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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 June 2015 |
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Main ID: |
NCT00663104 |
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Date of registration:
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21/04/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Exercise and Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause
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Scientific title:
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Effect of Exercise and Exercise + Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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126 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00663104 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Germany
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Contacts
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Name:
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Wolfgang Kemmler, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Erlangen-Nürnberg Medical School |
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Name:
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Michael Bebenek, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Erlangen-Nürnberg Medical School |
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Name:
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Willi A Kalender, Professor, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Erlangen-Nürnberg Medical School |
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Key inclusion & exclusion criteria
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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
Age minimum:
45 Years
Age maximum:
55 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Coronary Disease
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Bone Diseases
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Metabolic Syndrome X
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Intervention(s)
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Behavioral: exercise
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Behavioral: exercise + cimicifuga racemosa
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Behavioral: wellness control, placebo
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Primary Outcome(s)
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Bone Mineral Density
[Time Frame: baseline, 12 month]
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Secondary Outcome(s)
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blood lipids, glucose
[Time Frame: baseline, 12 month]
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blood pressure
[Time Frame: baseline, 12 month]
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body composition
[Time Frame: baseline, 12 month]
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10 year CHD-risk
[Time Frame: baseline, 12 months]
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menopausal complaints
[Time Frame: baseline, 12 months]
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Secondary ID(s)
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OFZ-Trace
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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