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

Coronary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00663104
• Other study ID #: OFZ-Trace
• Status: Terminated
• Phase: Phase 3
• First received: April 21, 2008
• Last updated: May 27, 2015
• Start date: April 2008
• Est. completion date: November 2009

Study information

• Verified date: May 2015
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesBavaria: Bavarian Ministry of Science, Research and Art
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 126
• Est. completion date: November 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bone Diseases
• Coronary Artery Disease
• Coronary Disease
• Menopause, Premature
• Metabolic Syndrome X
• Syndrome

Intervention

Behavioral:
• exercise
exercise: 3 joint sessions/week for 12 months
• exercise + cimicifuga racemosa
exercise: 3 sessions/week for 12 months,cimicifuga racemosa (40 mg/d)
• wellness control, placebo
2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months, placebo

Locations

Country	Name	City	State
Germany	Institute of Medical Physics	Erlangen

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Siemens-Betriebskrankenkasse

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Kemmler W, Lauber D, Weineck J, Hensen J, Kalender W, Engelke K. Benefits of 2 years of intense exercise on bone density, physical fitness, and blood lipids in early postmenopausal osteopenic women: results of the Erlangen Fitness Osteoporosis Prevention Study (EFOPS). Arch Intern Med. 2004 May 24;164(10):1084-91. — View Citation

Kemmler W, von Stengel S, Weineck J, Lauber D, Kalender W, Engelke K. Exercise effects on menopausal risk factors of early postmenopausal women: 3-yr Erlangen fitness osteoporosis prevention study results. Med Sci Sports Exerc. 2005 Feb;37(2):194-203. — View Citation

von Stengel S, Kemmler W, Kalender WA, Engelke K, Lauber D. Differential effects of strength versus power training on bone mineral density in postmenopausal women: a 2-year longitudinal study. Br J Sports Med. 2007 Oct;41(10):649-55; discussion 655. Epub 2007 Jun 5. Erratum in: Br J Sports Med. 2007 Dec;41(12):926. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density		baseline, 12 month	No
Secondary	body composition		baseline, 12 month	No
Secondary	blood lipids, glucose		baseline, 12 month	No
Secondary	blood pressure		baseline, 12 month	No
Secondary	10 year CHD-risk		baseline, 12 months	No
Secondary	menopausal complaints		baseline, 12 months	No