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Simvastatin to Prevent SCI-Induced Bone Loss

Sponsor
Craig Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02946424
Collaborator
(none)
76
Enrollment
1
Location
2
Arms
75
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Simvastatin to Improve Bone Health in SCI: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial
Actual Study Start Date :
Jul 1, 2017
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Change in knee bone mineral density [baseline and 12 months]

      assessed by DXA

    Secondary Outcome Measures

    1. Change in bone volume [baseline and 12 months]

      quantitative CT scan of the knee

    2. Change in mood [baseline and 12 months]

      Patient Health Questionnaire-9

    3. Change in pain [baseline and 12 months]

      International Spinal Cord Injury Basic Pain Data Set

    4. Satisfaction with life [baseline and 12 months]

      Satisfaction with Life Scale

    5. Change in community reintegration [baseline and 12 months]

      Craig Handicap and Assessment Reporting Technique-Short Form

    6. Change in motor score [baseline and 12 months]

      assessed by ISNCSCI exam

    7. Change in tibial bone strength [baseline and 12 months]

      assessed by finite element analysis of quantitative CT scan of the knee

    Other Outcome Measures

    1. Change in bone formation [baseline and 12 months]

      assessed by circulating osteocalcin level

    2. Change in bone resorption [baseline and 12 months]

      assessed by circulating c-telopeptide level

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Craig Hospital Englewood Colorado United States 80113-2811

    Sponsors and Collaborators

    • Craig Hospital

    Investigators

    • Principal Investigator: Leslie Morse, DO, Craig Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Leslie Morse, Principal Investigator, Craig Hospital
    ClinicalTrials.gov Identifier:
    NCT02946424
    Other Study ID Numbers:
    • SCIMS Statin
    First Posted:
    Oct 27, 2016
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Osteoporosis
    Spinal Cord Injuries
    Simvastatin

    Study Results

    No Results Posted as of Dec 8, 2021