Treatment With Zoledronic Acid in Patients With Breast Cancer, Multiple Myeloma, and Prostate Cancer With Cancer Related Bone Lesions

January 30, 2012 updated by: Novartis

A Prospective, Multicenter, Open-label Clinical Evaluation of the Effect of IV Zoledronic Acid 4mg on PAIN, QUALITY OF LIFE and TIME IN INFUSION CHAIR in Breast Cancer, Multiple Myeloma, and Prostate Cancer Patients With Cancer-related Bone Lesions

Patients with bone metastases or bone lesions caused by breast cancer, multiple myeloma or prostate cancer will be treated with IV Zometa in a 15 minute infusion. Pain will be evaluated, as well as time in chair, quality of life and safety of Zometa.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stockton, California, United States, 95204
        • Stockton Hematology Oncology Medical Group
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Osceola Cancer Center
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Nevada Cancer Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Hematology-Oncology Associates PC
      • Albuquerque, New Mexico, United States, 87102
        • New Mexico Oncology Hematology Consultants
    • Oregon
      • Medforo, Oregon, United States, 97504
        • Hematology Oncology Associates, PC
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Virginia Physicians, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Signed informed consent
  • Greater than 18 years of age
  • Proof of breast cancer, multiple myeloma or prostate cancer
  • Diagnosis of at least one cancer-related bone lesion
  • If patient is of child-bearing potential, negative pregnancy test and on a medically recognized form of contraception
  • ECOG performance status of 0,1 or 2
  • Ability to read, understand and write English or Spanish language
  • Normal renal function
  • Corrected serum calcium equal to or greater than 8mg/dl Exclusion Criteria
  • clinically symptomatic brain metastases
  • hypersensitivity to Zometa or other bisphosphonates
  • pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain score assessed by change from baseline

Secondary Outcome Measures

Outcome Measure
Quality of life
Safety assessed by adverse events (AEs)
Time in infusion chair

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (Actual)

November 1, 2002

Study Completion (Actual)

November 1, 2002

Study Registration Dates

First Submitted

January 9, 2002

First Submitted That Met QC Criteria

January 9, 2002

First Posted (Estimate)

January 10, 2002

Study Record Updates

Last Update Posted (Estimate)

February 1, 2012

Last Update Submitted That Met QC Criteria

January 30, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446EUS16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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