Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT00489918
Status:
COMPLETED
Last Update Posted:
2018-07-31
First Post:
2007-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dose Ranging Study - Macroflux Parathyroid Hormone (PTH) in Postmenopausal Women With Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019379', 'term': 'Teriparatide'}, {'id': 'D010281', 'term': 'Parathyroid Hormone'}], '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': {'email': 'dkellerman@zosanopharma.com', 'phone': '(510) 745-4004', 'title': 'Don Kellerman, VP of Clinical Development and Medical Affairs', 'organization': 'Zosano Pharma Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Macroflux® Placebo', 'description': 'Macroflux® placebo patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily', 'otherNumAtRisk': 33, 'otherNumAffected': 29, 'seriousNumAtRisk': 33, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Macroflux® 20 mcg', 'description': 'Macroflux® 20 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily', 'otherNumAtRisk': 34, 'otherNumAffected': 32, 'seriousNumAtRisk': 34, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Macroflux® 30 mcg', 'description': 'Macroflux® 30 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily', 'otherNumAtRisk': 32, 'otherNumAffected': 31, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Macroflux® 40 mcg', 'description': 'Macroflux® 40 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily', 'otherNumAtRisk': 33, 'otherNumAffected': 30, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'FORTEO®', 'description': 'FORTEO® 20 mcg injection\n\nteriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh', 'otherNumAtRisk': 33, 'otherNumAffected': 23, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Application site discolorations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Application site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Application site bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Application site edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hyperuricemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypercalciuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Subdural hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'dehydration', 'notes': 'Dehydration due to gastroenterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Macroflux® Placebo', 'description': 'Macroflux® placebo patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'OG001', 'title': 'Macroflux® 20 mcg', 'description': 'Macroflux® 20 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'OG002', 'title': 'Macroflux® 30 mcg', 'description': 'Macroflux® 30 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'OG003', 'title': 'Macroflux® 40 mcg', 'description': 'Macroflux® 40 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'OG004', 'title': 'FORTEO®', 'description': 'FORTEO® 20 mcg injection\n\nteriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.33', 'spread': '3.467', 'groupId': 'OG000'}, {'value': '2.96', 'spread': '3.524', 'groupId': 'OG001'}, {'value': '3.47', 'spread': '3.575', 'groupId': 'OG002'}, {'value': '4.97', 'spread': '4.114', 'groupId': 'OG003'}, {'value': '3.55', 'spread': '3.730', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Percent Change in Lumbar Spine Bone Mineral Density (BMD) from Baseline to Week 24', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT)/Safety Population'}, {'type': 'SECONDARY', 'title': 'Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Macroflux® Placebo', 'description': 'Macroflux® placebo patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'OG001', 'title': 'Macroflux® 20 mcg', 'description': 'Macroflux® 20 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'OG002', 'title': 'Macroflux® 30 mcg', 'description': 'Macroflux® 30 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'OG003', 'title': 'Macroflux® 40 mcg', 'description': 'Macroflux® 40 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'OG004', 'title': 'FORTEO®', 'description': 'FORTEO® 20 mcg injection\n\nteriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh'}], 'classes': [{'categories': [{'measurements': [{'value': '0.97', 'spread': '3.312', 'groupId': 'OG000'}, {'value': '1.55', 'spread': '2.606', 'groupId': 'OG001'}, {'value': '2.04', 'spread': '3.277', 'groupId': 'OG002'}, {'value': '2.5', 'spread': '2.86', 'groupId': 'OG003'}, {'value': '2.81', 'spread': '2.771', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Percent Change in Lumbar Spine Bone Mineral Density from Baseline to Week 12', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT/Safety Population'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Lumbar Spine BMD: Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Macroflux® Placebo', 'description': 'Macroflux® placebo patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'OG001', 'title': 'Macroflux® 20 mcg', 'description': 'Macroflux® 20 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'OG002', 'title': 'Macroflux® 30 mcg', 'description': 'Macroflux® 30 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'OG003', 'title': 'Macroflux® 40 mcg', 'description': 'Macroflux® 40 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'OG004', 'title': 'FORTEO®', 'description': 'FORTEO® 20 mcg injection\n\nteriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh'}], 'classes': [{'categories': [{'measurements': [{'value': '0.007', 'spread': '0.0234', 'groupId': 'OG000'}, {'value': '0.011', 'spread': '0.0191', 'groupId': 'OG001'}, {'value': '0.014', 'spread': '0.0238', 'groupId': 'OG002'}, {'value': '0.017', 'spread': '0.0285', 'groupId': 'OG003'}, {'value': '0.021', 'spread': '0.0201', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Absolute Change in Lumbar Spine BMD from Baseline to Week 12', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT/Safety Population'}, {'type': 'SECONDARY', 'title': 'Percent Change in Total Hip Bone Mineral Density: Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Macroflux® Placebo', 'description': 'Macroflux® placebo patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'OG001', 'title': 'Macroflux® 20 mcg', 'description': 'Macroflux® 20 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'OG002', 'title': 'Macroflux® 30 mcg', 'description': 'Macroflux® 30 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'OG003', 'title': 'Macroflux® 40 mcg', 'description': 'Macroflux® 40 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'OG004', 'title': 'FORTEO®', 'description': 'FORTEO® 20 mcg injection\n\nteriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.634', 'spread': '1.9719', 'groupId': 'OG000'}, {'value': '0.138', 'spread': '2.0386', 'groupId': 'OG001'}, {'value': '0.553', 'spread': '2.3694', 'groupId': 'OG002'}, {'value': '1.331', 'spread': '2.1111', 'groupId': 'OG003'}, {'value': '0.094', 'spread': '2.6194', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 Weeks', 'description': 'Percent Change in Total Hip Bone Mineral Density from Baseline to Week 24', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT/Safety Population'}, {'type': 'SECONDARY', 'title': 'Percent Change in Femoral Neck BMD: Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Macroflux® Placebo', 'description': 'Macroflux® placebo patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'OG001', 'title': 'Macroflux® 20 mcg', 'description': 'Macroflux® 20 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'OG002', 'title': 'Macroflux® 30 mcg', 'description': 'Macroflux® 30 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'OG003', 'title': 'Macroflux® 40 mcg', 'description': 'Macroflux® 40 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'OG004', 'title': 'FORTEO®', 'description': 'FORTEO® 20 mcg injection\n\nteriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh'}], 'classes': [{'categories': [{'measurements': [{'value': '0.172', 'spread': '3.3432', 'groupId': 'OG000'}, {'value': '0.949', 'spread': '3.2975', 'groupId': 'OG001'}, {'value': '0.599', 'spread': '2.6127', 'groupId': 'OG002'}, {'value': '0.750', 'spread': '2.6132', 'groupId': 'OG003'}, {'value': '-0.012', 'spread': '3.6600', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 Weeks', 'description': 'Percent Change in Femoral Neck BMD from Baseline to Week 24', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT/Safety Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Macroflux® Placebo', 'description': 'Macroflux® placebo patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'FG001', 'title': 'Macroflux® 20 mcg', 'description': 'Macroflux® 20 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'FG002', 'title': 'Macroflux® 30 mcg', 'description': 'Macroflux® 30 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'FG003', 'title': 'Macroflux® 40 mcg', 'description': 'Macroflux® 40 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'FG004', 'title': 'FORTEO®', 'description': 'FORTEO® 20 mcg injection\n\nteriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '33'}, {'groupId': 'FG004', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '32'}, {'groupId': 'FG004', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '165', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Macroflux® Placebo', 'description': 'Macroflux® placebo patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'BG001', 'title': 'Macroflux® 20 mcg', 'description': 'Macroflux® 20 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'BG002', 'title': 'Macroflux® 30 mcg', 'description': 'Macroflux® 30 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'BG003', 'title': 'Macroflux® 40 mcg', 'description': 'Macroflux® 40 mcg patch\n\nteriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily'}, {'id': 'BG004', 'title': 'FORTEO®', 'description': 'FORTEO® 20 mcg injection\n\nteriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.8', 'spread': '7.1', 'groupId': 'BG000'}, {'value': '64.1', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '63.6', 'spread': '5.8', 'groupId': 'BG002'}, {'value': '64.6', 'spread': '7.3', 'groupId': 'BG003'}, {'value': '63.2', 'spread': '6.8', 'groupId': 'BG004'}, {'value': '64.06', 'spread': '6.9', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '165', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '45', 'groupId': 'BG005'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '119', 'groupId': 'BG005'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Postmenopausal women with osteoporosis'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-03', 'studyFirstSubmitDate': '2007-06-19', 'resultsFirstSubmitDate': '2016-09-26', 'studyFirstSubmitQcDate': '2007-06-20', 'lastUpdatePostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-03', 'studyFirstPostDateStruct': {'date': '2007-06-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24', 'timeFrame': '24 weeks', 'description': 'Percent Change in Lumbar Spine Bone Mineral Density (BMD) from Baseline to Week 24'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12', 'timeFrame': '12 weeks', 'description': 'Percent Change in Lumbar Spine Bone Mineral Density from Baseline to Week 12'}, {'measure': 'Absolute Change in Lumbar Spine BMD: Baseline to Week 12', 'timeFrame': '12 weeks', 'description': 'Absolute Change in Lumbar Spine BMD from Baseline to Week 12'}, {'measure': 'Percent Change in Total Hip Bone Mineral Density: Baseline to Week 24', 'timeFrame': '24 Weeks', 'description': 'Percent Change in Total Hip Bone Mineral Density from Baseline to Week 24'}, {'measure': 'Percent Change in Femoral Neck BMD: Baseline to Week 24', 'timeFrame': '24 Weeks', 'description': 'Percent Change in Femoral Neck BMD from Baseline to Week 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '19858319', 'type': 'DERIVED', 'citation': 'Cosman F, Lane NE, Bolognese MA, Zanchetta JR, Garcia-Hernandez PA, Sees K, Matriano JA, Gaumer K, Daddona PE. Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women. J Clin Endocrinol Metab. 2010 Jan;95(1):151-8. doi: 10.1210/jc.2009-0358. Epub 2009 Oct 26.'}]}, 'descriptionModule': {'briefSummary': 'A Multi-center study to determine effects of various doses of Macroflux Parathryroid Hormone (PTH) in women with osteoporosis'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy postmenopausal women age 50 years or older\n* At least three lumbar vertebrae (L1-L4) must be evaluable by dual energy x-ray absorptiometry (DXA) for bone mineral densitometry that is, without fracture or significant degenerative disease, as determined by the central imaging facility\n* Have osteoporosis defined as: Either a T-score of ≤ -2.5 at the lumbar spine, femoral neck, or total hip, AND a T-score of at least \\< -1.0 at the lumbar spine; or A T-score of ≤ -2.0 at the lumbar spine, femoral neck, or total hip, AND at least one vertebral fracture;\n\nExclusion Criteria:\n\n* Active hepatitis;\n* Active pancreatitis;\n* Unstable cardiac disease;\n* Unstable pulmonary disease;\n* Celiac disease;\n* Hyper- or hypo-parathyroidism;\n* Hyperthyroidism;\n* Cushing's disease;\n* Osteomalacia;\n* Paget's disease;\n* Osteogenesis imperfecta;\n* Known blood disorders;\n* History of kidney stones;\n* Impaired renal function;\n* Autoimmune diseases;\n* Bone metastases or a history of skeletal malignancies;\n* Cancer history that includes any cancer within the previous 5 years, with the exception of squamous or basal cell carcinoma of the skin in which the lesions were fully resected with clear margins described in a written report by a pathologist, and the patient has had no recurrence of lesions for at least 1 year from the time of original resection;\n* Any condition or disease that may interfere with the ability to have or the evaluation of a DXA scan, for example, severe osteoarthritis of the spine, spinal fusion, pedicle screws, history of vertebroplasty, or degenerative disease that results in insufficient number of evaluable lumbar vertebrae, or \\>1 lumbar vertebral fracture in L1-L4;\n* More than 4 vertebral fractures in T4-L4;\n* Bilateral hip replacements;\n* Use of fluoride (e.g. fluoride therapy for osteoporosis) or strontium at any time;\n* Have received methotrexate or immunomodulatory agents with antiproliferative activity;\n* With known dermatological disorders that would interfere with the study procedures or assessments, or with a history of contact dermatitis;\n* With known allergy or sensitivity to tapes, adhesives, PTH, teriparatide or its analogs, or components of the Macroflux® systems;\n* Who, in the opinion of the investigator, should not participate in the study, or may not be capable of following the study schedule for any reason; and\n* Unwillingness or inability to abide by the requirements of the study.\n* Have received any intravenous (IV) administered bisphosphonates in the past 24 months, or \\>2 doses of IV administered bisphosphonates total;\n* Use of oral bisphosphonates before randomization, including investigational bisphosphonates, unless: \\<6 months of treatment and off for 6 months, or 6-12 months of treatment and off for 2 years, or \\>12 months of treatment and off for 5 years;"}, 'identificationModule': {'nctId': 'NCT00489918', 'briefTitle': 'Dose Ranging Study - Macroflux Parathyroid Hormone (PTH) in Postmenopausal Women With Osteoporosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zosano Pharma Corporation'}, 'officialTitle': 'A Dose Ranging Study of the Effects of Macroflux® PTH Compared With Macroflux® Placebo and FORTEO® in Postmenopausal Women With Osteoporosis', 'orgStudyIdInfo': {'id': 'CP-2006-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Macroflux® placebo', 'description': 'Macroflux® placebo patch', 'interventionNames': ['Drug: teriparatide']}, {'type': 'EXPERIMENTAL', 'label': 'Macroflux® 20 mcg', 'description': 'Macroflux® 20 mcg patch', 'interventionNames': ['Drug: teriparatide']}, {'type': 'EXPERIMENTAL', 'label': 'Macroflux® 30 mcg', 'description': 'Macroflux® 30 mcg patch', 'interventionNames': ['Drug: teriparatide']}, {'type': 'EXPERIMENTAL', 'label': 'Macroflux® 40 mcg', 'description': 'Macroflux® 40 mcg patch', 'interventionNames': ['Drug: teriparatide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FORTEO®', 'description': 'FORTEO® 20 mcg injection', 'interventionNames': ['Drug: teriparatide']}], 'interventions': [{'name': 'teriparatide', 'type': 'DRUG', 'otherNames': ['PTH(1-34)'], 'description': 'Macroflux® patch applied to the abdomen for 30 minutes daily', 'armGroupLabels': ['Macroflux® 20 mcg', 'Macroflux® 30 mcg', 'Macroflux® 40 mcg', 'Macroflux® placebo']}, {'name': 'teriparatide', 'type': 'DRUG', 'otherNames': ['FORTEO®'], 'description': 'FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh', 'armGroupLabels': ['FORTEO®']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Thorsten von Stein, MD, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zosano Pharma Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zosano Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}