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Simvastatin to Prevent SCI-Induced Bone Loss
Phase 2
Waitlist Available
Led By Leslie Morse, DO
Research Sponsored by Craig Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 months
Summary
This trial is testing whether taking simvastatin regularly can prevent bone loss in patients who have recently suffered a spinal cord injury. Simvastatin is usually used to lower cholesterol but may also help in keeping bones strong. The study will compare the effects of simvastatin to see if it makes a difference in bone health. Simvastatin is commonly used to lower cholesterol and has been studied for its potential effects on bone health.
Eligible Conditions
- Spinal Cord Injury
- Osteoporosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in knee bone mineral density
Secondary study objectives
Change in bone volume
Change in community reintegration
Change in mood
+4 moreOther study objectives
Change in bone formation
Change in bone resorption
Side effects data
From 2015 Phase 3 trial • 33 Patients • NCT0203004111%
Myalgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vitamin D and Placebo
Simvastatin and Placebo
Simvastatin and Vitamin D
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Simvastatin treatmentExperimental Treatment1 Intervention
Simvastatin for one year time period
Group II: Placebo treatmentPlacebo Group1 Intervention
Placebo for one year time period
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Simvastatin
2012
Completed Phase 4
~1270
Find a Location
Who is running the clinical trial?
Craig HospitalLead Sponsor
42 Previous Clinical Trials
8,388 Total Patients Enrolled
Leslie Morse, DOPrincipal Investigator - Craig Hospital
Craig Hospital
2 Previous Clinical Trials
94 Total Patients Enrolled