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This is a double blind, randomized, placebo -controlled clinical trial with the primary goal of determining the osteogenic benefits of simvastatin in acute SCI.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simvastatin treatment | Experimental | Simvastatin for one year time period |
|
| Placebo treatment | Placebo Comparator | Placebo for one year time period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Oral Capsule | Drug | 12 month course of daily placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in knee bone mineral density | assessed by DXA | baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in bone volume | quantitative CT scan of the knee | baseline and 12 months |
| Change in mood | Patient Health Questionnaire-9 | baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in bone formation | assessed by circulating osteocalcin level | baseline and 12 months |
| Change in bone resorption | assessed by circulating c-telopeptide level |
Inclusion Criteria:
Exclusion Criteria:
- have any simvastatin contraindications including:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Morse, DO | Craig Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Craig Hospital | Englewood | Colorado | 80113-2811 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34717922 | Derived | 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. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Simvastatin |
| Drug |
12 month course of daily simvastatin |
|
|
| Change in pain | International Spinal Cord Injury Basic Pain Data Set | baseline and 12 months |
| Satisfaction with life | Satisfaction with Life Scale | baseline and 12 months |
| Change in community reintegration | Craig Handicap and Assessment Reporting Technique-Short Form | baseline and 12 months |
| Change in motor score | assessed by ISNCSCI exam | baseline and 12 months |
| Change in tibial bone strength | assessed by finite element analysis of quantitative CT scan of the knee | baseline and 12 months |
| baseline and 12 months |
| D014947 | Wounds and Injuries |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |