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

Phase 2

Terminated

Interventions: Drug: Atorvastatin
Procedure: MRI, Venipuncture
Drug: Placebo

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Atorvastatin	MRI, Venipuncture	Atorvastatin 40mg
Placebo	MRI, Venipuncture	Tablets identical to atorvastatin 40mg
Placebo	Placebo	Tablets identical to atorvastatin 40mg
Atorvastatin	Atorvastatin	Atorvastatin 40mg

Primary Outcome Measures

Name	Time	Method
Number of Participants With AVN After 9 Months	9 months

Secondary Outcome Measures

Name	Time	Method
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
Number of Participants With AVN After 4 Months	4 months