The Effect of Zoledronic Acid on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy

September 11, 2017 updated by: Novartis Pharmaceuticals

The Effect of Zoledronic Acid Compared to Placebo on Bone Mineral Density in Patients Undergoing Androgen Deprivation Therapy

The purpose of this study is to compare the effect of an investigational drug used intravenously and placebo administered every three months for one year, on bone loss associated with initial androgen deprivation) in men with prostate cancer without metastasis. In order to participate in this trial male patients must be 18 years of age or older and have been diagnosed with prostate cancer without metastasis and within one year of starting their androgen deprivation therapy at the day of randomization onto this trial. In addition, patients who have undergone a recent orchiectomy (or"ke-ek'te-me) (removal of one or two testes) are eligible to participate.

Patients who received any prior bisphosphonate therapy or prior treatment with systemic corticosteroids within in the past 12 months are not eligible to participate. Also patients who are receiving treatment for osteoporosis are not eligible to participate.

Inclusion into this clinical trial with this investigational drug is based on the protocol entry criteria and evaluation from a participating trial investigator.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

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
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Millennium Therapeutics & Research
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Center
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Clinical Research Center
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Advanced Clinical Therapeutics
      • Tucson, Arizona, United States, 85712
        • Donald Gleason, MD
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Urology
    • California
      • Anaheim, California, United States, 92801
        • Advanced Urology Med. Center
      • Long Beach, California, United States, 90806
        • Atlantic Urological Medical Group
      • San Diego, California, United States, 92101
        • San Diego Uro. Research
      • Torrance, California, United States, 90505
        • Western Clinical Research
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Connecticut Surgical Group
      • New Britain, Connecticut, United States, 06052
        • Grove Hill Urology
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Atlantic Urological Associates
      • Miami, Florida, United States, 33176
        • University of Miami School of Medicine, Dept. of Urology
      • New Port Richey, Florida, United States, 34652
        • Advanced Research Institute, Inc.
      • Ocala, Florida, United States, 34470
        • UroSearch
      • Tallahassee, Florida, United States, 32308
        • Southeastern Urological Center, PA
    • Indiana
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center, LLC
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • The Iowa Clinic, PC, Iowa Urology Research
    • Maryland
      • Owings Mills, Maryland, United States, 21117
        • Summitt Clinical Research
    • Michigan
      • Southfield, Michigan, United States, 48075
        • Millennium Medical Center
    • Nebraska
      • Springfield, Nebraska, United States, 68059
        • Quality Clinical Research LLC
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Associated Urologic Specialist, PA
      • Morristown, New Jersey, United States, 07962
        • Morristown Memorial Hospital
      • West Orange, New Jersey, United States, 07052
        • Associates in Urology, LLC
    • New York
      • Garden City, New York, United States, 11530
        • AccuMed Research Associates
      • Garden City, New York, United States, 11530
        • Urological Surgeons of L.I.
      • Staten Island, New York, United States, 10304
        • Staten Island Urological Research, PC
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • The Urology Group
      • Columbus, Ohio, United States, 43222
        • Urological Associates, Inc.
      • Mount Vernon, Ohio, United States, 43050
        • Mount Vernon Urological Associates
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oregon Urology Specialists
      • Portland, Oregon, United States, 97210
        • The Urology Clinic
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Urologic Associates of Allentown
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center
      • Pittsburgh, Pennsylvania, United States, 15212
        • Triangle Urological Group
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Urologic Surgeons of New England, P.C.
      • Providence, Rhode Island, United States, 02906
        • University Urological Research Institute
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Integrity Clinical Research, LLC
    • Texas
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio Research
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Salt Lake Research
    • Washington
      • Seattle, Washington, United States, 98704
        • Seattle Urological Associates
      • Spokane, Washington, United States, 99220
        • Rockwood Clinic

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

Male

Description

  • Histologically confirmed diagnosis of carcinoma of the prostate
  • No distant metastases (stage TNMO) (ie. prostate cancer without metastases)
  • Patients within one year at the day of randomization from initiation of androgen deprivation therapy with a LHRH agonist (with or without an antiandrogen) and with the intended duration of androgen deprivation therapy of at least 12 months. Patients may also enter if they have received an orchiectomy (or"ke-ek'te-me) within two weeks of visit 1
  • Patients who received any prior bisphosphonate therapy in the past 12 months will be excluded
  • Patients who are currently receiving diethylstilbesterol (DES) or PC-SPES (treatment for osteoporosis) will be excluded
  • Patients who have received prior treatment with systemic corticosteroids within the past 12 months will be excluded (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting or for acute illness like asthma exacerbation, is acceptable)
  • Other eligibility criteria may apply

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percent change in bone mineral density of the lumbar spine (L2-L4) at one year.

Secondary Outcome Measures

Outcome Measure
Percent changes in bone mineral density of the total hip
biochemical markers of bone turnover at one year

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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

April 1, 2003

Study Completion

April 1, 2005

Study Registration Dates

First Submitted

July 1, 2003

First Submitted That Met QC Criteria

July 2, 2003

First Posted (Estimate)

July 3, 2003

Study Record Updates

Last Update Posted (Actual)

September 13, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446GUS45
  • ZENITH

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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