NCT02946424

Simvastatin to Prevent SCI-Induced Bone Loss

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Craig Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Injuries
• Osteoporosis

Interventions

Type	Name	Description
DRUG	Placebo Oral Capsule	12 month course of daily placebo
DRUG	Simvastatin	12 month course of daily simvastatin

Timeline

• Start date: 2017-07-01
• Primary completion: 2023-09-01
• Completion: 2023-09-30
• First posted: 2016-10-27
• Last updated: 2021-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study