Phase 1 Study of Zoledronic Acid in Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT00639392|
Recruitment Status : Withdrawn (Ended early due to inability to identify eligible subjects)
First Posted : March 20, 2008
Last Update Posted : November 11, 2011
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease||Drug: Placebo Drug: Zoledronic Acid||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Phase 1 Study of Zoledronic Acid in Sickle Cell Disease|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
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.
Patients will receive a single dose of placebo administered by vein over about 15 minutes. Placebo is mostly water without Zoledronic Acid.
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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639392
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||John D Roberts, M.D.||Virginia Commonwealth University|