Spinal Cord InjuriesPhase 2RoBaCONCT03113994
Statin Monotherapy for Treatment of Endocrine Metabolic Disease Risk
A Phase 2 study testing Rosuvastatin Calcium, Coenzyme Q10 and Calcium Carbonate in people with Spinal Cord Injuries and Osteoporosis, run by Dr. B. Catharine. Craven at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injuries, Osteoporosis, Metabolic Syndrome
- What is being tested?
- Rosuvastatin Calcium, Coenzyme Q10 and Calcium Carbonate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 26 Feb 2018to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University Of Miami Miller School of Medicine
Miami, Florida, 33136
Canada1 site
University Health Network - Toronto Rehab Lyndhurst Centre
Toronto, Ontario, M4G 3V9
About this study
Official title: The Efficacy and Safety of Rosuvastatin for Modifying Bone Mass and Cardiometabolic Disease Outcomes
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.
Read more
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.
Read the detailed description
Rationale: Individuals with motor-complete spinal cord injury (SCI) undergo dramatic changes in body composition in the first 18 months post-injury, including declines in bone mineral density (BMD) that increase lower-extremity fragility fracture risk, and increases in fat mass that increase cardio-metabolic disease (CMD) risk. While statins are an effective treatment for dyslipidemia, research evidence suggests additional pleiotropic effects on bone through promotion of osteogenesis, suppression of osteoblast apoptosis, and inhibition of osteoclastogenesis. There are currently no effective therapies to treat sublesional osteoporosis (SLOP) and reduce the risk of fragility fractures in individuals with SCI.
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
- Spinal Cord Injuries, Osteoporosis, Metabolic Syndrome
- Being tested
- Rosuvastatin Calcium, Placebo Oral Tablet, Coenzyme Q10, Calcium Carbonate, Vitamin D
- Keywords
- Spinal Cord Injury, Osteoporosis, Cardiometabolic Syndrome
- Medical subject headings
- Spinal Cord Injuries, Osteoporosis, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin CalciumDrug
10mg Rosuvastatin, daily for 12 months
Placebo Oral TabletDrug
Placebo, daily for 12 months
Coenzyme Q10Dietary supplement
100mg CoQ10, daily for 12 months
Calcium CarbonateDietary supplement
1250mg Calcium Carbonate, daily for 12 months
Vitamin DDietary supplement
2000IU Vitamin D, daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Active comparator | Not described Receives: Drug: Rosuvastatin Calcium; Dietary Supplement: Coenzyme Q10; Dietary Supplement: Calcium Carbonate; Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Oral Tablet; Dietary Supplement: Coenzyme Q10; Dietary Supplement: Calcium Carbonate; Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in areal BMD of the knee region
Dual Xray Absorptiometry (DXA) Assessment of areal bone mineral density (aBMD) of the knee region
Measured: Baseline and 12 months (or study completion)
Secondary outcomes (15)
Change from Baseline in Low density lipoprotein cholesterol (LDL)
Serum assessment of LDL
Measured: Baseline and 12 months (or study completion)
Change from Baseline in high density lipoprotein cholesterol (HDL)
Serum assessment of HDL
Measured: Baseline and 12 months (or study completion)
Change from Baseline in triglycerides (TG)
Serum assessment of TG
Measured: Baseline and 12 months (or study completion)
Change from Baseline in total cholesterol
Serum assessment of cholesterol
Measured: Baseline and 12 months (or study completion)
Change from Baseline in High sensitivity C-reactive Protein (hsCRP)
Serum assessment of hsCRP
Measured: Baseline and 12 months (or study completion)
Change from Baseline in Interleukin-1ß (IL-1ß)
Serum assessment of IL-1ß
Measured: Baseline and 12 months (or study completion)
Change from Baseline in interleukin-6 (IL-6)
Serum assessment of IL-6
Measured: Baseline and 12 months (or study completion)
Change from Baseline in tumor necrosis factor - alpha (TNF-alpha)
Serum assessment of TNF-alpha
Measured: Baseline and 12 months (or study completion)
Change from Baseline in erythrocyte sedimentation rate (ESR)
Serum assessment of ESR
Measured: Baseline and 12 months (or study completion)
Change from Baseline in Bone Specific Alkaline Phosphatase (BALP)
Serum assessment of BALP
Measured: Baseline, 6 months and 12 months (or study completion)
Change from Baseline in C-telopeptide (CTX)
Serum assessment of CTX
Measured: Baseline, 6 months and 12 months (or study completion)
Change from Baseline in Sclerostin
Serum assessment of Sclerostin
Measured: Baseline, 6 months and 12 months (or study completion)
Change from Baseline in RANK Ligand (RANK-L)
Serum assessment of RANK-L
Measured: Baseline, 6 months and 12 months (or study completion)
Change from Baseline in volumetric BMD of the tibia (pQCT)
Peripheral Quantitative Computed Tomography (pQCT) assessment - Toronto Site Only
Measured: Baseline and 12 months (or study completion)
Change from Baseline in volumetric BMD of the tibia (HR-pQCT)
High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) assessment - Toronto Site Only
Measured: Baseline and 12 months (or study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start26 Feb 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. B. Catharine. Craven
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation, Toronto Rehabilitation Institute, University Health Network, Toronto, University of Miami, Rick Hansen Institute
- Responsible party
- Sponsor-investigator, Dr. B. Catharine. Craven, Toronto Rehabilitation Institute
- Investigators
- B. Catharine Craven, BA, MD, FRCPC, MSc, Principal investigator, Toronto Rehabilitation Institute - UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113994
- Sponsor's protocol ID
- 2016-350642
- Other IDs
- 2016
- Acronym
- RoBaCO
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2017
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Rosuvastatin for Modifying Bone Mass and Cardiometabolic Disease Outcomes
- ClinicalTrials.gov ID
- NCT03113994
- Acronym / sponsor ID
- RoBaCO / 2016-350642
- Conditions
- Spinal Cord Injuries, Osteoporosis, Metabolic Syndrome
- Keywords
- Spinal Cord Injury, Osteoporosis, Cardiometabolic Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 Pandemic
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Dr. B. Catharine. CravenUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation, Toronto Rehabilitation Institute, University Health Network, Toronto, University of Miami, Rick Hansen Institute
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: Individuals with motor-complete spinal cord injury (SCI) undergo dramatic changes in body composition in the first 18 months post-injury, including declines in bone mineral density (BMD) that increase lower-extremity fragility fracture risk, and increases in fat mass that increase cardio-metabolic disease (CMD) risk. While statins are an effective treatment for dyslipidemia, research evidence suggests additional pleiotropic effects on bone through promotion of osteogenesis, suppression of osteoblast apoptosis, and inhibition of osteoclastogenesis. There are currently no effective therapies to treat sublesional osteoporosis (SLOP) and reduce the risk of fragility fractures in individuals with SCI.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Active comparator | Drug: Rosuvastatin Calcium, Dietary Supplement: Coenzyme Q10, Dietary Supplement: Calcium Carbonate, Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | Drug: Placebo Oral Tablet, Dietary Supplement: Coenzyme Q10, Dietary Supplement: Calcium Carbonate, Dietary Supplement: Vitamin D |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin Calcium10mg Rosuvastatin, daily for 12 months | Drug | Rosuvastatin |
| Placebo Oral TabletPlacebo, daily for 12 months | Drug | Placebo |
| Coenzyme Q10100mg CoQ10, daily for 12 months | Dietary supplement | Placebo, Rosuvastatin |
| Calcium Carbonate1250mg Calcium Carbonate, daily for 12 months | Dietary supplement | Placebo, Rosuvastatin |
| Vitamin D2000IU Vitamin D, daily for 12 months | Dietary supplement | Placebo, Rosuvastatin |
Primary outcome
Change from Baseline in areal BMD of the knee region
Time frame: Baseline and 12 months (or study completion)
Dual Xray Absorptiometry (DXA) Assessment of areal bone mineral density (aBMD) of the knee region
15 secondary outcomes
Change from Baseline in Low density lipoprotein cholesterol (LDL)
Time frame: Baseline and 12 months (or study completion)
Change from Baseline in high density lipoprotein cholesterol (HDL)
Time frame: Baseline and 12 months (or study completion)
Change from Baseline in triglycerides (TG)
Time frame: Baseline and 12 months (or study completion)
Change from Baseline in total cholesterol
Time frame: Baseline and 12 months (or study completion)
Change from Baseline in High sensitivity C-reactive Protein (hsCRP)
Time frame: Baseline and 12 months (or study completion)
Change from Baseline in Interleukin-1ß (IL-1ß)
Time frame: Baseline and 12 months (or study completion)
Change from Baseline in interleukin-6 (IL-6)
Time frame: Baseline and 12 months (or study completion)
Change from Baseline in tumor necrosis factor - alpha (TNF-alpha)
Time frame: Baseline and 12 months (or study completion)
Change from Baseline in erythrocyte sedimentation rate (ESR)
Time frame: Baseline and 12 months (or study completion)
Change from Baseline in Bone Specific Alkaline Phosphatase (BALP)
Time frame: Baseline, 6 months and 12 months (or study completion)
Change from Baseline in C-telopeptide (CTX)
Time frame: Baseline, 6 months and 12 months (or study completion)
Change from Baseline in Sclerostin
Time frame: Baseline, 6 months and 12 months (or study completion)
Change from Baseline in RANK Ligand (RANK-L)
Time frame: Baseline, 6 months and 12 months (or study completion)
Change from Baseline in volumetric BMD of the tibia (pQCT)
Time frame: Baseline and 12 months (or study completion)
Change from Baseline in volumetric BMD of the tibia (HR-pQCT)
Time frame: Baseline and 12 months (or study completion)
Results and safety
The study was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
B. Catharine Craven, BA, MD, FRCPC, MSc principal investigator
Toronto Rehabilitation Institute - UHN
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rosuvastatin Calcium, Coenzyme Q10 and Calcium Carbonate in people with Spinal Cord Injuries and Osteoporosis, run by Dr. B. Catharine. Craven at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in areal BMD of the knee region (time frame: Baseline and 12 months (or study completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.