Osteoporosis, Spinal Cord Injuries
Conditions
Brief summary
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
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.
Interventions
DRUGPlacebo Oral Capsule
12 month course of daily placebo
DRUGSimvastatin
12 month course of daily simvastatin
Sponsors
Craig Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in knee bone mineral density | baseline and 12 months | assessed by DXA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in bone volume | baseline and 12 months | quantitative CT scan of the knee |
| Change in mood | baseline and 12 months | Patient Health Questionnaire-9 |
| Change in pain | baseline and 12 months | International Spinal Cord Injury Basic Pain Data Set |
| Satisfaction with life | baseline and 12 months | Satisfaction with Life Scale |
| Change in motor score | baseline and 12 months | assessed by ISNCSCI exam |
| Change in tibial bone strength | baseline and 12 months | assessed by finite element analysis of quantitative CT scan of the knee |
| Change in community reintegration | baseline and 12 months | Craig Handicap and Assessment Reporting Technique-Short Form |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in bone formation | baseline and 12 months | assessed by circulating osteocalcin level |
| Change in bone resorption | baseline and 12 months | assessed by circulating c-telopeptide level |
Countries
United States
Outcome results
None listed