Phase 1 Study of Zoledronic Acid in Sickle Cell Disease
Withdrawn before enrolling · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Sickle Cell Disease
In brief
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 with sickle cell disease who experience chronic pain requiring medical treatment or use of narcotics.
Key facts
- Study ID
- NCT00639392
- Run by
- Virginia Commonwealth University
- People needed
- 0
- Starts
- 2007-06-01
- Expected to finish
- 2008-05-01
- Last updated by the study team
- 2011-11-11
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Virginia Commonwealth University — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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