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

NCT00663104 | Terminated Phase 3

• 1 other identifier: OFZ-Trace
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Bone Diseases; Metabolic Syndrome X; Coronary Disease

Keywords

early menopause; exercise; phytoestrogen; bone; CHD-risk factors

Outcome Measures

Primary Outcomes (1)

• Bone Mineral Density

  baseline, 12 month

Secondary Outcomes (5)

• body composition

  baseline, 12 month

• blood lipids, glucose

  baseline, 12 month

• blood pressure

  baseline, 12 month

• 10 year CHD-risk

  baseline, 12 months

• menopausal complaints

  baseline, 12 months

Study Arms (3)

1

ACTIVE COMPARATOR

exercise (3 sessions/week)

Behavioral: exercise

2

ACTIVE COMPARATOR

exercise and "phytoestrogen" (cimicifuga racemosa)

Behavioral: exercise + cimicifuga racemosa

3

PLACEBO COMPARATOR

wellness control, placebo

Behavioral: wellness control, placebo

Interventions

exercise BEHAVIORAL

exercise: 3 joint sessions/week for 12 months

1

exercise + cimicifuga racemosa BEHAVIORAL

exercise: 3 sessions/week for 12 months,cimicifuga racemosa (40 mg/d)

2

wellness control, placebo BEHAVIORAL

2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months, placebo

3

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years early postmenopausal
• Caucasian race

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• Siemens-Betriebskrankenkasse: collaborator

Study Sites (1)

Institute of Medical Physics

Erlangen, 91052, Germany

Location

Related 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. doi: 10.1001/archinte.164.10.1084.

  PMID: 15159265 BACKGROUND

• 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. doi: 10.1136/bjsm.2006.033480. Epub 2007 Jun 5.

  PMID: 17550916 BACKGROUND

• 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. doi: 10.1249/01.mss.0000152678.20239.76.

  PMID: 15692313 BACKGROUND

MeSH Terms

Conditions

Bone Diseases; Metabolic Syndrome; Coronary Disease; Primary Ovarian Insufficiency; Motor Activity

Interventions

Exercise; black cohosh root extract

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Michael Bebenek, MS

  University of Erlangen-Nürnberg Medical School

  PRINCIPAL INVESTIGATOR

• Wolfgang Kemmler, PhD

  University of Erlangen-Nürnberg Medical School

  STUDY DIRECTOR

• Willi A Kalender, Professor, PhD

  University of Erlangen-Nürnberg Medical School

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 22, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

DE (1)