Phase 1 Study of Zoledronic Acid in Sickle Cell Disease

• Status: Withdrawn
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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 with sickle cell disease who experience chronic pain requiring medical treatment or use of narcotics.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: Novartis
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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