Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT00729651
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2008-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, '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': 'D019386', 'term': 'Alendronate'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'C007792', 'term': 'Fumigant 93'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were followed up until 14 days after the last dose of investigational drug.', 'description': '1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group.\n\n1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.', 'eventGroups': [{'id': 'EG000', 'title': 'Fosamax Plus D', 'description': 'Once weekly Fosamax plus D tablet \\[Alendronate sodium 70 mg/Cholecalciferol 5600 IU\\] + once daily calcium formulation \\[500 mg/day\\]), 16 weeks and patients who received drugs at least once after randomization and was analyzed according to the actually administered study drugs', 'otherNumAtRisk': 171, 'otherNumAffected': 60, 'seriousNumAtRisk': 171, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Fosamax', 'description': 'Once weekly Fosamax 70 mg tablet \\[Alendronate sodium 70 mg\\] + once daily calcium formulation \\[500 mg/day\\]), 16 weeks and patients who received drugs at least once after randomization and was analyzed according to the actually administered study drugs', 'otherNumAtRisk': 170, 'otherNumAffected': 55, 'seriousNumAtRisk': 170, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastritis atrophic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Joint stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Musculoskeletal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Xeroderma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dacryostenosis acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lung abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Osteochondrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cystocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Uterine prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fosamax Plus D', 'description': 'Once weekly Fosamax plus D tablet \\[Alendronate sodium 70 mg/Cholecalciferol 5600 IU\\] + once daily calcium formulation \\[500 mg/day\\]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria'}, {'id': 'OG001', 'title': 'Fosamax', 'description': 'Once weekly Fosamax 70 mg tablet \\[Alendronate sodium 70 mg\\] + once daily calcium formulation \\[500 mg/day\\], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria'}], 'classes': [{'title': 'With Vitamin D Deficiency', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Without Vitamin D Deficiency', 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.08', 'estimateComment': "Mantel-Haenszel estimator of the common odds ratio was calculated by using Cochran-Mantel-Haenszel test for subjects' proportions with vitamin D deficiency changes at 16 weeks (visit 4) from baseline (visit 1) between treatment groups.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Primary efficacy endpoint was analyzed by a Cochran-Mantel-Haenszel test with baseline vitamin D level as covariate.'}], 'paramType': 'NUMBER', 'timeFrame': '16 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.'}, {'type': 'SECONDARY', 'title': 'Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fosamax Plus D', 'description': 'Once weekly Fosamax plus D tablet \\[Alendronate sodium 70 mg/Cholecalciferol 5600 IU\\] + once daily calcium formulation \\[500 mg/day\\]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria'}, {'id': 'OG001', 'title': 'Fosamax', 'description': 'Once weekly Fosamax 70 mg tablet \\[Alendronate sodium 70 mg\\] + once daily calcium formulation \\[500 mg/day\\], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '8.17', 'groupId': 'OG000', 'lowerLimit': '-3.24', 'upperLimit': '19.58'}, {'value': '29.98', 'groupId': 'OG001', 'lowerLimit': '18.34', 'upperLimit': '41.62'}]}]}], 'analyses': [{'pValue': '0.0091', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Least squares mean is mean of serum PTH percentage changes adjusted serum PTH level at baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 16 weeks', 'unitOfMeasure': 'Percentage Change Serum PTH', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.'}, {'type': 'POST_HOC', 'title': 'Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Less and Greater Than 20 ng/ml at 16 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fosamax Plus D', 'description': 'Once weekly Fosamax plus D tablet \\[Alendronate sodium 70 mg/Cholecalciferol 5600 IU\\] + once daily calcium formulation \\[500 mg/day\\]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria'}, {'id': 'OG001', 'title': 'Fosamax', 'description': 'Once weekly Fosamax 70 mg tablet \\[Alendronate sodium 70 mg\\] + once daily calcium formulation \\[500 mg/day\\], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria'}], 'classes': [{'title': 'With 25 OHD < 20ng/ml at 16 weeks of treatment', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': 'With 25 OHD >= 20ng/ml at 16 weeks of treatment', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.04', 'estimateComment': "Mantel-Haenszel estimator of the common odds ratio was calculated by using Cochran-Mantel-Haenszel test for subjects' proportions with vitamin D deficiency changes at 16 weeks (visit 4) from baseline (visit 1) between treatment groups.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'It was analyzed by a Cochran-Mantel-Haenszel test with baseline vitamin D level as covariate.'}], 'paramType': 'NUMBER', 'timeFrame': '16 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.'}, {'type': 'POST_HOC', 'title': 'Mean Serum 25 OHD(Serum 25-hydroxyvitamin D) at 16 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fosamax Plus D', 'description': 'Once weekly Fosamax plus D tablet \\[Alendronate sodium 70 mg/Cholecalciferol 5600 IU\\] + once daily calcium formulation \\[500 mg/day\\]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria'}, {'id': 'OG001', 'title': 'Fosamax', 'description': 'Once weekly Fosamax 70 mg tablet \\[Alendronate sodium 70 mg\\] + once daily calcium formulation \\[500 mg/day\\], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '30.08', 'spread': '5.87', 'groupId': 'OG000'}, {'value': '17.14', 'spread': '6.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fosamax Plus D', 'description': 'Once weekly Fosamax plus D tablet \\[Alendronate sodium 70 mg/Cholecalciferol 5600 IU\\] + once daily calcium formulation \\[500 mg/day\\]), 16 weeks'}, {'id': 'FG001', 'title': 'Fosamax', 'description': 'Once weekly Fosamax 70 mg tablet \\[Alendronate sodium 70 mg\\] + once daily calcium formulation \\[500 mg/day\\]), 16 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '170'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Visit 3, 25 OHD level ≤9 ng/mL', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': "Subject's private reason", 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '17 centers participated in this study (11 - Medical Center of the University, 7 - General Hospital).\n\nFPE(First patient enrolled) : March-2008, FPI(First patient in) : April-2008, LPO(Last patient out) : April-2009.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '343', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fosamax Plus D', 'description': 'Once weekly Fosamax plus D tablet \\[Alendronate sodium 70 mg/Cholecalciferol 5600 IU\\] + once daily calcium formulation \\[500 mg/day\\]), 16 weeks'}, {'id': 'BG001', 'title': 'Fosamax', 'description': 'Once weekly Fosamax 70 mg tablet \\[Alendronate sodium 70 mg\\] + once daily calcium formulation \\[500 mg/day\\]), 16 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.59', 'spread': '7.09', 'groupId': 'BG000'}, {'value': '65.31', 'spread': '7.62', 'groupId': 'BG001'}, {'value': '64.94', 'spread': '7.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<=44 years of age', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '45-49 years of age', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': '50-59 years of age', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}, {'title': '60-69 years of age', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}]}, {'title': '70-79 years of age', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}, {'title': '>=80 years of age', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '343', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Patients with/without Vitamin D deficiency', 'classes': [{'title': 'With Vitamin D deficiency at baseline', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}, {'title': 'Without Vitamin D deficiency at baseline', 'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Vitamin D deficiency means serum 25 OHD (hydroxyvitamin D) below the deficiency level (less than 15 ng/ml) in this study.', 'unitOfMeasure': 'participants'}, {'title': 'T-score classification by inclusion criteria: A fracture in spine Lumbar 1-4 and T-score ≤ -2.0]', 'classes': [{'title': 'A fracture in spine Lumbar 1-4 and T-score ≤ -2.0', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Not Applicable', 'categories': [{'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '329', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "T-score: a measurement expressed in standard deviation units from a given mean used in assessment of osteoporosis, equal to a patient's bone mineral density measurement by Dual Energy X-ray Absorptiometry (DEXA) minus the value in a young healthy person, divided by the standard deviation of the measurement in the population.", 'unitOfMeasure': 'Participants'}, {'title': 'T-score classification by inclusion criteria: Femoral neck T-score ≤ -2.5', 'classes': [{'title': 'Femoral neck T-score ≤ -2.5', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}, {'title': 'Not Applicable', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "T-score: a measurement expressed in standard deviation units from a given mean used in assessment of osteoporosis, equal to a patient's bone mineral density measurement by DEXA minus the value in a young healthy person, divided by the standard deviation of the measurement in the population.", 'unitOfMeasure': 'Participants'}, {'title': 'T-score classification by inclusion criteria: Femoral total T-score ≤ -2.5', 'classes': [{'title': 'Femoral total T-score ≤ -2.5', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'Not Applicable', 'categories': [{'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '298', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "T-score: a measurement expressed in standard deviation units from a given mean used in assessment of osteoporosis, equal to a patient's bone mineral density measurement by DEXA minus the value in a young healthy person, divided by the standard deviation of the measurement in the population.", 'unitOfMeasure': 'Participants'}, {'title': 'T-score classification by inclusion criteria: Spine (average of spine Lumbar 1-4 ) T-score ≤-2.5', 'classes': [{'title': 'Spine (average of spine Lumbar 1-4 ) T-score ≤-2.5', 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}]}]}, {'title': 'Not Applicable', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "T-score: a measurement expressed in standard deviation units from a given mean used in assessment of osteoporosis, equal to a patient's bone mineral density measurement by DEXA minus the value in a young healthy person, divided by the standard deviation of the measurement in the population.", 'unitOfMeasure': 'Participants'}, {'title': 'Two or more fractures in spine (Lumbar 1-4)', 'classes': [{'title': 'Two or more fractures in spine(Lumbar 1-4)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Not Applicable', 'categories': [{'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'A fracture in spine Lumbar 1, Lumbar 2, Lumbar 3, Lumbar 4 and T-score ≤-2.0', 'classes': [{'categories': [{'measurements': [{'value': '-2.44', 'spread': '0.71', 'groupId': 'BG000'}, {'value': '-2.34', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '-2.40', 'spread': '0.59', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The analyzable number of patients with A fracture in spine Lumbar 1, Lumbar 2, Lumbar 3, Lumbar 4 and T-score ≤ -2.0 are 9 in Fosamax Plus D Group and 5 in Fosamax Group.', 'unitOfMeasure': 'T-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '72.5', 'spread': '8.84', 'groupId': 'BG000'}, {'value': '73.82', 'spread': '8.85', 'groupId': 'BG001'}, {'value': '73.15', 'spread': '8.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '1 Participant from the Fosamax group is missing data for this Measure', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Femoral neck T-score ≤ -2.5', 'classes': [{'categories': [{'measurements': [{'value': '-2.95', 'spread': '0.48', 'groupId': 'BG000'}, {'value': '-2.94', 'spread': '0.42', 'groupId': 'BG001'}, {'value': '-2.94', 'spread': '0.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The analyzable number of patients with Femoral neck T-score ≤ -2.5 are 43 in Fosamax Plus D Group and 58 in Fosamax Group.', 'unitOfMeasure': 'T-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Femoral total T-score ≤ -2.5', 'classes': [{'categories': [{'measurements': [{'value': '-3.00', 'spread': '0.52', 'groupId': 'BG000'}, {'value': '-3.00', 'spread': '0.41', 'groupId': 'BG001'}, {'value': '-3.00', 'spread': '0.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The analyzable number of patients with Femoral total T-score ≤ -2.5 are 20 in Fosamax Plus D Group and 25 in Fosamax Group.', 'unitOfMeasure': 'T-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '152.11', 'spread': '5.88', 'groupId': 'BG000'}, {'value': '152.47', 'spread': '5.59', 'groupId': 'BG001'}, {'value': '152.29', 'spread': '5.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '2 Participants from the Fosamax group are missing data for this Measure', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum PTH (Parathyroid hormone)', 'classes': [{'categories': [{'measurements': [{'value': '25.27', 'spread': '11.01', 'groupId': 'BG000'}, {'value': '23.47', 'spread': '11.85', 'groupId': 'BG001'}, {'value': '24.38', 'spread': '11.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Spine (average of spine Lumbar 1, Lumbar 2, Lumbar 3, Lumbar 4 ) T-score ≤ -2.5', 'classes': [{'categories': [{'measurements': [{'value': '-2.96', 'spread': '0.40', 'groupId': 'BG000'}, {'value': '-3.06', 'spread': '0.50', 'groupId': 'BG001'}, {'value': '-3.01', 'spread': '0.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The analyzable number of patients with Spine (average of spine Lumbar 1, Lumbar 2, Lumbar 3, Lumbar 4) are 144 in Fosamax Plus D Group and 132 in Fosamax Group.', 'unitOfMeasure': 'T-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '122.83', 'spread': '15.8', 'groupId': 'BG000'}, {'value': '124.08', 'spread': '14.52', 'groupId': 'BG001'}, {'value': '123.45', 'spread': '15.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '1 Participant from the Fosamax group is missing data for this Measure', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '53.84', 'spread': '6.89', 'groupId': 'BG000'}, {'value': '54.8', 'spread': '7.03', 'groupId': 'BG001'}, {'value': '54.32', 'spread': '6.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '1 Participant from the Fosamax plus D group is missing data for this Measure, 2 Participants from the Fosamax group are missing data for this Measure', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'serum 25 OHD (Serum 25-hydroxyvitamin D)', 'classes': [{'categories': [{'measurements': [{'value': '18.82', 'spread': '6.46', 'groupId': 'BG000'}, {'value': '18.71', 'spread': '6.25', 'groupId': 'BG001'}, {'value': '18.77', 'spread': '6.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 343}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2009-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2008-08-05', 'resultsFirstSubmitDate': '2010-02-05', 'studyFirstSubmitQcDate': '2008-08-06', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-03-18', 'studyFirstPostDateStruct': {'date': '2008-08-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment', 'timeFrame': 'Baseline and 16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoporosis Postmenopausal']}, 'referencesModule': {'references': [{'pmid': '24719139', 'type': 'RESULT', 'citation': 'Kim KJ, Min YK, Koh JM, Chung YS, Kim KM, Byun DW, Kim IJ, Kim M, Kim SS, Min KW, Han KO, Park HM, Shin CS, Choi SH, Park JS, Chung DJ, Mok JO, Baek HS, Moon SH, Kim YS, Lim SK; VALUE study group. Efficacy and safety of weekly alendronate plus vitamin D(3) 5600 IU versus weekly alendronate alone in Korean osteoporotic women: 16-week randomized trial. Yonsei Med J. 2014 May;55(3):715-24. doi: 10.3349/ymj.2014.55.3.715. Epub 2014 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate the efficacy/safety of Fosamax Plus D'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient agrees to apply sunscreen and limit sunlight-exposure to 1 hour per day during the study\n* Patient has been diagnosed with osteoporosis\n* Patient has been postmenopausal for more than 6 months\n* Patient has no contraindication to taking oral bisphosphonates\n* Patient is eligible for dual energy x-ray absorptiometry in spine or hip\n\nExclusion Criteria:\n\n* Patients with esophageal dysfunction\n* Patients who can not sit or stand at least 30 minutes\n* Patients who had a malignant disease or active systemic disease 5 years prior to participating in this trial\n* Patients with diseases of bone or mineral metabolism besides osteoporosis or receiving therapies which affect bone metabolism or calcium metabolism\n* Patients with history of major gastrointestinal disease (peptic ulcer, malabsorption, esophageal disease, gastritis, gastroduodenitis, etc.) within the last 6 months'}, 'identificationModule': {'nctId': 'NCT00729651', 'briefTitle': 'Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Prospective, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Fosamax Plus D in Postmenopausal Osteoporotic Women', 'orgStudyIdInfo': {'id': '0217A-263'}, 'secondaryIdInfos': [{'id': 'MK0217A-263'}, {'id': '2008_015'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Alendronate sodium/Cholecalciferol', 'interventionNames': ['Drug: alendronate sodium (+) cholecalciferol', 'Dietary Supplement: Comparator: Calcium']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Alendronate sodium', 'interventionNames': ['Drug: Comparator: Alendronate sodium (Fosamax)', 'Dietary Supplement: Comparator: Calcium']}], 'interventions': [{'name': 'alendronate sodium (+) cholecalciferol', 'type': 'DRUG', 'otherNames': ['Fosamax Plus D'], 'description': 'Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks', 'armGroupLabels': ['1']}, {'name': 'Comparator: Alendronate sodium (Fosamax)', 'type': 'DRUG', 'description': 'Alendronate sodium; tablet, once weekly, for 16 weeks', 'armGroupLabels': ['2']}, {'name': 'Comparator: Calcium', 'type': 'DIETARY_SUPPLEMENT', 'description': '500 mg oral tablet calcium once daily, for 16 weeks', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}