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Sponsored by: |
New York University School of Medicine |
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Information provided by: | New York University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00412841 |
This study uses the cholesterol lowering drug atorvastatin, also known as lipitor, to show reduction of avascular necrosis in steroid treated lupus patients. Avascular necrosis is a disease resulting from the loss of blood supply to the bones which can cause the bone to collapse. The collapse of bone may require a surgical replacement of the joint and can be disabling for life. Avascular necrosis is presently not preventable but research has shown that lipid lowering drugs such as atorvastatin can reduce or prevent avascular necrosis in animals. We therefore hypothesize that lipitor will reduce the incidence of avascular necrosis in lupus patients taking high dose steroids.
Condition | Intervention | Phase |
---|---|---|
Avascular Necrosis |
Drug: Atorvastatin Procedure: MRI, Venipuncture |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | AVN Prevention With Lipitor in Lupus Erythematosus APLLE Trial |
Estimated Enrollment: | 90 |
Study Start Date: | November 2002 |
Estimated Study Completion Date: | January 2008 |
If you have started on prednisone 30mg or greater and expect to be on it for greater than two weeks you may be a candidate for the study. Also, you would need to be enrolled in the study within three days of starting prednisone. If you are eligible you will receive atorvastatin (lipitor) 40mg per day or pills which look exactly like atorvastatin but do not contain any medication (called placebo). During the time of the study, you will not know if you are taking lipitor or the placebo. The period of time that you will receive atorvastatin or placebo is 9 months and you must be willing to return for 5 follow up visits during this time which include blood tests, physical exams and 3 MRI studies of the hips, knees and ankles.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eileen J Lydon, CANP | 212-598-6518 | eileen.lydon@nyumc.org |
Contact: Howard M Belmont, M.D. | 212-598-6518 | michael.belmont@nyumc.org |
United States, New York | |
The New York University Hospital For Joint Diseases | Recruiting |
New York, New York, United States, 10003 | |
Contact: Eileen J Lydon, CANP 212-598-6518 | |
Contact: Howard M Belmont, MD 212-598-6518 | |
Principal Investigator: Howard M Belmont, MD |
Principal Investigator: | Howard M Belmont, M.D. | The New York University Hospital for Joint Diseases |
Study ID Numbers: | H-8795 |
Study First Received: | December 18, 2006 |
Last Updated: | December 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00412841 History of Changes |
Health Authority: | United States: Institutional Review Board |
Avascular Necrosis Lipitor SLE |
Antimetabolites Autoimmune Diseases Osteonecrosis Lupus Antilipemic Agents Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Bone Diseases Necrosis Lupus Erythematosus, Systemic Musculoskeletal Diseases Connective Tissue Diseases Atorvastatin |
Antimetabolites Autoimmune Diseases Molecular Mechanisms of Pharmacological Action Osteonecrosis Immune System Diseases Antilipemic Agents Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Bone Diseases Pharmacologic Actions Necrosis Pathologic Processes Lupus Erythematosus, Systemic Musculoskeletal Diseases Therapeutic Uses Connective Tissue Diseases Atorvastatin |