A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00172016
First received: September 13, 2005
Last updated: April 27, 2012
Last verified: April 2012
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Purpose
The purpose of this study is to assess the efficacy and tolerability of zoledronic acid in preventing skeletal-related events in patients with prostate cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer With at Least One Bone Lesion in Patients Receiving Hormonal Therapy and Treatment With Bisphosphonates is Indicated |
Drug: Zoledronic acid |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates |
Resource links provided by NLM:
Further study details as provided by Novartis:
| Enrollment: | 43 |
| Study Start Date: | January 2004 |
| Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ZOL446 (zoledronic acid) | Drug: Zoledronic acid |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Written informed consent must be obtained
- Age > 18 years
- Histologically confirmed diagnosis of carcinoma of the prostate
- Current (or previous) objective evidence of metastatic disease to the bone
- Currently receiving 1st line hormonal therapy with LHRH agonists or other hormonal treatments
- ECOG performance status of 0, 1, or 2
Exclusion Criteria:
- Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal or by a calculated creatinine clearance of 60 ml/minute or less
- Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L)
- WBC<3.0x1'000'000'000, ANC < 1500/mm3, Hgb<8.0 g/dL, platelets < 75 x 1'000'000'000/L.
- Liver function tests >2.5 ULN, serum creatinine >1.5 ULN.
- Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.
- Known hypersensitivity to zoledronic acid or other bisphosphonates
- Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study
Other protocol-defined inclusion / exclusion criteria apply.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00172016 History of Changes |
| Other Study ID Numbers: | CZOL446EHU01 |
| Study First Received: | September 13, 2005 |
| Last Updated: | April 27, 2012 |
| Health Authority: | Hungary: National Institute of Pharmacy |
Keywords provided by Novartis:
|
Zoledronic acid SRE Prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Zoledronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013