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Phase 1 Study of Zoledronic Acid in Sickle Cell Disease

NCT ID: NCT00639392

Last Updated: 2011-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-05-31

Brief Summary

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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

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Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Zoledronic Acid

Intervention Type DRUG

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

Interventions

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Placebo

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

Intervention Type DRUG

Zoledronic Acid

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John D Roberts, M.D.

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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VCU-PT101439

Identifier Type: -

Identifier Source: org_study_id