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HMG-CoA Reductase Inhibitor
Rosuvastatin for Spinal Cord Injury (RoBaCO Trial)
Phase 2
Waitlist Available
Led By B. Catharine Craven, BA, MD, FRCPC, MSc
Research Sponsored by Dr. B. Catharine. Craven
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, 6 months and 12 months (or study completion)
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Summary
This trial is testing whether a drug called Rosuvastatin can help to reduce bone loss and inflammation in people with long-term spinal cord injuries.
Eligible Conditions
- Spinal Cord Injury
- Osteoporosis
- Metabolic Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months and 12 months (or study completion)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months and 12 months (or study completion)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in areal BMD of the knee region
Secondary study objectives
Change from Baseline in Bone Specific Alkaline Phosphatase (BALP)
Change from Baseline in C-telopeptide (CTX)
Change from Baseline in High sensitivity C-reactive Protein (hsCRP)
+12 moreOther study objectives
Changes in aortic arterial stiffness
Changes in lean mass
Changes in visceral adipose tissue
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: RosuvastatinActive Control4 Interventions
Group II: PlaceboPlacebo Group4 Interventions
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Who is running the clinical trial?
Dr. B. Catharine. CravenLead Sponsor
The Craig H. Neilsen FoundationOTHER
59 Previous Clinical Trials
2,995 Total Patients Enrolled
Toronto Rehabilitation InstituteOTHER
53 Previous Clinical Trials
5,986 Total Patients Enrolled
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