Statin Monotherapy for Treatment of Endocrine Metabolic Disease Risk
Status:
Active, not recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Rationale: After having a spinal cord injury (SCI), people develop changes in their body
composition that influences their long-term health. Individuals with paralysis after SCI will
have large declines in their bone density ant increases in fat mass which increases their
risk of fracture and heart disease. Therapies to prevent SCI-related changes in body
composition and their health effects are needed. Drugs known as "statins" used often to
reduce high cholesterol, may help to reduce bone loss and inflammation.
Hypothesis: Among adults with SCI for a long time, treatment with a drug named Rosuvastatin
or a sugar pill, with supplements (coenzyme Q10, calcium and vitamin D), for twelve months
can decrease their endocrine metabolic disease risk by increasing bone density and reducing
inflammation.
Study Design: A clinical trial will be conducted in Toronto, Ontario and Miami, Florida.
Subjects will get statin therapy or placebo (sugar pill) by chance. Study subjects and
research staff will not know whether they are taking the study drug or a sugar pill until
after the study
Subjects: Fifty-four adults (age 18-60 years) with a long-term SCI and no movement below
their level of injury.
Treatment: Subjects will be prescribed Rosuvastatin 10 mg daily or a sugar pill. In addition,
all subjects will receive 100 mg of Co-Q10 daily, calcium carbonate 1250 mg and, vitamin D
2,000 IU once a day.
Data Collected: Subjects' bone density will be collected at the start and end of the study.
Change in bone density between the two groups will be compared to see if one is better. Blood
samples will be collected quarterly to make sure subjects are safe and do not develop
problems with their liver or muscles and to measure the effects of the study drugs on
inflammation throughout the body.
Clinical Implications: Statins may be safe and effective therapy for adults living with SCI
who are at increased risk of endocrine metabolic disease as they age.
Phase:
Phase 2
Details
Lead Sponsor:
Dr. B. Catharine. Craven
Collaborators:
Rick Hansen Institute The Craig H. Neilsen Foundation Toronto Rehabilitation Institute University Health Network, Toronto University of Miami