Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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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 lipitor 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.

Detailed Description
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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 lipitor 40mg per day or pills which look exactly like lipitor 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 lipitor 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.

Official Title
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AVN Prevention With Lipitor in Lupus Erythematosus APLLE Trial

Conditions
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Avascular Necrosis

Intervention / Treatment
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* Drug: Atorvastatin
* Procedure: MRI, Venipuncture
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All individuals must fulfill 4 of the revised criteria of the American College of Rheumatology for SLE Patient started on corticosteroids at a dose of at least .5mg/kg for an interval greater than two weeks To be able to come for all follow-up visits for nine months No contraindications to undergoing MRI Age 18-75 years Exclusion Criteria: Evidence of liver disease, not secondary to active lupus, or liver enzyme greater than 2x normal Elevated CPK at baseline Pregnancy or Lactating Allergy to a statin Current or recent use of a statin within 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin<br>Atorvastatin 40mg | Drug: Atorvastatin<br>* Atorvastatin 40mg vs placebo 40mg daily<br>* Other names: Atorvasatatin 40mg vs Placebo;Procedure: MRI, Venipuncture<br>* MRIs done baseline, four and nine months<br>* Other names: MRI at baseline, 4 months and 9 months;|
| Placebo Comparator: Placebo<br>Tablets identical to atorvastatin 40mg | Procedure: MRI, Venipuncture<br>* MRIs done baseline, four and nine months<br>* Other names: MRI at baseline, 4 months and 9 months;Drug: Placebo<br>* Tablets identical to atorvastatin 40mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With AVN After 9 Months |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With AVN After 4 Months |  | 4 months | 
| To Determine if Atorvastatin is Effective in Lowering Serum Lipid Levels Chol, TG, HDL, & LDL in SLE Patients |  | 6 years | 
| To Determine if Atorvastatin Has an Anti-inflammatory Effect in Active SLE That Reduces Biological Markers of the Inflammatory Process (ESR, Hs-CRP) and Reduces Disease Activity Assessed by Serology (C3, C4, Anti-dsDNA) or Clinical Instrument (SLEDAI) |  | 6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Avascular Necrosis, Lipitor, SLE