Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-26 @ 11:03 PM
Study NCT ID:
NCT00859703
Status:
COMPLETED
Last Update Posted:
2013-10-31
First Post:
2009-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess Efficacy of Risedronate in Preventing Bone Loss in Postmenopausal Women Treated for Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'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': 'D000068296', 'term': 'Risedronic Acid'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-30', 'studyFirstSubmitDate': '2009-03-10', 'studyFirstSubmitQcDate': '2009-03-10', 'lastUpdatePostDateStruct': {'date': '2013-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of the lumbar spine Bone Mineral Density after one year of treatment', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Evolution of femoral BMD after one year of treatment', 'timeFrame': '1 year'}, {'measure': 'Evolution of lumbar spine and femoral BMD after two years of treatment', 'timeFrame': '2 years'}, {'measure': 'Evolution of bone resorption and formation markers', 'timeFrame': '2 years'}, {'measure': 'Proportion of fractures after two years of treatment', 'timeFrame': '2 years'}, {'measure': 'Evolution of estradiol levels', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aromatase inhibitor treatment', 'osteoporosis', 'breast cancer', 'bisphosphonates'], 'conditions': ['Breast Cancer', 'Menopause', 'Osteopenia']}, 'referencesModule': {'references': [{'pmid': '38979716', 'type': 'DERIVED', 'citation': 'Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.'}]}, 'descriptionModule': {'briefSummary': 'Aromatase inhibitor therapy is in France the adjuvant reference treatment for postmenopausal women with early-stage breast cancer. This treatment induces bone loss and a higher risk of fractures.\n\nThis study aimed to document the effect of bisphosphonate therapy in preventing bone loss and osteoporotic fractures in postmenopausal women with aromatase inhibitor treatment for breast cancer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Postmenopausal women (more than one year since last menstrual period or removal of ovarian function by surgical or radiotherapic means)\n* Operated for an invasive breast cancer (histologically proven)\n* Surgical treatment completed and cycles of adjuvant chemotherapy (if necessary) completed\n* Treated with aromatase inhibitor\n* Osteopenic (-2.5\\<T score\\<-1) without osteoporotic fracture\n* With written informed consent signed\n* With social security\n\nExclusion Criteria:\n\n* Women presenting a history of osteoporotic fracture or a T score less than -2.5 at at least one measure site\n* Women presenting clinical signs of metastases\n* Having received other hormonal treatment in the last 3 months\n* Having received treatment by bisphosphonates, raloxifene, tamoxifen, parathormone, strontium ranelate, tibolone,calcitonin and corticosteroids at more than 5mg/d for 3 months in the last year\n* Presenting a known and untreated hyperthyroid\n* Presenting a known hyperadrenocorticism\n* Patients treated and followed for Paget's disease of bone\n* Presenting a untreated primary hyperparathyroid\n* Presenting an indication against risedronate (known hypersensibility to risedronate monosodium and/or one of its excipients, non-corrected hypocalcemia, pregnancy or breast feeding, severe renal insufficiency inferior to 30 ml/min)\n* Patients presenting malabsorption syndrome for glucose/galactose\n* Person participating in another clinical trial concerning a medicine susceptible to influence bone mass"}, 'identificationModule': {'nctId': 'NCT00859703', 'acronym': 'RISAROS', 'briefTitle': 'Study to Assess Efficacy of Risedronate in Preventing Bone Loss in Postmenopausal Women Treated for Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Randomized, Double-blinded, Placebo Controlled Study to Assess Efficacy of Oral 35 mg Per Week Risedronate in Preventing Bone Loss in Postmenopausal Women With Aromatase Inhibitor Therapy for Breast Cancer.', 'orgStudyIdInfo': {'id': '2006.45346'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Patients receive placebo 35 mg once a week plus a calcium and vitamin D supplementation.\n\nMeasure of bone density, bone markers, clinical examination and questionnaire regarding fractures will be assessed at 12 and 24 months of treatment', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Patients receive risedronate 35 mg once a week plus a calcium and vitamin D supplementation.\n\nMeasure of bone density, bone markers, clinical examination and questionnaire regarding fractures will be assessed at 12 and 24 months of treatment', 'interventionNames': ['Drug: Risedronate']}], 'interventions': [{'name': 'Risedronate', 'type': 'DRUG', 'description': '35mg oral risedronate once per week for 24 months', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo 35 mg once a week for 24 months', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69437', 'city': 'Lyon', 'country': 'France', 'facility': 'Service de Rhumatology et de Pathologie Osseuse, Hôpital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Aurélie Fontana, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Edouard Herriot'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}