This is a double blind, randomized, placebo -controlled clinical trial with the primary goal of determining the osteogenic benefits of simvastatin in acute SCI.
Investigators will test if a 1- year course of simvastatin (40 mg daily) will prevent bone loss compared to placebo in the first year following SCI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
76
12 month course of daily placebo
12 month course of daily simvastatin
Craig Hospital
Englewood, Colorado, United States
Change in knee bone mineral density
assessed by DXA
Time frame: baseline and 12 months
Change in bone volume
quantitative CT scan of the knee
Time frame: baseline and 12 months
Change in mood
Patient Health Questionnaire-9
Time frame: baseline and 12 months
Change in pain
International Spinal Cord Injury Basic Pain Data Set
Time frame: baseline and 12 months
Satisfaction with life
Satisfaction with Life Scale
Time frame: baseline and 12 months
Change in community reintegration
Craig Handicap and Assessment Reporting Technique-Short Form
Time frame: baseline and 12 months
Change in motor score
assessed by ISNCSCI exam
Time frame: baseline and 12 months
Change in tibial bone strength
assessed by finite element analysis of quantitative CT scan of the knee
Time frame: baseline and 12 months
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