Status:
WITHDRAWN
Phase 1 Study of Zoledronic Acid in Sickle Cell Disease
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
Novartis
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The long-term goal of this study is to learn if Zoledronic Acid can prevent or reduce pain in sickle cell disease. The goal of this study is to learn about the safety of Zoledronic Acid in persons wit...
Eligibility Criteria
Inclusion
- 18 years and older
- Male or female with sickle cell disease
- Pain related to sickle cell disease Patient history of health services utilization for acute SCD-related pain Patient history of use of narcotic analgesics for pain control within the past 6 months
- Able to tolerate hydration with 500 mL D51/2 NS prior to Zoledronic Acid or placebo
Exclusion
- Calculated creatinine clearance less than 60 mL/min
- Current active dental problems
- Recent (within 6 weeks) or planned dental or jaw surgery (e.g., extraction,implants)
- History of cirrhosis or chronic symptomatic liver disease; acute liver disease
- History of aspirin-induced asthma
- History of allergy to zoledronic acid or similar chemical-entities
- Pregnant or nursing
- No prior bisphosphonate use
- Receipt of an investigational drug within 30 days
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00639392
Start Date
June 1 2007
End Date
May 1 2008
Last Update
November 11 2011
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298