Clinical trial NCT00663104: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Bone Diseases
Metabolic Syndrome X
Coronary Disease
Keywords: early menopause
exercise
phytoestrogen
bone
CHD-risk factors
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: Siemens-Betriebskrankenkasse
First posted: 2008-04-22
Enrollment: 126
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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

Primary outcomes:
measure: Bone Mineral Density
timeFrame: baseline, 12 month
Secondary outcomes:
measure: body composition
timeFrame: baseline, 12 month
measure: blood lipids, glucose
timeFrame: baseline, 12 month
measure: blood pressure
timeFrame: baseline, 12 month
measure: 10 year CHD-risk
timeFrame: baseline, 12 months
measure: menopausal complaints
timeFrame: baseline, 12 months
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of Medical Physics
Study officials:
affiliation: University of Erlangen-Nürnberg Medical School
name: Michael Bebenek, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Erlangen-Nürnberg Medical School
name: Wolfgang Kemmler, PhD
role: STUDY_DIRECTOR
affiliation: University of Erlangen-Nürnberg Medical School
name: Willi A Kalender, Professor, PhD
role: STUDY_CHAIR
References:
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.
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.
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.