Effect of Creatine Supplementation and Exercise on Bone Health

Osteoporosis Clinical Trial

Official title:

Long-term Effects of Creatine Supplementation and Exercise Training on Bone Mineral Density and Bone Strength in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047864
• Other study ID #: 300561
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: July 2019

Study information

• Verified date: June 2020
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: July 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Sarcopenia

Intervention

Dietary Supplement:
• Creatine monohydrate

Locations

Country	Name	City	State
Canada	University of Regina	Regina	Saskatchewan
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in femoral neck bone mineral density		baseline, 12 months, 24 months
Secondary	Change from baseline in total hip bone mineral density		baseline, 12 months, 24 month
Secondary	Change from baseline in trochanter bone mineral density		baseline, 12 months, 24 month
Secondary	Change from baseline in Wards bone mineral density		baseline, 12 months, 24 months
Secondary	Change from baseline in lumbar spine bone mineral density		baseline, 12 months, 24 months
Secondary	Change from baseline in whole body bone mineral density		baseline, 12 months, 24 months
Secondary	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	baseline, 12 months, 24 months
Secondary	Change in radius speed of sound		baseline, 12 months, 24 months
Secondary	Change from baseline in tibial speed of sound		Baseline, 12 months, 24 months
Secondary	Change from baseline in lean tissue mass		baseline, 12 months, 24 months
Secondary	Change from baseline in squat maximal strength		baseline, 12 months, 24 months
Secondary	Change from baseline for chest press strength		baseline, 12 months, 24 months
Secondary	Change from baseline for dynamic balance		Baseline, 12 months, 24 months
Secondary	Change from baseline for walking speed		Baseline, 12 months, 24 months
Secondary	Number of falls		12, 24, and 36 months
Secondary	Number of fractures		12, 24, and 36 months
Secondary	Changes from baseline in blood markers of liver and kidney function and complete blood cell count		baseline, 12 months, 24 months
Secondary	Changes in diet from baseline		Baseline, 12 months, 24 months
Secondary	Changes in physical activity from baseline		Baseline, 12 months, 24 months
Secondary	Changes from baseline in adverse events		Baseline, 12 months, 24 months