Avascular Necrosis
Conditions
Keywords
Avascular Necrosis, Lipitor, SLE
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.
Interventions
DRUGAtorvastatin
Atorvastatin 40mg vs placebo 40mg daily
PROCEDUREMRI, Venipuncture
MRIs done baseline, four and nine months
DRUGPlacebo
Tablets identical to atorvastatin 40mg
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With AVN After 9 Months | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With AVN After 4 Months | 4 months |
| To Determine if Atorvastatin is Effective in Lowering Serum Lipid Levels Chol, TG, HDL, & LDL in SLE Patients | 6 years |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Atorvastatin Atorvastatin 40mg | 22 |
| Placebo | 21 |
| Total | 43 |
Baseline characteristics
| Characteristic | Placebo | Atorvastatin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 22 Participants | 43 Participants |
| Age, Continuous | 35 years | 35 years | 35 years |
| Region of Enrollment United States | 21 participants | 22 participants | 43 participants |
| Sex: Female, Male Female | 17 Participants | 19 Participants | 36 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 21 |
| serious Total, serious adverse events | 4 / 22 | 13 / 21 |
Outcome results
Primary
Number of Participants With AVN After 9 Months
Time frame: 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atorvastatin | Number of Participants With AVN After 9 Months | 12 participants |
| Placebo | Number of Participants With AVN After 9 Months | 16 participants |
Secondary
Number of Participants With AVN After 4 Months
Time frame: 4 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atorvastatin | Number of Participants With AVN After 4 Months | 14 participants |
| Placebo | Number of Participants With AVN After 4 Months | 19 participants |
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)
Time frame: 6 years
Population: Study Terminated. No data available for analysis. Secondary Outcome measure was not included in analysis.
Secondary
To Determine if Atorvastatin is Effective in Lowering Serum Lipid Levels Chol, TG, HDL, & LDL in SLE Patients
Time frame: 6 years
Population: Study Terminated. No data available for analysis. Secondary Outcome measure was not included in analysis.