Spinal Cord InjuriesPhase 2NCT02946424
Simvastatin to Prevent SCI-Induced Bone Loss
A Phase 2 study testing Simvastatin in people with Spinal Cord Injuries and Osteoporosis, run by Craig Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injuries, Osteoporosis
- What is being tested?
- Simvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 30 Sep 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years of age
- acute SCI (AIS A-C) who are enrolled at our center in an ongoing surveillance study.
- use a wheelchair as their primary mobility mode
- reside in the greater Denver metropolitan area
- within 3 months of injury
- medically stable
- able to follow directions
- provide informed consent.
Who cannot join
- have any simvastatin contraindications including:
- drug allergy,
- active liver disease,
- renal dysfunction,
- concurrent use of drugs that cause myopathy or increase the risk of myopathy with simvastatin therapy (gemfibrozil, niacin, cyclosporine, danazol, amiodarone, dronedarone, ranolazine, calcium channel blockers, colchicine), strong CYP34A inhibitors (itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone, cobicistat-containing products), low plasma cholesterol levels,
- uncontrolled or poorly controlled diabetes,
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- unstable anti-coagulation treatment,
- taking a statin in the preceding 12 months,
- metabolic bone disease, thyroid disorder,
- history of bilateral oophorectomy,
- current use of medications potentially affecting bone health including bisphosphonates, androgenic steroids, estrogenic steroids, anti-epileptics, lithium glucocorticoid use for more than 3 months,
- have received inhaled glucocorticoids in the past 12 months,
- pregnant or lactating women,
- women of childbearing potential who are unwilling or unable to use a reliable form of contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simvastatin to Improve Bone Health in SCI: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial
This is a double blind, randomized, placebo -controlled clinical trial with the primary goal of determining the osteogenic benefits of simvastatin in acute SCI.
Read the 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
- Being tested
- Placebo Oral Capsule, Simvastatin
- Medical subject headings
- Spinal Cord Injuries, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Oral CapsuleDrug
12 month course of daily placebo
SimvastatinDrug
Also called Zocor
12 month course of daily simvastatin
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin treatment | Experimental | Simvastatin for one year time period Receives: Drug: Simvastatin |
| Placebo treatment | Placebo comparator | Placebo for one year time period Receives: Drug: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knee bone mineral density
assessed by DXA
Measured: baseline and 12 months
Secondary outcomes (7)
Change in bone volume
quantitative CT scan of the knee
Measured: baseline and 12 months
Change in mood
Patient Health Questionnaire-9
Measured: baseline and 12 months
Change in pain
International Spinal Cord Injury Basic Pain Data Set
Measured: baseline and 12 months
Satisfaction with life
Satisfaction with Life Scale
Measured: baseline and 12 months
Change in community reintegration
Craig Handicap and Assessment Reporting Technique-Short Form
Measured: baseline and 12 months
Change in motor score
assessed by ISNCSCI exam
Measured: baseline and 12 months
Change in tibial bone strength
assessed by finite element analysis of quantitative CT scan of the knee
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start1 Jul 2017
- Primary completionSep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Morse, Craig Hospital
- Investigators
- Leslie Morse, DO, Principal investigator, Craig Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946424
- Sponsor's protocol ID
- SCIMS Statin
- Status last verified
- Dec 2021
- First submitted
- 13 Oct 2016
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kowalski JL, Nguyen N, Battaglino RA, Falci SP, Charlifue S, Morse LR. miR-338-5p Levels and Cigarette Smoking are Associated With Neuropathic Pain Severity in Individuals With Spinal Cord Injury: Preliminary Findings From a Genome-Wide microRNA Expression Profiling Screen. Arch Phys Med Rehabil. 2022 Apr;103(4):738-746. doi: 10.1016/j.apmr.2021.09.005. Epub 2021 Oct 27.
PubMed 34717922
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simvastatin to Improve Bone Health in SCI: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02946424
- Acronym / sponsor ID
- SCIMS Statin
- Conditions
- Spinal Cord Injuries, Osteoporosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin treatment | Experimental | Drug: SimvastatinSimvastatin for one year time period |
| Placebo treatment | Placebo comparator | Drug: Placebo Oral CapsulePlacebo for one year time period |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 18-60 years of age
- acute SCI (AIS A-C) who are enrolled at our center in an ongoing surveillance study.
- use a wheelchair as their primary mobility mode
- reside in the greater Denver metropolitan area
- within 3 months of injury
Key exclusion criteria (14 listed)
- have any simvastatin contraindications including:
- drug allergy,
- active liver disease,
- renal dysfunction,
- concurrent use of drugs that cause myopathy or increase the risk of myopathy with simvastatin therapy (gemfibrozil, niacin, cyclosporine, danazol, amiodarone, dronedarone, ranolazine, calcium channel blockers, colchicine), strong CYP34A inhibitors (itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone, cobicistat-containing products), low plasma cholesterol levels,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Oral Capsule12 month course of daily placebo | Drug | Placebo treatment |
| SimvastatinAlso: Zocor12 month course of daily simvastatin | Drug | Simvastatin treatment |
Primary outcome
Change in knee bone mineral density
Time frame: baseline and 12 months
assessed by DXA
7 secondary outcomes
Change in bone volume
Time frame: baseline and 12 months
Change in mood
Time frame: baseline and 12 months
Change in pain
Time frame: baseline and 12 months
Satisfaction with life
Time frame: baseline and 12 months
Change in community reintegration
Time frame: baseline and 12 months
Change in motor score
Time frame: baseline and 12 months
Change in tibial bone strength
Time frame: baseline and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Derived from this study: PubMed 34717922Kowalski JL, Nguyen N, Battaglino RA, Falci SP, Charlifue S, Morse LR. miR-338-5p Levels and Cigarette Smoking are Associated With Neuropathic Pain Severity in Individuals With Spinal Cord Injury: Preliminary Findings From a Genome-Wide microRNA Expression Profiling Screen. Arch Phys Med Rehabil. 2022 Apr;103(4):738-746. doi: 10.1016/j.apmr.2021.09.005. Epub 2021 Oct 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Morse, DO principal investigator
Craig Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simvastatin in people with Spinal Cord Injuries and Osteoporosis, run by Craig Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knee bone mineral density (time frame: baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02946424, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.