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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Canada

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.

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 groups in NCT02047864
Study groupRoleWhat they receive
Creatine monohydrateExperimentalCreatine monohydrate to be given during a resistance training program
Receives: Dietary Supplement: Creatine monohydrate
Sugar pillPlacebo comparatorPlacebo 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.

  1. Change from baseline in femoral neck bone mineral density

    Measured: baseline, 12 months, 24 months

Secondary outcomes (19)
  1. Change from baseline in total hip bone mineral density

    Measured: baseline, 12 months, 24 month

  2. Change from baseline in trochanter bone mineral density

    Measured: baseline, 12 months, 24 month

  3. Change from baseline in Wards bone mineral density

    Measured: baseline, 12 months, 24 months

  4. Change from baseline in lumbar spine bone mineral density

    Measured: baseline, 12 months, 24 months

  5. Change from baseline in whole body bone mineral density

    Measured: baseline, 12 months, 24 months

  6. 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

  7. Change in radius speed of sound

    Measured: baseline, 12 months, 24 months

  8. Change from baseline in tibial speed of sound

    Measured: Baseline, 12 months, 24 months

  9. Change from baseline in lean tissue mass

    Measured: baseline, 12 months, 24 months

  10. Change from baseline in squat maximal strength

    Measured: baseline, 12 months, 24 months

  11. Change from baseline for chest press strength

    Measured: baseline, 12 months, 24 months

  12. Change from baseline for dynamic balance

    Measured: Baseline, 12 months, 24 months

  13. Change from baseline for walking speed

    Measured: Baseline, 12 months, 24 months

  14. Number of falls

    Measured: 12, 24, and 36 months

  15. Number of fractures

    Measured: 12, 24, and 36 months

  16. Changes from baseline in blood markers of liver and kidney function and complete blood cell count

    Measured: baseline, 12 months, 24 months

  17. Changes in diet from baseline

    Measured: Baseline, 12 months, 24 months

  18. Changes in physical activity from baseline

    Measured: Baseline, 12 months, 24 months

  19. 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.

  1. First posted28 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2019
  4. Study completionJul 2019

Resources

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)
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

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.

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