Phase 1 Study of Zoledronic Acid in Sickle Cell Disease

Sickle Cell Disease Clinical Trial

Official title:

Phase 1 Study of Zoledronic Acid in Sickle Cell Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00639392
• Other study ID #: VCU-PT101439
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: March 14, 2008
• Last updated: November 10, 2011
• Start date: June 2007
• Est. completion date: May 2008

Study information

• Verified date: November 2011
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Drug:
• Placebo
Patients will receive a single dose of placebo administered by vein over about 15 minutes. Placebo is mostly water without Zoledronic Acid.
• Zoledronic Acid
Patients will receive a single dose of Zolendronic Acid. Zoledronic Acid is administered by vein over about 15 minutes.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The long-term goal of this project is to learn if Zoledronic Acid can prevent or reduce pain in sickle cell disease.		Within 2 weeks of study drug administration and then every month for approximately 1 year	Yes
Secondary	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.		Two weeks after study drug administration and then every month for approximately 1 year	Yes