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Home > "T" Clinical Trials Conditions > The Effect of Zometa on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy

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



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

For Condition: Prostate Cancer
Status: Recruiting
Sponsor(s): Novartis Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional,Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry 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
Total Enrollment: 200

Location and Contact Information:

Atlantic Urological Medical Group *Recruiting*
Long Beach,  California,  90806
United States
Recruiting Denise  Mazzanti 562-595-5977

Morristown Memorial Hospital *Recruiting*
Morristown,  New Jersey,  07962
United States
Recruiting Noreen  Benjamin 973-971-6175

The Urology Clinic *Recruiting*
Portland,  Oregon,  97210
United States
Recruiting Cindy  Payne 503-279-8602

Triangle Urological Group *Recruiting*
Pittsburgh,  Pennsylvania,  15212
United States
Recruiting Lori  Merlotti 412-281-1757

Alaska Clinical Research Center *Recruiting*
Anchorage,  Alaska,  99508
United States
Recruiting Sandie  Michaelson 907-276-1455

Integrity Clinical Research, LLC *Recruiting*
Germantown,  Tennessee,  38138
United States
Recruiting Melissa  Minn 731-723-9703

Urology San Antonio Research *Recruiting*
San Antonio,  Texas,  78229
United States
Recruiting Alex  Amaya 210-617-4116

Millennium Therapeutics & Research *Recruiting*
Birmingham,  Alabama,  35205
United States
Recruiting Linda  Crumbley 205-930-8439

University of Miami School of Medicine, Dept. of Urology *Recruiting*
Miami,  Florida,  33176
United States
Recruiting D.  Bateman 305-243-7207

Staten Island Urological Research, PC *Recruiting*
Staten Island,  New York,  10304
United States
Recruiting Nicole  Zampardi 718-720-6040

The Urology Group *Recruiting*
Cincinnati,  Ohio,  45212
United States
Recruiting Vicki  Rice 513-366-3412

The Iowa Clinic, PC, Iowa Urology Research *Recruiting*
Des Moines,  Iowa,  50309
United States
Recruiting Mary  Lepic 515-241-5347

Albert Einstein Medical Center *Recruiting*
Philadelphia,  Pennsylvania,  19141
United States
Recruiting Rosemary  Sandy 215-456-1177

Carolina Urologic Research Center *Recruiting*
Myrtle Beach,  South Carolina,  29572
United States
Recruiting Stacey  Harrelson 843-839-1679

Western Clinical Research *Recruiting*
Torrance,  California,  90505
United States
Recruiting Carolyn  Ferguson 310-378-5003

Urologic Surgeons of New England, P.C. *Recruiting*
Providence,  Rhode Island,  02904
United States
Recruiting Sue  Hillman 401-274-6565

Albert Einstein Medical Center *Recruiting*
Philadelphia,  Pennsylvania,  19141
United States
Recruiting Rosemary  Sandy 215-456-1177

University Urological Research Institute *Recruiting*
Providence,  Rhode Island,  02906
United States
Recruiting William  Webb 401-331-9242

Arkansas Urology *Recruiting*
Little Rock,  Arkansas,  72211
United States
Recruiting Anne  Tursky 501-537-7867

San Diego Uro. Research *Recruiting*
San Diego,  California,  92101
United States
Recruiting Patti  Sanchez-Emery 619-236-0045

Medical Affiliated Research Center *Recruiting*
Huntsville,  Alabama,  35801
United States
Recruiting Tammy  Tucker 256-564-7175

Grove Hill Urology *Recruiting*
New Britain,  Connecticut,  06052
United States
Recruiting Antonina  Vaverchak 860-826-4453

Medisphere Medical Research Center, LLC *Recruiting*
Evansville,  Indiana,  47714
United States
Recruiting Melinda  Swanker 812-471-4110

Urological Associates, Inc. *Recruiting*
Columbus,  Ohio,  43222
United States
Recruiting Brigit  Duggan 614-221-5189

Connecticut Surgical Group *Recruiting*
Hartford,  Connecticut,  06106
United States
Recruiting Christen  Garcia 860-524-4328

Atlantic Urological Associates *Recruiting*
Daytona Beach,  Florida,  32114
United States
Recruiting Sandra  Warrington 386-239-8535

Urologic Associates of Allentown *Recruiting*
Allentown,  Pennsylvania,  18103
United States
Recruiting Donna  Beltz 610-437-4320

Summitt Clinical Research *Recruiting*
Owings Mills,  Maryland,  21117
United States
Recruiting Karen  Sellers 410-581-1600

Advanced Urology Med. Center *Recruiting*
Anaheim,  California,  92801
United States
Recruiting Patricia  Nunez 714-776-2030

Salt Lake Research *Recruiting*
Salt Lake City,  Utah,  84124
United States
Recruiting Bianca  Bevan 801-288-9778

AccuMed Research Associates *Recruiting*
Garden City,  New York,  11530
United States
Recruiting Kerri  Weingard 516-746-2190

Southeastern Urological Center, PA *Recruiting*
Tallahassee,  Florida,  32308
United States
Recruiting Tammy  Horton 850-201-0411

Millennium Medical Center *Recruiting*
Southfield,  Michigan,  48075
United States
Recruiting Anthonia  Zamishe 248-569-6700

Seattle Urological Associates *Recruiting*
Seattle,  Washington,  98704
United States
Recruiting Jenni  Liekkio 206-292-6488

Urosearch *Recruiting*
Ocala,  Florida,  34470
United States
Recruiting Kathryn  Goad 352-732-6040

Associates In Urology, LLC *Recruiting*
West Orange,  New Jersey,  07052
United States
Recruiting Kit  Murtha 973-325-6100

Advanced Research Institute, Inc. *Recruiting*
New Port Richey,  Florida,  34652
United States
Recruiting Kristin  White 727-842-9561

Quality Clinical Research LLC *Recruiting*
Springfield,  Nebraska,  68059
United States
Recruiting Kim  Ganzel 402-253-2738

Oregon Urology Specialists *Recruiting*
Eugene,  Oregon,  97401
United States
Recruiting Caryl  Wilson 541-284-5508

Donald Gleason, MD *Recruiting*
Tucson,  Arizona,  85712
United States
Recruiting Peggy  Gleason 520-323-9601

Rockwood Clinic *Recruiting*
Spokane,  Washington,  99220
United States
Recruiting Krista  Sander 509-838-2531

Advanced Clinical Therapeutics *Recruiting*
Tucson,  Arizona,  85712
United States
Recruiting Peggy  Gleason 520-323-9601

Urological Surgeons of L.I. *Recruiting*
Garden City,  New York,  11530
United States
Recruiting Vincent  Gandolfo 516-742-3200

Mount Vernon Urological Associates *Recruiting*
Mount Vernon,  Ohio,  43050
United States
Recruiting Jamie  Breckler 740-392-0657

Associated Urologic Specialist, PA *Recruiting*
Marlton,  New Jersey,  08053
United States
Recruiting Beverly  Pfeifer 856-985-4286


Additional Information:
Study ID Numbers:
  CZOL446GUS45;  ZENITH
Study Start Date: April 2003
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063609

Other Prostate Cancer Studies:
1. Phase I Study of SU006668 in Patients With Advanced Solid Tumors

2. Prevention of Osteoporosis in Men with Prostate Cancer

3. The Effect of Zometa on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy

4. Reiki/Energy Healing in Prostate Cancer

5. Lycopene In Preventing of Prostate Cancer

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

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