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HMG-CoA Reductase Inhibitor

Rosuvastatin for Osteoporosis (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

2 years post-injury

Adult (age 18-60 years)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months and 12 months (or study completion)

Awards & highlights

RoBaCO Trial 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

Osteoporosis
Spinal Cord Injury
Metabolic Syndrome

RoBaCO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

RoBaCO Trial 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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months and 12 months (or study completion) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in areal BMD of the knee region

Secondary outcome measures

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 more

Other outcome measures

Changes in aortic arterial stiffness

Changes in lean mass

Changes in visceral adipose tissue

RoBaCO Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: RosuvastatinActive Control4 Interventions

Group II: PlaceboPlacebo Group4 Interventions

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dr. B. Catharine. CravenLead Sponsor

The Craig H. Neilsen FoundationOTHER

55 Previous Clinical Trials

2,927 Total Patients Enrolled

1 Trials studying Osteoporosis

21 Patients Enrolled for Osteoporosis

Toronto Rehabilitation InstituteOTHER

50 Previous Clinical Trials

5,613 Total Patients Enrolled

3 Trials studying Osteoporosis

144 Patients Enrolled for Osteoporosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial have an age limit?

"This trial includes a minimum age limit of 18 and participants must not be older than 60."

Answered by AI

Has Rosuvastatin been federally authorized for general use?

"Rosuvastatin's safety is estimated to be a 2. This means that while there is some evidence suggesting that it is safe, there is no data yet confirming its efficacy."

Answered by AI

What do we know about Rosuvastatin from other research projects?

"Development of Rosuvastatin began in 2009 at the University of Ioannina Medical School. To date, there are 762 completed trials with 42 active clinical trials ongoing. Many of these studies taking place in Toronto, Canada."

Answered by AI

What are patients generally taking Rosuvastatin for?

"Rosuvastatin is a popular medication used to combat hypertriglyceridemias. However, this drug can also be helpful for patients suffering from cardiovascular disease (cvd), cardiovascular events, and those that have undergone cardiovascular surgeries."

Answered by AI

Could I possibly take part in this examination?

"Up to 8 individuals aged 18-60 who have recently (within 2 years) suffered a spinal cord injury will be enrolled in this trial. Other important requirements for participants include having a working telephone and being able to commit to attending study visits."

Answered by AI

Are there any available patients slots for this clinical trial?

"The trial in question, which can be found on clinicaltrials.gov, is not recruiting patients at this time. This particular study was last updated on October 19th 2021 and was first posted February 26th 2018. There are 692 other trials that are currently looking for participants."

Answered by AI

How many individuals are being asked to participate in this research?

"Currently, this particular trial is not enrolling new patients. It was originally posted on February 26th, 2018 and last updated on October 19th, 2021. There are 650 trials for spinal cord injuries and 42 studies for Rosuvastatin currently recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Statin Monotherapy for Treatment of Endocrine Metabolic Disease Risk

Dr. B. Catharine. Craven 2018. "Statin Monotherapy for Treatment of Endocrine Metabolic Disease Risk". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03113994.

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