Simvastatin to Prevent SCI-Induced Bone Loss

Phase 2

• Conditions: Spinal Cord Injuries; Osteoporosis
• Interventions: Drug: Placebo Oral Capsule; Drug: Simvastatin

• Registration Number: NCT02946424
• Lead Sponsor: Craig Hospital

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.

Study Timeline

• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-27
• Study Start: 2017-07-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-08
• Primary Completion: 2023-09
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo treatment	Placebo Oral Capsule	Placebo for one year time period
Simvastatin treatment	Simvastatin	Simvastatin for one year time period

Primary Outcome Measures

Name	Time	Method
Change in knee bone mineral density	baseline and 12 months	assessed by DXA

Secondary Outcome Measures

Name	Time	Method
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 bone volume	baseline and 12 months	quantitative CT scan of the knee
Change in community reintegration	baseline and 12 months	Craig Handicap and Assessment Reporting Technique-Short Form
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

Trial Locations

Locations (1)

Craig Hospital; 🇺🇸 Englewood, Colorado, United States