Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT00092066
Status:
COMPLETED
Last Update Posted:
2024-08-14
First Post:
2004-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}], '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'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019386', 'term': 'Alendronate'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D000081206', 'term': 'Duration of Therapy'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 717}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2004-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2004-09-21', 'studyFirstSubmitQcDate': '2004-09-23', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with Vitamin D insufficiency (defined as serum 25-hydroxyvitamin levels <15 ng/mL) after 15 weeks of treatment.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with vitamin D deficiency (serum 25-hydroxyvitamin D levels <9 ng/mL) after 15 weeks of treatment.'}]}, 'conditionsModule': {'conditions': ['Osteoporosis', 'Vitamin D Deficiency']}, 'referencesModule': {'references': [{'pmid': '16968578', 'type': 'BACKGROUND', 'citation': 'Recker R, Lips P, Felsenberg D, Lippuner K, Benhamou L, Hawkins F, Delmas PD, Rosen C, Emkey R, Salzmann G, He W, Santora AC. Alendronate with and without cholecalciferol for osteoporosis: results of a 15-week randomized controlled trial. Curr Med Res Opin. 2006 Sep;22(9):1745-55. doi: 10.1185/030079906x120913.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the safety, tolerability and effectiveness of an investigational drug and dietary supplement to reduce the risk of vitamin D insufficiency and deficiency during the treatment of osteoporosis in men and postmenopausal women.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or postmenopausal women who are osteoporotic\n\nExclusion Criteria:\n\n* Vitamin D deficiency\n* Other disease of bone or mineral metabolism\n* Digestive disease causing malabsorption\n* Other significant medical conditions that are not adequately treated'}, 'identificationModule': {'nctId': 'NCT00092066', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A 15-Week, Double-Blind, Randomized, Active-Controlled, Multi-Center Study With 24-Week Extension to Evaluate the Safety, Tolerability, Efficacy of Alendronate 70 mg Plus Vitamin D3 2800 IU Combination Tablet in Men and Postmenopausal Women With Osteoporosis', 'orgStudyIdInfo': {'id': '0217A-227'}, 'secondaryIdInfos': [{'id': '2004_020'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 15 weeks', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}