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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	University of Erlangen-Nürnberg Institute of Gynecology, University of Erlangen-Nurnberg Institute of Medical Physics, University of Erlangen-Nurnberg Institute of Biometry and Medical Statistics, University of Erlangen-Nurnberg Siemens-Betriebskrankenkasse
Information provided by:	University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier:	NCT00663104

Purpose

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).

Condition	Intervention	Phase
Bone Diseases Metabolic Syndrome X Coronary Disease	Behavioral: exercise Behavioral: exercise + cimicifuga racemosa Behavioral: wellness control, placebo	Phase III

MedlinePlus related topics: Bone Diseases Coronary Artery Disease Exercise and Physical Fitness Menopause Metabolic Syndrome

Drug Information available for: Cimicifuga

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Exercise and Exercise + Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause

Further study details as provided by University of Erlangen-Nürnberg:

Primary Outcome Measures:

Bone Mineral Density [ Time Frame: baseline, 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

body composition [ Time Frame: baseline, 12 month ] [ Designated as safety issue: No ]
blood lipids, glucose [ Time Frame: baseline, 12 month ] [ Designated as safety issue: No ]
blood pressure [ Time Frame: baseline, 12 month ] [ Designated as safety issue: No ]
10 year CHD-risk [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]
menopausal complaints [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	126
Study Start Date:	April 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator exercise (3 sessions/week)	Behavioral: exercise exercise: 3 joint sessions/week for 12 months
2: Active Comparator exercise and "phytoestrogen" (cimicifuga racemosa)	Behavioral: exercise + cimicifuga racemosa exercise: 3 sessions/week for 12 months,cimicifuga racemosa (40 mg/d)
3: Placebo Comparator wellness control, placebo	Behavioral: wellness control, placebo 2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months, placebo

Eligibility

Ages Eligible for Study:	45 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663104

Locations

Germany
Institute of Medical Physics
Erlangen, Germany, 91052

Sponsors and Collaborators

University of Erlangen-Nürnberg

Institute of Gynecology, University of Erlangen-Nurnberg

Institute of Medical Physics, University of Erlangen-Nurnberg

Institute of Biometry and Medical Statistics, University of Erlangen-Nurnberg

Siemens-Betriebskrankenkasse

Investigators

Principal Investigator:	Michael Bebenek, MS	University of Erlangen-Nürnberg
Study Director:	Wolfgang Kemmler, PhD	University of Erlangen-Nürnberg
Study Chair:	Willi A Kalender, Professor, PhD	University of Erlangen-Nürnberg

More Information

Publications:

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.

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.

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.

Responsible Party:	Institute of Medical Physics, University of Erlangen-Nurnberg ( PD. Dr. Wolfgang Kemmler )
Study ID Numbers:	OFZ-Trace
Study First Received:	April 21, 2008
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00663104
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Bavaria: Bavarian Ministry of Science, Research and Art

Keywords provided by University of Erlangen-Nürnberg:

early menopause
exercise
phytoestrogen
bone
CHD-risk factors

Study placed in the following topic categories:

Arterial Occlusive Diseases
Metabolic Diseases
Metabolic Syndrome X
Heart Diseases
Menopause, Premature
Myocardial Ischemia
Vascular Diseases
Ischemia
Arteriosclerosis
Ovarian Diseases
Bone Diseases

Genital Diseases, Female
Coronary Disease
Hyperinsulinism
Musculoskeletal Diseases
Syndrome X
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Abdominal obesity metabolic syndrome
Menopause
Coronary Artery Disease

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009