Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412841
Status:
TERMINATED
Last Update Posted:
2018-11-23
First Post:
2006-12-18
Brief Title:
Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus Erythematosus
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
AVN Prevention With Lipitor in Lupus Erythematosus APLLE Trial
Status:
TERMINATED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None