Effect of Exercise Training and Soy-based Nutritional Supplementation on Prevention of Osteoporosis

Osteoporosis Clinical Trial

Official title:

Effect of Combined Exercise Therapy and Isoflavone Supplementation on Prevention of Osteoporosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204425
• Other study ID #: Bio 03-1077
• Secondary ID: 124322 FRN68095
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: September 9, 2011
• Start date: December 2004
• Est. completion date: April 2010

Study information

• Verified date: September 2011
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the effectiveness of combining exercise training (i.e. weight lifting and walking) and dietary supplementation with a soy-based nutritional supplement for increasing bone mineral density. We hypothesize that the exercise training and soy-based supplement will be additive for increasing bone mineral density.

Description:

Exercise training is effective for increasing bone mineral density and preventing osteoporosis, but the effects are small. When estrogen replacement is given to post-menopausal women the effectiveness of exercise training for improving bone mineral density is increased. Currently many women are concerned about the risks of taking hormone-replacement therapy and are seeking alternative therapies. The purpose of our study therefore is to use an estrogen-like dietary supplement derived from soy called a phytoestrogen (soy isoflavone) combined with exercise training for improving bone mineral density.

Comparisons: Four groups are being compared: 1) Exercise training (i.e. weight lifting 2 times per week and walking 4 times per week) plus soy isoflavone (90 mg aglycone equivalents per day); 2) Exercise training plus placebo; 3) Exercise placebo (flexibility exercises four times per week) plus soy isoflavone; 4) Exercise placebo plus placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: April 2010
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Post-menopausal women

Exclusion Criteria:

• Diagnosed osteoporotic

• Previous fragility fractures

• Previous breast cancer

• Previous endometrial cancer

• Taken bisphosphonates in past 12 months

• Taken hormone replacement therapy in past 12 months

• Taken selective estrogen receptor modulators in past 12 months

• Taken parathyroid hormone in past 12 months

• Taken calcitonin in past 12 months

• Currently taking corticosteroids

• Currently taking a thiazide diuretic

• Crohn's Disease

• Cushing Disease

• Allergy to soy

• Severe osteoarthritis

• Currently participating in vigorous exercise

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Osteopenia
• Osteoporosis

Intervention

Dietary Supplement:
• exercise/soy isoflavone
Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo

Locations

Country	Name	City	State
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Chilibeck PD. Exercise and estrogen or estrogen alternatives (phytoestrogens, bisphosphonates)for preservation of bone mineral in postmenopausal women. Can J Appl Physiol. 2004 Feb;29(1):59-75. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lumbar spine bone mineral density at 12 and 24 months		2 years	No
Secondary	Bone mineral density of the proximal femur at 12 and 24 months.		2 years	No
Secondary	Bone mineral density of the whole body at 12 and 24 months.		2 years	No
Secondary	Bone quality of the radius and tibia (ultrasound) at 12 and 24 months.		2 years	No
Secondary	Geometry of the proximal femur at at 12 and 24 months.		2 years	No
Secondary	Lean tissue mass at 12 and 24 months.		2 years	No
Secondary	Fat mass at 12 and 24 months.		2 years	No
Secondary	Body mass index at 12 and 24 months.		2 years	No
Secondary	Waist girth at 12 and 24 months.		2 years	No
Secondary	Blood lipids at 12 and 24 months.		2 years	No
Secondary	Muscular strength at 12 and 24 months.		2 years	No
Secondary	Self-paced walking ability at 12 and 24 months.		2 years	No
Secondary	Balance at 12 and 24 months.		2 years	No
Secondary	Flexibility at 12 and 24 months.		2 years	No
Secondary	Breast density at 24 months		2 years	Yes
Secondary	Endometrial thickness at 24 months.		2 years	Yes
Secondary	Menopausal symptoms at 3, 6, 9, 12, 15, 18, 21, and 24 months.		2 years	No