Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:32 PM
Study NCT ID:
NCT00936260
Status:
COMPLETED
Last Update Posted:
2009-07-10
First Post:
2009-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019386', 'term': 'Alendronate'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1998-01', 'completionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-09', 'studyFirstSubmitDate': '2009-07-09', 'studyFirstSubmitQcDate': '2009-07-09', 'lastUpdatePostDateStruct': {'date': '2009-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone mineral density', 'timeFrame': 'Every year'}], 'secondaryOutcomes': [{'measure': 'Fractures', 'timeFrame': 'Every year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osteoporosis', 'postmenopausal', 'alendronate'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the duration of the treatment with alendronate in postmenopausal women with osteoporosis.', 'detailedDescription': 'The duration of the treatment with alendronate is not well established. The investigators recruited 228 women with postmenopausal osteoporosis. They all received alendronate during the first 3 years of monitoring and were later on randomized to whether different regimens of intermittent treatment or to carry on 3 years more.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* postmenopausal osteoporosis under densitometric criteria of the World Health Organization\n\nExclusion Criteria:\n\n* secondary osteoporosis\n* alteration in analytic parameters (total proteins, calcium, phosphorus, vitamin D, parathyroid hormone, thyroid hormone, transaminase, creatinine)'}, 'identificationModule': {'nctId': 'NCT00936260', 'briefTitle': 'Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis', 'organization': {'class': 'OTHER', 'fullName': 'Ciudad Universitaria, Spain'}, 'officialTitle': 'Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis', 'orgStudyIdInfo': {'id': 'individual reseacher'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'alendronate 6 years', 'interventionNames': ['Drug: alendronate']}, {'type': 'EXPERIMENTAL', 'label': 'alendronate 5 years', 'description': 'No treatment during year 6th', 'interventionNames': ['Drug: alendronate']}, {'type': 'EXPERIMENTAL', 'label': 'alendronate 5 years, not continued', 'description': 'No treatment during year 5th', 'interventionNames': ['Drug: alendronate']}, {'type': 'EXPERIMENTAL', 'label': 'alendronate 4 years', 'description': 'No treatment during year 5th and 6th', 'interventionNames': ['Drug: alendronate']}, {'type': 'EXPERIMENTAL', 'label': 'alendronate 5 years, uncontinued', 'description': 'No treatment during year 4th', 'interventionNames': ['Drug: alendronate']}, {'type': 'EXPERIMENTAL', 'label': 'alendronate 4 years, not continued', 'description': 'No treatment during year 4th and 6th', 'interventionNames': ['Drug: alendronate']}, {'type': 'EXPERIMENTAL', 'label': 'alendronate 4 years, uncontinued', 'description': 'No treatment during year 4th and 5th', 'interventionNames': ['Drug: alendronate']}, {'type': 'EXPERIMENTAL', 'label': 'Alendronato 3 years', 'description': 'No treatment during the last 3 years', 'interventionNames': ['Drug: alendronate']}], 'interventions': [{'name': 'alendronate', 'type': 'DRUG', 'otherNames': ['fosamax'], 'description': 'several duration of treatment', 'armGroupLabels': ['Alendronato 3 years', 'alendronate 4 years', 'alendronate 4 years, not continued', 'alendronate 4 years, uncontinued', 'alendronate 5 years', 'alendronate 5 years, not continued', 'alendronate 5 years, uncontinued', 'alendronate 6 years']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'University San Carlos Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Carlos Lozano Tonkin, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'university san carlos hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ciudad Universitaria, Spain', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Esther Alvarez-Rodriguez', 'oldOrganization': 'University San Carlos Hospital'}}}}