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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Howard Michael Belmont, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00412841
First received: December 18, 2006
Last updated: January 17, 2013
Last verified: October 2012

December 18, 2006
January 17, 2013
November 2002
January 2008   (final data collection date for primary outcome measure)
A goal of 50% reduction of new AVN with atorvastatin assuming 50% of patients will develop at least one new site of AVN [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
A goal of 50% reduction of new AVN with atorvastatin assuming 50% of patients will develop at least one new site of AVN
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 [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
  • 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) [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
  • 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)
Not Provided
Not Provided
 
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 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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Avascular Necrosis
  • Drug: Atorvastatin
    Atorvastatin 40mg vs placebo 40mg daily
    Other Name: Atorvasatatin 40mg vs Placebo
  • Procedure: MRI, Venipuncture
    MRIs done baseline, four and nine months
    Other Name: MRI at baseline, 4 months and 9 months
Placebo Comparator: Atorvastatin vs Placebo
Atorvastatin 40mg vs Placebo
Interventions:
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
43
January 2008
January 2008   (final data collection date for primary outcome measure)

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 information is only displayed when the study is recruiting subjects
United States
 
NCT00412841
H-8795
Yes
Howard Michael Belmont, New York University School of Medicine
New York University School of Medicine
Not Provided
Principal Investigator: Howard M Belmont, M.D. The New York University Hospital for Joint Diseases
New York University School of Medicine
October 2012

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