NCT00412841

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

AVN Prevention With Lipitor in Lupus Erythematosus APLLE Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Avascular Necrosis

Interventions

Type	Name	Description
DRUG	Atorvastatin	Atorvastatin 40mg vs placebo 40mg daily
PROCEDURE	MRI, Venipuncture	MRIs done baseline, four and nine months
DRUG	Placebo	Tablets identical to atorvastatin 40mg

Timeline

• Start date: 2002-11-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2006-12-19
• Last updated: 2018-11-23
• Results posted: 2016-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study