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

• Status: Terminated
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

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