Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus Erythematosus

• ClinicalTrials.gov Identifier: NCT00412841
• Recruitment Status: Terminated
• First Posted: December 19, 2006
• Results First Posted: March 3, 2016
• Last Update Posted: November 23, 2018
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Avascular Necrosis	Drug: Atorvastatin; Procedure: MRI, Venipuncture; Drug: Placebo	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: AVN Prevention With Lipitor in Lupus Erythematosus APLLE Trial
• Study Start Date: November 2002
• Actual Primary Completion Date: January 2008
• Actual Study Completion Date: January 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Atorvastatin; Atorvastatin 40mg	Drug: Atorvastatin; Atorvastatin 40mg vs placebo 40mg daily; Other Name: Atorvasatatin 40mg vs Placebo; Procedure: MRI, Venipuncture; MRIs done baseline, four and nine months; Other Name: MRI at baseline, 4 months and 9 months
Placebo Comparator: Placebo; Tablets identical to atorvastatin 40mg	Procedure: MRI, Venipuncture; MRIs done baseline, four and nine months; Other Name: MRI at baseline, 4 months and 9 months; Drug: Placebo; Tablets identical to atorvastatin 40mg

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With AVN After 9 Months [ Time Frame: 9 months ]

Secondary Outcome Measures :

1. Number of Participants With AVN After 4 Months [ Time Frame: 4 months ]
2. To Determine if Atorvastatin is Effective in Lowering Serum Lipid Levels Chol, TG, HDL, & LDL in SLE Patients [ Time Frame: 6 years ]
3. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New York

The New York University Hospital For Joint Diseases

New York, New York, United States, 10003

Sponsors and Collaborators

NYU Langone Health

Investigators

• Principal Investigator: Howard M Belmont, M.D.; The New York University Hospital for Joint Diseases

More Information

Publications:

Belmont HM, Lydon E. Avascular necrosis prevention with lipitor in lupus erythematosus. Lupus. 2005;14(10):869-70.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT00412841
• Other Study ID Numbers: H-8795
• First Posted: December 19, 2006
• Results First Posted: March 3, 2016
• Last Update Posted: November 23, 2018
• Last Verified: October 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NYU Langone Health:

Avascular Necrosis; Lipitor; SLE

Additional relevant MeSH terms:

Osteonecrosis; Necrosis; Pathologic Processes; Bone Diseases; Musculoskeletal Diseases; Atorvastatin; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors