Full Text View
Tabular View
No Study Results Posted
Related Studies
Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus Erythematosus
This study is currently recruiting participants.
Study NCT00412841   Information provided by New York University School of Medicine
First Received: December 18, 2006   Last Updated: December 21, 2006   History of Changes

December 18, 2006
December 21, 2006
November 2002
 
A goal of 50% reduction of new AVN with atorvastatin assuming 50% of patients will develop at least one new site of AVN
Same as current
Complete list of historical versions of study NCT00412841 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
 
Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus Erythematosus
AVN Prevention With Lipitor in Lupus Erythematosus APLLE Trial

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.

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.

Phase II
Interventional
Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Avascular Necrosis
  • Drug: Atorvastatin
  • Procedure: MRI, Venipuncture
 
Belmont HM, Lydon E. Avascular necrosis prevention with lipitor in lupus erythematosus. Lupus. 2005;14(10):869-70. No abstract available.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
90
January 2008
 

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
Female
18 Years to 75 Years
No
Contact: Eileen J Lydon, CANP 212-598-6518 eileen.lydon@nyumc.org
Contact: Howard M Belmont, M.D. 212-598-6518 michael.belmont@nyumc.org
United States
 
NCT00412841
 
H-8795
New York University School of Medicine
 
Principal Investigator: Howard M Belmont, M.D. The New York University Hospital for Joint Diseases
New York University School of Medicine
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP