Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-27 @ 6:45 PM
Study NCT ID:
NCT00463268
Status:
COMPLETED
Last Update Posted:
2013-05-29
First Post:
2007-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteoporosis Prevention With Low Dose Alendronate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'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'}, {'id': 'D002118', 'term': 'Calcium'}, {'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-28', 'studyFirstSubmitDate': '2007-04-19', 'studyFirstSubmitQcDate': '2007-04-19', 'lastUpdatePostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of lumbar BMD modification after 2 years', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'percentage of hip BMD modification (total hip and sub-regions)', 'timeFrame': '2 years'}, {'measure': 'percentage of modification of bone remodeling markers', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osteopenia', 'osteoporosis prevention', 'alendronate'], 'conditions': ['Osteopenia']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the efficacy of the intermittent administration of alendronate in a low dose, 70 mg once every two week, as osteoporosis prevention for menopausal, osteopenic patients, who don't want or can't receive an oestrogenic substitution treatment."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 45 to 60 year-old women\n* Menopausal since at least 6 months\n* Baseline lumbar BMD from -1 till -2.5\n\nExclusion Criteria:\n\n* Bone disease other than osteopenia\n* Treatment with selective estrogen receptor modulator (SERMs), calcitonin or hormone replacement therapy within 6 monts prior to randomization\n* Former or current treatment with any bisphosphonate or bone forming agents\n* Chronic use of oral or iv corticosteroids\n* Any diagnosis of malignancy less than 12 months'}, 'identificationModule': {'nctId': 'NCT00463268', 'briefTitle': 'Osteoporosis Prevention With Low Dose Alendronate', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Mont-Godinne'}, 'officialTitle': 'Prevention of Postmenopausal Bone Loss in Osteopenic Women With Alendronate Given on a 70 mg Once-every Two Week Regimen: a 2-year, Double-blind, Placebo-controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'MG/OP 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Alendronate 70 mg every 2 weeks', 'interventionNames': ['Drug: alendronate', 'Dietary Supplement: Calcium/Vitamin D']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Alendronate 70 mg placebo tablet every 2 weeks', 'interventionNames': ['Dietary Supplement: Calcium/Vitamin D', 'Drug: placebo']}], 'interventions': [{'name': 'alendronate', 'type': 'DRUG', 'description': 'alendronate 70 mg every 2 weeks', 'armGroupLabels': ['1']}, {'name': 'Calcium/Vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Calcium 500 mg and vitamin D supplementation according to serum level', 'armGroupLabels': ['1', '2']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'identical placebo every 2 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5530', 'city': 'Yvoir', 'state': 'Namur', 'country': 'Belgium', 'facility': 'University (UCL) Louvain Hospital in Mont-Godinne', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}], 'overallOfficials': [{'name': 'Yves R Boutsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Mont-Godinne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professeur', 'investigatorFullName': 'Boutsen Yves', 'investigatorAffiliation': 'University Hospital of Mont-Godinne'}}}}