Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus Erythematosus
| Status: | Terminated |
|---|---|
| Conditions: | Lupus, Orthopedic |
| Therapuetic Areas: | Immunology / Infectious Diseases, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 11/24/2018 |
| Start Date: | November 2002 |
| End Date: | January 2008 |
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
