Simvastatin to Improve Bone Health in SCI: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

Project Type
Independent
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Principal Investigator Email
Start Date:
10/1/2016
End Date:
9/30/2021
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Abstract:
We will conduct a double blind, randomized, placebo-controlled clinical trial with the primary goal of determining the osteogenic benefits of statins in acute SCI. Specific Aim 1: Determine whether a 12-month course of daily simvastatin prevents bone loss in the paralyzed lower extremity. Hypothesis 1: 12 months of daily simvastatin will stimulate bone formation, suppress bone resorption, and prevent bone loss and loss of bone strength compared to placebo. Specific Aim 2 (Exploratory): Determine whether a 12-month course of daily simvastatin promotes neurological recovery after SCI. Hypothesis 2: 12 months of daily simvastatin will improve motor function compared to placebo. Specific Aim 3 (Exploratory): Determine whether a 12-month course of daily simvastatin reduces neuropathic pain after SCI. Hypothesis 3: 12 months of daily simvastatin will reduce neuropathic pain after SCI compared to placebo. These changes will be associated one or more of the following: improved mood, improved satisfaction with life, or improved community integration. Primary outcome measure: • Change in knee bone mineral density by DXA Secondary outcome measures: • Change in bone volume (qCT scan of the knee) • Change in tibial bone strength (FEA) • Change in mood (Patient Health Questionnaire-9) • Change in pain (International Spinal Cord Injury Basic Pain Data Set) • Change in satisfaction with life (SWLS) • Change in community reintegration (CHART-Short Form) • Change in in motor score (ISNCSCI exam)