Phase 1 Study of Zoledronic Acid in Sickle Cell Disease

NCT00639392 | Withdrawn Phase 1 DMC

• 1 other identifier: VCU-PT101439
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Sickle Cell Disease

Keywords

Sickle cell disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

2

PLACEBO COMPARATOR

Patients will receive a single dose of Zoledronic Acid or placebo. The chances that a subject will receive placebo are 1 out of 3.

Drug: Placebo

1

EXPERIMENTAL

Patients will receive a single dose of Zoledronic Acid or placebo. The chances that a subject will receive Zolendronic Acid are 2 out of 3.

Drug: Zoledronic Acid

Interventions

Placebo DRUG

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

2

Zoledronic Acid DRUG

Patients will receive a single dose of Zolendronic Acid. Zoledronic Acid is administered by vein over about 15 minutes.

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Novartis: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• John D Roberts, M.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2008
• First Posted: March 20, 2008
• Study Start: June 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: November 11, 2011

Record last verified: 2011-11

Locations

US (1)