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Simvastatin for Spinal Cord Injury

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
Awards & highlights

Study Summary

This trial is testing whether simvastatin can help improve bone health in people with acute spinal cord injuries.

Eligible Conditions
  • Spinal Cord Injury
  • Osteoporosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months 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 in knee bone mineral density
Secondary outcome measures
Change in bone volume
Change in community reintegration
Change in mood
+4 more
Other outcome measures
Change in bone formation
Change in bone resorption

Side effects data

From 2015 Phase 3 trial • 33 Patients • NCT02030041
11%
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
40 Previous Clinical Trials
8,283 Total Patients Enrolled
Leslie Morse, DOPrincipal Investigator - Craig Hospital
Craig Hospital
2 Previous Clinical Trials
94 Total Patients Enrolled

Frequently Asked Questions

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

To what degree is Simvastatin secure for patients?

"There are preliminary studies indicating the safety of simvastatin, thus granting it a score of 2 on our scale. However, there is yet to be any data confirming its efficacy."

Answered by AI

Who can qualify for this trial based on age criteria?

"The parameters for enrollment dictate that individuals must be between 18 and 60 years of age to qualify."

Answered by AI

In what medical scenarios is the medication Simvastatin typically recommended?

"Simvastatin is a popular treatment for high cholesterol, as well as diabetes mellitus, prevention of cardiovascular disease, and hypercholesterolemia."

Answered by AI

Is there still capacity to join this clinical trial?

"Unfortunately, this trial is not currently recruiting at the moment. The original listing was posted on July 1st 2017 with a final update occurring in December 2021. If you're searching for other studies related to osteoporosis, there are 483 trials still actively looking for participants and 37 clinical trials seeking individuals taking Simvastatin medication."

Answered by AI

Is this research pioneering in nature?

"The initial research into Simvastatin began in 2005, with Merck Sharp & Dohme LLC sponsoring the first clinical trial. Following this 80-person study, Phase 4 drug approval was granted for Simvastatin and today there are 37 active trials taking place across 239 cities and 31 countries."

Answered by AI

How many participants are being welcomed into this clinical experiment?

"This clinical trial is not presently seeking participants. The protocol was initially published on July 1st 2017, with the last update occurring December 6th 2021. If you are searching for an alternate study, there are 483 trials recruiting individuals who have osteoporosis and 37 studies accepting patients taking Simvastatin."

Answered by AI

Could I qualify to participate in the clinical research?

"This research project requires 76 individuals, aged 18-60, with a diagnosis of osteoporosis. Furthermore, participants must utilize wheelchairs as their primary means of locomotion and have sustained an acute spinal cord injury (AIS A-C) within the past three months. Lastly, they need to be able to understand directions in order to qualify for this study."

Answered by AI

Have there been any previous investigations into the efficacy of Simvastatin?

"At this time, 37 studies involving simvastatin are in progress. Of these research initiatives, 7 have progressed to the third phase of clinical trials. Although most experiments with Simvastatin are being conducted in Pontyclun, Wales; a total of 480 sites across multiple countries are running such investigations."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
What site did they apply to?
Craig Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have horrific osteoporosis. I had a horrific ortho trauma falling from my wheelchair. I am interested in any trial that could improve my risk for fracture. Thank you! I have been non ambulatory for 24 years.
PatientReceived 1 prior treatment
~10 spots leftby Apr 2025