NCT00219271CompletedPhase 4
Effect Of Zoledronic Acid On Circulating And Bone Marrow-Residing Prostate Cancer Cells In Patients With Clinically Localized Prostate Cancer
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To assess the activity of one year treatment with zoledronic acid
Study Overview
Brief Summary
The objective of this study is to assess the effect Of zoledronic acid on circulating and bone marrow-residing prostate cancer cells in patients with clinically localized prostate cancer
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Zoledronic acid
Experimental
4 mg IV infused over 15 minutes every 3 months
Intervention: Zoledronic acid (Drug)
Outcomes
Primary Outcomes
To assess the activity of one year treatment with zoledronic acid
Time Frame: 12 mos
Secondary Outcomes
- Three-year disease free survival(3 years)
- Change in bone mineral density at 12, 24 and 36 months versus baseline(12, 24 and 36 months)
- Changes in bone resorption markers at 12, 24 and 36 months versus baseline(12, 24 and 36 months)
- Safety and tolerability through abnormal values and AE reporting(upto 36 mos)
Investigators
Study Sites (1)
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