Simvastatin to Prevent SCI-Induced Bone Loss



Status:Recruiting
Conditions:Osteoporosis, Hospital, Orthopedic
Therapuetic Areas:Rheumatology, Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - 60
Updated:4/17/2018
Start Date:July 1, 2017
End Date:September 30, 2021
Contact:Leslie Morse, DO
Email:lmorse@craighospital.org
Phone:303-789-8970

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

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

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.

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.
We found this trial at
1
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Englewood, Colorado 80113
Principal Investigator: Leslie Morse, DO
Phone: 303-789-8970
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