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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00171639 |
This study is being conducted to evaluate the effect of an investigational drug on bone loss in men with prostate cancer who are receiving Androgen Deprivation Therapy (ADT).
In order to participate, male patients 18 years and older must be veterans from participating Veterans Administration Medical Centers that are receiving ADT for prostate cancer and have established osteoporosis.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: Zoledronic acid |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | The Use of Zoledronic Acid in Men on Androgen Deprivation Therapy for Prostate Cancer With Preexisting Osteoporosis |
Study Start Date: | June 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Inclusion Criteria:
Exclusion Criteria
Patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol, including:
Other protocol-defined exclusion criteria may apply.
United States, Arizona | |
Southern AZ VA Health Care System | |
Tucson, Arizona, United States, 85723 | |
United States, California | |
VA Medical Center-Long Beach | |
Long Beach, California, United States, 90822 | |
United States, District of Columbia | |
Washington VA Medical Center | |
Washington, District of Columbia, United States, 20422 | |
United States, Illinois | |
Hines VA Medical Center | |
Hines, Illinois, United States, 60141 | |
West Side VMAC | |
Chicago, Illinois, United States, 60612 | |
United States, Missouri | |
Kansas City VMAC | |
Kansas City, Missouri, United States, 64128 | |
United States, New York | |
VAWNY Buffalo | |
Buffalo, New York, United States, 14215 |
Principal Investigator: | Nirmala Bhoopalam, MD | Hines VA Medical Center |
Study ID Numbers: | CZOL446GUS72 |
Study First Received: | September 12, 2005 |
Last Updated: | June 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00171639 |
Health Authority: | United States: Food and Drug Administration |
Diphosphonates Zoledronic acid Prostatic Diseases Genital Neoplasms, Male Musculoskeletal Diseases Osteoporosis |
Urogenital Neoplasms Bone Diseases, Metabolic Genital Diseases, Male Bone Diseases Prostatic Neoplasms |
Neoplasms Neoplasms by Site Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |