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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin | Experimental | Atorvastatin 40mg |
|
| Placebo | Placebo Comparator | Tablets identical to atorvastatin 40mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Atorvastatin 40mg vs placebo 40mg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With AVN After 9 Months | 9 months |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Howard M Belmont, M.D. | The New York University Hospital for Joint Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The New York University Hospital For Joint Diseases | New York | New York | 10003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16302686 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin | 40 mg |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin | Atorvastatin 40mg |
| BG001 | Placebo | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With AVN After 9 Months | Posted | Number | participants | 9 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atorvastatin | Atorvastatin 40mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever of unknown origin | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. H. Michael Belmont | NYULMC | 212-598-6518 | michael.belmont@nyumc.org |
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| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D009682 | Magnetic Resonance Spectroscopy |
| D018962 | Phlebotomy |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| MRI, Venipuncture | Procedure | MRIs done baseline, four and nine months |
|
|
| Placebo | Drug | Tablets identical to atorvastatin 40mg |
|
| 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 |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Number of Participants With AVN After 4 Months | Posted | Number | participants | 4 months |
|
|
|
| Secondary | To Determine if Atorvastatin is Effective in Lowering Serum Lipid Levels Chol, TG, HDL, & LDL in SLE Patients | Study Terminated. No data available for analysis. Secondary Outcome measure was not included in analysis. | Posted | 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) | Study Terminated. No data available for analysis. Secondary Outcome measure was not included in analysis. | Posted | 6 years |
|
|
| 4 |
| 22 |
| 0 |
| 22 |
| EG001 | Placebo | Placebo | 13 | 21 | 0 | 21 |
| Fever, dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Elevated CPK | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Asystolic arrest | Cardiac disorders | Systematic Assessment |
|
| candida esophagitis | Infections and infestations | Systematic Assessment |
|
| elevated LFTS | Gastrointestinal disorders | Systematic Assessment |
|
| herpes zoster | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| pustular psoriasis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| palpitations | Cardiac disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| UTI | Renal and urinary disorders | Systematic Assessment |
|
| vaginal candidiasis | Reproductive system and breast disorders | Systematic Assessment |
|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| lung cancer | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| tooth abscess | Infections and infestations | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D001800 | Blood Specimen Collection |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |