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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Avascular Necrosis

In brief

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.

Key facts

Study ID: NCT00412841
Run by: NYU Langone Health
People needed: 43
Starts: 2002-11-01
Expected to finish: 2008-01-01
Last updated by the study team: 2018-11-23

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

The New York University Hospital For Joint Diseases — New York, New York, United States

Full record on ClinicalTrials.gov

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