OsteoporosisNCT02047864
Effect of Creatine Supplementation and Exercise on Bone Health
A study testing Creatine monohydrate in people with Osteoporosis and Sarcopenia, run by University of Saskatchewan at 2 sites in Canada.
Trial summary
Osteoporosis is an important health problem, costing the Canadian health care system over $2 billion per year. Loss of bone mineral and bone fragility is especially prevalent in postmenopausal women. Of all osteoporotic fractures, hip fractures are the most traumatic. Read more about this study
- Who is it for?
- Any age, women onlyHealthy 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
- 237 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2014to Jul 2019
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal women
- Low or moderate risk of fracture
Who cannot join
- High risk of fracture
- Have taken any bone-altering drugs within the previous 12 months
- Have taken creatine monohydrate in the previous 12 months
- Currently taking systemic corticosteroids
- Have Crohn's Disease or Cushings Disease
- Have severe osteoarthritis
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Regina
Regina, Saskatchewan, S4S 0A2
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 5B2
About this study
Official title: Long-term Effects of Creatine Supplementation and Exercise Training on Bone Mineral Density and Bone Strength in Postmenopausal Women
Osteoporosis is an important health problem, costing the Canadian health care system over $2 billion per year. Loss of bone mineral and bone fragility is especially prevalent in postmenopausal women. Of all osteoporotic fractures, hip fractures are the most traumatic. Creatine monohydrate is a nutritional supplement that is often combined with strength training to increase strength and muscle mass. The investigators recently completed a pilot study in a small number of postmenopausal women (n=33) that showed that creatine monohydrate significantly improved hip bone mineral density during a 1-year resistance training program. In our current proposal the investigators want to determine whether creatine combined with strength training can have an even larger effect on bone mineral density at the hip if given over 2 years in a large group of postmenopausal women (n=240). The investigators also want to determine whether this leads to reduced fractures in these women for up to a year after completing the creatine and strength training program.
Read the detailed description
Age-related bone and muscle loss is a major risk factor for falls, injuries, and fracture and, as Canada's population is aging, prevalence of such health concerns is escalating. Osteoporosis alone is estimated to cost the Canadian health care system $2.3 billion per year or 1.3%, of Canada's total healthcare budget. Postmenopausal women are at high risk of osteoporosis and experience the highest rate of hip fracture, resulting in disability, loss of physical function and premature death. The investigators' study aims to improve bone mass and bone strength at the most clinically relevant bone site, the femoral neck, in order to reduce the risk of hip fracture. Specifically, it will determine the effects of a nutritional supplement (creatine monohydrate) combined with exercise training on bone mineral density (BMD) at the proximal femur in postmenopausal women. .
Creatine monohydrate is found in small amounts in meats and fish and, when taken as a nutritional supplement, increases muscle mass and strength. The investigators have conducted a number of preliminary studies showing that when a creatine supplement is taken during a resistance training program, urinary markers of bone resorption (i.e. bone catabolism) are reduced compared to placebo. The investigators recently completed a small 12-month randomized controlled trial in 33 postmenopausal women who either supplemented with creatine monohydrate (10 g/d) or placebo during a resistance training program. Bone mineral density of the femoral neck decreased by 0.5% in the creatine group, and 3.9% in the placebo group (p<0.05 between groups). This proposed randomized controlled trial will replicate the investigators' pilot design for longer duration (i.e. 2 years) to determine if sustained supplementation with creatine monohydrate combined with exercise training can induce a clinically significant difference in bone mineral density at the femoral neck (the investigators estimate a 5% difference between creatine and placebo groups capable of predicting a significant reduction in fracture risk).
This trial will use a randomized, double blind, placebo controlled, parallel group, repeated measures design, performed at the Universities of Saskatchewan and Regina. Post-menopausal women (n=240) will be randomized to creatine (10g/d) or placebo groups while participating in an exercise program (resistance training and walking) three times per week for 24 months. The investigators' main dependent variable is femoral neck bone mineral density, which will be assessed at baseline, 12, and 24 months. Secondary variables to be assessed at the same time points include geometric properties of the proximal femur (predictors of bone strength), lumbar spine bone mineral density, ultrasound measurements of bone at the distal radius and tibia (predictive of the architectural integrity of bone), lean tissue mass, muscular strength, dynamic balance, and gait speed. The investigators will assess incidence of falls and fractures at the same time points and also at 12 months post-intervention (i.e. at 36 months). The results of this study have clinical potential, providing physicians and health-care professionals evidence-based advice to give to postmenopausal women interested in taking creatine as a novel strategy to increase bone mineral density and prevent osteoporosis.
- Conditions
- Osteoporosis, Sarcopenia
- Being tested
- Creatine monohydrate
- Keywords
- Osteoporosis, Sarcopenia, Strength, Bone, Muscle, 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
| Study group | Role | What they receive |
|---|---|---|
| Creatine monohydrate | Experimental | Creatine monohydrate to be given during a resistance training program Receives: Dietary Supplement: Creatine monohydrate |
| Sugar pill | Placebo comparator | Placebo to be given during a resistance training program Receives: Dietary Supplement: Creatine monohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in femoral neck bone mineral density
Measured: baseline, 12 months, 24 months
Secondary outcomes (19)
Change from baseline in total hip bone mineral density
Measured: baseline, 12 months, 24 month
Change from baseline in trochanter bone mineral density
Measured: baseline, 12 months, 24 month
Change from baseline in Wards bone mineral density
Measured: baseline, 12 months, 24 months
Change from baseline in lumbar spine bone mineral density
Measured: baseline, 12 months, 24 months
Change from baseline in whole body bone mineral density
Measured: baseline, 12 months, 24 months
Change from baseline in hip geometric properties
The geometric properties include cross-sectional area, subperiosteal width, cross-sectional moment of inertia, and section modulus at the femoral neck, intertrochanteric site, and the femoral shaft
Measured: baseline, 12 months, 24 months
Change in radius speed of sound
Measured: baseline, 12 months, 24 months
Change from baseline in tibial speed of sound
Measured: Baseline, 12 months, 24 months
Change from baseline in lean tissue mass
Measured: baseline, 12 months, 24 months
Change from baseline in squat maximal strength
Measured: baseline, 12 months, 24 months
Change from baseline for chest press strength
Measured: baseline, 12 months, 24 months
Change from baseline for dynamic balance
Measured: Baseline, 12 months, 24 months
Change from baseline for walking speed
Measured: Baseline, 12 months, 24 months
Number of falls
Measured: 12, 24, and 36 months
Number of fractures
Measured: 12, 24, and 36 months
Changes from baseline in blood markers of liver and kidney function and complete blood cell count
Measured: baseline, 12 months, 24 months
Changes in diet from baseline
Measured: Baseline, 12 months, 24 months
Changes in physical activity from baseline
Measured: Baseline, 12 months, 24 months
Changes from baseline in adverse events
Measured: Baseline, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2019
- Study completionJul 2019
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 237 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 D Chilibeck, PhD, Principal investigator, University of SaskatchewanDarren Candow, PhD, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047864
- Sponsor's protocol ID
- 300561
- Status last verified
- Jun 2020
- First submitted
- 26 Jan 2014
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chilibeck PD, Candow DG, Gordon JJ, Duff WRD, Mason R, Shaw K, Taylor-Gjevre R, Nair B, Zello GA. A 2-yr Randomized Controlled Trial on Creatine Supplementation during Exercise for Postmenopausal Bone Health. Med Sci Sports Exerc. 2023 Oct 1;55(10):1750-1760. doi: 10.1249/MSS.0000000000003202. Epub 2023 May 5.
PubMed 37144634
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Creatine Supplementation and Exercise Training on Bone Mineral Density and Bone Strength in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT02047864
- Acronym / sponsor ID
- 300561
- Conditions
- Osteoporosis, Sarcopenia
- Keywords
- Osteoporosis, Sarcopenia, Strength, Bone, Muscle, Creatine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 28 Jan 2014 (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.
Osteoporosis is an important health problem, costing the Canadian health care system over $2 billion per year. Loss of bone mineral and bone fragility is especially prevalent in postmenopausal women. Of all osteoporotic fractures, hip fractures are the most traumatic. Creatine monohydrate is a nutritional supplement that is often combined with strength training to increase strength and muscle mass. The investigators recently completed a pilot study in a small number of postmenopausal women (n=33) that showed that creatine monohydrate significantly improved hip bone mineral density during a 1-year resistance training program. In our current proposal the investigators want to determine whether creatine combined with strength training can have an even larger effect on bone mineral density at the hip if given over 2 years in a large group of postmenopausal women (n=240). The investigators also want to determine whether this leads to reduced fractures in these women for up to a year after completing the creatine and strength training program.
Detailed description
Age-related bone and muscle loss is a major risk factor for falls, injuries, and fracture and, as Canada's population is aging, prevalence of such health concerns is escalating. Osteoporosis alone is estimated to cost the Canadian health care system $2.3 billion per year or 1.3%, of Canada's total healthcare budget. Postmenopausal women are at high risk of osteoporosis and experience the highest rate of hip fracture, resulting in disability, loss of physical function and premature death. The investigators' study aims to improve bone mass and bone strength at the most clinically relevant bone site, the femoral neck, in order to reduce the risk of hip fracture. Specifically, it will determine the effects of a nutritional supplement (creatine monohydrate) combined with exercise training on bone mineral density (BMD) at the proximal femur in postmenopausal women. .
Creatine monohydrate is found in small amounts in meats and fish and, when taken as a nutritional supplement, increases muscle mass and strength. The investigators have conducted a number of preliminary studies showing that when a creatine supplement is taken during a resistance training program, urinary markers of bone resorption (i.e. bone catabolism) are reduced compared to placebo. The investigators recently completed a small 12-month randomized controlled trial in 33 postmenopausal women who either supplemented with creatine monohydrate (10 g/d) or placebo during a resistance training program. Bone mineral density of the femoral neck decreased by 0.5% in the creatine group, and 3.9% in the placebo group (p<0.05 between groups). This proposed randomized controlled trial will replicate the investigators' pilot design for longer duration (i.e. 2 years) to determine if sustained supplementation with creatine monohydrate combined with exercise training can induce a clinically significant difference in bone mineral density at the femoral neck (the investigators estimate a 5% difference between creatine and placebo groups capable of predicting a significant reduction in fracture risk).
This trial will use a randomized, double blind, placebo controlled, parallel group, repeated measures design, performed at the Universities of Saskatchewan and Regina. Post-menopausal women (n=240) will be randomized to creatine (10g/d) or placebo groups while participating in an exercise program (resistance training and walking) three times per week for 24 months. The investigators' main dependent variable is femoral neck bone mineral density, which will be assessed at baseline, 12, and 24 months. Secondary variables to be assessed at the same time points include geometric properties of the proximal femur (predictors of bone strength), lumbar spine bone mineral density, ultrasound measurements of bone at the distal radius and tibia (predictive of the architectural integrity of bone), lean tissue mass, muscular strength, dynamic balance, and gait speed. The investigators will assess incidence of falls and fractures at the same time points and also at 12 months post-intervention (i.e. at 36 months). The results of this study have clinical potential, providing physicians and health-care professionals evidence-based advice to give to postmenopausal women interested in taking creatine as a novel strategy to increase bone mineral density and prevent osteoporosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creatine monohydrate | Experimental | Dietary Supplement: Creatine monohydrateCreatine monohydrate to be given during a resistance training program |
| Sugar pill | Placebo comparator | Dietary Supplement: Creatine monohydratePlacebo to be given during a resistance training program |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal women
- Low or moderate risk of fracture
Key exclusion criteria (6 listed)
- High risk of fracture
- Have taken any bone-altering drugs within the previous 12 months
- Have taken creatine monohydrate in the previous 12 months
- Currently taking systemic corticosteroids
- Have Crohn's Disease or Cushings 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 |
|---|---|---|
| Creatine monohydrate | Dietary supplement | Creatine monohydrate, Sugar pill |
Primary outcome
Change from baseline in femoral neck bone mineral density
Time frame: baseline, 12 months, 24 months
19 secondary outcomes
Change from baseline in total hip bone mineral density
Time frame: baseline, 12 months, 24 month
Change from baseline in trochanter bone mineral density
Time frame: baseline, 12 months, 24 month
Change from baseline in Wards bone mineral density
Time frame: baseline, 12 months, 24 months
Change from baseline in lumbar spine bone mineral density
Time frame: baseline, 12 months, 24 months
Change from baseline in whole body bone mineral density
Time frame: baseline, 12 months, 24 months
Change from baseline in hip geometric properties
Time frame: baseline, 12 months, 24 months
Change in radius speed of sound
Time frame: baseline, 12 months, 24 months
Change from baseline in tibial speed of sound
Time frame: Baseline, 12 months, 24 months
Change from baseline in lean tissue mass
Time frame: baseline, 12 months, 24 months
Change from baseline in squat maximal strength
Time frame: baseline, 12 months, 24 months
Change from baseline for chest press strength
Time frame: baseline, 12 months, 24 months
Change from baseline for dynamic balance
Time frame: Baseline, 12 months, 24 months
Change from baseline for walking speed
Time frame: Baseline, 12 months, 24 months
Number of falls
Time frame: 12, 24, and 36 months
Number of fractures
Time frame: 12, 24, and 36 months
Changes from baseline in blood markers of liver and kidney function and complete blood cell count
Time frame: baseline, 12 months, 24 months
Changes in diet from baseline
Time frame: Baseline, 12 months, 24 months
Changes in physical activity from baseline
Time frame: Baseline, 12 months, 24 months
Changes from baseline in adverse events
Time frame: Baseline, 12 months, 24 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 11 Jun 2020.
- Derived from this study: PubMed 37144634Chilibeck PD, Candow DG, Gordon JJ, Duff WRD, Mason R, Shaw K, Taylor-Gjevre R, Nair B, Zello GA. A 2-yr Randomized Controlled Trial on Creatine Supplementation during Exercise for Postmenopausal Bone Health. Med Sci Sports Exerc. 2023 Oct 1;55(10):1750-1760. doi: 10.1249/MSS.0000000000003202. Epub 2023 May 5.
- Individual participant dataSharing planned: No
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
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 D Chilibeck, PhD principal investigator
University of Saskatchewan
Darren Candow, PhD 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 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 2 inclusion and 6 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 11 Jun 2020. 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.
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?
Change from baseline in femoral neck bone mineral density (time frame: baseline, 12 months, 24 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 NCT02047864, 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 11 Jun 2020.