Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT01430104
Status:
COMPLETED
Last Update Posted:
2013-01-14
First Post:
2011-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Teriparatide in Japanese Osteoporosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019379', 'term': 'Teriparatide'}], 'ancestors': [{'id': 'D010281', 'term': 'Parathyroid Hormone'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data were collected during the 28-day Teriparatide Treatment Period and the 7-day Follow-up Period.', 'eventGroups': [{'id': 'EG000', 'title': '600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide', 'description': 'Aspara-CA (600 milligrams \\[mg\\]) and Alfarol (1.0 microgram \\[µg\\]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.', 'otherNumAtRisk': 29, 'otherNumAffected': 5, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide', 'description': 'Aspara-CA (600 milligrams \\[mg\\]) and Alfarol (1.0 microgram \\[µg\\]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.'}], 'classes': [{'title': '16 hours postdose', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': '24 hours postdose', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28 (16 and 24 hours postdose)', 'description': 'Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \\[g/dL\\]). Postdose refers to after Teriparatide dose.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of Teriparatide and had either a 16-hour or 24-hour postdose serum calcium assessment on Day 28 were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) and 13.5 mg/dL, Respectively at Any Time Postbaseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide', 'description': 'Aspara-CA (600 milligrams \\[mg\\]) and Alfarol (1.0 microgram \\[µg\\]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.'}], 'classes': [{'title': 'Serum Calcium > 11.0 mg/dL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Serum Calcium > 13.5 mg/dL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Day 28 (Teriparatide Treatment Period)', 'description': 'Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \\[g/dL\\]). Serum calcium levels presented are for any time postdose on any day during the 28-day Teriparatide Treatment Period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum calcium assessment were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Serum Calcium Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide', 'description': 'Aspara-CA (600 milligrams \\[mg\\]) and Alfarol (1.0 microgram \\[µg\\]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.'}], 'classes': [{'title': 'Baseline: 0 h predose', 'categories': [{'measurements': [{'value': '9.00', 'groupId': 'OG000', 'lowerLimit': '8.92', 'upperLimit': '9.07'}]}]}, {'title': 'Baseline: 2 h postdose', 'categories': [{'measurements': [{'value': '9.11', 'groupId': 'OG000', 'lowerLimit': '9.03', 'upperLimit': '9.19'}]}]}, {'title': 'Baseline: 4 h postdose', 'categories': [{'measurements': [{'value': '8.98', 'groupId': 'OG000', 'lowerLimit': '8.91', 'upperLimit': '9.05'}]}]}, {'title': 'Baseline: 6 h postdose', 'categories': [{'measurements': [{'value': '8.92', 'groupId': 'OG000', 'lowerLimit': '8.86', 'upperLimit': '8.98'}]}]}, {'title': 'Baseline: 16 h postdose', 'categories': [{'measurements': [{'value': '8.97', 'groupId': 'OG000', 'lowerLimit': '8.90', 'upperLimit': '9.03'}]}]}, {'title': 'Baseline: 24 h postdose', 'categories': [{'measurements': [{'value': '8.74', 'groupId': 'OG000', 'lowerLimit': '8.67', 'upperLimit': '8.81'}]}]}, {'title': 'Day 1: 0 h predose', 'categories': [{'measurements': [{'value': '8.74', 'groupId': 'OG000', 'lowerLimit': '8.67', 'upperLimit': '8.81'}]}]}, {'title': 'Day 1: 2 h postdose', 'categories': [{'measurements': [{'value': '9.17', 'groupId': 'OG000', 'lowerLimit': '9.10', 'upperLimit': '9.24'}]}]}, {'title': 'Day 1: 4 h postdose', 'categories': [{'measurements': [{'value': '9.16', 'groupId': 'OG000', 'lowerLimit': '9.09', 'upperLimit': '9.24'}]}]}, {'title': 'Day 1: 6 h postdose', 'categories': [{'measurements': [{'value': '9.14', 'groupId': 'OG000', 'lowerLimit': '9.07', 'upperLimit': '9.21'}]}]}, {'title': 'Day 1: 16 h postdose', 'categories': [{'measurements': [{'value': '8.85', 'groupId': 'OG000', 'lowerLimit': '8.79', 'upperLimit': '8.91'}]}]}, {'title': 'Day 1: 24 h postdose', 'categories': [{'measurements': [{'value': '8.70', 'groupId': 'OG000', 'lowerLimit': '8.64', 'upperLimit': '8.77'}]}]}, {'title': 'Day 7: 0 h predose (n=28)', 'categories': [{'measurements': [{'value': '9.02', 'groupId': 'OG000', 'lowerLimit': '8.95', 'upperLimit': '9.09'}]}]}, {'title': 'Day 7: 2 h postdose (n=28)', 'categories': [{'measurements': [{'value': '9.41', 'groupId': 'OG000', 'lowerLimit': '9.33', 'upperLimit': '9.48'}]}]}, {'title': 'Day 7: 4 h postdose (n=28)', 'categories': [{'measurements': [{'value': '9.43', 'groupId': 'OG000', 'lowerLimit': '9.35', 'upperLimit': '9.51'}]}]}, {'title': 'Day 7: 6 h postdose (n=28)', 'categories': [{'measurements': [{'value': '9.36', 'groupId': 'OG000', 'lowerLimit': '9.29', 'upperLimit': '9.42'}]}]}, {'title': 'Day 7: 16 h postdose (n=28)', 'categories': [{'measurements': [{'value': '9.02', 'groupId': 'OG000', 'lowerLimit': '8.96', 'upperLimit': '9.09'}]}]}, {'title': 'Day 7: 24 h postdose (n=28)', 'categories': [{'measurements': [{'value': '8.82', 'groupId': 'OG000', 'lowerLimit': '8.75', 'upperLimit': '8.89'}]}]}, {'title': 'Day 14: 0 h predose (n=28)', 'categories': [{'measurements': [{'value': '8.99', 'groupId': 'OG000', 'lowerLimit': '8.91', 'upperLimit': '9.06'}]}]}, {'title': 'Day 14: 2 h postdose (n=28)', 'categories': [{'measurements': [{'value': '9.35', 'groupId': 'OG000', 'lowerLimit': '9.28', 'upperLimit': '9.43'}]}]}, {'title': 'Day 14: 4 h postdose (n=28)', 'categories': [{'measurements': [{'value': '9.39', 'groupId': 'OG000', 'lowerLimit': '9.31', 'upperLimit': '9.46'}]}]}, {'title': 'Day 14: 6 h postdose (n=28)', 'categories': [{'measurements': [{'value': '9.29', 'groupId': 'OG000', 'lowerLimit': '9.22', 'upperLimit': '9.36'}]}]}, {'title': 'Day 14: 16 h postdose (n=28)', 'categories': [{'measurements': [{'value': '9.03', 'groupId': 'OG000', 'lowerLimit': '8.96', 'upperLimit': '9.09'}]}]}, {'title': 'Day 14: 24 h postdose (n=28)', 'categories': [{'measurements': [{'value': '8.89', 'groupId': 'OG000', 'lowerLimit': '8.82', 'upperLimit': '8.96'}]}]}, {'title': 'Day 28: 0 h predose (n=28)', 'categories': [{'measurements': [{'value': '8.98', 'groupId': 'OG000', 'lowerLimit': '8.91', 'upperLimit': '9.05'}]}]}, {'title': 'Day 28: 2 h postdose (n=28)', 'categories': [{'measurements': [{'value': '9.41', 'groupId': 'OG000', 'lowerLimit': '9.33', 'upperLimit': '9.48'}]}]}, {'title': 'Day 28: 4 h postdose (n=28)', 'categories': [{'measurements': [{'value': '9.42', 'groupId': 'OG000', 'lowerLimit': '9.34', 'upperLimit': '9.50'}]}]}, {'title': 'Day 28: 6 h postdose (n=28)', 'categories': [{'measurements': [{'value': '9.33', 'groupId': 'OG000', 'lowerLimit': '9.26', 'upperLimit': '9.39'}]}]}, {'title': 'Day 28: 16 h postdose (n=28)', 'categories': [{'measurements': [{'value': '9.04', 'groupId': 'OG000', 'lowerLimit': '8.98', 'upperLimit': '9.11'}]}]}, {'title': 'Day 28: 24 h postdose (n=28)', 'categories': [{'measurements': [{'value': '8.85', 'groupId': 'OG000', 'lowerLimit': '8.78', 'upperLimit': '8.92'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day -1 of 14-day Lead-in Period) and Day 1 and Day 7 and Day 14 and Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period)', 'description': 'Daily profiles of corrected mean serum calcium levels were determined for each participant. Corrected calcium (milligram per deciliter \\[mg/dL\\]) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \\[g/dL\\]). The Least Squares (LS) means were adjusted for Day, Timepoint, Day\\*Timepoint, and random error. At baseline, participants received only Aspara-CA and Alfarol supplements and the timepoints were based on the times before Aspara-CA and Alfarol administration (predose) and after Aspara-CA and Alfarol administration (postdose). During the 28-day Teriparatide Treatment Period, timepoints were based on before Teriparatide administration (predose) and after Teriparatide administration (postdose).', 'unitOfMeasure': 'mg/dL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of Teriparatide, completed all protocol requirements, and had at least 1 postdose serum calcium assessment were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide', 'description': 'Aspara-CA (600 milligrams \\[mg\\]) and Alfarol (1.0 microgram \\[µg\\]) were administered orally once daily after the Teriparatide planned dose during 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.'}], 'classes': [{'title': 'Change from Baseline Day 1: 0 h predose', 'categories': [{'measurements': [{'value': '-0.255', 'groupId': 'OG000', 'lowerLimit': '-0.317', 'upperLimit': '-0.194'}]}]}, {'title': 'Change from Baseline at Day 1: 2 h postdose', 'categories': [{'measurements': [{'value': '0.059', 'groupId': 'OG000', 'lowerLimit': '-0.006', 'upperLimit': '0.123'}]}]}, {'title': 'Change from Baseline at Day 1: 4 h postdose', 'categories': [{'measurements': [{'value': '0.183', 'groupId': 'OG000', 'lowerLimit': '0.113', 'upperLimit': '0.252'}]}]}, {'title': 'Change from Baseline at Day 1: 6 h postdose', 'categories': [{'measurements': [{'value': '0.221', 'groupId': 'OG000', 'lowerLimit': '0.163', 'upperLimit': '0.278'}]}]}, {'title': 'Change from Baseline at Day 1: 16 h postdose', 'categories': [{'measurements': [{'value': '-0.117', 'groupId': 'OG000', 'lowerLimit': '-0.172', 'upperLimit': '-0.062'}]}]}, {'title': 'Change from Baseline at Day 1: 24 h postdose', 'categories': [{'measurements': [{'value': '-0.038', 'groupId': 'OG000', 'lowerLimit': '-0.092', 'upperLimit': '0.016'}]}]}, {'title': 'Change from Baseline at Day 7: 0 h predose, n=28', 'categories': [{'measurements': [{'value': '0.018', 'groupId': 'OG000', 'lowerLimit': '-0.045', 'upperLimit': '0.080'}]}]}, {'title': 'Change from Baseline at Day 7: 2 h postdose, n=28', 'categories': [{'measurements': [{'value': '0.286', 'groupId': 'OG000', 'lowerLimit': '0.220', 'upperLimit': '0.351'}]}]}, {'title': 'Change from Baseline at Day 7: 4 h postdose, n=28', 'categories': [{'measurements': [{'value': '0.450', 'groupId': 'OG000', 'lowerLimit': '0.379', 'upperLimit': '0.521'}]}]}, {'title': 'Change from Baseline at Day 7: 6 h postdose, n=28', 'categories': [{'measurements': [{'value': '0.436', 'groupId': 'OG000', 'lowerLimit': '0.377', 'upperLimit': '0.494'}]}]}, {'title': 'Change from Baseline at Day 7: 16 h postdose, n=28', 'categories': [{'measurements': [{'value': '0.061', 'groupId': 'OG000', 'lowerLimit': '0.005', 'upperLimit': '0.117'}]}]}, {'title': 'Change from Baseline at Day 7: 24 h postdose, n=28', 'categories': [{'measurements': [{'value': '0.068', 'groupId': 'OG000', 'lowerLimit': '0.013', 'upperLimit': '0.123'}]}]}, {'title': 'Change from Baseline at Day 14: 0 h predose, n=28', 'categories': [{'measurements': [{'value': '-0.018', 'groupId': 'OG000', 'lowerLimit': '-0.080', 'upperLimit': '0.045'}]}]}, {'title': 'Change from Baseline at Day 14: 2 h postdose, n=28', 'categories': [{'measurements': [{'value': '0.232', 'groupId': 'OG000', 'lowerLimit': '0.166', 'upperLimit': '0.298'}]}]}, {'title': 'Change from Baseline at Day 14: 4 h postdose, n=28', 'categories': [{'measurements': [{'value': '0.404', 'groupId': 'OG000', 'lowerLimit': '0.333', 'upperLimit': '0.474'}]}]}, {'title': 'Change from Baseline at Day 14: 6 h postdose, n=28', 'categories': [{'measurements': [{'value': '0.368', 'groupId': 'OG000', 'lowerLimit': '0.309', 'upperLimit': '0.426'}]}]}, {'title': 'Change from Baseline at Day 14: 16 h postdose,n=28', 'categories': [{'measurements': [{'value': '0.068', 'groupId': 'OG000', 'lowerLimit': '0.012', 'upperLimit': '0.124'}]}]}, {'title': 'Change from Baseline at Day 14: 24 h postdose,n=28', 'categories': [{'measurements': [{'value': '0.143', 'groupId': 'OG000', 'lowerLimit': '0.088', 'upperLimit': '0.198'}]}]}, {'title': 'Change from Baseline at Day 28: 0 h predose, n=28', 'categories': [{'measurements': [{'value': '-0.021', 'groupId': 'OG000', 'lowerLimit': '-0.084', 'upperLimit': '0.041'}]}]}, {'title': 'Change from Baseline at Day 28: 2 h postdose, n=28', 'categories': [{'measurements': [{'value': '0.286', 'groupId': 'OG000', 'lowerLimit': '0.220', 'upperLimit': '0.351'}]}]}, {'title': 'Change from Baseline at Day 28: 4 h postdose, n=28', 'categories': [{'measurements': [{'value': '0.436', 'groupId': 'OG000', 'lowerLimit': '0.365', 'upperLimit': '0.506'}]}]}, {'title': 'Change from Baseline at Day 28: 6 h postdose, n=28', 'categories': [{'measurements': [{'value': '0.404', 'groupId': 'OG000', 'lowerLimit': '0.345', 'upperLimit': '0.462'}]}]}, {'title': 'Change from Baseline at Day 28: 16 h postdose,n=28', 'categories': [{'measurements': [{'value': '0.082', 'groupId': 'OG000', 'lowerLimit': '0.026', 'upperLimit': '0.138'}]}]}, {'title': 'Change from Baseline at Day 28: 24 h postdose,n=28', 'categories': [{'measurements': [{'value': '0.104', 'groupId': 'OG000', 'lowerLimit': '0.049', 'upperLimit': '0.159'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day -1 of the 14-day Lead-in Period), Day 1, Day 7, Day 14, Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period)', 'description': 'Corrected calcium (milligram per deciliter \\[mg/dL\\]) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \\[g/dL\\]). The Least Squares (LS) means were controlled for Day, Timepoint, Day\\*Timepoint, and random error. Postdose refers to after Teriparatide dose.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who complied received at least 1 dose of Teriparatide, completed all protocol requirements, and had at least 1 postdose serum calcium assessment were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide', 'description': 'Aspara-CA (600 milligrams \\[mg\\]) and Alfarol (1.0 microgram \\[µg\\]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Day 28 (28-day Teriparatide Treatment Period)', 'description': 'Urine calcium levels presented are for any day during the 28-day Teriparatide Treatment Period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose urine calcium assessment were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Daily Urine Calcium Excreted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide', 'description': 'Aspara-CA (600 milligrams \\[mg\\]) and Alfarol (1.0 microgram \\[µg\\]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.05', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 (N=27)', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.05', 'groupId': 'OG000'}]}]}, {'title': 'Day 14 (N=27)', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.05', 'groupId': 'OG000'}]}]}, {'title': 'Day 28 (N=27)', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.05', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period)', 'unitOfMeasure': 'grams per day (g/day)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose urine calcium assessment were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Daily Urine Calcium Excreted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide', 'description': 'Aspara-CA (600 milligrams \\[mg\\]) and Alfarol (1.0 microgram \\[µg\\]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.'}], 'classes': [{'title': 'Change from Baseline at Day 1', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.02', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Day 7 (N=27)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Day 14 (N=27)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.04', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Day 28 (N=27)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.04', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period)', 'unitOfMeasure': 'grams per day (g/day)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of Teriparatide, had a baseline urine calcium assessment, and at least 1 postdose urine calcium assessment were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Serum 25-Hydroxy-Vitamin D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide', 'description': 'Aspara-CA (600 milligrams \\[mg\\]) and Alfarol (1.0 microgram \\[µg\\]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and after the planned Teriparatide dose during the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '23.0', 'spread': '5.4', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N=28)', 'categories': [{'measurements': [{'value': '22.1', 'spread': '6.2', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N=28)', 'categories': [{'measurements': [{'value': '21.5', 'spread': '6.6', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N=28)', 'categories': [{'measurements': [{'value': '20.1', 'spread': '8.0', 'groupId': 'OG000'}]}]}, {'title': 'Day 35 (N=28)', 'categories': [{'measurements': [{'value': '21.6', 'spread': '7.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period)', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum 25-Hydroxy-Vitamin D assessment were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide', 'description': 'Aspara-CA (600 milligrams \\[mg\\]) and Alfarol (1.0 microgram \\[µg\\]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and after the planned Teriparatide dose during the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '54.0', 'spread': '16.9', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N=28)', 'categories': [{'measurements': [{'value': '105.3', 'spread': '35.2', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N=28)', 'categories': [{'measurements': [{'value': '108.5', 'spread': '40.2', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N=28)', 'categories': [{'measurements': [{'value': '98.1', 'spread': '32.0', 'groupId': 'OG000'}]}]}, {'title': 'Day 35 (N=28)', 'categories': [{'measurements': [{'value': '53.9', 'spread': '22.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period)', 'unitOfMeasure': 'picogram per milliliter (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum 1,25-Hydroxy-Vitamin D3 assessment were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide', 'description': 'Aspara-CA (600 milligrams \\[mg\\]) and Alfarol (1.0 microgram \\[µg\\]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.'}], 'periods': [{'title': '14-Day Lead-In Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '28-Day Teriparatide Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '1 participant withdrew from the study after completing the 14-day Lead-in Period.', 'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'Received at Least 1 Dose of Teriparatide', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide', 'description': 'Aspara-CA (600 milligrams \\[mg\\]) and Alfarol (1.0 microgram \\[µg\\]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '4.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of Participants with Urine Calcium Excreted Over 0.3 Grams per Day (g/day)', 'classes': [{'title': 'Urine calcium excreted >0.3 g/day', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Urine calcium excreted ≤0.3 g/day', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Baseline calcium measures were assessed over a 24-hour period on the last day of the 14-day Lead-in Period (Day -1), after participants had been receiving Aspara-CA and Alfarol supplements, to determine the total urine calcium excreted per day.', 'unitOfMeasure': 'participants'}, {'title': 'Mean Urine Calcium Excreted', 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '0.05', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline calcium measures were assessed on the last day of the 14-day Lead-in Period (Day -1), after participants had been receiving Aspara-CA and Alfarol supplements. One participant was excluded from the analysis because the participant accidentally dropped the urine collection sample during baseline (N=28).', 'unitOfMeasure': 'grams per day (g/day)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-07', 'studyFirstSubmitDate': '2011-09-06', 'resultsFirstSubmitDate': '2012-11-27', 'studyFirstSubmitQcDate': '2011-09-06', 'lastUpdatePostDateStruct': {'date': '2013-01-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-27', 'studyFirstPostDateStruct': {'date': '2011-09-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL)', 'timeFrame': 'Day 28 (16 and 24 hours postdose)', 'description': 'Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \\[g/dL\\]). Postdose refers to after Teriparatide dose.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) and 13.5 mg/dL, Respectively at Any Time Postbaseline', 'timeFrame': 'Day 1 up to Day 28 (Teriparatide Treatment Period)', 'description': 'Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \\[g/dL\\]). Serum calcium levels presented are for any time postdose on any day during the 28-day Teriparatide Treatment Period.'}, {'measure': 'Mean Serum Calcium Levels', 'timeFrame': 'Baseline (Day -1 of 14-day Lead-in Period) and Day 1 and Day 7 and Day 14 and Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period)', 'description': 'Daily profiles of corrected mean serum calcium levels were determined for each participant. Corrected calcium (milligram per deciliter \\[mg/dL\\]) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \\[g/dL\\]). The Least Squares (LS) means were adjusted for Day, Timepoint, Day\\*Timepoint, and random error. At baseline, participants received only Aspara-CA and Alfarol supplements and the timepoints were based on the times before Aspara-CA and Alfarol administration (predose) and after Aspara-CA and Alfarol administration (postdose). During the 28-day Teriparatide Treatment Period, timepoints were based on before Teriparatide administration (predose) and after Teriparatide administration (postdose).'}, {'measure': 'Change From Baseline in Serum Calcium', 'timeFrame': 'Baseline (Day -1 of the 14-day Lead-in Period), Day 1, Day 7, Day 14, Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period)', 'description': 'Corrected calcium (milligram per deciliter \\[mg/dL\\]) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \\[g/dL\\]). The Least Squares (LS) means were controlled for Day, Timepoint, Day\\*Timepoint, and random error. Postdose refers to after Teriparatide dose.'}, {'measure': 'Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline', 'timeFrame': 'Day 1 up to Day 28 (28-day Teriparatide Treatment Period)', 'description': 'Urine calcium levels presented are for any day during the 28-day Teriparatide Treatment Period.'}, {'measure': 'Mean Daily Urine Calcium Excreted', 'timeFrame': 'Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period)'}, {'measure': 'Change From Baseline in Daily Urine Calcium Excreted', 'timeFrame': 'Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period)'}, {'measure': 'Concentrations of Serum 25-Hydroxy-Vitamin D', 'timeFrame': 'Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period)'}, {'measure': 'Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3', 'timeFrame': 'Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to assess the effects on serum calcium when teriparatide is used with active vitamin D in osteoporosis patients.\n\nThis study consists of a Screening Period, a 14-day Lead-in Period, a 28-day Treatment Period, and a 7-day Follow-up Period. Patients will take vitamin D and calcium supplementation from the Lead-in Period throughout the study. During the Treatment Period, daily administration of teriparatide will be added.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ambulatory Japanese males or postmenopausal females with osteoporosis, as determined by the Japanese Society for Bone and Mineral Research (JSBMR) diagnostic criteria\n\nExclusion Criteria:\n\n* Prior treatment with parathyroid hormone (PTH) or any PTH analog\n* History of metabolic bone disorders other than primary osteoporosis\n* Fractures caused by diseases other than osteoporosis\n* Abnormal thyroid function\n* Hyperparathyroidism or hypoparathyroidism\n* Severe or chronically disabling conditions other than osteoporosis\n* Currently has or has a history of spruce, inflammatory bowel disease, or malabsorption syndrome\n* Currently has, or a has a history of, nephrolithiasis or urolithiasis in the 2 years prior to screening\n* Clinically significant abnormal laboratory values or electrocardiogram\n* Treatment with oral bisphosphonates at any time in the 3 months prior to enrollment, treatment with any bisphosphonate for more than 60 days in the 6 months prior to enrollment, or with intravenous bisphosphonates at any time in the 24 months prior to enrollment; or in case of oral bisphosphonates administered once a week, the equivalent as the above\n* Treatment with injectable calcitonin in the 3 months prior to enrollment\n* Treatment with raloxifene hydrochloride for more than 3 months in the 6 months prior to enrollment\n* Treatment with systemic corticosteroids, except for orally inhaled or nasally inhaled corticosteroids, in doses \\<= 800 micrograms per day (µg/day) beclomethasone dipropionate or equivalent in the 3 months prior to screening, or for more than 30 days in the 12 months prior to enrollment\n* Treatment with anticonvulsants, except for benzodiazepines, in the 6 months prior to enrollment\n* Prior treatment with strontiumranate or denosumab (anti-RANKL antibody)\n* Prior external beam radiation therapy involving the skeleton\n* Current or a history of malignant neoplasm in the 5 years prior to screening, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that had been definitively treated'}, 'identificationModule': {'nctId': 'NCT01430104', 'briefTitle': 'A Study of Teriparatide in Japanese Osteoporosis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Study to Assess the Effects on Serum Calcium When Teriparatide is Used With Active Vitamin D in Osteoporosis Patients', 'orgStudyIdInfo': {'id': '14454'}, 'secondaryIdInfos': [{'id': 'B3D-JE-GHDT', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Teriparatide + Aspara-CA + Alfarol', 'description': 'Aspara-CA 600 milligrams (mg) and Alfarol 1.0 microgram (µg) administered orally once daily throughout the study. Teriparatide 20 µg administered subcutaneously once daily for 28 days during the Treatment Period.', 'interventionNames': ['Drug: Teriparatide', 'Drug: Aspara-CA 600 mg', 'Drug: Alfarol 1.0 µg']}], 'interventions': [{'name': 'Teriparatide', 'type': 'DRUG', 'otherNames': ['LY333334', 'Forteo', 'Forsteo'], 'description': 'Administered subcutaneously during the Treatment Period', 'armGroupLabels': ['Teriparatide + Aspara-CA + Alfarol']}, {'name': 'Aspara-CA 600 mg', 'type': 'DRUG', 'description': 'Administered orally throughout the study', 'armGroupLabels': ['Teriparatide + Aspara-CA + Alfarol']}, {'name': 'Alfarol 1.0 µg', 'type': 'DRUG', 'description': 'Administered orally throughout the study', 'armGroupLabels': ['Teriparatide + Aspara-CA + Alfarol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}