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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00412841
Recruitment Status : Terminated
First Posted : December 19, 2006
Results First Posted : March 3, 2016
Last Update Posted : November 23, 2018
Information provided by (Responsible Party):
NYU Langone Health

Brief 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.

Condition or disease Intervention/treatment Phase
Avascular Necrosis Drug: Atorvastatin Procedure: MRI, Venipuncture Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: AVN Prevention With Lipitor in Lupus Erythematosus APLLE Trial
Study Start Date : November 2002
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Atorvastatin
Atorvastatin 40mg
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: Placebo
Tablets identical to atorvastatin 40mg
Procedure: MRI, Venipuncture
MRIs done baseline, four and nine months
Other Name: MRI at baseline, 4 months and 9 months

Drug: Placebo
Tablets identical to atorvastatin 40mg

Primary Outcome Measures :
  1. Number of Participants With AVN After 9 Months [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Number of Participants With AVN After 4 Months [ Time Frame: 4 months ]
  2. To Determine if Atorvastatin is Effective in Lowering Serum Lipid Levels Chol, TG, HDL, & LDL in SLE Patients [ Time Frame: 6 years ]
  3. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00412841

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United States, New York
The New York University Hospital For Joint Diseases
New York, New York, United States, 10003
Sponsors and Collaborators
NYU Langone Health
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Principal Investigator: Howard M Belmont, M.D. The New York University Hospital for Joint Diseases
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Responsible Party: NYU Langone Health Identifier: NCT00412841    
Other Study ID Numbers: H-8795
First Posted: December 19, 2006    Key Record Dates
Results First Posted: March 3, 2016
Last Update Posted: November 23, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Avascular Necrosis
Additional relevant MeSH terms:
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Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors