Simvastatin to Prevent SCI-Induced Bone Loss

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02946424
• Other study ID #: SCIMS Statin
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 1, 2017
• Est. completion date: September 30, 2023

Study information

• Verified date: December 2021
• Source: Craig Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: September 30, 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis
• Spinal Cord Injuries

Intervention

Drug:
• Placebo Oral Capsule
12 month course of daily placebo
• Simvastatin
12 month course of daily simvastatin

Locations

Country	Name	City	State
United States	Craig Hospital	Englewood	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Craig Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in bone formation	assessed by circulating osteocalcin level	baseline and 12 months
Other	Change in bone resorption	assessed by circulating c-telopeptide level	baseline and 12 months
Primary	Change in knee bone mineral density	assessed by DXA	baseline and 12 months
Secondary	Change in bone volume	quantitative CT scan of the knee	baseline and 12 months
Secondary	Change in mood	Patient Health Questionnaire-9	baseline and 12 months
Secondary	Change in pain	International Spinal Cord Injury Basic Pain Data Set	baseline and 12 months
Secondary	Satisfaction with life	Satisfaction with Life Scale	baseline and 12 months
Secondary	Change in community reintegration	Craig Handicap and Assessment Reporting Technique-Short Form	baseline and 12 months
Secondary	Change in motor score	assessed by ISNCSCI exam	baseline and 12 months
Secondary	Change in tibial bone strength	assessed by finite element analysis of quantitative CT scan of the knee	baseline and 12 months