Status:
COMPLETED
Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Pain
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of 4 mg zoledronic acid administered intravenously every 3-4 weeks in the treatment of bone metastases-related pain in patients with prostate cancer.
Eligibility Criteria
Inclusion
- Histologically proven adenocarcinoma of the prostate
- Bone-scan documented metastases
- Age \> 18 years
- Non-controlled bone pain despite systemic anti-tumor therapy (hormone or chemotherapy) initiated at least 4 weeks before inclusion
- Life expectancy \> 3 months
- Written informed consent
Exclusion
- New systemic anti-tumor therapy initiated less than 4 weeks before study entry or predictable need for starting a new treatment within 8 weeks
- Radiation therapy on bone target lesions or bone-targeted isotope therapy (strontium or samarium) completed less than 4 weeks before study entry
- Bisphosphonate therapy within 8 weeks before study entry
- Abnormal renal function (serum creatinine \> 2 x the upper normal limit or creatinine clearance \< 30 ml/min)
- Corrected serum calcium \> 3 mmol/L or \< 2 mmol/L
- Clinically relevant hypersensitivity to zoledronic acid, or another bisphosphonate, or one component present in the formulation of the study drug
- Severe concomitant medical condition that could hamper patient's quality of life or influence the interpretation of pain
- Patients unable to fill in a questionnaire (neurologic or psychiatric conditions, illiteracy, etc.)
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00375648
Start Date
June 1 2005
Last Update
June 2 2017
Active Locations (1)
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1
Novartis Investigative Site
Monpellier, France