Simvastatin to Prevent SCI-Induced Bone Loss

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Spinal Cord Injuries, Osteoporosis

In brief

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

Key facts

Study ID

NCT02946424

Run by

Craig Hospital

People needed

76

Starts

2017-07-01

Expected to finish

2023-09-30

Last updated by the study team

2021-12-08

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Craig Hospital — Englewood, Colorado, United States

Full record on ClinicalTrials.gov

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