Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-20 @ 1:41 PM
Study NCT ID:
NCT01011556
Status:
COMPLETED
Last Update Posted:
2012-10-23
First Post:
2009-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study for the Transdermal Application of Teriparatide
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': 'D010281', 'term': 'Parathyroid Hormone'}, {'id': 'D019379', 'term': 'Teriparatide'}], 'ancestors': [{'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': {'eventGroups': [{'id': 'EG000', 'title': '20 Mcg Subcutaneous Teriparatide', 'description': 'Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.', 'otherNumAtRisk': 57, 'otherNumAffected': 30, 'seriousNumAtRisk': 57, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': '30 Mcg Transdermal Teriparatide', 'description': 'Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.', 'otherNumAtRisk': 56, 'otherNumAffected': 33, 'seriousNumAtRisk': 56, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': '50 Mcg Transdermal Teriparatide', 'description': 'Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.', 'otherNumAtRisk': 54, 'otherNumAffected': 30, 'seriousNumAtRisk': 54, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': '80 Mcg Transdermal Teriparatide', 'description': 'Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.', 'otherNumAtRisk': 64, 'otherNumAffected': 39, 'seriousNumAtRisk': 64, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Application site discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Subcutaneous haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypercalciuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Intra-abdominal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20 Mcg Subcutaneous Teriparatide', 'description': 'Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.'}, {'id': 'OG001', 'title': '30 Mcg Transdermal Teriparatide', 'description': 'Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG002', 'title': '50 Mcg Transdermal Teriparatide', 'description': 'Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG003', 'title': '80 Mcg Transdermal Teriparatide', 'description': 'Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.80', 'groupId': 'OG000', 'lowerLimit': '6.867', 'upperLimit': '8.730'}, {'value': '0.63', 'groupId': 'OG001', 'lowerLimit': '-0.321', 'upperLimit': '1.578'}, {'value': '0.32', 'groupId': 'OG002', 'lowerLimit': '-0.657', 'upperLimit': '1.287'}, {'value': '1.63', 'groupId': 'OG003', 'lowerLimit': '0.739', 'upperLimit': '2.519'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-7.17', 'ciLowerLimit': '-8.489', 'ciUpperLimit': '-5.851', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A noninferiority margin of 3.5% was used.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-7.48', 'ciLowerLimit': '-8.822', 'ciUpperLimit': '-6.144', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A noninferiority margin of 3.5% was used.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-6.17', 'ciLowerLimit': '-7.448', 'ciUpperLimit': '-4.891', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A noninferiority margin of 3.5% was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 Months', 'description': 'Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model and least square (LS) means were adjusted for baseline BMD values as a covariate and pooled site and treatment as fixed effects.', 'unitOfMeasure': 'percentage change in BMD', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of drug and had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using intention-to-treat (ITT) principle, last observation carried forward method and ANCOVA model.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20 Mcg Subcutaneous Teriparatide', 'description': 'Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.'}, {'id': 'OG001', 'title': '30 Mcg Transdermal Teriparatide', 'description': 'Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG002', 'title': '50 Mcg Transdermal Teriparatide', 'description': 'Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG003', 'title': '80 Mcg Transdermal Teriparatide', 'description': 'Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.74', 'groupId': 'OG000', 'lowerLimit': '3.953', 'upperLimit': '5.537'}, {'value': '0.16', 'groupId': 'OG001', 'lowerLimit': '-0.661', 'upperLimit': '0.983'}, {'value': '0.88', 'groupId': 'OG002', 'lowerLimit': '0.051', 'upperLimit': '1.705'}, {'value': '1.19', 'groupId': 'OG003', 'lowerLimit': '0.418', 'upperLimit': '1.957'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-4.58', 'ciLowerLimit': '-5.716', 'ciUpperLimit': '-3.452', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.87', 'ciLowerLimit': '-5.006', 'ciUpperLimit': '-2.727', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.56', 'ciLowerLimit': '-4.652', 'ciUpperLimit': '-2.464', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 6 Months', 'description': 'Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.', 'unitOfMeasure': 'percentage change in BMD', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of drug and had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using intent-to-treat principal, last observation carried forward method and ANCOVA model.'}, {'type': 'SECONDARY', 'title': 'Time Course Change of BMD Response at the Lumbar Spine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20 Mcg Subcutaneous Teriparatide', 'description': 'Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.'}, {'id': 'OG001', 'title': '30 Mcg Transdermal Teriparatide', 'description': 'Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG002', 'title': '50 Mcg Transdermal Teriparatide', 'description': 'Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG003', 'title': '80 Mcg Transdermal Teriparatide', 'description': 'Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}], 'classes': [{'title': '6 months (n=54, 52, 51, 58)', 'categories': [{'measurements': [{'value': '4.72', 'groupId': 'OG000', 'lowerLimit': '3.927', 'upperLimit': '5.516'}, {'value': '0.19', 'groupId': 'OG001', 'lowerLimit': '-0.630', 'upperLimit': '1.019'}, {'value': '0.78', 'groupId': 'OG002', 'lowerLimit': '-0.050', 'upperLimit': '1.606'}, {'value': '1.19', 'groupId': 'OG003', 'lowerLimit': '0.421', 'upperLimit': '1.965'}]}]}, {'title': '12 months (n=52, 48, 45, 50)', 'categories': [{'measurements': [{'value': '8.12', 'groupId': 'OG000', 'lowerLimit': '7.181', 'upperLimit': '9.060'}, {'value': '0.62', 'groupId': 'OG001', 'lowerLimit': '-0.367', 'upperLimit': '1.601'}, {'value': '0.66', 'groupId': 'OG002', 'lowerLimit': '-0.348', 'upperLimit': '1.663'}, {'value': '1.93', 'groupId': 'OG003', 'lowerLimit': '0.989', 'upperLimit': '2.881'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-4.53', 'ciLowerLimit': '-5.663', 'ciUpperLimit': '-3.392', 'pValueComment': 'p-value is for change in BMD at 6 months', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.687', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\\*visit interaction. Repeat measure occurred at each visit.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.94', 'ciLowerLimit': '-5.086', 'ciUpperLimit': '-2.800', 'pValueComment': 'p-value is for change in BMD at 6 months', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.692', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\\*visit interaction. Repeat measure occurred at each visit.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.53', 'ciLowerLimit': '-4.627', 'ciUpperLimit': '-2.430', 'pValueComment': 'p-value is for change in BMD at 6 months', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.665', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\\*visit interaction. Repeat measure occurred at each visit.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-7.50', 'ciLowerLimit': '-8.856', 'ciUpperLimit': '-6.151', 'pValueComment': 'p-value is for change in BMD at 12 months', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.818', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\\*visit interaction. Repeat measure occurred at each visit.', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-7.46', 'ciLowerLimit': '-8.835', 'ciUpperLimit': '-6.091', 'pValueComment': 'p-value for change in BMD at 12 months', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.830', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\\*visit interaction. Repeat measure occurred at each visit.', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-6.19', 'ciLowerLimit': '-7.510', 'ciUpperLimit': '-4.860', 'pValueComment': 'p-value is for change in BMD at 12 months', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.802', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\\*visit interaction. Repeat measure occurred at each visit.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 6 Months and 12 Months', 'description': 'To assess the time course of the treatment, the BMD data of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) and analyzed using a mixed model repeated measures (MMRM) method, with the repeated measure occurring at each visit (for example, 6 and 12 month). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar).', 'unitOfMeasure': 'percentage change in BMD', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of drug, had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using ITT principal.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20 Mcg Subcutaneous Teriparatide', 'description': 'Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.'}, {'id': 'OG001', 'title': '30 Mcg Transdermal Teriparatide', 'description': 'Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG002', 'title': '50 Mcg Transdermal Teriparatide', 'description': 'Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG003', 'title': '80 Mcg Transdermal Teriparatide', 'description': 'Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}], 'classes': [{'title': '1 month (n=49, 53, 49, 60)', 'categories': [{'measurements': [{'value': '112.47', 'spread': '65.390', 'groupId': 'OG000'}, {'value': '19.29', 'spread': '35.274', 'groupId': 'OG001'}, {'value': '27.78', 'spread': '31.064', 'groupId': 'OG002'}, {'value': '42.06', 'spread': '53.000', 'groupId': 'OG003'}]}]}, {'title': '3 months (n=50, 51, 49, 59)', 'categories': [{'measurements': [{'value': '174.88', 'spread': '118.745', 'groupId': 'OG000'}, {'value': '35.68', 'spread': '50.358', 'groupId': 'OG001'}, {'value': '53.53', 'spread': '64.625', 'groupId': 'OG002'}, {'value': '116.34', 'spread': '117.697', 'groupId': 'OG003'}]}]}, {'title': '6 months (n=48, 49, 48, 56)', 'categories': [{'measurements': [{'value': '284.89', 'spread': '228.773', 'groupId': 'OG000'}, {'value': '62.99', 'spread': '78.579', 'groupId': 'OG001'}, {'value': '93.82', 'spread': '93.575', 'groupId': 'OG002'}, {'value': '221.28', 'spread': '233.297', 'groupId': 'OG003'}]}]}, {'title': '12 months (n=47, 46, 43, 49)', 'categories': [{'measurements': [{'value': '232.41', 'spread': '176.557', 'groupId': 'OG000'}, {'value': '72.17', 'spread': '86.747', 'groupId': 'OG001'}, {'value': '97.14', 'spread': '98.007', 'groupId': 'OG002'}, {'value': '178.02', 'spread': '181.361', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 1 month.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 1 month.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 1 month.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 3 months.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 3 months.', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 3 months.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 6 months.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 6 months.', 'testedNonInferiority': False}, {'pValue': '0.029', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 6 months.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 12 months.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 12 months.', 'testedNonInferiority': False}, {'pValue': '0.047', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 12 months.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 Month, 3 Months, 6 Months, 12 Months', 'description': 'Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.', 'unitOfMeasure': 'percentage change in P1NP', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline of C-Terminal Telopeptide (CTX)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20 Mcg Subcutaneous Teriparatide', 'description': 'Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.'}, {'id': 'OG001', 'title': '30 Mcg Transdermal Teriparatide', 'description': 'Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level'}, {'id': 'OG002', 'title': '50 Mcg Transdermal Teriparatide', 'description': 'Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG003', 'title': '80 Mcg Transdermal Teriparatide', 'description': 'Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}], 'classes': [{'title': '1 month (n=49, 53, 49, 60)', 'categories': [{'measurements': [{'value': '20.57', 'spread': '64.980', 'groupId': 'OG000'}, {'value': '8.05', 'spread': '26.070', 'groupId': 'OG001'}, {'value': '13.35', 'spread': '29.384', 'groupId': 'OG002'}, {'value': '21.66', 'spread': '46.572', 'groupId': 'OG003'}]}]}, {'title': '3 months (n=50, 51, 49, 59)', 'categories': [{'measurements': [{'value': '87.78', 'spread': '96.777', 'groupId': 'OG000'}, {'value': '30.66', 'spread': '42.048', 'groupId': 'OG001'}, {'value': '42.40', 'spread': '58.620', 'groupId': 'OG002'}, {'value': '90.36', 'spread': '103.367', 'groupId': 'OG003'}]}]}, {'title': '6 months (n=48, 49, 48, 56)', 'categories': [{'measurements': [{'value': '123.36', 'spread': '128.832', 'groupId': 'OG000'}, {'value': '37.36', 'spread': '52.875', 'groupId': 'OG001'}, {'value': '68.63', 'spread': '71.059', 'groupId': 'OG002'}, {'value': '127.81', 'spread': '152.725', 'groupId': 'OG003'}]}]}, {'title': '12 months (n=47, 46, 43, 49)', 'categories': [{'measurements': [{'value': '97.52', 'spread': '109.981', 'groupId': 'OG000'}, {'value': '37.75', 'spread': '58.035', 'groupId': 'OG001'}, {'value': '61.25', 'spread': '60.862', 'groupId': 'OG002'}, {'value': '114.11', 'spread': '157.485', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.822', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 1 month.', 'testedNonInferiority': False}, {'pValue': '0.406', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 1 month.', 'testedNonInferiority': False}, {'pValue': '0.312', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 1 month.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 3 months.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 3 months.', 'testedNonInferiority': False}, {'pValue': '0.952', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 3 months.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 6 months.', 'testedNonInferiority': False}, {'pValue': '0.011', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 6 months.', 'testedNonInferiority': False}, {'pValue': '0.997', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 6 months.', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 12 months.', 'testedNonInferiority': False}, {'pValue': '0.112', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 12 months.', 'testedNonInferiority': False}, {'pValue': '0.988', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 12 months.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 Month, 3 Months, 6 Months, 12 Months', 'description': 'C-terminal telopeptide is a marker of bone resorption.', 'unitOfMeasure': 'percentage change in CTX', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20 Mcg Subcutaneous Teriparatide', 'description': 'Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.'}, {'id': 'OG001', 'title': '30 Mcg Transdermal Teriparatide', 'description': 'Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG002', 'title': '50 Mcg Transdermal Teriparatide', 'description': 'Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG003', 'title': '80 Mcg Transdermal Teriparatide', 'description': 'Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.10', 'spread': '85.421', 'groupId': 'OG000'}, {'value': '4.63', 'spread': '29.694', 'groupId': 'OG001'}, {'value': '12.30', 'spread': '30.153', 'groupId': 'OG002'}, {'value': '23.84', 'spread': '44.813', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 1 month.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 1 month.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise comparison p-value at 1 month.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 1 Month', 'description': 'Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.', 'unitOfMeasure': 'percentage change in P1CP', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.'}, {'type': 'SECONDARY', 'title': 'Convenience/Ease of Use Questionnaire (CEUQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20 Mcg Subcutaneous Teriparatide', 'description': 'Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.'}, {'id': 'OG001', 'title': '30 Mcg Transdermal Teriparatide', 'description': 'Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG002', 'title': '50 Mcg Transdermal Teriparatide', 'description': 'Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG003', 'title': '80 Mcg Transdermal Teriparatide', 'description': 'Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}], 'classes': [{'title': 'S1-Stronly Disagree', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'S1-Somewhat Disagree', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'S1-Neutral', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'S1-Somewhat Agree', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'S1-Strongly Agree', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}]}, {'title': 'S2-Strongly Disagree', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'S2-Somewhat Disagree', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'S2-Neutral', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'S2-Somewhat Agree', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'S2-Strongly Agree', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}]}, {'title': 'S3-Not Confident', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'S3-Somewhat Not Confident', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'S3-Neutral', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'S3-Somewhat Confident', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'S3-Very Confident', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}, {'title': 'S4-Extremely Fearful', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'S4-Somewhat Fearful', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'S4-Neutral', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'S4-Somewhat Not Fearful', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'S4-Not Fearful', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}]}, {'title': 'S5-Very Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'S5-Somewhat Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'S5-Neutral', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'S5-Somewhat Satisfied', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'S5-Very Satisfied', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline up to 12 months', 'description': 'CEUQ consists of 5 sections and 16 questions using a 5-point Likert scale designed to collect measures for ease of use (S1), convenience of use (S2), confidence of use (S3), fear of use (S4), and overall satisfaction with therapy (S5). CEUQ is not a validated instrument.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had CEUQ assessment. Last observation was carried forward, unless the last observation was also the first completed questionnaire.'}, {'type': 'SECONDARY', 'title': 'Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20 Mcg Subcutaneous Teriparatide', 'description': 'Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.'}, {'id': 'OG001', 'title': '30 Mcg Transdermal Teriparatide', 'description': 'Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG002', 'title': '50 Mcg Transdermal Teriparatide', 'description': 'Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG003', 'title': '80 Mcg Transdermal Teriparatide', 'description': 'Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}], 'classes': [{'title': 'Baseline- predose; no adjustment (n=54,53,51,62)', 'categories': [{'measurements': [{'value': '2.391', 'spread': '0.0776', 'groupId': 'OG000'}, {'value': '2.362', 'spread': '0.0933', 'groupId': 'OG001'}, {'value': '2.389', 'spread': '0.0921', 'groupId': 'OG002'}, {'value': '2.392', 'spread': '0.0915', 'groupId': 'OG003'}]}]}, {'title': 'Baseline- 4 h PD; no adjustment (n=55,53,51,63)', 'categories': [{'measurements': [{'value': '2.432', 'spread': '0.1191', 'groupId': 'OG000'}, {'value': '2.358', 'spread': '0.1315', 'groupId': 'OG001'}, {'value': '2.403', 'spread': '0.1160', 'groupId': 'OG002'}, {'value': '2.393', 'spread': '0.1113', 'groupId': 'OG003'}]}]}, {'title': 'Baseline- 6 h PD; no adjustment (n=52,51,48,59)', 'categories': [{'measurements': [{'value': '2.440', 'spread': '0.1159', 'groupId': 'OG000'}, {'value': '2.369', 'spread': '0.0789', 'groupId': 'OG001'}, {'value': '2.400', 'spread': '0.1167', 'groupId': 'OG002'}, {'value': '2.397', 'spread': '0.1048', 'groupId': 'OG003'}]}]}, {'title': '12 mon-predose; no adjustment (n=52,47,45,50)', 'categories': [{'measurements': [{'value': '2.463', 'spread': '0.1243', 'groupId': 'OG000'}, {'value': '2.427', 'spread': '0.0977', 'groupId': 'OG001'}, {'value': '2.427', 'spread': '0.0842', 'groupId': 'OG002'}, {'value': '2.432', 'spread': '0.0937', 'groupId': 'OG003'}]}]}, {'title': '12 mon-4 h PD; no adjustment (n=51,46,44,51)', 'categories': [{'measurements': [{'value': '2.516', 'spread': '0.1815', 'groupId': 'OG000'}, {'value': '2.428', 'spread': '0.1024', 'groupId': 'OG001'}, {'value': '2.430', 'spread': '0.1199', 'groupId': 'OG002'}, {'value': '2.464', 'spread': '0.1042', 'groupId': 'OG003'}]}]}, {'title': '12 mon-6 h PD; no adjustment (n=50,45,44,51)', 'categories': [{'measurements': [{'value': '2.532', 'spread': '0.1429', 'groupId': 'OG000'}, {'value': '2.426', 'spread': '0.0866', 'groupId': 'OG001'}, {'value': '2.443', 'spread': '0.0997', 'groupId': 'OG002'}, {'value': '2.467', 'spread': '0.0959', 'groupId': 'OG003'}]}]}, {'title': 'baseline-predose albumin adjusted (n=53,53,50,60)', 'categories': [{'measurements': [{'value': '2.363', 'spread': '0.0811', 'groupId': 'OG000'}, {'value': '2.341', 'spread': '0.0949', 'groupId': 'OG001'}, {'value': '2.376', 'spread': '0.0807', 'groupId': 'OG002'}, {'value': '2.373', 'spread': '0.0809', 'groupId': 'OG003'}]}]}, {'title': 'baseline-4 h PD; albumin adjusted (n=52,52,50,61)', 'categories': [{'measurements': [{'value': '2.418', 'spread': '0.1099', 'groupId': 'OG000'}, {'value': '2.348', 'spread': '0.1283', 'groupId': 'OG001'}, {'value': '2.403', 'spread': '0.0928', 'groupId': 'OG002'}, {'value': '2.386', 'spread': '0.1045', 'groupId': 'OG003'}]}]}, {'title': 'baseline-6 h PD; albumin adjusted (n=49,50,47,57)', 'categories': [{'measurements': [{'value': '2.423', 'spread': '0.1100', 'groupId': 'OG000'}, {'value': '2.363', 'spread': '0.0727', 'groupId': 'OG001'}, {'value': '2.404', 'spread': '0.0908', 'groupId': 'OG002'}, {'value': '2.394', 'spread': '0.0934', 'groupId': 'OG003'}]}]}, {'title': '12 mon- predose albumin adjusted (n=52,47,45,50)', 'categories': [{'measurements': [{'value': '2.461', 'spread': '0.0998', 'groupId': 'OG000'}, {'value': '2.432', 'spread': '0.0806', 'groupId': 'OG001'}, {'value': '2.449', 'spread': '0.0861', 'groupId': 'OG002'}, {'value': '2.442', 'spread': '0.0840', 'groupId': 'OG003'}]}]}, {'title': '12 mon- 4 h PD; albumin adjusted (n=51,46,44,51)', 'categories': [{'measurements': [{'value': '2.523', 'spread': '0.1680', 'groupId': 'OG000'}, {'value': '2.438', 'spread': '0.1022', 'groupId': 'OG001'}, {'value': '2.458', 'spread': '0.1012', 'groupId': 'OG002'}, {'value': '2.482', 'spread': '0.0962', 'groupId': 'OG003'}]}]}, {'title': '12 mon-6 h PD; albumin adjusted (n=52,47,45,50)', 'categories': [{'measurements': [{'value': '2.547', 'spread': '0.1236', 'groupId': 'OG000'}, {'value': '2.443', 'spread': '0.0838', 'groupId': 'OG001'}, {'value': '2.481', 'spread': '0.1044', 'groupId': 'OG002'}, {'value': '2.483', 'spread': '0.1348', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 Months', 'description': 'Serum calcium adjusted for serum albumin levels is calculated using the following formula: Total Calcium + \\[(40 - albumin) x 0.02\\]. Analysis for serum calcium and albumin adjusted serum calcium were collected at predose, 4 hours (h) post-dose (PD) and 6 h PD at baseline and 12 months (mon).', 'unitOfMeasure': 'millimole/Liter (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had serum calcium measurements or adjusted serum calcium measurements at the indicated timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urine Calcium Excretion at 6 and 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20 Mcg Subcutaneous Teriparatide', 'description': 'Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.'}, {'id': 'OG001', 'title': '30 Mcg Transdermal Teriparatide', 'description': 'Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG002', 'title': '50 Mcg Transdermal Teriparatide', 'description': 'Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG003', 'title': '80 Mcg Transdermal Teriparatide', 'description': 'Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.45', 'spread': '1.851', 'groupId': 'OG000'}, {'value': '4.21', 'spread': '1.766', 'groupId': 'OG001'}, {'value': '4.26', 'spread': '1.673', 'groupId': 'OG002'}, {'value': '4.24', 'spread': '1.876', 'groupId': 'OG003'}]}]}, {'title': '6 months (n=54, 50, 49, 56)', 'categories': [{'measurements': [{'value': '2.02', 'spread': '4.122', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '3.467', 'groupId': 'OG001'}, {'value': '1.20', 'spread': '2.768', 'groupId': 'OG002'}, {'value': '1.35', 'spread': '2.360', 'groupId': 'OG003'}]}]}, {'title': '12 months (n=51, 47, 41, 51)', 'categories': [{'measurements': [{'value': '5.25', 'spread': '3.694', 'groupId': 'OG000'}, {'value': '4.97', 'spread': '2.192', 'groupId': 'OG001'}, {'value': '4.80', 'spread': '2.738', 'groupId': 'OG002'}, {'value': '4.51', 'spread': '2.770', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 Months, 12 Months', 'unitOfMeasure': 'millimole/day (mmol/day)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had urine calcium measurements at the indicated timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20 Mcg Subcutaneous Teriparatide', 'description': 'Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.'}, {'id': 'OG001', 'title': '30 Mcg Transdermal Teriparatide', 'description': 'Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG002', 'title': '50 Mcg Transdermal Teriparatide', 'description': 'Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG003', 'title': '80 Mcg Transdermal Teriparatide', 'description': 'Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}], 'classes': [{'title': 'BL, supine, SBP, 30 min (n=56,54,51,62)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '10.71', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '10.25', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '11.59', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '10.77', 'groupId': 'OG003'}]}]}, {'title': 'BL, supine, SBP, 2 h (n=56,56,53,63)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '13.06', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '10.97', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '9.97', 'groupId': 'OG002'}, {'value': '-0.6', 'spread': '12.91', 'groupId': 'OG003'}]}]}, {'title': 'BL, supine, DBP, 30 min (n=56,54,51,62)', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '7.63', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '7.59', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '7.50', 'groupId': 'OG002'}, {'value': '-1.1', 'spread': '7.17', 'groupId': 'OG003'}]}]}, {'title': 'BL, supine, DBP, 2 h (n=56,56,53,63)', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '7.59', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '8.51', 'groupId': 'OG001'}, {'value': '-3.6', 'spread': '7.02', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '7.67', 'groupId': 'OG003'}]}]}, {'title': '12mon, supine, SBP, 30min (n=51,47,44,51)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '8.52', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '7.47', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '8.87', 'groupId': 'OG002'}, {'value': '-2.0', 'spread': '9.82', 'groupId': 'OG003'}]}]}, {'title': '12mon, supine, SBP, 2 h (n=51,47,44,51)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '10.71', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '11.19', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '9.54', 'groupId': 'OG002'}, {'value': '-1.9', 'spread': '10.87', 'groupId': 'OG003'}]}]}, {'title': '12mon, supine, DBP, 30min (n=52,48,45,51)', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '7.14', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '6.08', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '6.77', 'groupId': 'OG002'}, {'value': '-1.2', 'spread': '7.25', 'groupId': 'OG003'}]}]}, {'title': '12mon, supine, DBP, 2 h (n=51,47,44,51)', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '6.94', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '7.79', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '6.79', 'groupId': 'OG002'}, {'value': '-2.0', 'spread': '8.59', 'groupId': 'OG003'}]}]}, {'title': 'BL, standing, SBP, 30 min (n=56,54,51,62)', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '9.38', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '8.93', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '10.65', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '10.04', 'groupId': 'OG003'}]}]}, {'title': 'BL, standing, SBP, 2 h (n=56,56,53,64)', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '11.57', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '11.03', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '10.96', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '12.11', 'groupId': 'OG003'}]}]}, {'title': 'BL, standing, DBP, 30 min (n=56,54,51,62)', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '6.56', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '8.18', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '8.34', 'groupId': 'OG002'}, {'value': '-1.2', 'spread': '7.80', 'groupId': 'OG003'}]}]}, {'title': 'BL, standing, DBP, 2 h (n=56,56,53,64)', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '7.55', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '7.80', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '7.25', 'groupId': 'OG002'}, {'value': '-1.7', 'spread': '8.84', 'groupId': 'OG003'}]}]}, {'title': '12mon, standing, SBP, 30min(n=51,47,44,51)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '10.55', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '8.41', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '8.68', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '8.72', 'groupId': 'OG003'}]}]}, {'title': '12mon, standing, SBP, 2 h (n=51,47,44,51)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '11.86', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '7.64', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '12.97', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '10.24', 'groupId': 'OG003'}]}]}, {'title': '12mon, standing, DBP, 30 min(n=51,47,44,51', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '7.12', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '6.04', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '8.09', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '7.75', 'groupId': 'OG003'}]}]}, {'title': '12mon, standing, DBP, 2 h (n=51,47,44,51)', 'categories': [{'measurements': [{'value': '1.1', 'spread': '6.93', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '7.35', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '7.70', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '7.44', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Dose, 30 minutes, 2 hours Post-Dose at Baseline and 12 Months', 'description': 'Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) measured at pre-dose and 30 minutes (min) and 2 hours (hr) post-dose in both the supine and standing position.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had predose and postdose blood pressure measurements at the indicated timepoint and body position.'}, {'type': 'SECONDARY', 'title': 'Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20 Mcg Subcutaneous Teriparatide', 'description': 'Received 20 mcg teriparatide subcutaneously once daily in an unblinded manner.'}, {'id': 'OG001', 'title': '30 Mcg Transdermal Teriparatide', 'description': 'Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG002', 'title': '50 Mcg Transdermal Teriparatide', 'description': 'Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG003', 'title': '80 Mcg Transdermal Teriparatide', 'description': 'Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}], 'classes': [{'title': 'BL, supine, 30 min (n=56,54,51,62)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '5.96', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '7.21', 'groupId': 'OG002'}, {'value': '-0.6', 'spread': '6.50', 'groupId': 'OG003'}]}]}, {'title': 'BL, supine, 2 h (n=56,56,53,63)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '8.01', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '5.61', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '8.49', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '6.90', 'groupId': 'OG003'}]}]}, {'title': 'BL, standing, 30 min (n=56,54,51,62)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '6.41', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '7.36', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '6.68', 'groupId': 'OG002'}, {'value': '-1.2', 'spread': '7.61', 'groupId': 'OG003'}]}]}, {'title': 'BL, standing, 2 h (n=56,56,53,64)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '8.03', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '8.51', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '6.51', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '8.05', 'groupId': 'OG003'}]}]}, {'title': '12 mon, supine, 30 min (n=51,47,44,51)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '4.81', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '4.74', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '4.06', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '5.22', 'groupId': 'OG003'}]}]}, {'title': '12 mon, supine, 2 h (n=51,47,44,51)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '6.74', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '6.60', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '5.43', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '6.69', 'groupId': 'OG003'}]}]}, {'title': '12 mon, standing, 30 min (n=51,47,44,51)', 'categories': [{'measurements': [{'value': '1.2', 'spread': '7.35', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '5.28', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '5.97', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '6.90', 'groupId': 'OG003'}]}]}, {'title': '12 mon, standing, 2 h (n=51,47,44,51)', 'categories': [{'measurements': [{'value': '0.9', 'spread': '9.03', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '7.36', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '7.03', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '7.72', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 30 minutes, 2 hours at Baseline and 12 Months', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had predose and postdose heart rate measurements at the indicated timepoint and body position.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20 Mcg Subcutaneous Teriparatide', 'description': 'Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.'}, {'id': 'OG001', 'title': '30 Mcg Transdermal Teriparatide', 'description': 'Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG002', 'title': '50 Mcg Transdermal Teriparatide', 'description': 'Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG003', 'title': '80 Mcg Transdermal Teriparatide', 'description': 'Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}], 'classes': [{'title': 'Baseline: anti-recombinant ND (n=57, 54, 53, 64)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}]}, {'title': 'Baseline:anti-recombinant titer 1:8(n=57,54,53,64)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '1 mon:anti-recombinant ND (n=54,54,51,62)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}]}, {'title': '1 mon:anti-recombinant titer 1:8 (n=54,54,51,62', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '3 mon:anti-recombinant ND (n=55,52,51,61)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}]}, {'title': '3 mon:anti-recombinant titer 1:8 (n=55,52,51,6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '12 mon:anti-recombinant ND (n=52,48,45,51)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}]}, {'title': '12 mon:anti-recombinant titer 1:8 (n=52,48,45,51)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '13 mon:anti-recombinant ND (n=50,46,44,50)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}]}, {'title': '13 mon:anti-recombinant titer 1:8 (n=50,46,44,50)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Baseline:anti-synthetic ND (n=57,54,53,64)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}]}, {'title': 'Baseline:anti-synthetic titer 1:8 (n=57,54,53,64)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '1 mon:anti-synthetic ND (N=54,54,51,62)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}]}, {'title': '1 mon:anti-synthetic titer 1:8 (N=54,54,51,62)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '3 mon:anti-synthetic ND (n=55,52,51,61)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}]}, {'title': '3 mon:anti-synthetic titer 1:8 (n=55,52,51,61)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '12 mon:anti-synthetic ND (n=52,48,45,51)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}]}, {'title': '12 mon:anti-synthetic titer 18 (n=52,48,45,51)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '13 mon:anti-synthetic ND (n=50,46,44,50)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}]}, {'title': '13 mon:anti-synthetic titer 1:8 (n=50,46,44,50)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1, 3, 12, and 13 Months (mon)', 'description': 'Participants were tested for anti-recombinant teriparatide and anti-synthetic teriparatide titers. Either none were detected (ND) or antibodies were determined to be present if the teriparatide specific antibody titers were at least 1:8 (titer 1:8).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had antibody results.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics Parameters: Area Under the Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20 Mcg Subcutaneous Teriparatide', 'description': 'Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.'}, {'id': 'OG001', 'title': '30 Mcg Transdermal Teriparatide', 'description': 'Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG002', 'title': '50 Mcg Transdermal Teriparatide', 'description': 'Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG003', 'title': '80 Mcg Transdermal Teriparatide', 'description': 'Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}], 'timeFrame': 'Baseline, 1 Month, 3 Months, and 12 Months', 'description': 'Due to high intra-subject variability, data was not analyzed for this outcome measure.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to high intra-subject variability, zero participants were analyzed on this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics Parameters: Maximal Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20 Mcg Subcutaneous Teriparatide', 'description': 'Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.'}, {'id': 'OG001', 'title': '30 Mcg Transdermal Teriparatide', 'description': 'Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG002', 'title': '50 Mcg Transdermal Teriparatide', 'description': 'Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG003', 'title': '80 Mcg Transdermal Teriparatide', 'description': 'Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}], 'timeFrame': 'Baseline, 1 Month, 3 Months, 12 Months', 'description': 'Due to high intra-subject variability, data was not analyzed for this outcome measure.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to high intra-subject variability, zero participants were analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20 Mcg Subcutaneous Teriparatide', 'description': 'Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.'}, {'id': 'OG001', 'title': '30 Mcg Transdermal Teriparatide', 'description': 'Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG002', 'title': '50 Mcg Transdermal Teriparatide', 'description': 'Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG003', 'title': '80 Mcg Transdermal Teriparatide', 'description': 'Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}], 'classes': [{'title': '0=no edema', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}]}, {'title': '1=very slight edema to 4=severe edema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '13 Month follow-up', 'description': 'Severity of edema was categorized based on a 5 point scale: 0=no edema, 4=severe edema (defined as an area raised more than 1 millimeter and extending beyond area of exposure)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had edema measurements at 13 months.'}, {'type': 'SECONDARY', 'title': 'DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20 Mcg Subcutaneous Teriparatide', 'description': 'Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.'}, {'id': 'OG001', 'title': '30 Mcg Transdermal Teriparatide', 'description': 'Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG002', 'title': '50 Mcg Transdermal Teriparatide', 'description': 'Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'OG003', 'title': '80 Mcg Transdermal Teriparatide', 'description': 'Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}], 'classes': [{'title': '0=no erythema', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}]}, {'title': '1=very slight erythema to 4=severe erythema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '13 Month follow-up', 'description': 'Severity of erythema was categorized based on a 5 point scale: 0=no erythema, 4=severe erythema (defined as beet red to eschar)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had erythema measurements at 13 months.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '20 Mcg Subcutaneous Teriparatide', 'description': 'Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.'}, {'id': 'FG001', 'title': '30 Mcg Transdermal Teriparatide', 'description': 'Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'FG002', 'title': '50 Mcg Transdermal Teriparatide', 'description': 'Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'FG003', 'title': '80 Mcg Transdermal Teriparatide', 'description': 'Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '64'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Inclusion/exclusion criteria not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '231', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '20 Mcg Subcutaneous Teriparatide', 'description': 'Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.'}, {'id': 'BG001', 'title': '30 Mcg Transdermal Teriparatide', 'description': 'Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'BG002', 'title': '50 Mcg Transdermal Teriparatide', 'description': 'Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'BG003', 'title': '80 Mcg Transdermal Teriparatide', 'description': 'Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '65.0', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '67.6', 'spread': '8.4', 'groupId': 'BG002'}, {'value': '65.1', 'spread': '7.2', 'groupId': 'BG003'}, {'value': '65.4', 'spread': '7.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '231', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}]}, {'title': 'Latin American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Mexican', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '137', 'groupId': 'BG004'}]}]}, {'title': 'South American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Spaniard', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Estonia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 233}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'dispFirstSubmitDate': '2012-07-13', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-21', 'studyFirstSubmitDate': '2009-11-09', 'dispFirstSubmitQcDate': '2012-07-13', 'resultsFirstSubmitDate': '2012-09-21', 'studyFirstSubmitQcDate': '2009-11-09', 'dispFirstPostDateStruct': {'date': '2012-07-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-10-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-21', 'studyFirstPostDateStruct': {'date': '2009-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months', 'timeFrame': 'Baseline, 12 Months', 'description': 'Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model and least square (LS) means were adjusted for baseline BMD values as a covariate and pooled site and treatment as fixed effects.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months', 'timeFrame': 'Baseline, 6 Months', 'description': 'Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.'}, {'measure': 'Time Course Change of BMD Response at the Lumbar Spine', 'timeFrame': 'Baseline to 6 Months and 12 Months', 'description': 'To assess the time course of the treatment, the BMD data of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) and analyzed using a mixed model repeated measures (MMRM) method, with the repeated measure occurring at each visit (for example, 6 and 12 month). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar).'}, {'measure': 'Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)', 'timeFrame': 'Baseline, 1 Month, 3 Months, 6 Months, 12 Months', 'description': 'Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.'}, {'measure': 'Percent Change From Baseline of C-Terminal Telopeptide (CTX)', 'timeFrame': 'Baseline, 1 Month, 3 Months, 6 Months, 12 Months', 'description': 'C-terminal telopeptide is a marker of bone resorption.'}, {'measure': 'Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month', 'timeFrame': 'Baseline, 1 Month', 'description': 'Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.'}, {'measure': 'Convenience/Ease of Use Questionnaire (CEUQ)', 'timeFrame': 'baseline up to 12 months', 'description': 'CEUQ consists of 5 sections and 16 questions using a 5-point Likert scale designed to collect measures for ease of use (S1), convenience of use (S2), confidence of use (S3), fear of use (S4), and overall satisfaction with therapy (S5). CEUQ is not a validated instrument.'}, {'measure': 'Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours', 'timeFrame': 'Baseline, 12 Months', 'description': 'Serum calcium adjusted for serum albumin levels is calculated using the following formula: Total Calcium + \\[(40 - albumin) x 0.02\\]. Analysis for serum calcium and albumin adjusted serum calcium were collected at predose, 4 hours (h) post-dose (PD) and 6 h PD at baseline and 12 months (mon).'}, {'measure': 'Change From Baseline in Urine Calcium Excretion at 6 and 12 Months', 'timeFrame': 'Baseline, 6 Months, 12 Months'}, {'measure': 'Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)', 'timeFrame': 'Pre-Dose, 30 minutes, 2 hours Post-Dose at Baseline and 12 Months', 'description': 'Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) measured at pre-dose and 30 minutes (min) and 2 hours (hr) post-dose in both the supine and standing position.'}, {'measure': 'Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).', 'timeFrame': 'Pre-dose, 30 minutes, 2 hours at Baseline and 12 Months'}, {'measure': 'Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels', 'timeFrame': 'Baseline and 1, 3, 12, and 13 Months (mon)', 'description': 'Participants were tested for anti-recombinant teriparatide and anti-synthetic teriparatide titers. Either none were detected (ND) or antibodies were determined to be present if the teriparatide specific antibody titers were at least 1:8 (titer 1:8).'}, {'measure': 'Pharmacokinetics Parameters: Area Under the Curve (AUC)', 'timeFrame': 'Baseline, 1 Month, 3 Months, and 12 Months', 'description': 'Due to high intra-subject variability, data was not analyzed for this outcome measure.'}, {'measure': 'Pharmacokinetics Parameters: Maximal Concentration (Cmax)', 'timeFrame': 'Baseline, 1 Month, 3 Months, 12 Months', 'description': 'Due to high intra-subject variability, data was not analyzed for this outcome measure.'}, {'measure': 'DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up', 'timeFrame': '13 Month follow-up', 'description': 'Severity of edema was categorized based on a 5 point scale: 0=no edema, 4=severe edema (defined as an area raised more than 1 millimeter and extending beyond area of exposure)'}, {'measure': 'DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up', 'timeFrame': '13 Month follow-up', 'description': 'Severity of erythema was categorized based on a 5 point scale: 0=no erythema, 4=severe erythema (defined as beet red to eschar)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Age Related Osteoporosis', 'Senile Osteoporosis'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to help answer the following research questions:\n\n1. How teriparatide given using a skin patch (transferred through the skin using the ViaDerm Teriparatide System) compares to teriparatide injected under the skin with a needle (pen injector) affects your bone density (how solid or porous your bones are).\n2. The safety of the teriparatide skin patch and any side effects that might be associated with it.', 'detailedDescription': 'Teriparatide 20 micrograms (mcg) per day is currently only available as a subcutaneous (SQ) injection and many patients with severe osteoporosis for whom anabolic therapy with teriparatide is appropriate are either unwilling or physically unable to self-inject. The purpose of this Phase 2 study is to identify a transdermal dose or doses that will be comparable to the teriparatide 20 mcg SQ dose from a pharmacodynamic (PD) and safety standpoint for use in future Phase 3 studies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ambulatory, postmenopausal women.\n* Centrally confirmed lumbar spine or femoral neck bone mineral density (BMD) T-score of less than or equal to -2.5.\n* Without language barrier, cooperative, expected to return for all follow-up procedures, and have given informed consent after being informed of the risks, medications, and procedures to be used in the study.\n* Able to use the pen-type injection delivery system and the ViaDerm Teriparatide System satisfactorily in the opinion of the investigator, or with the help of a family member or caregiver.\n* Able to be reached by telephone for follow-up contact between visits\n\nExclusion Criteria:\n\n* Abnormal laboratory values for albumin and alkaline phosphatase.\n* Laboratory values outside the ranges defined in the protocol for the following: Serum calcium, intact parathyroid hormone (iPTH), 25 hydroxyvitamin D, and 24-hour urine calcium\n* History of diseases other than postmenopausal osteoporosis that affect bone metabolism, such as Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hypoparathyroidism, hyperparathyroidism, and intestinal malabsorption.\n* History of malignant neoplasms in the 5 years prior to randomization, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may be randomized.\n* Use of a pacemaker.\n* Known chronic dermatological disorder, such as contact dermatitis\n* History of allergy or sensitivity to tapes or adhesives\n* Patients prone to bleeding with coagulopathies, such as hemophilia or thrombocytopenia.\n* Patients who have an increased baseline risk of osteosarcoma, Paget's disease of the bone, or unexplained elevations of alkaline phosphatase; or prior external beam, implant radiation therapy involving the skeleton, or previous primary skeletal malignancy.\n* Major fracture within the past year in the femur, tibia, humerus, or radius (with or without ulna).\n\nTreatment with:\n\n* calcitonins in the 2 months prior to randomization.\n* oral, transdermal/patch, or injectable estrogens, progestins, estrogen analogs, estrogen agonists, estrogen antagonists, selective estrogen receptor modulators, or tibolone in the 3 months prior to randomization; treatment with intravaginal estrogens in doses higher than 0.3 mg of conjugated equine estrogen, or the equivalent, for more than 3 doses per week in the 3 months prior to randomization.\n* androgens or other anabolic steroids in the 6 months prior to randomization.\n* fluorides in the 2 years prior to randomization. (Previous or current use of fluoridated water or topical dental fluoride treatments are permitted.)\n* oral bisphosphonates for more than 2 consecutive months in the 6 months prior to randomization; treatment with intravenous bisphosphonates in the 6 months prior to randomization; treatment with more than 1 cycle of intermittent oral bisphosphonates in the 6 months prior to randomization; or having received the last cycle of this intermittent oral regimen less than 4 weeks prior to screening.\n* patients receiving intravenous zoledronic acid during the 12 months prior to randomization.\n* vitamin D greater than 50,000 International Units (IU) per week or with any dose of calcitriol or vitamin D analogs or agonists in the 6 months prior to randomization.\n* systemic corticosteroids in the 1 month prior to randomization or for more than 30 days in the 1 year prior to randomization. (Ophthalmic, otic, topical, orally inhaled, nasally inhaled, or intra-articular corticosteroid therapy may be used without these restrictions.)\n* any other drug known to significantly affect bone metabolism in the 6 months prior to randomization.\n* warfarin or other coumadin anticoagulants in the 1 month prior to randomization.\n* any investigational drug in the 1 month prior to entry into the study."}, 'identificationModule': {'nctId': 'NCT01011556', 'briefTitle': 'A Study for the Transdermal Application of Teriparatide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 2 Study for Transdermal Application of Teriparatide', 'orgStudyIdInfo': {'id': '12641'}, 'secondaryIdInfos': [{'id': 'I2Y-MC-GHFA(c)', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '20 mcg Subcutaneous Teriparatide', 'description': 'Received 20 micrograms (mcg) subcutaneously once daily in an unblinded manner.', 'interventionNames': ['Drug: Subcutaneous Teriparatide']}, {'type': 'EXPERIMENTAL', 'label': '30 mcg Transdermal Teriparatide', 'description': 'Received 30 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.', 'interventionNames': ['Drug: Transdermal Teriparatide']}, {'type': 'EXPERIMENTAL', 'label': '50 mcg Transdermal Teriparatide', 'description': 'Received 50 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.', 'interventionNames': ['Drug: Transdermal Teriparatide']}, {'type': 'EXPERIMENTAL', 'label': '80 mcg Transdermal Teriparatide', 'description': 'Received 80 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.', 'interventionNames': ['Drug: Transdermal Teriparatide']}], 'interventions': [{'name': 'Subcutaneous Teriparatide', 'type': 'DRUG', 'otherNames': ['recombinant human parathyroid hormone (rhPTH) (1-34)', 'recombinant human teriparatide', 'Forteo', 'Forsteo', 'LY333334'], 'description': 'Administered subcutaneously once daily for 12 months', 'armGroupLabels': ['20 mcg Subcutaneous Teriparatide']}, {'name': 'Transdermal Teriparatide', 'type': 'DRUG', 'otherNames': ['synthetic human parathyroid hormone (shPTH) (1-34)', 'synthetic human teriparatide'], 'description': 'Administered transdermally, applied once daily for 6 hours over 12 months', 'armGroupLabels': ['30 mcg Transdermal Teriparatide', '50 mcg Transdermal Teriparatide', '80 mcg Transdermal Teriparatide']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1128AAF', 'city': 'Buenos Aires', 'country': 'Argentina', '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': -34.61315, 'lon': -58.37723}}, {'zip': '80010', 'city': 'Pärnu', 'country': 'Estonia', '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': 58.38588, 'lon': 24.49711}}, {'zip': '10138', 'city': 'Tallinn', 'country': 'Estonia', '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': 59.43696, 'lon': 24.75353}}, {'zip': '50410', 'city': 'Tartu', 'country': 'Estonia', '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': 58.38062, 'lon': 26.72509}}, {'zip': '8230', 'city': 'Balatonfüred', 'country': 'Hungary', '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': 46.96188, 'lon': 17.87187}}, {'zip': '1036', 'city': 'Budapest', 'country': 'Hungary', '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': 47.49835, 'lon': 19.04045}}, {'zip': '4043', 'city': 'Debrecen', 'country': 'Hungary', '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': 47.53167, 'lon': 21.62444}}, {'zip': '2500', 'city': 'Esztergom', 'country': 'Hungary', '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': 47.7928, 'lon': 18.74148}}, {'zip': '9023', 'city': 'Győr', 'country': 'Hungary', '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': 47.68333, 'lon': 17.63512}}, {'zip': 'H-9700', 'city': 'Szombathely', 'country': 'Hungary', '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': 47.23088, 'lon': 16.62155}}, {'zip': '2800', 'city': 'Tatabánya', 'country': 'Hungary', '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': 47.59247, 'lon': 18.38099}}, {'zip': '44158', 'city': 'Guadalajara', 'country': 'Mexico', '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': 20.67738, 'lon': -103.34749}}, {'zip': '03300', 'city': 'Mexico City', 'country': 'Mexico', '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': 19.42847, 'lon': -99.12766}}, {'zip': '64460', 'city': 'Monterrey', 'country': 'Mexico', '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': 25.68435, 'lon': -100.31721}}, {'zip': '011025', 'city': 'Bucharest', 'country': 'Romania', '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': 44.43225, 'lon': 26.10626}}, {'zip': '400006', 'city': 'Cluj-Napoca', 'country': 'Romania', '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': 46.76667, 'lon': 23.6}}, {'zip': '700111', 'city': 'Lasi', 'country': 'Romania', '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.'}, {'zip': '300736', 'city': 'Timișoara', 'country': 'Romania', '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': 45.75372, 'lon': 21.22571}}], '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'}, 'collaborators': [{'name': 'TransPharma Medical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}