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

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00063609

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: zoledronic acid	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Zoledronic Acid Compared to Placebo on Bone Mineral Density in Patients Undergoing Androgen Deprivation Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Minerals Osteoporosis Prostate Cancer

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	April 2003
Estimated Study Completion Date:	April 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063609

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Locations

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

Sponsors and Collaborators

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CZOL446GUS45, ZENITH
Study First Received:	July 1, 2003
Last Updated:	November 20, 2009
ClinicalTrials.gov Identifier:	NCT00063609 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Prostate Cancer
Bone Loss
Osteoporosis
Bone Mineral Density
Androgen Deprivation Therapy

Additional relevant MeSH terms:

Zoledronic acid
Genital Neoplasms, Male
Prostatic Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Urogenital Neoplasms
Genital Diseases, Male

Hormones
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Diphosphonates
Prostatic Neoplasms
Androgens

ClinicalTrials.gov processed this record on November 27, 2009