OsteoporosisPhase 3NCT01057680
Effectiveness of Creatine Supplementation and Exercise on Muscle and Bone
A Phase 3 study testing creatine monohydrate in people with Osteoporosis and Sarcopenia, run by University of Saskatchewan at 2 sites in Canada.
Trial summary
As we age, we experience a reduction in muscle and bone which inevitably decreases strength and the ability to perform tasks of daily living such as gardening, carrying groceries, and climbing stairs. Health costs associated with aging muscle and bone loss are in the billions of dollars. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Sarcopenia
- What is being tested?
- creatine monohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2010to Feb 2012
- Phase
- Phase 3
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- greater than or equal to 50 years of age
- males or postmenopausal females
- not currently participating in resistance training
Who cannot join
- pre-existing kidney abnormalities
- previous fragility fractures
- history of taking medications that affect bone mineral density in the past year including bisphosphonates, parathyroid hormone, calcitonin, hormone replacement therapy, or corticosteroids (i.e. within the past year)
- suffer from severe osteoarthritis
- have taken creatine supplementation within the past 6 months
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Faculty of Kinesiology and Health Sciences
Regina, Saskatchewan, S4S 0A2
College of Kinesiology, University of Saskatchewan
Saskatoon, Saskatchewan, S7N 5B2
About this study
Official title: Potential of Resistance-Exercise and Creatine Supplementation on Aging Musculoskeletal Health
As we age, we experience a reduction in muscle and bone which inevitably decreases strength and the ability to perform tasks of daily living such as gardening, carrying groceries, and climbing stairs. Health costs associated with aging muscle and bone loss are in the billions of dollars. With the projected increase in life expectancy, the incidence of muscle and bone loss will rise and further drain the healthcare system, with greater need for hospitalization, treatment, and rehabilitation. Without effective strategies to counteract aging muscle and bone loss, we may face a healthcare crisis in the future. Creatine, a compound found in red meat and seafood, increases creatine phosphate stores in muscle, providing increased energy during high-intensity exercise. Short-term (i.e. 3-4 months) resistance-exercise and supplementation with creatine, have been shown to have a favorable effect on properties of aging muscle and bone. However, the longer-term (i.e. 1 year) effects of these interventions are unknown. Therefore, the purpose of this innovative research is to determine the longer-term effects of resistance-exercise and creatine supplementation (0.1g•kg-1) in older adults. The primary dependent variables to be assessed will include muscle hypertrophy, bone mineral and bone geometry, strength, and urinary and blood indicators of liver and kidney function. This innovative, multidisciplinary research will help contribute to the successful pursuit of prolonged independent living by improving aging musculoskeletal health for older Saskatchewan adults. Saskatchewan provides a relevant setting for this research, given the higher percentage of older adults (15%), compared to the national average (12%).
We hypothesize that creatine supplementation will increase muscle mass, strength, and bone mineral density more than placebo.
- Conditions
- Osteoporosis, Sarcopenia
- Being tested
- creatine monohydrate, sugar placebo
- Keywords
- Bone, Muscle, Strength, Kidney, Liver, Creatine
- Medical subject headings
- Osteoporosis, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
creatine monohydrateDietary supplement
Also called Rivalus
Powder, 0.1 g per day, 12 months
sugar placeboDietary supplement
powder, 0.1 g/day, 12 months
| Study group | Role | What they receive |
|---|---|---|
| creatine | Experimental | This arm will involve creatine supplementation 0.1 g per kg body mass per day while participating in a resistance training program (1 hour per day, 3 days per week). Receives: Dietary Supplement: creatine monohydrate |
| Sugar | Placebo comparator | This arm will involve placebo (maltodextrin) given every day while the participant does a resistance training program (1 hour per day, 3 days per week). Receives: Dietary Supplement: sugar placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar spine bone mineral density
Measured: Baseline and 12 months
Secondary outcomes (10)
Proximal femur bone mineral density
Measured: Baseline and 12 months
Whole body bone mineral density
Measured: baseline and 12 months
lean tissue mass
Measured: baseline and 12 months
Muscular strength
Measured: baseline and 12 months
Muscle thickness
Measured: baseline and 12 months
Bone speed of sound
Measured: Baseline and 12 months
bone geometry
Measured: baseline and 12 months
Complete blood count
Measured: baseline, 4 months, 8 months, 12 months
Liver enzymes
Measured: baseline, 4 months, 8 months, 12 months
kidney function (creatinine clearance)
Measured: baseline, 4 months, 8 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phil Chilibeck, University of Saskatchewan
- Investigators
- Philip Chilibeck, Ph.D., Principal investigator, University of SaskatchewanDarren Candow, Ph.D., Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057680
- Sponsor's protocol ID
- 09-169
- Status last verified
- Dec 2012
- First submitted
- 26 Jan 2010
- Last updated
- 27 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Candow DG, Chilibeck PD, Gordon JJ, Kontulainen S. Efficacy of Creatine Supplementation and Resistance Training on Area and Density of Bone and Muscle in Older Adults. Med Sci Sports Exerc. 2021 Nov 1;53(11):2388-2395. doi: 10.1249/MSS.0000000000002722.
PubMed 34107512
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential of Resistance-Exercise and Creatine Supplementation on Aging Musculoskeletal Health
- ClinicalTrials.gov ID
- NCT01057680
- Acronym / sponsor ID
- 09-169
- Conditions
- Osteoporosis, Sarcopenia
- Keywords
- Bone, Muscle, Strength, Kidney, Liver, Creatine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Jan 2010 (estimated)
- 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.
As we age, we experience a reduction in muscle and bone which inevitably decreases strength and the ability to perform tasks of daily living such as gardening, carrying groceries, and climbing stairs. Health costs associated with aging muscle and bone loss are in the billions of dollars. With the projected increase in life expectancy, the incidence of muscle and bone loss will rise and further drain the healthcare system, with greater need for hospitalization, treatment, and rehabilitation. Without effective strategies to counteract aging muscle and bone loss, we may face a healthcare crisis in the future. Creatine, a compound found in red meat and seafood, increases creatine phosphate stores in muscle, providing increased energy during high-intensity exercise. Short-term (i.e. 3-4 months) resistance-exercise and supplementation with creatine, have been shown to have a favorable effect on properties of aging muscle and bone. However, the longer-term (i.e. 1 year) effects of these interventions are unknown. Therefore, the purpose of this innovative research is to determine the longer-term effects of resistance-exercise and creatine supplementation (0.1g•kg-1) in older adults. The primary dependent variables to be assessed will include muscle hypertrophy, bone mineral and bone geometry, strength, and urinary and blood indicators of liver and kidney function. This innovative, multidisciplinary research will help contribute to the successful pursuit of prolonged independent living by improving aging musculoskeletal health for older Saskatchewan adults. Saskatchewan provides a relevant setting for this research, given the higher percentage of older adults (15%), compared to the national average (12%).
We hypothesize that creatine supplementation will increase muscle mass, strength, and bone mineral density more than placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| creatine | Experimental | Dietary Supplement: creatine monohydrateThis arm will involve creatine supplementation 0.1 g per kg body mass per day while participating in a resistance training program (1 hour per day, 3 days per week). |
| Sugar | Placebo comparator | Dietary Supplement: sugar placeboThis arm will involve placebo (maltodextrin) given every day while the participant does a resistance training program (1 hour per day, 3 days per week). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- greater than or equal to 50 years of age
- males or postmenopausal females
- not currently participating in resistance training
Key exclusion criteria (5 listed)
- pre-existing kidney abnormalities
- previous fragility fractures
- history of taking medications that affect bone mineral density in the past year including bisphosphonates, parathyroid hormone, calcitonin, hormone replacement therapy, or corticosteroids (i.e. within the past year)
- suffer from severe osteoarthritis
- have taken creatine supplementation within the past 6 months
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 |
|---|---|---|
| creatine monohydrateAlso: RivalusPowder, 0.1 g per day, 12 months | Dietary supplement | creatine |
| sugar placebopowder, 0.1 g/day, 12 months | Dietary supplement | Sugar |
Primary outcome
Lumbar spine bone mineral density
Time frame: Baseline and 12 months
10 secondary outcomes
Proximal femur bone mineral density
Time frame: Baseline and 12 months
Whole body bone mineral density
Time frame: baseline and 12 months
lean tissue mass
Time frame: baseline and 12 months
Muscular strength
Time frame: baseline and 12 months
Muscle thickness
Time frame: baseline and 12 months
Bone speed of sound
Time frame: Baseline and 12 months
bone geometry
Time frame: baseline and 12 months
Complete blood count
Time frame: baseline, 4 months, 8 months, 12 months
Liver enzymes
Time frame: baseline, 4 months, 8 months, 12 months
kidney function (creatinine clearance)
Time frame: baseline, 4 months, 8 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2012.
- Derived from this study: PubMed 34107512Candow DG, Chilibeck PD, Gordon JJ, Kontulainen S. Efficacy of Creatine Supplementation and Resistance Training on Area and Density of Bone and Muscle in Older Adults. Med Sci Sports Exerc. 2021 Nov 1;53(11):2388-2395. doi: 10.1249/MSS.0000000000002722.
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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.
Philip Chilibeck, Ph.D. principal investigator
University of Saskatchewan
Darren Candow, Ph.D. principal investigator
University of Regina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing creatine monohydrate in people with Osteoporosis and Sarcopenia, run by University of Saskatchewan at 2 sites in Canada.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 27 Dec 2012. 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lumbar spine bone mineral density (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01057680, which also lists 1 linked publication.
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 27 Dec 2012.