NCT02946424

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2017

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

December 8, 2021

Status Verified

December 1, 2021

Enrollment Period

6.2 years

First QC Date

October 13, 2016

Last Update Submit

December 6, 2021

Conditions

Spinal Cord InjuriesOsteoporosis

Outcome Measures

Primary Outcomes (1)

  • Change in knee bone mineral density

    assessed by DXA

    baseline and 12 months

Secondary Outcomes (7)

  • Change in bone volume

    baseline and 12 months

  • Change in mood

    baseline and 12 months

  • Change in pain

    baseline and 12 months

  • Satisfaction with life

    baseline and 12 months

  • Change in community reintegration

    baseline and 12 months

  • +2 more secondary outcomes

Other Outcomes (2)

  • Change in bone formation

    baseline and 12 months

  • Change in bone resorption

    baseline and 12 months

Study Arms (2)

Simvastatin treatment

EXPERIMENTAL

Simvastatin for one year time period

Drug: Simvastatin

Placebo treatment

PLACEBO COMPARATOR

Placebo for one year time period

Drug: Placebo Oral Capsule

Interventions

Placebo Oral CapsuleDRUG

12 month course of daily placebo

Placebo treatment
SimvastatinDRUG

12 month course of daily simvastatin

Also known as: Zocor
Simvastatin treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113-2811, United States

Location

Related Publications (1)

  • 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.

    PMID: 34717922DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesOsteoporosis

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Leslie Morse, DO

    Craig Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 13, 2016

First Posted

October 27, 2016

Study Start

July 1, 2017

Primary Completion

September 1, 2023

Study Completion

September 30, 2023

Last Updated

December 8, 2021

Record last verified: 2021-12

Locations

US(1)