Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis
- Conditions
- Prostate Cancer
- Registration Number
- NCT00035997
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose of this trial with Zometa is to investigate the effect ZOMETA 4 mg (zoledronic acid for injection in 100mg solution ) has in preventing associated bone loss in prostate cancer patients with bone metastasis when administered in conjunction with hormonal cancer therapy. This trial will seek to determine the effect of ZOMETA in stabilizing and increasing bone mineral density in these patients.
This prospective, open-label, single arm, multicenter study will enroll approximately 200 prostate cancer patients with a history of at least one documented bone lesion documented by bone scan or radiograph. Patients must already be receiving hormone therapy and meet the following additional criteria:
* 18 years of age or older
* Histologically confirmed diagnoses of prostate cancer
* Confirmed objective evidence of metastatic bone disease as evidenced by bone scan or radiograph
* Received or will receive hormonal treatment also know as androgen deprivation therapy with an LHRH agonist or other hormonal treatments
Throughout the course of this 12-month trial, patients will be identified based on the duration of established hormonal treatment at the time of enrollment. Each patients duration of participation will be up to 56 weeks including a 4 week screening, 48 week treatment and a 4 week follow up.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 261
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Changes in bone mineral density of the lumbar spine (L2-L4) at 12 months
- Secondary Outcome Measures
Name Time Method Changes in biochemical markers of bone turnover over 12 months Changes in bone mineral density of the total hip at 12 months Time to first skeletal-related event Overall safety measured by adverse events (AEs)
Trial Locations
- Locations (56)
Urology Associates of Central CA
🇺🇸Fresno, California, United States
Advanced Urology Medical Office
🇺🇸Los Angeles, California, United States
Southwest Florida Urologic Association
🇺🇸Fort Myers, Florida, United States
Georgia Urology Research Institute
🇺🇸Atlanta, Georgia, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Cary Urology, P.A.
🇺🇸Cary, North Carolina, United States
Center for Urological Research
🇺🇸La Mesa, California, United States
Advanced Urology Medical Offices
🇺🇸Los Angeles, California, United States
Atlantic Urological Medical Group
🇺🇸Long Beach, California, United States
Norwood Clinic
🇺🇸Birmingham, Alabama, United States
Diagnostic Clinic
🇺🇸Largo, Florida, United States
Grand Strand Urology
🇺🇸Myrtle Beach, South Carolina, United States
AccuMed Research Associates
🇺🇸Garden City, New York, United States
Urology Associates
🇺🇸Stratford, New Jersey, United States
Associates in Urology, LLC
🇺🇸West Orange, New Jersey, United States
Kingston Urological Assoc.
🇺🇸Kingston, New York, United States
Shaukat M. Qureshi, MD
🇺🇸Pennsville, New Jersey, United States
Southwest Urology
🇺🇸Parma, Ohio, United States
American Academy of Urology
🇺🇸Las Vegas, Nevada, United States
The Urology Group
🇺🇸Cincinnati, Ohio, United States
Urology Associates, PA
🇺🇸Nashville, Tennessee, United States
Research Across America
🇺🇸Carrollton, Texas, United States
Matrix Research, LLC
🇺🇸Greenville, North Carolina, United States
Roger N. Andrews, MD Inc.
🇺🇸Arcadia, Pennsylvania, United States
Urological Surgeons of Long Island PC
🇺🇸Garden City, New York, United States
Advanced Urology Medical Center
🇺🇸Anaheim, California, United States
Alaska Clinical Research Center, LLC
🇺🇸Anchorage, Alaska, United States
Urology Associates, P.C.
🇺🇸Denver, Colorado, United States
Boulder Medical Center
🇺🇸Boulder, Colorado, United States
Marvin Stein, MD
🇺🇸Margate, Florida, United States
Atlantic Urological Associates
🇺🇸Daytona Beach, Florida, United States
DMI Health Care Group, Inc.
🇺🇸Largo, Florida, United States
Miami Cancer Institute
🇺🇸Miami, Florida, United States
Florida Foundation for Healthcare Research
🇺🇸Ocala, Florida, United States
Pinellas Urology, Inc.
🇺🇸St. Petersburg, Florida, United States
Southeastern Urological Center
🇺🇸Tallahassee, Florida, United States
Urology Associates of Northeast Florida, PA
🇺🇸Orange Park, Florida, United States
Lakeside Urology, P.C.
🇺🇸Saint Joseph, Michigan, United States
Drs. Werner, Murdock and Francis PA Urology Associates
🇺🇸Greenbelt, Maryland, United States
Urology Associates of Middlesex County, Inc.
🇺🇸Marlborough, Massachusetts, United States
Urological Surgical Associates
🇺🇸Edison, New Jersey, United States
Ball Memorial Hospital
🇺🇸Muncie, Indiana, United States
Millennium Medical Center
🇺🇸Southfield, Michigan, United States
The Prostate Center of Greater St. Louis
🇺🇸St. Louis, Missouri, United States
UroResearch, LLC
🇺🇸Morristown, New Jersey, United States
Urological Associates PC
🇺🇸Davenport, Iowa, United States
Urology Institute of Pittsburgh
🇺🇸Monroeville, Pennsylvania, United States
Urologic Surgery, PC
🇺🇸Bala Cynwyd, Pennsylvania, United States
Center for Urologic Care of Berks County
🇺🇸West Reading, Pennsylvania, United States
Urology Center of the South P.C.
🇺🇸Germantown, Tennessee, United States
Murfreesboro Medical Clinic
🇺🇸Murfreesboro, Tennessee, United States
CAMC Clinical Trials
🇺🇸Charleston, West Virginia, United States
Winter Park Urology Associates
🇺🇸Orlando, Florida, United States
Kansas City Urology Care
🇺🇸Kansas City, Missouri, United States
Advanced Research Institute
🇺🇸New Port Richey, Florida, United States
James W. Thompson, MD Ltd.
🇺🇸Bryn Mawr, Pennsylvania, United States