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


Phase 4
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

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

Authority:

United States: Food and Drug Administration

Study ID:

CZOL446GUS45

NCT ID:

NCT00063609

Start Date:

April 2003

Completion Date:

April 2005

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Bone Loss
  • Osteoporosis
  • Bone Mineral Density
  • Androgen Deprivation Therapy
  • Prostatic Neoplasms

Name

Location

Morristown Memorial Hospital Morristown, New Jersey  07962-1956
Urology San Antonio Research San Antonio, Texas  78229
Atlantic Urological Associates Daytona Beach, Florida  32114
Seattle Urological Associates Seattle, Washington  98104-1360
Medical Affiliated Research Center Huntsville, Alabama  35801
UroSearch Leesburg, Florida  34748
Albert Einstein Medical Center Philadelphia, Pennsylvania  19141
Atlantic Urological Medical Group Long Beach, California  90806
Millennium Medical Center Southfield, Michigan  48075
Associates in Urology, LLC West Orange, New Jersey  07052
AccuMed Research Associates Garden City, New York  11530
The Urology Group Cincinnati, Ohio  45212
Oregon Urology Specialists Eugene, Oregon  97401
Urologic Associates of Allentown Allentown, Pennsylvania  18103
Southeastern Urological Center, PA Tallahassee, Florida  32308
Salt Lake Research Salt Lake City, Utah  84124
University Urological Research Institute Providence, Rhode Island  02904
Advanced Clinical Therapeutics Tucson, Arizona  85712
Arkansas Urology Little Rock, Arkansas  72211
Western Clinical Research Torrance, California  90505
Millennium Therapeutics & Research Birmingham, Alabama  35205
Alaska Clinical Research Center Anchorage, Alaska  99508
Donald Gleason, MD Tucson, Arizona  85712
Advanced Urology Med. Center Anaheim, California  92801
San Diego Uro. Research San Diego, California  92101
Connecticut Surgical Group Hartford, Connecticut  06106
Grove Hill Urology New Britain, Connecticut  06052
University of Miami School of Medicine, Dept. of Urology Miami, Florida  33176
Advanced Research Institute, Inc. New Port Richey, Florida  34652
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
Quality Clinical Research LLC Springfield, Nebraska  68059
Associated Urologic Specialist, PA Marlton, New Jersey  08053
Urological Surgeons of L.I. Garden City, New York  11530
Staten Island Urological Research, PC Staten Island, New York  10304
Urological Associates, Inc. Columbus, Ohio  43222
Mount Vernon Urological Associates Mount Vernon, Ohio  43050
The Urology Clinic Portland, Oregon  97210
Triangle Urological Group Pittsburgh, Pennsylvania  15212
Urologic Surgeons of New England, P.C. Providence, Rhode Island  02904
Carolina Urologic Research Center Myrtle Beach, South Carolina  29572
Integrity Clinical Research, LLC Germantown, Tennessee  38138
Rockwood Clinic Spokane, Washington  99220