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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 HospitalMorristown, New Jersey  07962-1956
Urology San Antonio ResearchSan Antonio, Texas  78229
Atlantic Urological AssociatesDaytona Beach, Florida  32114
Seattle Urological AssociatesSeattle, Washington  98104-1360
Medical Affiliated Research CenterHuntsville, Alabama  35801
UroSearchLeesburg, Florida  34748
Albert Einstein Medical CenterPhiladelphia, Pennsylvania  19141
Atlantic Urological Medical GroupLong Beach, California  90806
Millennium Medical CenterSouthfield, Michigan  48075
Associates in Urology, LLCWest Orange, New Jersey  07052
AccuMed Research AssociatesGarden City, New York  11530
The Urology GroupCincinnati, Ohio  45212
Oregon Urology SpecialistsEugene, Oregon  97401
Urologic Associates of AllentownAllentown, Pennsylvania  18103
Southeastern Urological Center, PATallahassee, Florida  32308
Salt Lake ResearchSalt Lake City, Utah  84124
University Urological Research InstituteProvidence, Rhode Island  02904
Advanced Clinical TherapeuticsTucson, Arizona  85712
Arkansas UrologyLittle Rock, Arkansas  72211
Western Clinical ResearchTorrance, California  90505
Millennium Therapeutics & ResearchBirmingham, Alabama  35205
Alaska Clinical Research CenterAnchorage, Alaska  99508
Donald Gleason, MDTucson, Arizona  85712
Advanced Urology Med. CenterAnaheim, California  92801
San Diego Uro. ResearchSan Diego, California  92101
Connecticut Surgical GroupHartford, Connecticut  06106
Grove Hill UrologyNew Britain, Connecticut  06052
University of Miami School of Medicine, Dept. of UrologyMiami, Florida  33176
Advanced Research Institute, Inc.New Port Richey, Florida  34652
Medisphere Medical Research Center, LLCEvansville, Indiana  47714
The Iowa Clinic, PC, Iowa Urology ResearchDes Moines, Iowa  50309
Summitt Clinical ResearchOwings Mills, Maryland  21117
Quality Clinical Research LLCSpringfield, Nebraska  68059
Associated Urologic Specialist, PAMarlton, New Jersey  08053
Urological Surgeons of L.I.Garden City, New York  11530
Staten Island Urological Research, PCStaten Island, New York  10304
Urological Associates, Inc.Columbus, Ohio  43222
Mount Vernon Urological AssociatesMount Vernon, Ohio  43050
The Urology ClinicPortland, Oregon  97210
Triangle Urological GroupPittsburgh, Pennsylvania  15212
Urologic Surgeons of New England, P.C.Providence, Rhode Island  02904
Carolina Urologic Research CenterMyrtle Beach, South Carolina  29572
Integrity Clinical Research, LLCGermantown, Tennessee  38138
Rockwood ClinicSpokane, Washington  99220