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

This study has been terminated.
Information provided by (Responsible Party):
Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School Identifier:
First received: April 21, 2008
Last updated: May 27, 2015
Last verified: May 2015
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Exercise and Exercise + Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Bone Mineral Density [ Time Frame: baseline, 12 month ]

Secondary Outcome Measures:
  • body composition [ Time Frame: baseline, 12 month ]
  • blood lipids, glucose [ Time Frame: baseline, 12 month ]
  • blood pressure [ Time Frame: baseline, 12 month ]
  • 10 year CHD-risk [ Time Frame: baseline, 12 months ]
  • menopausal complaints [ Time Frame: baseline, 12 months ]

Enrollment: 126
Study Start Date: April 2008
Study Completion Date: November 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
exercise (3 sessions/week)
Behavioral: exercise
exercise: 3 joint sessions/week for 12 months
Active Comparator: 2
exercise and "phytoestrogen" (cimicifuga racemosa)
Behavioral: exercise + cimicifuga racemosa
exercise: 3 sessions/week for 12 months,cimicifuga racemosa (40 mg/d)
Placebo Comparator: 3
wellness control, placebo
Behavioral: wellness control, placebo
2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months, placebo


Ages Eligible for Study:   45 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00663104

Institute of Medical Physics
Erlangen, Germany, 91052
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Principal Investigator: Michael Bebenek, MS University of Erlangen-Nürnberg Medical School
Study Director: Wolfgang Kemmler, PhD University of Erlangen-Nürnberg Medical School
Study Chair: Willi A Kalender, Professor, PhD University of Erlangen-Nürnberg Medical School
  More Information

Responsible Party: Wolfgang Kemmler, Principal Investigator, University of Erlangen-Nürnberg Medical School Identifier: NCT00663104     History of Changes
Other Study ID Numbers: OFZ-Trace
Study First Received: April 21, 2008
Last Updated: May 27, 2015

Keywords provided by University of Erlangen-Nürnberg Medical School:
early menopause
CHD-risk factors

Additional relevant MeSH terms:
Metabolic Syndrome X
Coronary Disease
Coronary Artery Disease
Bone Diseases
Menopause, Premature
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Musculoskeletal Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Estrogens, Non-Steroidal
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 23, 2017