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NCT00869206 · OUTCOME

Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Prostate 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 24 months

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: 207 prostate cancer patients who were treated and included in this portion of the substudy.

Groups in this outcome

Prostate Cancer 4 Weeks

Patients with Prostate 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.

Prostate Cancer 12 Weeks

Patients with Prostate Cancer 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
Prostate Cancer 4 Weeks104
Prostate Cancer 12 Weeks103

Reported measurements

Low CTX (<0.415ng/ml)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Prostate Cancer 4 Weeks34Not reportedNot reportedNot reportedNot reported
Prostate Cancer 12 Weeks49Not reportedNot reportedNot reportedNot reported
High CTX (>.0.415ng/ml)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Prostate Cancer 4 Weeks70Not reportedNot reportedNot reportedNot reported
Prostate Cancer 12 Weeks54Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        49
    title
    Low CTX (<0.415ng/ml)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        70
      2. group Id
        OG001
        value
        54
    title
    High CTX (>.0.415ng/ml)
denoms
  1. counts
    1. group Id
      OG000
      value
      104
    2. group Id
      OG001
      value
      103
    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 Prostate 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
    Prostate Cancer 4 Weeks
  2. description
    Patients with Prostate Cancer 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
    Prostate Cancer 12 Weeks
param Type
COUNT_OF_PARTICIPANTS
population Description
207 prostate cancer patients who were treated and included in this portion of the substudy.
reporting Status
POSTED
time Frame
from baseline up to 24 months
title
Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Prostate Cancer)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice