Zoledronic Acid in the Prevention of Skeletal-related Events in Hormone Refractory and Hormone-sensitive Prostate Cancer Patients With Bone Metastases
Phase 4
Completed
- Conditions
- Prostate Cancer
- Registration Number
- NCT00219219
- Lead Sponsor
- Novartis
- Brief Summary
The present study will give information about the course over time in skeletal-related events (SRE) in prostate cancer patients with bone metastases treated with zoledronic acid 4 mg administered as a 15-minute infusion every 4 weeks for a maximum of 15 infusions. The protocol will enroll patients with recent diagnosis of bone metastases from prostate cancer who are hormone-refractory, hormone-naïve or still hormone-sensitive, that represent the entire population of prostate cancer patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method occurence of skeletale related events (SREs) over time (time to first SRE,skeletal morbidity rate and proportion of patients experiencing SRE)
- Secondary Outcome Measures
Name Time Method Bone pain Use of analgesic medication and ECOG performance status every three months Bone specific alkaline phosphatase, serum N-telopeptide and parathyroid hormone will be evaluated after one month of treatment and then every three months
Trial Locations
- Locations (1)
Bologna
🇮🇹Bologna, Italy