The Effect of Zoledronic Acid on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
- Conditions
- Prostate Cancer
- Registration Number
- NCT00063609
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percent change in bone mineral density of the lumbar spine (L2-L4) at one year.
- Secondary Outcome Measures
Name Time Method Percent changes in bone mineral density of the total hip biochemical markers of bone turnover at one year
Trial Locations
- Locations (44)
Southeastern Urological Center, PA
🇺🇸Tallahassee, Florida, United States
Advanced Urology Med. Center
🇺🇸Anaheim, California, United States
Grove Hill Urology
🇺🇸New Britain, Connecticut, United States
Millennium Medical Center
🇺🇸Southfield, Michigan, United States
Urological Associates, Inc.
🇺🇸Columbus, Ohio, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Seattle Urological Associates
🇺🇸Seattle, Washington, United States
The Urology Group
🇺🇸Cincinnati, Ohio, United States
Millennium Therapeutics & Research
🇺🇸Birmingham, Alabama, United States
Alaska Clinical Research Center
🇺🇸Anchorage, Alaska, United States
Advanced Clinical Therapeutics
🇺🇸Tucson, Arizona, United States
Arkansas Urology
🇺🇸Little Rock, Arkansas, United States
San Diego Uro. Research
🇺🇸San Diego, California, United States
Donald Gleason, MD
🇺🇸Tucson, Arizona, United States
Atlantic Urological Medical Group
🇺🇸Long Beach, California, United States
Western Clinical Research
🇺🇸Torrance, California, United States
Connecticut Surgical Group
🇺🇸Hartford, Connecticut, United States
Advanced Research Institute, Inc.
🇺🇸New Port Richey, Florida, United States
University of Miami School of Medicine, Dept. of Urology
🇺🇸Miami, Florida, United States
Urosearch
🇺🇸Ocala, Florida, United States
Summitt Clinical Research
🇺🇸Owings Mills, Maryland, United States
The Iowa Clinic, PC, Iowa Urology Research
🇺🇸Des Moines, Iowa, United States
Medisphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
Associates In Urology, LLC
🇺🇸West Orange, New Jersey, United States
AccuMed Research Associates
🇺🇸Garden City, New York, United States
Staten Island Urological Research, PC
🇺🇸Staten Island, New York, United States
Mount Vernon Urological Associates
🇺🇸Mount Vernon, Ohio, United States
Oregon Urology Specialists
🇺🇸Eugene, Oregon, United States
The Urology Clinic
🇺🇸Portland, Oregon, United States
Urologic Associates of Allentown
🇺🇸Allentown, Pennsylvania, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Urology San Antonio Research
🇺🇸San Antonio, Texas, United States
Integrity Clinical Research, LLC
🇺🇸Germantown, Tennessee, United States
University Urological Research Institute
🇺🇸Providence, Rhode Island, United States
Salt Lake Research
🇺🇸Salt Lake City, Utah, United States
Rockwood Clinic
🇺🇸Spokane, Washington, United States
Associated Urologic Specialist, PA
🇺🇸Marlton, New Jersey, United States
Medical Affiliated Research Center
🇺🇸Huntsville, Alabama, United States
Atlantic Urological Associates
🇺🇸Daytona Beach, Florida, United States
Urological Surgeons of L.I.
🇺🇸Garden City, New York, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Quality Clinical Research LLC
🇺🇸Springfield, Nebraska, United States
Triangle Urological Group
🇺🇸Pittsburgh, Pennsylvania, United States
Urologic Surgeons of New England, P.C.
🇺🇸Providence, Rhode Island, United States