Ignite Creation Date:
2025-12-24 @ 7:54 PM
Ignite Modification Date:
2026-01-25 @ 1:44 AM
Study NCT ID:
NCT00663104
Status:
TERMINATED
Last Update Posted:
2015-05-28
First Post:
2008-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Exercise and Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D016649', 'term': 'Primary Ovarian Insufficiency'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'C000713173', 'term': 'black cohosh root extract'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-27', 'studyFirstSubmitDate': '2008-04-21', 'studyFirstSubmitQcDate': '2008-04-21', 'lastUpdatePostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone Mineral Density', 'timeFrame': 'baseline, 12 month'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['early menopause', 'exercise', 'phytoestrogen', 'bone', 'CHD-risk factors'], 'conditions': ['Bone Diseases', 'Metabolic Syndrome X', 'Coronary Disease']}, 'referencesModule': {'references': [{'pmid': '15159265', 'type': 'BACKGROUND', '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.'}, {'pmid': '17550916', 'type': 'BACKGROUND', '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.'}, {'pmid': '15692313', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1-3 years early postmenopausal\n* Caucasian race\n\nExclusion Criteria:\n\n* CHD-diseases\n* thrombosis, embolism\n* fractures at lumbar spine or hip\n* secondary osteoporosis\n* hyperparathyroidism\n* medication, diseases with impact on muscle or bone\n* cancer and hormone derived malign diseases\n* weight reduction of \\> 5 kg during the last 6 months'}, 'identificationModule': {'nctId': 'NCT00663104', 'briefTitle': 'Effect of Exercise and Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Effect of Exercise and Exercise + Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause', 'orgStudyIdInfo': {'id': 'OFZ-Trace'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'exercise (3 sessions/week)', 'interventionNames': ['Behavioral: exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'exercise and "phytoestrogen" (cimicifuga racemosa)', 'interventionNames': ['Behavioral: exercise + cimicifuga racemosa']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'wellness control, placebo', 'interventionNames': ['Behavioral: wellness control, placebo']}], 'interventions': [{'name': 'exercise', 'type': 'BEHAVIORAL', 'description': 'exercise: 3 joint sessions/week for 12 months', 'armGroupLabels': ['1']}, {'name': 'exercise + cimicifuga racemosa', 'type': 'BEHAVIORAL', 'description': 'exercise: 3 sessions/week for 12 months,cimicifuga racemosa (40 mg/d)', 'armGroupLabels': ['2']}, {'name': 'wellness control, placebo', 'type': 'BEHAVIORAL', 'description': '2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months, placebo', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91052', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Institute of Medical Physics', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'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', 'affiliation': 'University of Erlangen-Nürnberg Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Siemens-Betriebskrankenkasse', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wolfgang Kemmler', 'investigatorAffiliation': 'University of Erlangen-Nürnberg Medical School'}}}}