LUPUS ATHEROSCLEROSIS PREVENTION STUDY (LAPS) SUPPLEMENT

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Alliance for Lupus (part of the Arthritis Foundation) has funded the Lupus Atherosclerosis Prevention Study (LAPS) [See Appendix F], a prospective, randomized double-blind placebo-controlled trial of atorvastatin vs. placebo, with two outcomes: 1) prevention of atherosclerosis (determined by baseline and 2-year measures of coronary calcification by helical CT) and 2) assessment of the immunomodulatory effects of statins on SLE (determined by assessment of disease activity measure on a quarterly basis). This trial affords the opportunity to assess another outcome, the effect of statins on corticosteroid-induced osteoporosis. Over 90% of the SLE patients participating will be on chronic prednisone; osteoporotic fractures are the most common musculoskeletal system damaged in SLE. In past longitudinal studies, we have found that 70% of SLE patients have osteoporosis and that prednisone is the major risk factor. Data from other investigation strongly suggests that atorvastatin has a beneficial effect on osteoporosis, likely mediated by an effect on the BMP-2 promotor. In this application, we are requesting that the Clinical Research center fund baseline and one-year DEXA scans in the 200 participants in the LAPS trial. SPECIFIC AIMS Hypothesis: There will be a 1.9% or greater difference between atorvastatin and placebo arms in bone mineral density at one year, due either to improvement in or prevention of osteoporosis in the Atorvastatin arm, or to progression in the placebo arm.