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Simvastatin to Prevent SCI-Induced Bone Loss

Primary Purpose

Spinal Cord Injuries, Osteoporosis

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Placebo Oral Capsule

Simvastatin

About this trial

This is an interventional prevention trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Craig Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Simvastatin treatment

Placebo treatment

Arm Description

Simvastatin for one year time period

Placebo for one year time period

Outcomes

Primary Outcome Measures

Change in knee bone mineral density

assessed by DXA

Secondary Outcome Measures

Change in bone volume

quantitative CT scan of the knee

Change in mood

Patient Health Questionnaire-9

Change in pain

International Spinal Cord Injury Basic Pain Data Set

Satisfaction with life

Satisfaction with Life Scale

Change in community reintegration

Craig Handicap and Assessment Reporting Technique-Short Form

Change in motor score

assessed by ISNCSCI exam

Change in tibial bone strength

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

Full Information

NCT ID

NCT02946424

First Posted

October 13, 2016

Last Updated

December 6, 2021

Sponsor

Craig Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02946424

Brief Title

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

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Craig Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries, Osteoporosis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Simvastatin treatment

Arm Type

Experimental

Arm Description

Simvastatin for one year time period

Arm Title

Placebo treatment

Arm Type

Placebo Comparator

Arm Description

Placebo for one year time period

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Capsule

Intervention Description

12 month course of daily placebo

Intervention Type

Drug

Intervention Name(s)

Simvastatin

Other Intervention Name(s)

Zocor

Intervention Description

12 month course of daily simvastatin

Primary Outcome Measure Information:

Title

Change in knee bone mineral density

Description

assessed by DXA

Time Frame

baseline and 12 months

Secondary Outcome Measure Information:

Title

Change in bone volume

Description

quantitative CT scan of the knee

Time Frame

baseline and 12 months

Title

Change in mood

Description

Patient Health Questionnaire-9

Time Frame

baseline and 12 months

Title

Change in pain

Description

International Spinal Cord Injury Basic Pain Data Set

Time Frame

baseline and 12 months

Title

Satisfaction with life

Description

Satisfaction with Life Scale

Time Frame

baseline and 12 months

Title

Change in community reintegration

Description

Craig Handicap and Assessment Reporting Technique-Short Form

Time Frame

baseline and 12 months

Title

Change in motor score

Description

assessed by ISNCSCI exam

Time Frame

baseline and 12 months

Title

Change in tibial bone strength

Description

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

Time Frame

baseline and 12 months

Other Pre-specified Outcome Measures:

Title

Change in bone formation

Description

assessed by circulating osteocalcin level

Time Frame

baseline and 12 months

Title

Change in bone resorption

Description

assessed by circulating c-telopeptide level

Time Frame

baseline and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leslie Morse, DO

Organizational Affiliation

Craig Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Craig Hospital

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80113-2811

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34717922

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.

Results Reference

derived

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Simvastatin to Prevent SCI-Induced Bone Loss

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