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

Primary Purpose

Bone Diseases, Metabolic Syndrome X, Coronary Disease

Status

Terminated

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

exercise

exercise + cimicifuga racemosa

wellness control, placebo

About this trial

This is an interventional prevention trial for Bone Diseases focused on measuring early menopause, exercise, phytoestrogen, bone, CHD-risk factors

Eligibility Criteria

45 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Institute of Medical Physics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

exercise (3 sessions/week)

exercise and "phytoestrogen" (cimicifuga racemosa)

wellness control, placebo

Outcomes

Primary Outcome Measures

Bone Mineral Density

Secondary Outcome Measures

body composition

blood lipids, glucose

blood pressure

10 year CHD-risk

menopausal complaints

Full Information

NCT ID

NCT00663104

First Posted

April 21, 2008

Last Updated

May 27, 2015

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

Siemens-Betriebskrankenkasse

1. Study Identification

Unique Protocol Identification Number

NCT00663104

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Terminated

Study Start Date

April 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

Siemens-Betriebskrankenkasse

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bone Diseases, Metabolic Syndrome X, Coronary Disease

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

exercise (3 sessions/week)

Arm Title

Arm Type

Active Comparator

Arm Description

exercise and "phytoestrogen" (cimicifuga racemosa)

Arm Title

Arm Type

Placebo Comparator

Arm Description

wellness control, placebo

Intervention Type

Behavioral

Intervention Name(s)

exercise

Intervention Description

exercise: 3 joint sessions/week for 12 months

Intervention Type

Behavioral

Intervention Name(s)

exercise + cimicifuga racemosa

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

wellness control, placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Bone Mineral Density

Time Frame

baseline, 12 month

Secondary Outcome Measure Information:

Title

body composition

Time Frame

baseline, 12 month

Title

blood lipids, glucose

Time Frame

baseline, 12 month

Title

blood pressure

Time Frame

baseline, 12 month

Title

10 year CHD-risk

Time Frame

baseline, 12 months

Title

menopausal complaints

Time Frame

baseline, 12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Bebenek, MS

Organizational Affiliation

University of Erlangen-Nürnberg Medical School

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Wolfgang Kemmler, PhD

Organizational Affiliation

University of Erlangen-Nürnberg Medical School

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Willi A Kalender, Professor, PhD

Organizational Affiliation

University of Erlangen-Nürnberg Medical School

Official's Role

Study Chair

Facility Information:

Facility Name

Institute of Medical Physics

City

Erlangen

ZIP/Postal Code

91052

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

15159265

Citation

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.

Results Reference

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PubMed Identifier

17550916

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. doi: 10.1136/bjsm.2006.033480. Epub 2007 Jun 5. Erratum In: Br J Sports Med. 2007 Dec;41(12):926.

Results Reference

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PubMed Identifier

15692313

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. doi: 10.1249/01.mss.0000152678.20239.76.

Results Reference

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

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