The Effect of Zoledronic Acid on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
Completed · Phase 4
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT00063609
- Run by
- Novartis Pharmaceuticals
- People needed
- 200
- Starts
- 2003-04-01
- Expected to finish
- 2005-04-01
- Last updated by the study team
- 2017-09-13
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Millennium Therapeutics & Research — Birmingham, Alabama, United States
- Medical Affiliated Research Center — Huntsville, Alabama, United States
- Alaska Clinical Research Center — Anchorage, Alaska, United States
- Advanced Clinical Therapeutics — Tucson, Arizona, United States
- Donald Gleason, MD — Tucson, Arizona, United States
- Arkansas Urology — Little Rock, Arkansas, United States
- Advanced Urology Med. Center — Anaheim, California, United States
- Atlantic Urological Medical Group — Long Beach, California, United States
- San Diego Uro. Research — San Diego, California, United States
- Western Clinical Research — Torrance, California, United States
- Connecticut Surgical Group — Hartford, Connecticut, United States
- Grove Hill Urology — New Britain, Connecticut, United States
- Atlantic Urological Associates — Daytona Beach, Florida, United States
- University of Miami School of Medicine, Dept. of Urology — Miami, Florida, United States
- Advanced Research Institute, Inc. — New Port Richey, Florida, United States
- Urosearch — Ocala, Florida, United States
- Southeastern Urological Center, PA — Tallahassee, Florida, United States
- Medisphere Medical Research Center, LLC — Evansville, Indiana, United States
- The Iowa Clinic, PC, Iowa Urology Research — Des Moines, Iowa, United States
- Summitt Clinical Research — Owings Mills, Maryland, United States
- Millennium Medical Center — Southfield, Michigan, United States
- Quality Clinical Research LLC — Springfield, Nebraska, United States
- Associated Urologic Specialist, PA — Marlton, New Jersey, United States
- Morristown Memorial Hospital — Morristown, New Jersey, United States
- Associates In Urology, LLC — West Orange, New Jersey, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.