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

NYU Langone Health

Status and phase: Terminated; Phase 2

Conditions: Avascular Necrosis

Treatments: Drug: Placebo; Drug: Atorvastatin; Procedure: MRI, Venipuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT00412841

H-8795

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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43 participants in 2 patient groups, including a placebo group

Atorvastatin

Experimental group

Description:

Atorvastatin 40mg

Treatment:

Procedure: MRI, Venipuncture

Drug: Atorvastatin

Placebo

Placebo Comparator group

Description:

Tablets identical to atorvastatin 40mg

Treatment:

Procedure: MRI, Venipuncture

Drug: Placebo