Statin Monotherapy for Treatment of Endocrine Metabolic Disease Risk (RoBaCO)

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal Cord Injury, Osteoporosis, Cardiometabolic Syndrome Read More

Inclusion Criteria:

• Adult (age 18-60 years)
• Motor complete SCI (C1-T10 AIS A/B)
• 2 years post-injury
• Have a telephone, and ability to attend the study visits
• Able to take oral medications and swallow independently
• Can provide free and informed consent
• Ability to understand instructions in English
• May report current use of oral alendronate 10mg daily or 70mg weekly or risedronate 5mg daily, 30mg weekly or 150mg monthly

Exclusion Criteria:

These criteria are intended to exclude those in whom; Rosuvastatin would be unsafe, DXA/pQCT measurement or biomarker assessment would be invalid, or in whom other co-morbid health conditions may confound the study results. Exclusion criteria include:

• Current and/or one year prior to enrolment treatment with any statin such as atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, simvastatin and rosuvastatin.
• Current treatment with IV bisphosphonate, denosumab, recombinant PTH, ovarian hormone therapy, an oral contraceptive, Immunosuppressants (Including Cyclosporine) and fusidic acid.
• Known allergy to Rosuvastatin, lactose powder, CoQ10, calcium carbonate, vitamin D2 and vitamin D3, or any other ingredient found in rosuvastatin, placebo or study supplements.
• History of Paget's disease, osteomalacia, steroid induced osteoporosis, or untreated parathyroid or untreated thyroid disease.
• Subjects with history of stage 4 chronic kidney disease. (124)
• Current Weight ≥136 kg.
• Bilateral knee region metal implants (hardware), history of bilateral knee region contracture >30 degrees, fracture or any other bilateral knee region pathology which would preclude accurate DXA assessment of one limb.
• Post-menopausal women (absence of menses for a minimum of 1 year).
• Women with amenorrhea due to bilateral surgical removal of the ovaries and/or uterus (women with amenorrhea due to spinal cord injury are able to participate).
• Pregnancy or lactation.
• Female of child-bearing potential who is engaged in active heterosexual relations and is not using appropriate birth control methods. Appropriate methods of birth control will include: surgical sterilization at least 6 months prior to using study drug or sexual activity restricted to a vasectomized partner, barrier contraception with a condom or diaphragm in conjunction with spermicidal gel in use at least 30 days prior to using study drug OR sexual abstinence as a lifestyle.
• History of liver disease or abnormal Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT), ≥1.5 times the upper limit of the normal reference range at enrolment.
• History of symptomatic hypocalcemia or hypophosphatemia.
• Concurrent treatment with prednisone (>7.5mg/day for 90 days).
• Vitamin D deficiency (Serum Vitamin D level <75nmol/L) after completing 8 to 12 weeks of treatment for Vitamin D deficiency as per the Vitamin D correction protocol (Appendix Page 1).
• History of heart attack or stroke.
• Untreated hypertension defined as: elevated BP above (135/85mmHg) assessed with an automated blood pressure cuff at 3 distinct time points in a 7-10 day period.(125, 126)
• Current alcohol or street drug abuse.
• Any illness or condition interfering with the trial conduct or subject safety.