Prostate Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Prostate Cancer

Phase:

Phase 4

Estimated Enrollment:

200

Study ID:

NCT00063609

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 42 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 4

Estimated Enrollment:

200

Study ID:

NCT00063609

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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