Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-25 @ 5:33 PM
Study NCT ID:
NCT01343004
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2011-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596789', 'term': 'abaloparatide'}, {'id': 'D019379', 'term': 'Teriparatide'}], 'ancestors': [{'id': 'D010281', 'term': 'Parathyroid Hormone'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@radiuspharm.com', 'phone': '(617) 551-4700', 'title': 'Program Director', 'organization': 'Radius Health, Inc.'}, 'certainAgreement': {'otherDetails': "Results may not be published prior to the Study Report completion. Investigators may publish results, providing a manuscript to the Sponsor =/\\> 30 days prior to its submission to a publisher. Sponsor will provide manuscript to Investigators =/\\> 30 days prior to its submission. Investigator shall comply with Sponsor's policy, withholding publication for an additional 60 days to permit the Sponsor to obtain patent or other proprietary rights protection, if deemed necessary.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo identical in appearance to BA058 study drug\n\nPlacebo: Placebo 0 mcg subcutaneous daily', 'otherNumAtRisk': 820, 'otherNumAffected': 447, 'seriousNumAtRisk': 820, 'seriousNumAffected': 90}, {'id': 'EG001', 'title': 'BA058 80 mcg (Abaloparatide)', 'description': 'BA058 80 mcg: BA058 80 mcg subcutaneous daily', 'otherNumAtRisk': 822, 'otherNumAffected': 492, 'seriousNumAtRisk': 822, 'seriousNumAffected': 80}, {'id': 'EG002', 'title': 'Teriparatide', 'description': 'Blinded until after randomization, then open-label\n\nteriparatide: teriparatide 20 mcg subcutaneous daily', 'otherNumAtRisk': 818, 'otherNumAffected': 456, 'seriousNumAtRisk': 818, 'seriousNumAffected': 82}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 13}], 'organSystem': 'Cardiac disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 34}], 'organSystem': 'Infections and infestations'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 52}], 'organSystem': 'Infections and infestations'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 73}], 'organSystem': 'Infections and infestations'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 41}], 'organSystem': 'Infections and infestations'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 71}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 70}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 58}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 42}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Hypercalciuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 93}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 102}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 41}], 'organSystem': 'Vascular disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 59}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 51}], 'organSystem': 'Nervous system disorders'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Myocardial infraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Mitral valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Vestibular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Endocrine disorders'}, {'term': 'Thyroid cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Endocrine disorders'}, {'term': 'Malculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Retinal artery occulusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Gastric Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 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{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Change of bowel habit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Enterocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 820, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 822, 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[{'value': '820', 'groupId': 'OG000'}, {'value': '822', 'groupId': 'OG001'}, {'value': '818', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo identical in appearance to BA058 study drug\n\nPlacebo: Placebo 0 mcg subcutaneous daily'}, {'id': 'OG001', 'title': 'BA058 80 mcg (Abaloparatide)', 'description': 'BA058 80 mcg: BA058 80 mcg subcutaneous daily'}, {'id': 'OG002', 'title': 'Teriparatide', 'description': 'Blinded until after randomization, then open-label\n\nteriparatide: teriparatide 20 mcg subcutaneous daily'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'unitOfMeasure': 'Hypercalcemic events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all patients who received 1 or more doses of study medication'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo identical in appearance to BA058 study drug\n\nPlacebo: Placebo 0 mcg subcutaneous daily'}, {'id': 'FG001', 'title': 'BA058 80 mcg (Abaloparatide)', 'description': 'BA058 80 mcg: BA058 80 mcg subcutaneous daily'}, {'id': 'FG002', 'title': 'Teriparatide', 'description': 'Blinded until after randomization, then open-label\n\nteriparatide: teriparatide 20 mcg subcutaneous daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '821'}, {'groupId': 'FG001', 'numSubjects': '824'}, {'groupId': 'FG002', 'numSubjects': '818'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '637'}, {'groupId': 'FG001', 'numSubjects': '606'}, {'groupId': 'FG002', 'numSubjects': '658'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '218'}, {'groupId': 'FG002', 'numSubjects': '160'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '821', 'groupId': 'BG000'}, {'value': '824', 'groupId': 'BG001'}, {'value': '818', 'groupId': 'BG002'}, {'value': '2463', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo identical in appearance to BA058 study drug\n\nPlacebo: Placebo 0 mcg subcutaneous daily'}, {'id': 'BG001', 'title': 'BA058 80 mcg (Abaloparatide)', 'description': 'BA058 80 mcg: BA058 80 mcg subcutaneous daily'}, {'id': 'BG002', 'title': 'Teriparatide', 'description': 'Blinded until after randomization, then open-label\n\nteriparatide: teriparatide 20 mcg subcutaneous daily'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.7', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '68.9', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '68.8', 'spread': '6.6', 'groupId': 'BG002'}, {'value': '68.8', 'spread': '6.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '821', 'groupId': 'BG000'}, {'value': '824', 'groupId': 'BG001'}, {'value': '818', 'groupId': 'BG002'}, {'value': '2463', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) Population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2463}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-10', 'studyFirstSubmitDate': '2011-04-26', 'resultsFirstSubmitDate': '2016-10-25', 'studyFirstSubmitQcDate': '2011-04-26', 'lastUpdatePostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-10', 'studyFirstPostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With New Vertebral Fractures at 18 Months', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months', 'timeFrame': 'Basline and 18 months'}, {'measure': 'Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18', 'timeFrame': 'Baseline and 18 months'}, {'measure': 'Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18', 'timeFrame': 'Baseline and 18 months'}, {'measure': 'Number of Participants With Non-vertebral Fractures at 18 Months', 'timeFrame': '18 months'}, {'measure': 'Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['BA058', 'abaloparatide', 'Abaloparatide-SC', 'osteoporosis', 'postmenopausal', 'bone loss', 'ACTIVE', 'fracture'], 'conditions': ['Osteoporosis', 'Postmenopausal Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '40786602', 'type': 'DERIVED', 'citation': 'Sheth NP, Krohn K, Torkelson J, Winzenrieth R, Humbert L, Pearman L, Wang Y, Boxberger JI, Bostrom MP. Abaloparatide effects on BMD in acetabular regions corresponding to DeLee and Charnley zones in women with postmenopausal osteoporosis. Bone Rep. 2025 Jul 19;26:101858. doi: 10.1016/j.bonr.2025.101858. eCollection 2025 Sep.'}, {'pmid': '39999474', 'type': 'DERIVED', 'citation': 'DeSapri KT, Clarke BL, Kostenuik P, Wang Y, Mitlak BH. Effect of abaloparatide on fracture incidence and bone mineral density in postmenopausal women with osteoporosis at highest risk for fracture. Menopause. 2025 May 1;32(5):388-395. doi: 10.1097/GME.0000000000002516.'}, {'pmid': '36588166', 'type': 'DERIVED', 'citation': 'Cosman F, Hans D, Shevroja E, Wang Y, Mitlak B. Effect of Abaloparatide on Bone Microarchitecture Assessed by Trabecular Bone Score in Women With Osteoporosis: Post Hoc Analysis of ACTIVE and ACTIVExtend. J Bone Miner Res. 2023 Apr;38(4):464-470. doi: 10.1002/jbmr.4764. Epub 2023 Feb 12.'}, {'pmid': '34231877', 'type': 'DERIVED', 'citation': 'Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013424. doi: 10.1002/14651858.CD013424.pub2.'}, {'pmid': '32658264', 'type': 'DERIVED', 'citation': 'Cosman F, Peterson LR, Towler DA, Mitlak B, Wang Y, Cummings SR. Cardiovascular Safety of Abaloparatide in Postmenopausal Women With Osteoporosis: Analysis From the ACTIVE Phase 3 Trial. J Clin Endocrinol Metab. 2020 Nov 1;105(11):3384-95. doi: 10.1210/clinem/dgaa450.'}, {'pmid': '32513495', 'type': 'DERIVED', 'citation': 'Saag KG, Williams SA, Wang Y, Weiss RJ, Cauley JA. Effect of Abaloparatide on Bone Mineral Density and Fracture Incidence in a Subset of Younger Postmenopausal Women with Osteoporosis at High Risk for Fracture. Clin Ther. 2020 Jun;42(6):1099-1107.e1. doi: 10.1016/j.clinthera.2020.04.012. Epub 2020 Jun 6.'}, {'pmid': '31674644', 'type': 'DERIVED', 'citation': 'Leder BZ, Mitlak B, Hu MY, Hattersley G, Bockman RS. Effect of Abaloparatide vs Alendronate on Fracture Risk Reduction in Postmenopausal Women With Osteoporosis. J Clin Endocrinol Metab. 2020 Mar 1;105(3):938-43. doi: 10.1210/clinem/dgz162.'}, {'pmid': '31411768', 'type': 'DERIVED', 'citation': 'Leder BZ, Zapalowski C, Hu MY, Hattersley G, Lane NE, Singer AJ, Dore RK. Fracture and Bone Mineral Density Response by Baseline Risk in Patients Treated With Abaloparatide Followed by Alendronate: Results From the Phase 3 ACTIVExtend Trial. J Bone Miner Res. 2019 Dec;34(12):2213-2219. doi: 10.1002/jbmr.3848. Epub 2019 Sep 11.'}, {'pmid': '27826127', 'type': 'DERIVED', 'citation': 'Moreira CA, Fitzpatrick LA, Wang Y, Recker RR. Effects of abaloparatide-SC (BA058) on bone histology and histomorphometry: The ACTIVE phase 3 trial. Bone. 2017 Apr;97:314-319. doi: 10.1016/j.bone.2016.11.004. Epub 2016 Nov 5.'}, {'pmid': '27612281', 'type': 'DERIVED', 'citation': 'Cosman F, Hattersley G, Hu MY, Williams GC, Fitzpatrick LA, Black DM. Effects of Abaloparatide-SC on Fractures and Bone Mineral Density in Subgroups of Postmenopausal Women With Osteoporosis and Varying Baseline Risk Factors. J Bone Miner Res. 2017 Jan;32(1):17-23. doi: 10.1002/jbmr.2991. Epub 2016 Sep 28.'}, {'pmid': '27533157', 'type': 'DERIVED', 'citation': 'Miller PD, Hattersley G, Riis BJ, Williams GC, Lau E, Russo LA, Alexandersen P, Zerbini CA, Hu MY, Harris AG, Fitzpatrick LA, Cosman F, Christiansen C; ACTIVE Study Investigators. Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial. JAMA. 2016 Aug 16;316(7):722-33. doi: 10.1001/jama.2016.11136.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled, comparative Phase 3, multicenter international study to evaluate the efficacy and safety of BA058 (abaloparatide) 80 µg in the prevention of fracture in otherwise healthy ambulatory postmenopausal women with severe osteoporosis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy ambulatory postmenopausal (≥ 5 years) women from 50 to 85 years of age (inclusive) with a diagnosis of osteoporosis\n* The women are to have a bone mineral density (BMD) T score ≤ -2.5 and \\> -5.0 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years. Postmenopausal women older than 65 who meet the above fracture criteria but have a T score ≤ -2.0 and \\> -5.0 may be enrolled. Women older than 65 who do not meet the fracture criteria may also be enrolled if their T score is ≤ -3.0 and \\> -5.0\n* Normal physical exam, vital signs, electrocardiogram (ECG) and medical history\n* Laboratory tests within the normal range including serum calcium, PTH(1-84), serum phosphorus and alkaline phosphatase\n\nExclusion Criteria:\n\n* History of more than 4 mild or moderate spine fractures or any severe fracture\n* Abnormality of the spine or hip that would prohibit assessment of bone mineral density (BMD)\n* Unexplained elevation of serum alkaline phosphatase, history of bone disorders (such as Paget's disease) or a diagnosis of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin)\n* History of thyroid, parathyroid, or adrenal disorders, or malabsorptive syndromes or any chronic or recurrent diseases or disturbances that would interfere with the interpretation of study data or compromise the safety of the patient\n* Prior treatment with parathyroid hormone (PTH) or parathyroid hormone-related peptid (PTHrP)\n* Prior treatment with bisphosphonates, fluoride, or strontium within the past five years or treatment with androgens, anabolic steroids, corticosteroids or selective estrogen receptor modulators within the past 12 months (except hormone replacement therapy)\n* Prior treatment with an investigational drug within the past 12 months\n* History of nephrolithiasis or urolithiasis within the past five years, or history of osteosarcoma at any time"}, 'identificationModule': {'nctId': 'NCT01343004', 'acronym': 'ACTIVE', 'briefTitle': 'Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Radius Health, Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-Controlled, Comparative Multicenter Phase 3 Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Injection for Prevention of Fracture in Ambulatory Postmenopausal Women With Severe Osteoporosis and at Risk of Fracture', 'orgStudyIdInfo': {'id': 'BA058-05-003'}, 'secondaryIdInfos': [{'id': 'ACTIVE Trial', 'type': 'OTHER', 'domain': 'Radius Health, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo identical in appearance to BA058 study drug', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BA058 80 mcg (abaloparatide)', 'interventionNames': ['Drug: BA058 80 mcg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'teriparatide', 'description': 'Blinded until after randomization, then open-label', 'interventionNames': ['Drug: teriparatide']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo 0 mcg subcutaneous daily', 'armGroupLabels': ['Placebo']}, {'name': 'BA058 80 mcg', 'type': 'DRUG', 'otherNames': ['abaloparatide, Abaloparatide-SC'], 'description': 'BA058 80 mcg subcutaneous daily', 'armGroupLabels': ['BA058 80 mcg (abaloparatide)']}, {'name': 'teriparatide', 'type': 'DRUG', 'otherNames': ['Forteo', 'Forsteo'], 'description': 'teriparatide 20 mcg subcutaneous daily', 'armGroupLabels': ['teriparatide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Brasília', 'country': 'Brazil', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}, {'city': 'Curitiba', 'country': 'Brazil', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'city': 'Rio de Janeiro', 'country': 'Brazil', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Vitória', 'country': 'Brazil', 'geoPoint': {'lat': -20.31944, 'lon': -40.33778}}, {'city': 'Brno', 'country': 'Czechia', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Pardubice', 'country': 'Czechia', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Aalborg', 'country': 'Denmark', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'city': 'Ballerup Municipality', 'country': 'Denmark', 'geoPoint': {'lat': 55.73165, 'lon': 12.36328}}, {'city': 'Vejle', 'country': 'Denmark', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}, {'city': 'Tallinn', 'country': 'Estonia', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Tartu', 'country': 'Estonia', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Vilnius', 'country': 'Lithuania', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': 'Bialystok', 'country': 'Poland', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Katowice', 'country': 'Poland', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Kielce', 'country': 'Poland', 'geoPoint': {'lat': 50.87033, 'lon': 20.62752}}, {'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Zgierz', 'country': 'Poland', 'geoPoint': {'lat': 51.85561, 'lon': 19.40623}}, {'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}], 'overallOfficials': [{'name': 'Radius Health, Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Radius Health, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radius Health, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}