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Simvastatin to Prevent SCI-Induced Bone Loss

Simvastatin to Improve Bone Health in SCI: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

NCT02946424•Craig Hospital

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

Age

18 - 60 years

Sex

ALL

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,
+4 more criteria

Locations (1)

Craig Hospital

Englewood, Colorado, United States

Key Dates

Start Date

July 1, 2017

Primary Completion Date

September 1, 2023

Completion Date

September 30, 2023

Last Updated

December 8, 2021

Enrollment

ESTIMATED participants

Conditions

Spinal Cord InjuriesOsteoporosis

Interventions

Placebo Oral Capsule

DRUG

Simvastatin

DRUG

Low Oxygen Therapy to Enhance Walking Recovery After SCI.

NCT06521723

Spinal Cord Injuries

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RECRUITINGNA

Combination Therapy to Improve SCI Recovery.

NCT05563103

Spinal Cord Injuries

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RECRUITINGNA

Health Information for Persons With Spinal Cord Injury

NCT07386522

Spinal Cord Injuries (SCI)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Simvastatin to Prevent SCI-Induced Bone Loss

Inclusion Criteria

Exclusion Criteria

Low Oxygen Therapy to Enhance Walking Recovery After SCI.

Combination Therapy to Improve SCI Recovery.

Health Information for Persons With Spinal Cord Injury

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