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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00237159 |
It is the aim of this clinical study to evaluate the skeletal-related event rate and tolerability of zoledronic acid in patients with prostate cancer patients and bone metastases.
Condition | Intervention | Phase |
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Prostate Cancer Patients With Bone Metastasis |
Drug: Zoledronic acid |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Effect of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastasis |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
A calculated creatinine clearance < 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula:
CrCl= [140-age (years)] x weight (kg) {x 0.85 for female patients} [72 x serum creatinine (mg/dL)]
Study ID Numbers: | CZOL446EDE07 |
Study First Received: | October 9, 2005 |
Last Updated: | July 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00237159 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Prostate cancer Bone metastasis Skeletal related event |
Zoledronic acid Bone Neoplasms Genital Neoplasms, Male Prostatic Diseases Hematologic Diseases Bone Density Conservation Agents Urogenital Neoplasms |
Genital Diseases, Male Bone Diseases Diphosphonates Musculoskeletal Diseases Neoplasm Metastasis Bone Marrow Diseases Prostatic Neoplasms |
Zoledronic acid Bone Neoplasms Genital Neoplasms, Male Prostatic Diseases Hematologic Diseases Physiological Effects of Drugs Bone Density Conservation Agents Urogenital Neoplasms Genital Diseases, Male Bone Diseases |
Pharmacologic Actions Neoplastic Processes Neoplasms Diphosphonates Pathologic Processes Neoplasms by Site Musculoskeletal Diseases Neoplasm Metastasis Bone Marrow Diseases Prostatic Neoplasms |