NCT00172016CompletedPhase 4
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 43
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
ZOL446 (zoledronic acid)
Experimental
Intervention: Zoledronic acid (Drug)
Investigators
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