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Sponsors and Collaborators: |
Novartis Società Italiana di Urologia (SIU) |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00219219 |
The present study will give information about the course over time in skeletal-related events (SRE) in prostate cancer patients with bone metastases treated with zoledronic acid 4 mg administered as a 15-minute infusion every 4 weeks for a maximum of 15 infusions. The protocol will enroll patients with recent diagnosis of bone metastases from prostate cancer who are hormone-refractory, hormone-naïve or still hormone-sensitive, that represent the entire population of prostate cancer patients
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Zoledronic acid |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Zoledronic Acid in the Prevention of Skeletal-Related Events in Hormone Refractory and Hormone-Sensitive Prostate Cancer Patients With Bone Metastases |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | October 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Study ID Numbers: | CZOL446EIT04 |
Study First Received: | September 7, 2005 |
Last Updated: | December 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00219219 History of Changes |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
zoledronic acid prostate cancer SRE |
Diphosphonates Zoledronic acid Prostatic Diseases Genital Neoplasms, Male Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
Neoplasm Metastasis Bone Density Conservation Agents Urogenital Neoplasms Genital Diseases, Male Hormones Prostatic Neoplasms |
Zoledronic acid Genital Neoplasms, Male Prostatic Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Urogenital Neoplasms Genital Diseases, Male Hormones |
Pharmacologic Actions Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site Diphosphonates Neoplasm Metastasis Prostatic Neoplasms |