Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 7:08 AM
Study NCT ID:
NCT01216293
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2010-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Dexlansoprazole on Bone Homeostasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064748', 'term': 'Dexlansoprazole'}, {'id': 'D064747', 'term': 'Lansoprazole'}, {'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D009853', 'term': 'Omeprazole'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': "Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 6, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 8, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Esomeprazole 40mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 9, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Calcium Absorption Sub Study: Placebo', 'description': 'Following the main study participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 3, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Calcium Absorption Sub Study: Dexlansoprazole 60 mg', 'description': 'Following the main study Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Calcium Absorption Sub Study: Esomeprazole 40 mg', 'description': 'Following the main study participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 5, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}], 'seriousEvents': [{'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline to Week 26 in Bone Formation Marker Aminoterminal Propeptide of Type 1 Collagen (P1NP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-35', 'upperLimit': '75'}, {'value': '19.3', 'groupId': 'OG001', 'lowerLimit': '-33', 'upperLimit': '82'}, {'value': '16.9', 'groupId': 'OG002', 'lowerLimit': '-8', 'upperLimit': '73'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.2', 'ciLowerLimit': '7.0', 'ciUpperLimit': '30.2', 'estimateComment': 'Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.2', 'ciLowerLimit': '6.7', 'ciUpperLimit': '30.4', 'estimateComment': 'Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 26', 'description': 'The percent change in bone formation marker P1NP measured at week 26 from P1NP measured at baseline. Serum samples for P1NP were analyzed at a central laboratory for bone biomarker P1NP using an electrochemiluminescence immunoassay measured in nanograms per milliliter (ng/mL).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Pharmacodynamic Set, all randomized participants who received study drug with evaluable calcium absorption data at Day 1 and Week 26, with data available for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline to Week 26 in Bone Resorption Marker C-telopeptide of Collagen Cross-links (CTX)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.441', 'groupId': 'OG000', 'lowerLimit': '-65.59', 'upperLimit': '54.55'}, {'value': '29.524', 'groupId': 'OG001', 'lowerLimit': '-28.81', 'upperLimit': '171.74'}, {'value': '23.897', 'groupId': 'OG002', 'lowerLimit': '-21.90', 'upperLimit': '110.53'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.366', 'ciLowerLimit': '12.749', 'ciUpperLimit': '42.957', 'estimateComment': 'Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.025', 'ciLowerLimit': '8.357', 'ciUpperLimit': '35.714', 'estimateComment': 'Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 26', 'description': 'The percent change in bone resorption marker CTX measured at week 26 from CTX measured at baseline. Plasma samples were analyzed at a central laboratory for bone biomarker CTX using an electrochemiluminescence immunoassay measured in ng/mL.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Pharmacodynamic Set, all randomized participants who received study drug with evaluable calcium absorption data at Day 1 and Week 26, with data available for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 26 in Urine N-telopeptide of Collagen Cross-links (NTx) Calculated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.1', 'groupId': 'OG000', 'lowerLimit': '-53', 'upperLimit': '86'}, {'value': '16.9', 'groupId': 'OG001', 'lowerLimit': '-45', 'upperLimit': '100'}, {'value': '6.2', 'groupId': 'OG002', 'lowerLimit': '-45', 'upperLimit': '67'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.1', 'ciLowerLimit': '4.0', 'ciUpperLimit': '34.4', 'estimateComment': 'Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.6', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '28.3', 'estimateComment': 'Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 26', 'description': 'The percent change in bone resorption marker NTx measured at week 26 from NTx measured at baseline. Urine samples were analyzed at a central laboratory for NTx using an enzyme-linked immunosorbent assay calculated as (nmol BCE/mmol creatinine). BCE=bone collagen equivalent', 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Pharmacodynamic Set, all randomized participants who received study drug with evaluable calcium absorption data at Day 1 and Week 26, with data available for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 26 in Bone-specific Alkaline Phosphatase (BsAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '-22.7', 'upperLimit': '27.2'}, {'value': '8.68', 'groupId': 'OG001', 'lowerLimit': '-14.6', 'upperLimit': '36.2'}, {'value': '6.23', 'groupId': 'OG002', 'lowerLimit': '-13.5', 'upperLimit': '48.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.83', 'ciLowerLimit': '0.40', 'ciUpperLimit': '12.78', 'estimateComment': 'Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.23', 'ciLowerLimit': '0.59', 'ciUpperLimit': '12.86', 'estimateComment': 'Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 26', 'description': 'The percent change in bone formation marker BsAP measured at week 26 from BsAP measured at baseline. Serum samples were analyzed at a central laboratory for bone biomarker BsAP using an enzyme immunoassay measured in units per liter (U/L).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Pharmacodynamic Set, all randomized participants who received study drug with evaluable calcium absorption data at Day 1 and Week 26, with data available for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in P1NP at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '18.27', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '25.02', 'groupId': 'OG001'}, {'value': '11.6', 'spread': '18.23', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 13', 'description': 'Serum samples for P1NP were analyzed using an electrochemiluminescence immunoassay measured in ng/mL.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in CTX at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.510', 'spread': '29.9739', 'groupId': 'OG000'}, {'value': '32.069', 'spread': '45.6413', 'groupId': 'OG001'}, {'value': '23.212', 'spread': '23.8900', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 13', 'description': 'Plasma samples were analyzed for bone biomarker CTX using an electrochemiluminescence immunoassay measured in ng/mL.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6632', 'spread': '2.48314', 'groupId': 'OG000'}, {'value': '-1.6039', 'spread': '2.58207', 'groupId': 'OG001'}, {'value': '-1.0596', 'spread': '2.41731', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 26', 'description': 'DXA is a means of measuring BMD through x-ray.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Total Hip BMD Measured by DXA at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1928', 'spread': '1.42242', 'groupId': 'OG000'}, {'value': '-0.7190', 'spread': '1.78479', 'groupId': 'OG001'}, {'value': '-0.5330', 'spread': '1.50491', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 26', 'description': 'DXA is a means of measuring BMD through x-ray.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Lumbar Spine BMD Measured by DXA at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2486', 'spread': '3.29581', 'groupId': 'OG000'}, {'value': '-1.0753', 'spread': '3.46909', 'groupId': 'OG001'}, {'value': '-1.2873', 'spread': '2.06722', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 26', 'description': 'DXA is a means of measuring BMD through x-ray.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Week 26 in Femoral Neck BMD Measured by DXA at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0063', 'spread': '2.57407', 'groupId': 'OG000'}, {'value': '-0.3439', 'spread': '2.39680', 'groupId': 'OG001'}, {'value': '0.2689', 'spread': '2.67283', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 26 and Week 52', 'description': 'DXA is a means of measuring BMD through x-ray.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Weeks 26 in Total Hip BMD Measured by DXA at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0201', 'spread': '1.28096', 'groupId': 'OG000'}, {'value': '-0.3324', 'spread': '1.58091', 'groupId': 'OG001'}, {'value': '-0.0799', 'spread': '1.81755', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 26 and Week 52', 'description': 'DXA is a means of measuring BMD through x-ray.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Weeks 26 in Lumbar Spine BMD Measured by DXA at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4913', 'spread': '3.01161', 'groupId': 'OG000'}, {'value': '-0.3561', 'spread': '2.42934', 'groupId': 'OG001'}, {'value': '0.8565', 'spread': '2.46230', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 26 and Week 52', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Fracture Including Vertebral Fracture During Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 26', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in 24-hour Urinary Calcium Excretion at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '160.3', 'spread': '76.16', 'groupId': 'OG000'}, {'value': '184.8', 'spread': '79.52', 'groupId': 'OG001'}, {'value': '153.7', 'spread': '90.09', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 26', 'categories': [{'measurements': [{'value': '-24.4', 'spread': '87.16', 'groupId': 'OG000'}, {'value': '-50.6', 'spread': '84.95', 'groupId': 'OG001'}, {'value': '-49.7', 'spread': '94.38', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 26', 'unitOfMeasure': 'milligram per day (mg/d)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Parathyroid Hormone (PTH) at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.67', 'spread': '10.068', 'groupId': 'OG000'}, {'value': '30.68', 'spread': '11.917', 'groupId': 'OG001'}, {'value': '31.10', 'spread': '8.254', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.16', 'spread': '7.793', 'groupId': 'OG000'}, {'value': '2.08', 'spread': '7.765', 'groupId': 'OG001'}, {'value': '3.37', 'spread': '9.525', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 26', 'unitOfMeasure': 'picogram per milliliter (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Serum Calcium at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.48', 'spread': '0.347', 'groupId': 'OG000'}, {'value': '9.47', 'spread': '0.291', 'groupId': 'OG001'}, {'value': '9.58', 'spread': '0.308', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.440', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.333', 'groupId': 'OG001'}, {'value': '-0.07', 'spread': '0.331', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 26', 'unitOfMeasure': 'milligram per deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Serum Phosphorus at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.73', 'spread': '0.377', 'groupId': 'OG000'}, {'value': '3.92', 'spread': '0.422', 'groupId': 'OG001'}, {'value': '3.89', 'spread': '0.335', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.445', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.271', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.393', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 26', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Serum Magnesium at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.72', 'spread': '0.124', 'groupId': 'OG000'}, {'value': '1.72', 'spread': '0.145', 'groupId': 'OG001'}, {'value': '1.77', 'spread': '0.127', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.118', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.109', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.096', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 26', 'unitOfMeasure': 'milliequivalent per liter (meq/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Urine Magnesium at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '3.46', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '2.85', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '2.83', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '2.80', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 26', 'unitOfMeasure': 'meq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline to Week 26 in Vitamin D3 (25-OH-D) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41.3', 'spread': '9.96', 'groupId': 'OG000'}, {'value': '39.4', 'spread': '11.64', 'groupId': 'OG001'}, {'value': '36.4', 'spread': '8.48', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '10.20', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '12.07', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '9.75', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 26', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Intestinal Calcium Absorption by True Fractional Calcium Absorption (TFCA) in a Subset of Participants at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'OG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.064', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.043', 'groupId': 'OG001'}, {'value': '0.17', 'spread': '0.049', 'groupId': 'OG002'}]}]}, {'title': 'Change at week 26', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.049', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.042', 'groupId': 'OG001'}, {'value': '0.05', 'spread': '0.050', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 26', 'unitOfMeasure': 'mg/d', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The PD set included participants with evaluable calcium absorption data on Day-1 and Week 26.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'FG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'FG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}], 'periods': [{'title': 'Main Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '35'}]}, {'type': 'Safety Set: Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '35'}]}, {'type': 'Randomized, Not Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Major Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Voluntary Withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Other Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Randomized, Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Calcium Absorption Substudy', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Safety Set: Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Major Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Voluntary Withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 10 investigative sites in the United States from 01 November 2010 (first subject signed informed consent form) to 1 February 2015.', 'preAssignmentDetails': 'Healthy post-menopausal women were enrolled equally in 1 of 3 treatment groups, once a day, placebo, 60 mg dexlansoprazole delayed-release capsules or 40 mg esomeprazole delayed-release capsules.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'BG001', 'title': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'BG002', 'title': 'Esomeprazole 40 mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '112', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '61.2', 'groupId': 'BG000', 'lowerLimit': '51', 'upperLimit': '73'}, {'value': '62.4', 'groupId': 'BG001', 'lowerLimit': '52', 'upperLimit': '75'}, {'value': '63.2', 'groupId': 'BG002', 'lowerLimit': '54', 'upperLimit': '74'}, {'value': '62.2', 'groupId': 'BG003', 'lowerLimit': '51', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Number analyzed are the participants with data available for Age'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '164.4', 'groupId': 'BG000', 'lowerLimit': '153', 'upperLimit': '175'}, {'value': '164.9', 'groupId': 'BG001', 'lowerLimit': '154', 'upperLimit': '178'}, {'value': '164.6', 'groupId': 'BG002', 'lowerLimit': '152', 'upperLimit': '180'}, {'value': '164.6', 'groupId': 'BG003', 'lowerLimit': '152', 'upperLimit': '180'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'FULL_RANGE'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '69.25', 'groupId': 'BG000', 'lowerLimit': '54.4', 'upperLimit': '87.7'}, {'value': '66.54', 'groupId': 'BG001', 'lowerLimit': '51.4', 'upperLimit': '92.0'}, {'value': '69.47', 'groupId': 'BG002', 'lowerLimit': '55.4', 'upperLimit': '97.5'}, {'value': '68.1', 'groupId': 'BG003', 'lowerLimit': '51.4', 'upperLimit': '97.5'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'FULL_RANGE'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '25.61', 'groupId': 'BG000', 'lowerLimit': '21.3', 'upperLimit': '30.9'}, {'value': '24.46', 'groupId': 'BG001', 'lowerLimit': '18.2', 'upperLimit': '31.3'}, {'value': '25.65', 'groupId': 'BG002', 'lowerLimit': '19.6', 'upperLimit': '30.7'}, {'value': '25.24', 'groupId': 'BG003', 'lowerLimit': '18.2', 'upperLimit': '31.3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Smoking Classification', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Never smoked', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}, {'title': 'Current smoker', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Ex-smoker', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol Classification', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Never drank', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Current drinker', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}, {'title': 'Ex-drinker', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Caffeine Consumption', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Had caffeine consumption', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}, {'title': 'Not had caffeine consumption', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Calcium at Screening Visit', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '9.93', 'groupId': 'BG000', 'lowerLimit': '9.0', 'upperLimit': '10.7'}, {'value': '9.87', 'groupId': 'BG001', 'lowerLimit': '9.0', 'upperLimit': '10.7'}, {'value': '9.97', 'groupId': 'BG002', 'lowerLimit': '9.4', 'upperLimit': '10.9'}, {'value': '9.92', 'groupId': 'BG003', 'lowerLimit': '9.0', 'upperLimit': '10.9'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'FULL_RANGE'}, {'title': 'Vitamin D at Screening Visit', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'BG000', 'lowerLimit': '13', 'upperLimit': '74'}, {'value': '33.2', 'groupId': 'BG001', 'lowerLimit': '17', 'upperLimit': '63'}, {'value': '33.4', 'groupId': 'BG002', 'lowerLimit': '11', 'upperLimit': '75'}, {'value': '34.1', 'groupId': 'BG003', 'lowerLimit': '11', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Safety set includes all randomized participants who received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2015-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-04', 'studyFirstSubmitDate': '2010-10-05', 'resultsFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2010-10-05', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-04', 'studyFirstPostDateStruct': {'date': '2010-10-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percent Change From Baseline in P1NP at Week 13', 'timeFrame': 'Baseline and Week 13', 'description': 'Serum samples for P1NP were analyzed using an electrochemiluminescence immunoassay measured in ng/mL.'}, {'measure': 'Percent Change From Baseline in CTX at Week 13', 'timeFrame': 'Baseline and Week 13', 'description': 'Plasma samples were analyzed for bone biomarker CTX using an electrochemiluminescence immunoassay measured in ng/mL.'}, {'measure': 'Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 26', 'timeFrame': 'Baseline and Week 26', 'description': 'DXA is a means of measuring BMD through x-ray.'}, {'measure': 'Percent Change From Baseline in Total Hip BMD Measured by DXA at Week 26', 'timeFrame': 'Baseline and Week 26', 'description': 'DXA is a means of measuring BMD through x-ray.'}, {'measure': 'Percent Change From Baseline in Lumbar Spine BMD Measured by DXA at Week 26', 'timeFrame': 'Baseline and Week 26', 'description': 'DXA is a means of measuring BMD through x-ray.'}, {'measure': 'Percent Change From Week 26 in Femoral Neck BMD Measured by DXA at Week 52', 'timeFrame': 'Week 26 and Week 52', 'description': 'DXA is a means of measuring BMD through x-ray.'}, {'measure': 'Percent Change From Weeks 26 in Total Hip BMD Measured by DXA at Week 52', 'timeFrame': 'Week 26 and Week 52', 'description': 'DXA is a means of measuring BMD through x-ray.'}, {'measure': 'Percent Change From Weeks 26 in Lumbar Spine BMD Measured by DXA at Week 52', 'timeFrame': 'Week 26 and Week 52'}, {'measure': 'Number of Participants With Fracture Including Vertebral Fracture During Study Treatment', 'timeFrame': 'Baseline up to Week 26'}, {'measure': 'Change From Baseline in 24-hour Urinary Calcium Excretion at Week 26', 'timeFrame': 'Baseline and Week 26'}, {'measure': 'Change From Baseline in Parathyroid Hormone (PTH) at Week 26', 'timeFrame': 'Baseline and Week 26'}, {'measure': 'Change From Baseline in Serum Calcium at Week 26', 'timeFrame': 'Baseline and Week 26'}, {'measure': 'Change From Baseline in Serum Phosphorus at Week 26', 'timeFrame': 'Baseline and Week 26'}, {'measure': 'Change From Baseline in Serum Magnesium at Week 26', 'timeFrame': 'Baseline and Week 26'}, {'measure': 'Change From Baseline in Urine Magnesium at Week 26', 'timeFrame': 'Baseline and Week 26'}, {'measure': 'Change From Baseline to Week 26 in Vitamin D3 (25-OH-D) Level', 'timeFrame': 'Baseline and Week 26'}, {'measure': 'Change From Baseline in Intestinal Calcium Absorption by True Fractional Calcium Absorption (TFCA) in a Subset of Participants at Week 26', 'timeFrame': 'Baseline and Week 26'}], 'primaryOutcomes': [{'measure': 'Percent Change From Baseline to Week 26 in Bone Formation Marker Aminoterminal Propeptide of Type 1 Collagen (P1NP)', 'timeFrame': 'Baseline and Week 26', 'description': 'The percent change in bone formation marker P1NP measured at week 26 from P1NP measured at baseline. Serum samples for P1NP were analyzed at a central laboratory for bone biomarker P1NP using an electrochemiluminescence immunoassay measured in nanograms per milliliter (ng/mL).'}, {'measure': 'Percent Change From Baseline to Week 26 in Bone Resorption Marker C-telopeptide of Collagen Cross-links (CTX)', 'timeFrame': 'Baseline and Week 26', 'description': 'The percent change in bone resorption marker CTX measured at week 26 from CTX measured at baseline. Plasma samples were analyzed at a central laboratory for bone biomarker CTX using an electrochemiluminescence immunoassay measured in ng/mL.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline to Week 26 in Urine N-telopeptide of Collagen Cross-links (NTx) Calculated', 'timeFrame': 'Baseline and Week 26', 'description': 'The percent change in bone resorption marker NTx measured at week 26 from NTx measured at baseline. Urine samples were analyzed at a central laboratory for NTx using an enzyme-linked immunosorbent assay calculated as (nmol BCE/mmol creatinine). BCE=bone collagen equivalent'}, {'measure': 'Percent Change From Baseline to Week 26 in Bone-specific Alkaline Phosphatase (BsAP)', 'timeFrame': 'Baseline and Week 26', 'description': 'The percent change in bone formation marker BsAP measured at week 26 from BsAP measured at baseline. Serum samples were analyzed at a central laboratory for bone biomarker BsAP using an enzyme immunoassay measured in units per liter (U/L).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Homeostasis', 'Bone and Bones']}, 'referencesModule': {'references': [{'pmid': '30445008', 'type': 'DERIVED', 'citation': 'Hansen KE, Nieves JW, Nudurupati S, Metz DC, Perez MC. Dexlansoprazole and Esomeprazole Do Not Affect Bone Homeostasis in Healthy Postmenopausal Women. Gastroenterology. 2019 Mar;156(4):926-934.e6. doi: 10.1053/j.gastro.2018.11.023. Epub 2018 Nov 13.'}], 'seeAlsoLinks': [{'url': 'http://general.takedapharm.com/content/file/pi.pdf?applicationcode=9efb34b3-fb69-4190-a2be-a90b8cb94e25&filetypecode=DEXILANTPI', 'label': 'Dexilant Package Insert'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of dexlansoprazole modified release (MR), once daily (QD), on bone homeostasis.', 'detailedDescription': 'Research on drugs that affect bone homeostasis have shown changes in levels of bone formation and resorption biomarkers. This study will evaluate the effect of dexlansoprazole on bone homeostasis by assessing changes in biochemical markers of bone formation and bone resorption. This study will also assess changes in bone mineral density by dual-energy x-ray absorptiometry scan and other markers of bone homeostasis.\n\nThe study will consist of a 12-week screening period, a 26-week treatment period with a total of 5 visits during the treatment period and a follow-up visit at Week 52 for bone mineral density assessment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is postmenopausal female in general good health with a body mass index of ≥18 and ≤30 kg/m2.\n* Must have biochemical markers of bone formation, procollagen type 1 N-terminal propeptide and bone-specific alkaline phosphatase, and bone resorption, crosslinked β-C-terminal telopeptide of type 1 collagen and urine N-telopeptide within normal postmenopausal female ranges.\n* Has not taken proton pump inhibitor medications within 6 months prior to screening and agrees to refrain from taking them through the last dose of study drug, except study-supplied dexlansoprazole or esomeprazole.\n\nExclusion Criteria:\n\n* Has parathyroid hormone or thyroid stimulating hormone levels outside of the reference range at Week -12 and has 25-OH-D level \\<32 ng/mL at Week -2.\n* Has baseline bone mineral density by dual-energy x-ray absorptiometry defined as a T-score lower than -2.0 at the total hip, spine, or femoral neck based on Caucasian reference values.\n* Has a disorder strongly associated with osteoporosis\n* Has a history of lumbar laminectomy, vertebroplasty, vertebral deformity or severe lumbar scoliosis that interferes with measurement or performance of the dual x-ray absorptiometry .\n* Has a history or clinical manifestations of uncontrolled or significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, immunologic, or psychiatric disorder as determined by the investigator which may affect the ability of the subject to participate or potentially confound the trial results.\n* Has family history of genetic bone disorders.'}, 'identificationModule': {'nctId': 'NCT01216293', 'briefTitle': 'Effect of Dexlansoprazole on Bone Homeostasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Dexlansoprazole 60 mg Delayed Release Capsules and Esomeprazole 40 mg Delayed Release Capsules on Bone Homeostasis in Healthy Postmenopausal Female Subjects', 'orgStudyIdInfo': {'id': 'TAK-390MR_104'}, 'secondaryIdInfos': [{'id': 'U1111-1116-1638', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dexlansoprazole 60 mg', 'description': 'Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.', 'interventionNames': ['Drug: Dexlansoprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Esomeprazole 40mg', 'description': 'Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.', 'interventionNames': ['Drug: Esomeprazole']}], 'interventions': [{'name': 'Dexlansoprazole', 'type': 'DRUG', 'otherNames': ['Dexilant', 'Kapidex'], 'description': 'Dexlansoprazole 60 mg capsules', 'armGroupLabels': ['Dexlansoprazole 60 mg']}, {'name': 'Esomeprazole', 'type': 'DRUG', 'otherNames': ['Nexium'], 'description': 'Esomeprazole 40 mg capsules', 'armGroupLabels': ['Esomeprazole 40mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo-matching capsules', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Medical Director Clinical Science', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}