Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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 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 Intervention Phase
Avascular Necrosis
Drug: Atorvastatin
Procedure: MRI, Venipuncture
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: AVN Prevention With Lipitor in Lupus Erythematosus APLLE Trial

Resource links provided by NLM:


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 [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 43
Study Start Date: November 2002
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Atorvastatin vs Placebo
Atorvastatin 40mg vs Placebo
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

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.

  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
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, see Learn About Clinical Studies.

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:
Responsible Party: Howard Michael Belmont, MD, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00412841     History of Changes
Other Study ID Numbers: H-8795
Study First Received: December 18, 2006
Last Updated: January 17, 2013
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
Autoimmune Diseases
Bone Diseases
Connective Tissue Diseases
Immune System Diseases
Musculoskeletal Diseases
Pathologic Processes
Atorvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014