Effect of Exercise and Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause

University of Erlangen-Nürnberg Medical School

Status and phase: Terminated; Phase 3

Conditions: Bone Diseases; Metabolic Syndrome X; Coronary Disease

Treatments: Behavioral: wellness control, placebo; Behavioral: exercise + cimicifuga racemosa; Behavioral: exercise

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00663104

OFZ-Trace

Details and patient eligibility

About

The aim of the study is to compare the effect of a progressive, periodized exercise training designed to impact bone, CHD-risk-factors and menopausal complaints versus the combined effect of exercise and "phytoestrogen" (cimicifuga racemosa; CR). After randomization, 84 females 1-3 year postmenopausal with no medication or illness affecting bone metabolism exercise over 12 months (EG; 42 with, 42 without CR), 42 women serve as wellness-control. Three group training sessions/week will be performed in the EG. Both groups will be individually supplemented with calcium and Vit-D (cholecalciferol).

Enrollment: 126 patients

Sex: Female

Ages: 45 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 1-3 years early postmenopausal
• Caucasian race

Exclusion criteria

• CHD-diseases
• thrombosis, embolism
• fractures at lumbar spine or hip
• secondary osteoporosis
• hyperparathyroidism
• medication, diseases with impact on muscle or bone
• cancer and hormone derived malign diseases
• weight reduction of > 5 kg during the last 6 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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126 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

exercise (3 sessions/week)

Treatment:

Behavioral: exercise

2

Active Comparator group

Description:

exercise and "phytoestrogen" (cimicifuga racemosa)

Treatment:

Behavioral: exercise + cimicifuga racemosa

3

Placebo Comparator group

Description:

wellness control, placebo

Treatment:

Behavioral: wellness control, placebo