Statin Monotherapy for Treatment of Endocrine Metabolic Disease Risk

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.

Conditions

• Spinal Cord Injuries
• Osteoporosis
• Metabolic Syndrome

Interventions

DRUG

Rosuvastatin Calcium

10mg Rosuvastatin, daily for 12 months

DRUG

Placebo Oral Tablet

Placebo, daily for 12 months

DIETARY_SUPPLEMENT

Coenzyme Q10

100mg CoQ10, daily for 12 months

DIETARY_SUPPLEMENT

Calcium Carbonate

1250mg Calcium Carbonate, daily for 12 months

DIETARY_SUPPLEMENT

Vitamin D

2000IU Vitamin D, daily for 12 months

Sponsors & Collaborators

• The Craig H. Neilsen Foundation

  collaborator OTHER

• Toronto Rehabilitation Institute

  collaborator OTHER

• University Health Network, Toronto

  collaborator OTHER

• University of Miami

  collaborator OTHER

• Rick Hansen Institute

  collaborator OTHER

• Dr. B. Catharine. Craven

  lead OTHER

Principal Investigators

• B. Catharine Craven, BA, MD, FRCPC, MSc · Toronto Rehabilitation Institute - UHN

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-26

Primary Completion

2022-12-31

Completion

2022-12-31

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations