Phase 1 Study of Zoledronic Acid in Sickle Cell Disease - Full Text View

Sponsor:	Virginia Commonwealth University
Collaborator:	Novartis
Information provided by (Responsible Party):	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00639392

Purpose

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.

Condition	Intervention	Phase
Sickle Cell Disease	Drug: Placebo Drug: Zoledronic Acid	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title:	Phase 1 Study of Zoledronic Acid in Sickle Cell Disease

Resource links provided by NLM:

Genetics Home Reference related topics: sickle cell disease

MedlinePlus related topics: Sickle Cell Anemia

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:

The long-term goal of this project is to learn if Zoledronic Acid can prevent or reduce pain in sickle cell disease. [ Time Frame: Within 2 weeks of study drug administration and then every month for approximately 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Time Frame: Two weeks after study drug administration and then every month for approximately 1 year ] [ Designated as safety issue: Yes ]

Enrollment:	0
Study Start Date:	June 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 2 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 Patients will receive a single dose of placebo administered by vein over about 15 minutes. Placebo is mostly water without Zoledronic Acid.
Experimental: 1 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 Patients will receive a single dose of Zolendronic Acid. Zoledronic Acid is administered by vein over about 15 minutes.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639392

Locations

United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Virginia Commonwealth University

Novartis

Investigators

Principal Investigator:

John D Roberts, M.D.

Virginia Commonwealth University

More Information

No publications provided

Responsible Party:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00639392 History of Changes
Other Study ID Numbers:	VCU-PT101439
Study First Received:	March 14, 2008
Last Updated:	November 10, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Virginia Commonwealth University:

Sickle cell disease

Additional relevant MeSH terms:

Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies

Genetic Diseases, Inborn
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2012