Phase 1 Study of Zoledronic Acid in Sickle Cell Disease

This study has been withdrawn prior to enrollment.

(Ended early due to inability to identify eligible subjects)

Sponsor:

Collaborator:

Novartis

Information provided by (Responsible Party):

Virginia Commonwealth University

ClinicalTrials.gov Identifier:

NCT00639392

First received: March 14, 2008

Last updated: November 10, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 14, 2008

Last Updated Date

November 10, 2011

Start Date ^ICMJE

June 2007

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00639392 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Phase 1 Study of Zoledronic Acid in Sickle Cell Disease

Official Title ^ICMJE

Phase 1 Study of Zoledronic Acid in Sickle Cell Disease

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Sickle Cell Disease

Intervention ^ICMJE

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

Study Arm (s)

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.

Intervention: Drug: Placebo
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.

Intervention: Drug: Zoledronic Acid

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00639392

Other Study ID Numbers ^ICMJE

VCU-PT101439

Has Data Monitoring Committee

Yes

Responsible Party

Virginia Commonwealth University

Study Sponsor ^ICMJE

Virginia Commonwealth University

Collaborators ^ICMJE

Novartis

Investigators ^ICMJE

Principal Investigator:

John D Roberts, M.D.

Virginia Commonwealth University

Information Provided By

Virginia Commonwealth University

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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