Phase 1 Study of Zoledronic Acid in Sickle Cell Disease
Information source: Virginia Commonwealth University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sickle Cell Disease
Intervention: Placebo (Drug); Zoledronic Acid (Drug)
Phase: Phase 1/Phase 2
Status: Withdrawn
Sponsored by: Virginia Commonwealth University Official(s) and/or principal investigator(s): John D Roberts, M.D., Principal Investigator, Affiliation: Virginia Commonwealth University
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.
Clinical Details
Official title: Phase 1 Study of Zoledronic Acid in Sickle Cell Disease
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
Primary outcome: The long-term goal of this project is to learn if Zoledronic Acid can prevent or reduce pain in sickle cell disease.
Secondary outcome: The specific purposes of this study are to learn if Zoledronic Acid has serious side effects for subjects with sickle cell disease and to study the effects of Zoledronic acid in subjects with sickle cell disease.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Virginia Commonwealth University, Richmond, Virginia 23298, United States
Additional Information
Starting date: June 2007
Last updated: November 10, 2011
|