Clinical trial NCT00204425: Effect of Exercise Training and Soy-based Nutritional Supplementation on Prevention of Osteoporosis
Official title: Effect of Combined Exercise Therapy and Isoflavone Supplementation on Prevention of Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Osteopenia
Keywords: Osteoporosis
Bone
Exercise
Soy
Isoflavone
Phytoestrogen
Menopause
Lipids
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-09-20
Enrollment: 351
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lumbar spine bone mineral density at 12 and 24 months
timeFrame: 2 years
Secondary outcomes:
measure: Bone mineral density of the proximal femur at 12 and 24 months.
timeFrame: 2 years
measure: Bone mineral density of the whole body at 12 and 24 months.
timeFrame: 2 years
measure: Bone quality of the radius and tibia (ultrasound) at 12 and 24 months.
timeFrame: 2 years
measure: Geometry of the proximal femur at at 12 and 24 months.
timeFrame: 2 years
measure: Lean tissue mass at 12 and 24 months.
timeFrame: 2 years
measure: Fat mass at 12 and 24 months.
timeFrame: 2 years
measure: Body mass index at 12 and 24 months.
timeFrame: 2 years
measure: Waist girth at 12 and 24 months.
timeFrame: 2 years
measure: Blood lipids at 12 and 24 months.
timeFrame: 2 years
measure: Muscular strength at 12 and 24 months.
timeFrame: 2 years
measure: Self-paced walking ability at 12 and 24 months.
timeFrame: 2 years
measure: Balance at 12 and 24 months.
timeFrame: 2 years
measure: Flexibility at 12 and 24 months.
timeFrame: 2 years
measure: Breast density at 24 months
timeFrame: 2 years
measure: Endometrial thickness at 24 months.
timeFrame: 2 years
measure: Menopausal symptoms at 3, 6, 9, 12, 15, 18, 21, and 24 months.
timeFrame: 2 years
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Philip D Chilibeck, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Saskatchewan
name: H J Biem, M.D.
role: STUDY_DIRECTOR
affiliation: University of Saskatchewan
name: Allison Case, M.D.
role: STUDY_DIRECTOR
affiliation: University of Saskatchewan
name: Olufemi Olantunbosun, M.D.
role: STUDY_DIRECTOR
affiliation: University of Saskatchewan
name: Roger Pierson, PhD
role: STUDY_DIRECTOR
affiliation: University of Saskatchewan
name: Susan Whiting, PhD
role: STUDY_DIRECTOR
affiliation: University of Saskatchewan
name: Punam Pahwa, PhD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1139/h04-006.