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Completed Phase 4 Interventional

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

ClinicalTrials.gov ID: NCT00063609

Public ClinicalTrials.gov record NCT00063609. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 29, 2026, 8:49 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00063609
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
200 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 2003 (Type not available)
Primary completion
Not listed
Completion
Apr 2005 (Type not available)
Last update posted
Sep 13, 2017

2003 – 2005

United States locations

U.S. sites
44
U.S. states
23
U.S. cities
41
Facility City State ZIP Site status
Millennium Therapeutics & Research Birmingham Alabama 35205 —
Medical Affiliated Research Center Huntsville Alabama 35801 —
Alaska Clinical Research Center Anchorage Alaska 99508 —
Advanced Clinical Therapeutics Tucson Arizona 85712 —
Donald Gleason, MD Tucson Arizona 85712 —
Arkansas Urology Little Rock Arkansas 72211 —
Advanced Urology Med. Center Anaheim California 92801 —
Atlantic Urological Medical Group Long Beach California 90806 —
San Diego Uro. Research San Diego California 92101 —
Western Clinical Research Torrance California 90505 —
Connecticut Surgical Group Hartford Connecticut 06106 —
Grove Hill Urology New Britain Connecticut 06052 —
Atlantic Urological Associates Daytona Beach Florida 32114 —
University of Miami School of Medicine, Dept. of Urology Miami Florida 33176 —
Advanced Research Institute, Inc. New Port Richey Florida 34652 —
Urosearch Ocala Florida 34470 —
Southeastern Urological Center, PA Tallahassee Florida 32308 —
Medisphere Medical Research Center, LLC Evansville Indiana 47714 —
The Iowa Clinic, PC, Iowa Urology Research Des Moines Iowa 50309 —
Summitt Clinical Research Owings Mills Maryland 21117 —
Millennium Medical Center Southfield Michigan 48075 —
Quality Clinical Research LLC Springfield Nebraska 68059 —
Associated Urologic Specialist, PA Marlton New Jersey 08053 —
Morristown Memorial Hospital Morristown New Jersey 07962 —
Associates In Urology, LLC West Orange New Jersey 07052 —
AccuMed Research Associates Garden City New York 11530 —
Urological Surgeons of L.I. Garden City New York 11530 —
Staten Island Urological Research, PC Staten Island New York 10304 —
The Urology Group Cincinnati Ohio 45212 —
Urological Associates, Inc. Columbus Ohio 43222 —
Mount Vernon Urological Associates Mount Vernon Ohio 43050 —
Oregon Urology Specialists Eugene Oregon 97401 —
The Urology Clinic Portland Oregon 97210 —
Urologic Associates of Allentown Allentown Pennsylvania 18103 —
Albert Einstein Medical Center Philadelphia Pennsylvania 19141 —
Triangle Urological Group Pittsburgh Pennsylvania 15212 —
Urologic Surgeons of New England, P.C. Providence Rhode Island 02904 —
University Urological Research Institute Providence Rhode Island 02906 —
Carolina Urologic Research Center Myrtle Beach South Carolina 29572 —
Integrity Clinical Research, LLC Germantown Tennessee 38138 —
Urology San Antonio Research San Antonio Texas 78229 —
Salt Lake Research Salt Lake City Utah 84124 —
Seattle Urological Associates Seattle Washington 98704 —
Rockwood Clinic Spokane Washington 99220 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00063609, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 13, 2017 · Synced Oct 29, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00063609 live on ClinicalTrials.gov.

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