Clinical trial NCT02946424: Simvastatin to Prevent SCI-Induced Bone Loss
Official title: Simvastatin to Improve Bone Health in SCI: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Spinal Cord Injuries
Osteoporosis
Lead sponsor: Craig Hospital
Sponsor class: OTHER
First posted: 2016-10-27
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in knee bone mineral density
timeFrame: baseline and 12 months
Secondary outcomes:
measure: Change in bone volume
timeFrame: baseline and 12 months
measure: Change in mood
timeFrame: baseline and 12 months
measure: Change in pain
timeFrame: baseline and 12 months
measure: Satisfaction with life
timeFrame: baseline and 12 months
measure: Change in community reintegration
timeFrame: baseline and 12 months
measure: Change in motor score
timeFrame: baseline and 12 months
measure: Change in tibial bone strength
timeFrame: baseline and 12 months
Other outcomes:
measure: Change in bone formation
timeFrame: baseline and 12 months
measure: Change in bone resorption
timeFrame: baseline and 12 months
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
Study officials:
affiliation: Craig Hospital
name: Leslie Morse, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kowalski JL, Nguyen N, Battaglino RA, Falci SP, Charlifue S, Morse LR. miR-338-5p Levels and Cigarette Smoking are Associated With Neuropathic Pain Severity in Individuals With Spinal Cord Injury: Preliminary Findings From a Genome-Wide microRNA Expression Profiling Screen. Arch Phys Med Rehabil. 2022 Apr;103(4):738-746. doi: 10.1016/j.apmr.2021.09.005. Epub 2021 Oct 27.