Clinical trial NCT00412841: Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus Erythematosus
Official title: AVN Prevention With Lipitor in Lupus Erythematosus APLLE Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Avascular Necrosis
Keywords: Avascular Necrosis
Lipitor
SLE
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2006-12-19
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Number of Participants With AVN After 9 Months
timeFrame: 9 months
Secondary outcomes:
measure: Number of Participants With AVN After 4 Months
timeFrame: 4 months
measure: To Determine if Atorvastatin is Effective in Lowering Serum Lipid Levels Chol, TG, HDL, & LDL in SLE Patients
timeFrame: 6 years
measure: 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)
timeFrame: 6 years
Other outcomes:
Locations:
city: New York
country: United States
facility: The New York University Hospital For Joint Diseases
state: New York
Study officials:
affiliation: The New York University Hospital for Joint Diseases
name: Howard M Belmont, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Belmont HM, Lydon E. Avascular necrosis prevention with lipitor in lupus erythematosus. Lupus. 2005;14(10):869-70. doi: 10.1191/0961203305lu2189xx. No abstract available.