Simvastatin to Prevent SCI-Induced Bone Loss

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoporosis; Spinal Cord Injuries
• Intervention / Treatment: Drug: Simvastatin; Drug: Placebo Oral Capsule

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 Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113-2811
      • Craig Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simvastatin treatment; Simvastatin for one year time period	Drug: Simvastatin; 12 month course of daily simvastatin; Other Names: Zocor
Placebo Comparator: Placebo treatment; Placebo for one year time period	Drug: Placebo Oral Capsule; 12 month course of daily placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in knee bone mineral density	assessed by DXA	baseline and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in bone volume	quantitative CT scan of the knee	baseline and 12 months
Change in mood	Patient Health Questionnaire-9	baseline and 12 months
Change in pain	International Spinal Cord Injury Basic Pain Data Set	baseline and 12 months
Satisfaction with life	Satisfaction with Life Scale	baseline and 12 months
Change in community reintegration	Craig Handicap and Assessment Reporting Technique-Short Form	baseline and 12 months
Change in motor score	assessed by ISNCSCI exam	baseline and 12 months
Change in tibial bone strength	assessed by finite element analysis of quantitative CT scan of the knee	baseline and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in bone formation	assessed by circulating osteocalcin level	baseline and 12 months
Change in bone resorption	assessed by circulating c-telopeptide level	baseline and 12 months

Collaborators and Investigators

• Sponsor: Craig Hospital
• Investigators: Principal Investigator: Leslie Morse, DO, Craig Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (Estimate): October 27, 2016

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Musculoskeletal Diseases; Trauma, Nervous System; Spinal Cord Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Spinal Cord Injuries; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin
• Other Study ID Numbers: SCIMS Statin

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No