Simvastatin to Prevent SCI-Induced Bone Loss

Study Overview
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Brief Summary
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This is a double blind, randomized, placebo -controlled clinical trial with the primary goal of determining the osteogenic benefits of simvastatin in acute SCI.

Detailed Description
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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.

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

Conditions
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Spinal Cord Injuries, Osteoporosis

Intervention / Treatment
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* Drug: Placebo Oral Capsule
* Drug: Simvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-60 years of age acute SCI (AIS A-C) who are enrolled at our center in an ongoing surveillance study. use a wheelchair as their primary mobility mode reside in the greater Denver metropolitan area within 3 months of injury medically stable able to follow directions provide informed consent. Exclusion Criteria: - have any simvastatin contraindications including: drug allergy, active liver disease, renal dysfunction, concurrent use of drugs that cause myopathy or increase the risk of myopathy with simvastatin therapy (gemfibrozil, niacin, cyclosporine, danazol, amiodarone, dronedarone, ranolazine, calcium channel blockers, colchicine), strong CYP34A inhibitors (itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone, cobicistat-containing products), low plasma cholesterol levels, uncontrolled or poorly controlled diabetes, unstable anti-coagulation treatment, taking a statin in the preceding 12 months, metabolic bone disease, thyroid disorder, history of bilateral oophorectomy, current use of medications potentially affecting bone health including bisphosphonates, androgenic steroids, estrogenic steroids, anti-epileptics, lithium glucocorticoid use for more than 3 months, have received inhaled glucocorticoids in the past 12 months, pregnant or lactating women, women of childbearing potential who are unwilling or unable to use a reliable form of contraception.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simvastatin treatment<br>Simvastatin for one year time period | Drug: Simvastatin<br>* 12 month course of daily simvastatin<br>* Other names: Zocor;|
| Placebo Comparator: Placebo treatment<br>Placebo for one year time period | Drug: Placebo Oral Capsule<br>* 12 month course of daily placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in knee bone mineral density | assessed by DXA | baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bone volume | quantitative CT scan of the knee | baseline and 12 months | 
| Change in mood | Patient Health Questionnaire-9 | baseline and 12 months | 
| Change in pain | International Spinal Cord Injury Basic Pain Data Set | baseline and 12 months | 
| Satisfaction with life | Satisfaction with Life Scale | baseline and 12 months | 
| Change in community reintegration | Craig Handicap and Assessment Reporting Technique-Short Form | baseline and 12 months | 
| Change in motor score | assessed by ISNCSCI exam | baseline and 12 months | 
| Change in tibial bone strength | assessed by finite element analysis of quantitative CT scan of the knee | baseline and 12 months |