Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-02-21 @ 10:02 AM
Study NCT ID:
NCT00575250
Status:
COMPLETED
Last Update Posted:
2007-12-18
First Post:
2007-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Education for Osteoporosis in Persons With Existing Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-17', 'studyFirstSubmitDate': '2007-12-17', 'studyFirstSubmitQcDate': '2007-12-17', 'lastUpdatePostDateStruct': {'date': '2007-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between groups at three months on osteoporosis knowledge, confidence in ability to consume calcium and to exercise, actual calcium consumption and exercise levels', 'timeFrame': 'Three and nine months'}], 'secondaryOutcomes': [{'measure': 'Changes between baseline and three months within each group on osteoporosis knowledge, confidence in the ability to each calcium-containing foods and exercise, and the amount of calcium consumed in foods and exercise undertaken', 'timeFrame': 'Three and nine months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoporosis/prevention & control', 'Osteoporosis Prevention and Self-Management Course', 'Patient Education/*trends//Questionnaires', 'Adult//Aged//Middle Aged', 'Life Style//'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'We wish to investigate whether a weekly, 2½ hour group-based osteoporosis education intervention (the Osteoporosis Prevention and Self-Management Course), is different to one session course (1x 2½ hours) on osteoporosis knowledge, confidence to eat calcium-containing foods, confidence to exercise, and amount of exercise undertaken after three and nine months of follow-up in people aged over 50 years who have already had a bone fracture.', 'detailedDescription': 'Instruments used to determine change after 3 and 9 months:\n\nOsteoporosis knowledge: Osteoporosis Knowledge Assessment Test (Winzenberg et al. BMC Musculoskelet Disord 2003) Calcium intake: Food frequency questionnaire (Angus et al. J Am Diet Assoc 1989) Calcium and exercise self-efficacy: Osteoporosis Self-Efficacy Scale (Horan et al Res Nurs Health 1998) Physical activity: CHAMPS II (Stewart et al. J Gerontol A Biol Sci Med Sci 2001)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Presented to Modbury Hospital's Accident and Emergency Department with a new bone fracture\n\nExclusion Criteria:\n\n* Residence in nursing home\n* Fracture sustained in motor bike, push bike or motor vehicle accident\n* Fracture sustained due to high trauma, such as fall from roof or ladder\n* Dementia\n* Inability to participate in group settings\n* Inability to understand spoken English\n* Inability to provide informed consent\n* Pathological fracture\n* Usual place of residence outside South Australia"}, 'identificationModule': {'nctId': 'NCT00575250', 'briefTitle': 'Education for Osteoporosis in Persons With Existing Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of Adelaide'}, 'officialTitle': 'Osteoporosis Education Clinic Study', 'orgStudyIdInfo': {'id': '2.180405'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Osteoporosis Prevention and Self-Management Course (4 x 2 1/2 hours)', 'interventionNames': ['Behavioral: Osteoporosis Prevention and Self-Management Course']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'One "introductory" osteoporosis education session (1 x 2 1/2 hours)', 'interventionNames': ['Behavioral: Introductory education session on osteoporosis']}], 'interventions': [{'name': 'Osteoporosis Prevention and Self-Management Course', 'type': 'BEHAVIORAL', 'description': 'Four weekly education sessions of 2 1/2 hours duration, in a group session facilitated by a community nurse and trained lay leader.', 'armGroupLabels': ['1']}, {'name': 'Introductory education session on osteoporosis', 'type': 'BEHAVIORAL', 'description': 'Introductory education session, 1 x 2 1/2 hours in a group session facilitated by a community nurse and trained lay person.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5092', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Modbury Hospital, Modbury', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'overallOfficials': [{'name': 'Laura L Laslett, MMedSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Adelaide'}, {'name': 'Julian D McNeil, PhD FRACP', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Adelaide'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Adelaide', 'class': 'OTHER'}, 'collaborators': [{'name': 'Osteoporosis SA', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Ms Laura Laslett', 'oldOrganization': 'University of Adelaide'}}}}