Statin Monotherapy for Treatment of Endocrine Metabolic Disease Risk
NCT ID: NCT03113994
Last Updated: 2021-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
8 participants
INTERVENTIONAL
2018-02-26
2022-12-31
Brief Summary
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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.
Detailed Description
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Hypothesis: Twelve months of statin therapy with concurrent coenzyme Q10 (CoQ10), to reduce risk of statin neuromyotoxicity, and standard care (calcium 1250mg OD and vitamin D3 2000IU OD) will be superior to placebo with CoQ10 and standard care, for augmenting knee region BMD and reducing inflammatory stress (hs-CRP), thereby reducing endocrine metabolic disease risk.
Objective: To determine the safety and efficacy of statin therapy for augmenting distal femoral BMD among adults with chronic motor-complete SCI in Toronto, Ontario and Miami, Florida.
Study Design: Multi-centre, double-blind, randomized controlled Phase II safety and efficacy trial.
Subjects: Consenting men and premenopausal women (N=54, age 18-60 yrs) with chronic (≥2 years) spinal cord injury with a neurological level between C1-T10 and an AIS category of A/B.
Intervention: Rosuvastatin 10 mg po daily at night versus placebo for 12 months. All subjects will receive osteoporosis standard care (calcium carbonate 1250mg po daily and vitamin D3 2000 IU po daily) to maintain bone mass and CoQ10 100mg po daily to prevent statin-induced myopathy.
Outcomes: Primary safety outcomes: i) establish the safety of rosuvastatin in chronic SCI by reporting the frequency of myotoxicity and type II diabetes onset; ii) frequency and mean duration of liver transaminase elevations in the rosuvastatin and placebo groups. Primary efficacy outcome: measure the mean between group absolute changes in distal femur areal BMD (aBMD, g/cm2) from baseline to one year. Secondary efficacy outcomes: will examine the mean absolute changes from baseline in: i) volumetric BMD (vBMD, g/cm3); ii) markers of bone turnover - Bone Specific Alkaline Phosphatase (BALP), telopeptide (CTX), Sclerostin and RANK Ligand (RANK-L); iii) serum inflammatory markers including high sensitivity C-reactive Protein (hs-CRP), Interleukin-1ß (IL-1ß). interleukin-6 (IL-6), tumor necrosis factor - alpha (TNF-alpha), erythrocyte sedimentation rate (ESR); and, iv) lipid profile; low density lipoprotein cholesterol (LDL), high density lipoprotein cholesterol (HDL), triglycerides, and total cholesterol Clinical Implications: Should rosuvastatin prove to be safe and efficacious for reducing endocrine metabolic disease risk for adults with chronic SCI, the results will advance the health of people with SCI by reducing the frequency and severity of heart disease and fracture as they age, with a single intervention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rosuvastatin
Rosuvastatin Calcium
10mg Rosuvastatin, daily for 12 months
Coenzyme Q10
100mg CoQ10, daily for 12 months
Calcium Carbonate
1250mg Calcium Carbonate, daily for 12 months
Vitamin D
2000IU Vitamin D, daily for 12 months
Placebo
Placebo Oral Tablet
Placebo, daily for 12 months
Coenzyme Q10
100mg CoQ10, daily for 12 months
Calcium Carbonate
1250mg Calcium Carbonate, daily for 12 months
Vitamin D
2000IU Vitamin D, daily for 12 months
Interventions
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Rosuvastatin Calcium
10mg Rosuvastatin, daily for 12 months
Placebo Oral Tablet
Placebo, daily for 12 months
Coenzyme Q10
100mg CoQ10, daily for 12 months
Calcium Carbonate
1250mg Calcium Carbonate, daily for 12 months
Vitamin D
2000IU Vitamin D, daily for 12 months
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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The Craig H. Neilsen Foundation
OTHER
Toronto Rehabilitation Institute
OTHER
University Health Network, Toronto
OTHER
University of Miami
OTHER
Rick Hansen Institute
OTHER
Dr. B. Catharine. Craven
OTHER
Responsible Party
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Dr. B. Catharine. Craven
Clinician Scientist/Principal Investigator
Principal Investigators
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B. Catharine Craven, BA, MD, FRCPC, MSc
Role: PRINCIPAL_INVESTIGATOR
Toronto Rehabilitation Institute - UHN
Locations
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University Of Miami Miller School of Medicine
Miami, Florida, United States
University Health Network - Toronto Rehab Lyndhurst Centre
Toronto, Ontario, Canada
Countries
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Other Identifiers
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2016-350642
Identifier Type: -
Identifier Source: org_study_id