Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus Erythematosus - Full Text View

Sponsor:	New York University School of Medicine
Information provided by:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT00412841

Purpose

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 atorvastatin 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.

Condition	Intervention	Phase
Avascular Necrosis	Drug: Atorvastatin Procedure: MRI, Venipuncture	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	AVN Prevention With Lipitor in Lupus Erythematosus APLLE Trial

Resource links provided by NLM:

MedlinePlus related topics: Lupus Osteonecrosis

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:

A goal of 50% reduction of new AVN with atorvastatin assuming 50% of patients will develop at least one new site of AVN

Secondary Outcome Measures:

To determine if atorvastatin is effective in lowering serum lipid levels Chol, TG, HDL, & LDL in SLE patients
To determine if atorvastatin has an anti-inflammatory effect in active SLE that reduces biological markers of the inflammatory process (ESR, hs-CRP) and reduces disease activity assessed by serology (C3, C4, anti-dsDNA) or clinical instrument (SLEDAI)

Estimated Enrollment:	90
Study Start Date:	November 2002
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

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 atorvastatin (lipitor) 40mg per day or pills which look exactly like atorvastatin 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 atorvastatin 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412841

Locations

United States, New York
The New York University Hospital For Joint Diseases
New York, New York, United States, 10003

Sponsors and Collaborators

New York University School of Medicine

Investigators

Principal Investigator:

Howard M Belmont, M.D.

The New York University Hospital for Joint Diseases

More Information

Publications:

Belmont HM, Lydon E. Avascular necrosis prevention with lipitor in lupus erythematosus. Lupus. 2005;14(10):869-70. No abstract available.

ClinicalTrials.gov Identifier:	NCT00412841 History of Changes
Other Study ID Numbers:	H-8795
Study First Received:	December 18, 2006
Last Updated:	March 12, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by New York University School of Medicine:

Avascular Necrosis
Lipitor
SLE

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic
Necrosis
Osteonecrosis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Atorvastatin

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012