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
ClinicalTrials.gov 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ 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 ]

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
Genders 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 ClinicalTrials.gov 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
ClinicalTrials.gov Identifier: NCT00663104     History of Changes
Other Study ID Numbers: OFZ-Trace 
Study First Received: April 21, 2008
Last Updated: May 27, 2015
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 Medical School:
early menopause
CHD-risk factors

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

ClinicalTrials.gov processed this record on May 23, 2016