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Sponsors and Collaborators: |
Virginia Commonwealth University Novartis |
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Information provided by: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT00639392 |
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 |
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Sickle Cell Disease |
Drug: Placebo Drug: Zoledronic Acid |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Phase 1 Study of Zoledronic Acid in Sickle Cell Disease |
Estimated Enrollment: | 15 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Placebo Comparator
Patients will receive a single dose of Zoledronic Acid or placebo. The chances that a subject will receive placebo are 1 out of 3.
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Drug: Placebo
Patients will receive a single dose of placebo administered by vein over about 15 minutes. Placebo is mostly water without Zoledronic Acid.
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1: Experimental
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.
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Drug: Zoledronic Acid
Patients will receive a single dose of Zolendronic Acid. Zoledronic Acid is administered by vein over about 15 minutes.
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pamela Summers, BS, CCRP | (804) 628-2631 | pksummers@vcu.edu |
Contact: Tammy Anderson, CCRC, CCRC | (804) 827-1856 | tnanders@vcu.edu |
United States, Virginia | |
Virginia Commonwealth University | Recruiting |
Richmond, Virginia, United States, 23298 | |
Contact: Pamela Summers, BS,CCRP 804-628-2631 pksummers@vcu.edu | |
Principal Investigator: John D Roberts, MD |
Principal Investigator: | John D Roberts, M.D. | Virginia Commonwealth University |
Responsible Party: | Virginia Commonwealth University ( John D. Roberts, MD ) |
Study ID Numbers: | VCU-PT101439 |
Study First Received: | March 14, 2008 |
Last Updated: | March 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00639392 |
Health Authority: | United States: Food and Drug Administration |
Sickle cell disease |
Anemia, Hemolytic, Congenital Diphosphonates Zoledronic acid Genetic Diseases, Inborn Hematologic Diseases Hemoglobinopathies |
Anemia Anemia, Hemolytic Hemoglobinopathy Anemia, Sickle Cell Sickle cell anemia |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |