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An Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Mineral Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis


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

Thank you

Trial Information

An Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Mineral Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis

Inclusion Criteria


Inclusion criteria:

- Signed informed consent

- Age > 18 years

- Histologically confirmed diagnosis of carcinoma of the prostate

- Objective evidence of metastatic disease to the bone as evidenced by bone scan or
radiograph at any point since their diagnosis of prostate cancer

- Currently receiving, or will begin receiving, hormonal therapy with an LHRH agonist
or other hormonal treatments for either < 6 months or > 6 months

- ECOG performance status of 0, 1, or 2

Exclusion criteria:

- Patients who are hormone sensitive without metastatic disease to the bone

- Patients who are hormone refractory typically defined as two or three consecutive
increases in PSA measured at least one month apart while on hormone therapy

- Patients who are not treated with LHRH agonist or other hormonal treatments

- Patients who are currently receiving diethylstilbestrol (DES) or PC-SPES

- Patients with another nonmalignant disease which would confound the evaluation of
primary endpoints or prevent the patient complying with the protocol.

- Patients with abnormal renal function as evidenced by either a serum creatinine
greater than 2 mg/dL or by a calculated creatinine clearance of 60 ml/minute or less

- Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00
mmol/L)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Changes in bone mineral density of the lumbar spine (L2-L4) at 12 months

Principal Investigator

Scott L. Pescatore, PharmD.

Investigator Role:

Study Director

Investigator Affiliation:

Novartis

Authority:

United States: Food and Drug Administration

Study ID:

CZOL446EUS24

NCT ID:

NCT00035997

Start Date:

April 2002

Completion Date:

January 2004

Related Keywords:

  • Prostate Cancer
  • Hormone-sensitive Prostate Cancer
  • Prostate Cancer
  • Bone Metastasis
  • Neoplasm Metastasis
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location

Ball Memorial Hospital Muncie, Indiana  47303-3499
Advanced Urology Medical Center Anaheim, California  92801
Atlantic Urological Associates Daytona Beach, Florida  32114
Albert Einstein Medical Center Philadelphia, Pennsylvania  19141
Advanced Research Institute New Port Richey, Florida  34652
Lakeside Urology, P.C. St. Joseph, Michigan  49085-2521
Norwood Clinic Birmingham, Alabama  35234
Alaska Clinical Research Center, LLC Anchorage, Alaska  99508
Urology Associates of Central CA Fresno, California  93720
Center for Urological Research La Mesa, California  91942
Atlantic Urological Medical Group Long Beach, California  90806
Advanced Urology Medical Office Los Angeles, California  90045
Advanced Urology Medical Offices Los Angeles, California  90045
Boulder Medical Center Boulder, Colorado  
Urology Associates, P.C. Denver, Colorado  80210
Southwest Florida Urologic Association Fort Myers, Florida  
DMI Health Care Group, Inc. Largo, Florida  33773
Diagnostic Clinic Largo, Florida  33770
Marvin Stein, MD Margate, Florida  33063
Miami Cancer Institute Miami, Florida  33143
Florida Foundation for Healthcare Research Ocala, Florida  34474
Urology Associates of Northeast Florida, PA Orange Park, Florida  32073
Winter Park Urology Associates Orlando, Florida  32803
Pinellas Urology, Inc. St. Petersburg, Florida  33710
Southeastern Urological Center Tallahassee, Florida  32308
Georgia Urology Research Institute Atlanta, Georgia  30342
Urological Associates PC Davenport, Iowa  52807
Drs. Werner, Murdock and Francis PA Urology Associates Greenbelt, Maryland  20770
Urology Associates of Middlesex County, Inc. Marlborough, Massachusetts  01752
Millennium Medical Center Southfield, Michigan  48075
Kansas City Urology Care Kansas City, Missouri  64131
The Prostate Center of Greater St. Louis St. Louis, Missouri  63136
American Academy of Urology Las Vegas, Nevada  89119
Urological Surgical Associates Edison, New Jersey  
UroResearch, LLC Morristown, New Jersey  07960
Shaukat M. Qureshi, MD Pennsville, New Jersey  08070
Urology Associates Stratford, New Jersey  
Associates in Urology, LLC West Orange, New Jersey  07052
AccuMed Research Associates Garden City, New York  11530
Urological Surgeons of Long Island PC Garden City, New York  11530
Kingston Urological Assoc. Kingston, New York  12401
Cary Urology, P.A. Cary, North Carolina  27511
Matrix Research, LLC Greenville, North Carolina  29607
The Urology Group Cincinnati, Ohio  45212
Southwest Urology Parma, Ohio  44129
Roger N. Andrews, MD Inc. Arcadia, Pennsylvania  91007
Urologic Surgery, PC Bala Cynwyd, Pennsylvania  19004
James W. Thompson, MD Ltd. Bryn Mawr, Pennsylvania  09010
Urology Institute of Pittsburgh Monroeville, Pennsylvania  15146
Center for Urologic Care of Berks County West Reading, Pennsylvania  19611
Grand Strand Urology Myrtle Beach, South Carolina  29572
Urology Center of the South P.C. Germantown, Tennessee  38138
Murfreesboro Medical Clinic Murfreesboro, Tennessee  37130
Urology Associates, PA Nashville, Tennessee  37209
Research Across America Carrollton, Texas  75010
CAMC Clinical Trials Charleston, West Virginia  25304