Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-29 @ 2:20 AM
Study NCT ID:
NCT00453492
Status:
COMPLETED
Last Update Posted:
2008-03-11
First Post:
2007-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risedronate Sodium in Post Menopausal Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}], 'ancestors': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'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': '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 246}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'lastUpdateSubmitDate': '2008-03-10', 'studyFirstSubmitDate': '2007-03-28', 'studyFirstSubmitQcDate': '2007-03-28', 'lastUpdatePostDateStruct': {'date': '2008-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of subject satisfaction using a questionnaire at 12 and 24 weeks and a tablets counts at 12 and 24 weeks.'}, {'measure': 'Optional: the effects of Actonel on bone resorption will be assessed by a change of urinary NTx, after 12 and 24 weeks of treatment as compared to baseline.'}]}, 'conditionsModule': {'conditions': ['Osteoporosis, Postmenopausal']}, 'descriptionModule': {'briefSummary': 'The primary objective is to compare subject satisfaction of once a week dosing of 35 mg Actonel to once daily dosing of 5 mg Actonel in postmenopausal osteoporotic women.\n\nThe secondary objectives are to measure compliance (50 % drug taken), and persistence, \\[and urinary NTx (N-telopeptides) (optional)\\].'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Five years or greater postmenopausal who present with a diagnosis of postmenopausal osteoporosis based on standard clinical practice criteria.\n* Subjects must discontinue bisphosphonates, calcitonin, fluoride, glucocorticoids (≥ 5 mg prednisone or equivalent per day) and hormone replacement therapy including estrogen-related compounds at least 6 months prior to randomization. During the study, these drugs are not permitted other than the study medication, Actonel.\n* Other concomitant medications should be kept to a minimum, but if the drugs are considered necessary for the subject's welfare and are unlikely to interfere with study medication, they may be given at the discretion of the Investigator.\n\nExclusion criteria :\n\n* Had a history of cancer within the past 5 years. Relatively benign skin malignancies, such as basal cell carcinoma or squamous cell carcinoma, are not an exclusion criteria if the subject has been in remission for at least 6 months prior to enrollment.\n* Diagnosis of hypocalcemia, hyperparathyroidism, and hyperthyroidism.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00453492', 'briefTitle': 'Risedronate Sodium in Post Menopausal Osteoporosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Multicenter, Prospective, Randomized, 2-Way Crossover, Open-Label Study pn Postmenopausal Women With Osteoporosis Examining Subject Satisfaction and Compliance When Risedronate Sodium (Actonel) in Administered 35mg Once a Week or 5mg Once Daily', 'orgStudyIdInfo': {'id': 'HMR4003B_4036'}}, 'armsInterventionsModule': {'interventions': [{'name': 'risedronate sodium', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Edibe Taylan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi-aventis, Turkey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Procter and Gamble', 'class': 'INDUSTRY'}]}}}