Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Richmond, Virginia 23298


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.


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


Study is Available At:


Original ID:

VCU-PT101439


NCT ID:

NCT00639392


Secondary ID:


Study Acronym:


Brief Title:

Phase 1 Study of Zoledronic Acid in Sickle Cell Disease


Official Title:

Phase 1 Study of Zoledronic Acid in Sickle Cell Disease


Overall Status:

Terminated


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Virginia Commonwealth University


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Ended early due to inability to identify eli


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:John D Roberts, M.D.
Principal Investigator
Virginia Commonwealth University

Study Dates

Start Date:June 2007
Completion Date:May 2008
Completion Type:Actual
Primary Completion Date:May 2008
Primary Completion Type:Actual
Verification Date:October 2011
Last Changed Date:October 20, 2011
First Received Date:March 14, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:True
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:Placebo
Description:Patients will receive a single dose of placebo administered by vein over about 15 minutes. Placebo is mostly water without Zoledronic Acid.
Arm Name:2
Intervention Type:Drug
Name:Zoledronic Acid
Description:Patients will receive a single dose of Zolendronic Acid. Zoledronic Acid is administered by vein over about 15 minutes.
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description: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.
Study Arm Type:Placebo Comparator
Arm Name:2
Description:Patients will receive a single dose of Zoledronic Acid or placebo. The chances that a subject will receive placebo are 1 out of 3.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Virginia Commonwealth University
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Novartis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.