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

NCT ID: NCT00063609

Last Updated: 2017-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2005-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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zoledronic acid

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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Millennium Therapeutics & Research

Birmingham, Alabama, United States

Site Status

Medical Affiliated Research Center

Huntsville, Alabama, United States

Site Status

Alaska Clinical Research Center

Anchorage, Alaska, United States

Site Status

Advanced Clinical Therapeutics

Tucson, Arizona, United States

Site Status

Donald Gleason, MD

Tucson, Arizona, United States

Site Status

Arkansas Urology

Little Rock, Arkansas, United States

Site Status

Advanced Urology Med. Center

Anaheim, California, United States

Site Status

Atlantic Urological Medical Group

Long Beach, California, United States

Site Status

San Diego Uro. Research

San Diego, California, United States

Site Status

Western Clinical Research

Torrance, California, United States

Site Status

Connecticut Surgical Group

Hartford, Connecticut, United States

Site Status

Grove Hill Urology

New Britain, Connecticut, United States

Site Status

Atlantic Urological Associates

Daytona Beach, Florida, United States

Site Status

University of Miami School of Medicine, Dept. of Urology

Miami, Florida, United States

Site Status

Advanced Research Institute, Inc.

New Port Richey, Florida, United States

Site Status

Urosearch

Ocala, Florida, United States

Site Status

Southeastern Urological Center, PA

Tallahassee, Florida, United States

Site Status

Medisphere Medical Research Center, LLC

Evansville, Indiana, United States

Site Status

The Iowa Clinic, PC, Iowa Urology Research

Des Moines, Iowa, United States

Site Status

Summitt Clinical Research

Owings Mills, Maryland, United States

Site Status

Millennium Medical Center

Southfield, Michigan, United States

Site Status

Quality Clinical Research LLC

Springfield, Nebraska, United States

Site Status

Associated Urologic Specialist, PA

Marlton, New Jersey, United States

Site Status

Morristown Memorial Hospital

Morristown, New Jersey, United States

Site Status

Associates In Urology, LLC

West Orange, New Jersey, United States

Site Status

AccuMed Research Associates

Garden City, New York, United States

Site Status

Urological Surgeons of L.I.

Garden City, New York, United States

Site Status

Staten Island Urological Research, PC

Staten Island, New York, United States

Site Status

The Urology Group

Cincinnati, Ohio, United States

Site Status

Urological Associates, Inc.

Columbus, Ohio, United States

Site Status

Mount Vernon Urological Associates

Mount Vernon, Ohio, United States

Site Status

Oregon Urology Specialists

Eugene, Oregon, United States

Site Status

The Urology Clinic

Portland, Oregon, United States

Site Status

Urologic Associates of Allentown

Allentown, Pennsylvania, United States

Site Status

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Triangle Urological Group

Pittsburgh, Pennsylvania, United States

Site Status

Urologic Surgeons of New England, P.C.

Providence, Rhode Island, United States

Site Status

University Urological Research Institute

Providence, Rhode Island, United States

Site Status

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Site Status

Integrity Clinical Research, LLC

Germantown, Tennessee, United States

Site Status

Urology San Antonio Research

San Antonio, Texas, United States

Site Status

Salt Lake Research

Salt Lake City, Utah, United States

Site Status

Seattle Urological Associates

Seattle, Washington, United States

Site Status

Rockwood Clinic

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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ZENITH

Identifier Type: -

Identifier Source: secondary_id

CZOL446GUS45

Identifier Type: -

Identifier Source: org_study_id

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