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Effect of Creatine Supplementation and Exercise on Bone Health

Primary Purpose

Osteoporosis, Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Creatine monohydrate
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring Osteoporosis, Sarcopenia, Strength, Bone, Muscle, Creatine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Postmenopausal women
  • Low or moderate risk of fracture

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Regina
  • University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Creatine monohydrate

Sugar pill

Arm Description

Creatine monohydrate to be given during a resistance training program

Placebo to be given during a resistance training program

Outcomes

Primary Outcome Measures

Change from baseline in femoral neck bone mineral density

Secondary Outcome Measures

Change from baseline in total hip bone mineral density
Change from baseline in trochanter bone mineral density
Change from baseline in Wards bone mineral density
Change from baseline in lumbar spine bone mineral density
Change from baseline in whole body bone mineral density
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
Change in radius speed of sound
Change from baseline in tibial speed of sound
Change from baseline in lean tissue mass
Change from baseline in squat maximal strength
Change from baseline for chest press strength
Change from baseline for dynamic balance
Change from baseline for walking speed
Number of falls
Number of fractures
Changes from baseline in blood markers of liver and kidney function and complete blood cell count
Changes in diet from baseline
Changes in physical activity from baseline
Changes from baseline in adverse events

Full Information

First Posted
January 26, 2014
Last Updated
June 10, 2020
Sponsor
University of Saskatchewan
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1. Study Identification

Unique Protocol Identification Number
NCT02047864
Brief Title
Effect of Creatine Supplementation and Exercise on Bone Health
Official Title
Long-term Effects of Creatine Supplementation and Exercise Training on Bone Mineral Density and Bone Strength in Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Sarcopenia
Keywords
Osteoporosis, Sarcopenia, Strength, Bone, Muscle, Creatine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
237 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Creatine monohydrate
Arm Type
Experimental
Arm Description
Creatine monohydrate to be given during a resistance training program
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Placebo to be given during a resistance training program
Intervention Type
Dietary Supplement
Intervention Name(s)
Creatine monohydrate
Primary Outcome Measure Information:
Title
Change from baseline in femoral neck bone mineral density
Time Frame
baseline, 12 months, 24 months
Secondary Outcome Measure Information:
Title
Change from baseline in total hip bone mineral density
Time Frame
baseline, 12 months, 24 month
Title
Change from baseline in trochanter bone mineral density
Time Frame
baseline, 12 months, 24 month
Title
Change from baseline in Wards bone mineral density
Time Frame
baseline, 12 months, 24 months
Title
Change from baseline in lumbar spine bone mineral density
Time Frame
baseline, 12 months, 24 months
Title
Change from baseline in whole body bone mineral density
Time Frame
baseline, 12 months, 24 months
Title
Change from baseline in hip geometric properties
Description
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
Time Frame
baseline, 12 months, 24 months
Title
Change in radius speed of sound
Time Frame
baseline, 12 months, 24 months
Title
Change from baseline in tibial speed of sound
Time Frame
Baseline, 12 months, 24 months
Title
Change from baseline in lean tissue mass
Time Frame
baseline, 12 months, 24 months
Title
Change from baseline in squat maximal strength
Time Frame
baseline, 12 months, 24 months
Title
Change from baseline for chest press strength
Time Frame
baseline, 12 months, 24 months
Title
Change from baseline for dynamic balance
Time Frame
Baseline, 12 months, 24 months
Title
Change from baseline for walking speed
Time Frame
Baseline, 12 months, 24 months
Title
Number of falls
Time Frame
12, 24, and 36 months
Title
Number of fractures
Time Frame
12, 24, and 36 months
Title
Changes from baseline in blood markers of liver and kidney function and complete blood cell count
Time Frame
baseline, 12 months, 24 months
Title
Changes in diet from baseline
Time Frame
Baseline, 12 months, 24 months
Title
Changes in physical activity from baseline
Time Frame
Baseline, 12 months, 24 months
Title
Changes from baseline in adverse events
Time Frame
Baseline, 12 months, 24 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Postmenopausal women Low or moderate risk of fracture Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip D Chilibeck, PhD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Darren Candow, PhD
Organizational Affiliation
University of Regina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Regina
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4S 0A2
Country
Canada
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 5B2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Creatine Supplementation and Exercise on Bone Health

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