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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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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

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Avascular Necrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Atorvastatin

Atorvastatin 40mg

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Atorvastatin 40mg vs placebo 40mg daily

MRI, Venipuncture

Intervention Type PROCEDURE

MRIs done baseline, four and nine months

Placebo

Tablets identical to atorvastatin 40mg

Group Type PLACEBO_COMPARATOR

MRI, Venipuncture

Intervention Type PROCEDURE

MRIs done baseline, four and nine months

Placebo

Intervention Type DRUG

Tablets identical to atorvastatin 40mg

Interventions

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Atorvastatin

Atorvastatin 40mg vs placebo 40mg daily

Intervention Type DRUG

MRI, Venipuncture

MRIs done baseline, four and nine months

Intervention Type PROCEDURE

Placebo

Tablets identical to atorvastatin 40mg

Intervention Type DRUG

Other Intervention Names

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Atorvasatatin 40mg vs Placebo MRI at baseline, 4 months and 9 months

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No