Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer
- Registration Number
- NCT00375648
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 61
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description zoledronate Zoledronic acid -
- Primary Outcome Measures
Name Time Method to measure the intensity of the pain relief of the patients at the end of treatment with a five classes score (TOTPAR = TOTal PAin Relief) at 12 weeks or at 16 weeks (end of treatment)
- Secondary Outcome Measures
Name Time Method To evaluate the pain variation with BPI (=Brief Pain Inventory) and correlate with VAS (=Visual Analog Scale) every 3 or 4 weeks during 12 to 16 weeks To measure the intensity of the pain relief of the patients with the PAR at each visit every 3 or 4 weeks during 12 to 16 weeks To evaluate the variations of PSA (=Prostate specific Antigen) between V1 and End of study or premature withdrawal at 12 weeks or at 16 weeks (end of treatment) To evaluate the pain variation with VAS between V1 and V2, V3, V4, V5. every 3 or 4 weeks during 12 to 16 weeks To evaluate the use of analgesic (analgesic score) and the number of patients needing an analgesic radiotherapy between V1 and V5 every 3 or 4 weeks during 12 to 16 weeks To evaluate the duration of responses at 12 weeks or at 16 weeks (end of treatment) To evaluate the number of skeletal related events by patient every 3 or 4 weeks during 12 to 16 weeks To evaluate the effect on functional disability, professional activity (BPI), the PS and overall condition (VAS) between V1 and V5 every 3 or 4 weeks during 12 to 16 weeks
Trial Locations
- Locations (1)
Novartis Investigative Site
🇫🇷Monpellier, France