<0.415ng/ml)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        54
      2. group Id
        OG001
        value
        54
    title
    High CTX (>0.415ng/ml)
denoms
  1. counts
    1. group Id
      OG000
      value
      137
    2. group Id
      OG001
      value
      129
    units
    Participants
description
To compare the suppression of serum markers of bone resorption 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 number of patients with high \& low CTX values by arm will be reported here.
groups
  1. description
    Patients with Breast Cancer 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
    Breast Cancer 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
    Breast Cancer 12 Weeks
param Type
COUNT_OF_PARTICIPANTS
population Description
266 breast cancer patients who were treated and included in this portion of the substudy.
reporting Status
POSTED
time Frame
from baseline up to 2 years
title
Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Breast Cancer)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice