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

Phase 3

Completed

• Conditions: Osteoporosis; Osteopenia
• Interventions: Dietary Supplement: exercise/soy isoflavone

• Registration Number: NCT00204425
• Lead Sponsor: University of Saskatchewan

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2007-12
• Study Completion: 2010-04
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-09
• Last Update Posted: 2011-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 351

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	exercise/soy isoflavone	exercise/soy isoflavone
2	exercise/soy isoflavone	exercise/isoflavone placebo
3	exercise/soy isoflavone	exercise placebo/soy isoflavone
4	exercise/soy isoflavone	exercise placebo/isoflavone placebo

Primary Outcome Measures

Name	Time	Method
Lumbar spine bone mineral density at 12 and 24 months	2 years

Secondary Outcome Measures

Name	Time	Method
Bone mineral density of the proximal femur at 12 and 24 months.	2 years
Bone mineral density of the whole body at 12 and 24 months.	2 years
Bone quality of the radius and tibia (ultrasound) at 12 and 24 months.	2 years
Geometry of the proximal femur at at 12 and 24 months.	2 years
Lean tissue mass at 12 and 24 months.	2 years
Fat mass at 12 and 24 months.	2 years
Body mass index at 12 and 24 months.	2 years
Waist girth at 12 and 24 months.	2 years
Blood lipids at 12 and 24 months.	2 years
Muscular strength at 12 and 24 months.	2 years
Self-paced walking ability at 12 and 24 months.	2 years
Balance at 12 and 24 months.	2 years
Flexibility at 12 and 24 months.	2 years
Breast density at 24 months	2 years
Endometrial thickness at 24 months.	2 years
Menopausal symptoms at 3, 6, 9, 12, 15, 18, 21, and 24 months.	2 years

Trial Locations

Locations (1)

University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada