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

Avascular Necrosis Clinical Trial

Official title:

AVN Prevention With Lipitor in Lupus Erythematosus APLLE Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00412841
• Other study ID #: H-8795
• Status: Terminated
• Phase: Phase 2
• Start date: November 2002
• Est. completion date: January 2008

Study information

• Verified date: October 2018
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Avascular Necrosis
• Necrosis
• Osteonecrosis

Intervention

Drug:
• Atorvastatin
Atorvastatin 40mg vs placebo 40mg daily

Procedure:
• MRI, Venipuncture
MRIs done baseline, four and nine months

Drug:
• Placebo
Tablets identical to atorvastatin 40mg

Locations

Country	Name	City	State
United States	The New York University Hospital For Joint Diseases	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Belmont HM, Lydon E. Avascular necrosis prevention with lipitor in lupus erythematosus. Lupus. 2005;14(10):869-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With AVN After 9 Months		9 months
Secondary	Number of Participants With AVN After 4 Months		4 months
Secondary	To Determine if Atorvastatin is Effective in Lowering Serum Lipid Levels Chol, TG, HDL, & LDL in SLE Patients		6 years
Secondary	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)		6 years