Simvastatin to Prevent SCI-Induced Bone Loss

Craig Hospital

Status and phase: Unknown; Phase 2

Conditions: Osteoporosis; Spinal Cord Injuries

Treatments: Drug: Placebo Oral Capsule; Drug: Simvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02946424

SCIMS Statin

Details and patient eligibility

About

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

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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76 participants in 2 patient groups, including a placebo group

Simvastatin treatment

Experimental group

Description:

Simvastatin for one year time period

Treatment:

Drug: Simvastatin

Placebo treatment

Placebo Comparator group

Description:

Placebo for one year time period

Treatment:

Drug: Placebo Oral Capsule