Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-25 @ 4:52 PM
Study NCT ID:
NCT04701203
Status:
COMPLETED
Last Update Posted:
2025-03-18
First Post:
2021-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Adults With Hypoparathyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007011', 'term': 'Hypoparathyroidism'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ADS@ascendispharma.com', 'phone': '+1 650 352 8389', 'title': 'Aimee D. Shu, MD', 'organization': 'Ascendis Pharma, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '26 Week Blinded Period and Open-Label Period starting at Week 26 up to Week 78', 'eventGroups': [{'id': 'EG000', 'title': 'TransCon PTH', 'description': 'TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose during the blinded period\n\nTransCon PTH: TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 50, 'seriousNumAtRisk': 61, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo for TransCon PTH delivered once daily by subcutaneous injection during the blinded period\n\nPlacebo: Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 20, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'TransCon PTH Period', 'description': 'The total period of exposure to TransCon PTH. For subjects randomized to TransCon PTH at enrollment, this was the time from the first dose of blinded TransCon PTH until data cutoff in the open-label extension (OLE) period. The TransCon PTH Period for subjects randomized to placebo at enrollment was the time from first exposure to TransCon PTH at the time of cross-over from placebo, until data cutoff in the OLE.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 74, 'seriousNumAtRisk': 80, 'deathsNumAffected': 1, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Blood thyroid stimulating hormone decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Muscle twitching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Medication error', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Postural orthostatic tachycardia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'seriousEvents': [{'term': 'Invasive breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Endometrial disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Intestinal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Oropharyngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy - Primary Endpoint During the Blinded Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TransCon PTH', 'description': 'TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose\n\nTransCon PTH: TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for TransCon PTH delivered once daily by subcutaneous injection\n\nPlacebo: Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.7', 'groupId': 'OG000', 'lowerLimit': '66.3', 'upperLimit': '88.1'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '23.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For the primary efficacy endpoint, the Cochran-Mantel Haenszel test stratified by etiology of hypoparathyroidism (postsurgical or other) was used to compare the proportion of participants meeting the composite primary endpoint in the TransCon PTH versus placebo groups. Participants without week 26 albumin-adjusted serum calcium or with \\>25% (ie, \\>7 days) missing diary data of active vitamin D or elemental calcium during the 4 weeks before week 26 were considered non-responders.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks', 'description': 'The primary endpoint was a composite endpoint defined as the percentage of subjects who met the following criteria at 26 weeks of blinded treatment: 1) albumin-adjusted serum calcium measured within 4 weeks prior to and on Week 26 visit within the normal range (8.3 to 10.6 mg/dL), and 2) independence from active vitamin D within 4 weeks prior to Week 26 visit (i.e., all daily standing dose of active vitamin D equal to zero AND use of PRN ≤7 days during the 4 weeks), and 3) independence from therapeutic doses of calcium within 4 weeks prior to Week 26 visit (i.e., average daily standing dose of elemental calcium ≤600 mg AND use of PRN doses on ≤7 days during the 4 weeks), and 4) no increase in prescribed study drug within 4 weeks prior to Week 26 visit.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in HPES Symptom - Physical Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TransCon PTH', 'description': 'TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose\n\nTransCon PTH: TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for TransCon PTH delivered once daily by subcutaneous injection\n\nPlacebo: Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.01', 'groupId': 'OG000', 'lowerLimit': '-25.41', 'upperLimit': '-16.60'}, {'value': '-4.81', 'groupId': 'OG001', 'lowerLimit': '-15.22', 'upperLimit': '5.59'}]}]}], 'analyses': [{'pValue': '= 0.0038', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Change from baseline in Hypoparathyroidism Patient Experience Scale (HPES) Symptom - Physical Domain score, a disease-specific patient reported outcome, at 26 weeks of treatment. The measure uses a scale of 0-100 and values represent the change in scores from baseline. A decrease in HPES score denotes an improvement in hypoparathyroidism disease related physical symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed represents the number of subjects with both baseline and Week 26 visit values available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in HPES Symptom - Cognitive Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TransCon PTH', 'description': 'TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose\n\nTransCon PTH: TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for TransCon PTH delivered once daily by subcutaneous injection\n\nPlacebo: Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.49', 'groupId': 'OG000', 'lowerLimit': '-25.67', 'upperLimit': '-15.31'}, {'value': '-6.16', 'groupId': 'OG001', 'lowerLimit': '-15.92', 'upperLimit': '3.60'}]}]}], 'analyses': [{'pValue': '= 0.0055', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Change from baseline in Hypoparathyroidism Patient Experience Scale (HPES) Symptom - Cognitive Domain score, a disease-specific patient reported outcome, at 26 weeks of treatment. The measure uses a scale of 0-100 and values represent the change in scores from baseline. A decrease in HPES score denotes an improvement in hypoparathyroidism disease related cognitive symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed represents the number of subjects with both baseline and Week 26 visit values available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in HPES Impact - Physical Functioning Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TransCon PTH', 'description': 'TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose\n\nTransCon PTH: TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for TransCon PTH delivered once daily by subcutaneous injection\n\nPlacebo: Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.29', 'groupId': 'OG000', 'lowerLimit': '-23.59', 'upperLimit': '-12.99'}, {'value': '-1.01', 'groupId': 'OG001', 'lowerLimit': '-12.40', 'upperLimit': '10.38'}]}]}], 'analyses': [{'pValue': '= 0.0046', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Change from baseline in Hypoparathyroidism Patient Experience Scale (HPES) Impact - Physical Functioning Domain score, a disease-specific patient reported outcome, at 26 weeks of treatment. The measure uses a scale of 0-100 and values represent the change in scores from baseline. A decrease in HPES score denotes an improvement in physical functioning health-related quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed represents the number of subjects with both baseline and Week 26 visit values available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in HPES Impact - Daily Life Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TransCon PTH', 'description': 'TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose\n\nTransCon PTH: TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for TransCon PTH delivered once daily by subcutaneous injection\n\nPlacebo: Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.65', 'groupId': 'OG000', 'lowerLimit': '-22.39', 'upperLimit': '-12.91'}, {'value': '-0.36', 'groupId': 'OG001', 'lowerLimit': '-12.19', 'upperLimit': '11.46'}]}]}], 'analyses': [{'pValue': '= 0.0061', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Change from baseline in Hypoparathyroidism Patient Experience Scale (HPES) Impact - Daily Life Domain score, a disease-specific patient reported outcome, at 26 weeks of treatment. The measure uses a scale of 0-100 and values represent the change in scores from baseline. A decrease in HPES score denotes an improvement in daily health-related quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed represents the number of subjects with both baseline and Week 26 visit values available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in SF-36 Physical Functioning Subscale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TransCon PTH', 'description': 'TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose\n\nTransCon PTH: TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for TransCon PTH delivered once daily by subcutaneous injection\n\nPlacebo: Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.29', 'groupId': 'OG000', 'lowerLimit': '3.47', 'upperLimit': '7.10'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '-4.64', 'upperLimit': '4.89'}]}]}], 'analyses': [{'pValue': '= 0.0347', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Change from baseline in the 36-item Short Form Survey (SF-36) Physical Functioning subscale score, a generic health survey, at 26 weeks of treatment. The Physical Functioning subscale uses a range of 19-57.6 and values represent the change in scores from baseline. An increase in SF-36 score denotes an improvement in physical functioning health-related quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed represents the number of subjects with both baseline and Week 26 visit values available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TransCon PTH', 'description': 'TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose\n\nTransCon PTH: TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo for TransCon PTH delivered once daily by subcutaneous injection\n\nPlacebo: Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.'}, {'id': 'FG002', 'title': 'Open-Label TransCon PTH', 'description': 'Subjects who completed the 26-week blinded period were offered open-label treatment with TransCon PTH through trial Week 182.'}], 'periods': [{'title': 'Blinded Period (Weeks 0 to 26)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Open-Label Period (Weeks 26 to 182)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '79'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '79'}]}], 'dropWithdraws': [{'type': 'Study Ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '79'}]}]}], 'recruitmentDetails': 'Overall, 84 subjects were randomized and 82 subjects were dosed. Enrollment of subjects occurred in seven countries: Canada, Denmark, Germany, Italy, Hungary, Norway, and the United States.', 'preAssignmentDetails': 'A total of 106 subjects were screened and 84 of these met eligibility criteria and were enrolled into the study. Two subjects randomized to TransCon PTH were not treated (1 subject was diagnosed with a recurrence of cancer, and 1 subject withdrew consent). A total of 82 subjects were therefore included in the Intent-to-Treat (ITT) and the Safety analysis populations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TransCon PTH', 'description': 'TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose\n\nTransCon PTH: TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo for TransCon PTH delivered once daily by subcutaneous injection\n\nPlacebo: Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.0', 'spread': '13.13', 'groupId': 'BG000'}, {'value': '47.3', 'spread': '11.43', 'groupId': 'BG001'}, {'value': '48.6', 'spread': '12.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '168.22', 'spread': '8.353', 'groupId': 'BG000'}, {'value': '166.67', 'spread': '8.831', 'groupId': 'BG001'}, {'value': '167.82', 'spread': '8.450', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '77.18', 'spread': '17.335', 'groupId': 'BG000'}, {'value': '81.61', 'spread': '15.631', 'groupId': 'BG001'}, {'value': '78.31', 'spread': '16.932', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '27.27', 'spread': '5.813', 'groupId': 'BG000'}, {'value': '29.47', 'spread': '5.691', 'groupId': 'BG001'}, {'value': '27.83', 'spread': '5.828', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-25', 'size': 9796499, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-05T13:55', 'hasProtocol': True}, {'date': '2022-09-26', 'size': 5133524, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-05T13:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blind, placebo controlled, parallel group with subjects randomized into two treatment groups (3:1): TransCon PTH at a starting dose of 18 mcg/day and titrated to an optimal dose, and placebo for TransCon PTH'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'dispFirstSubmitDate': '2022-08-05', 'completionDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2021-01-06', 'resultsFirstSubmitDate': '2024-08-09', 'studyFirstSubmitQcDate': '2021-01-06', 'dispFirstPostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-24', 'studyFirstPostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy - Primary Endpoint During the Blinded Period', 'timeFrame': '26 weeks', 'description': 'The primary endpoint was a composite endpoint defined as the percentage of subjects who met the following criteria at 26 weeks of blinded treatment: 1) albumin-adjusted serum calcium measured within 4 weeks prior to and on Week 26 visit within the normal range (8.3 to 10.6 mg/dL), and 2) independence from active vitamin D within 4 weeks prior to Week 26 visit (i.e., all daily standing dose of active vitamin D equal to zero AND use of PRN ≤7 days during the 4 weeks), and 3) independence from therapeutic doses of calcium within 4 weeks prior to Week 26 visit (i.e., average daily standing dose of elemental calcium ≤600 mg AND use of PRN doses on ≤7 days during the 4 weeks), and 4) no increase in prescribed study drug within 4 weeks prior to Week 26 visit.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 26 in HPES Symptom - Physical Domain Score', 'timeFrame': '26 weeks', 'description': 'Change from baseline in Hypoparathyroidism Patient Experience Scale (HPES) Symptom - Physical Domain score, a disease-specific patient reported outcome, at 26 weeks of treatment. The measure uses a scale of 0-100 and values represent the change in scores from baseline. A decrease in HPES score denotes an improvement in hypoparathyroidism disease related physical symptoms.'}, {'measure': 'Change From Baseline to Week 26 in HPES Symptom - Cognitive Domain Score', 'timeFrame': '26 weeks', 'description': 'Change from baseline in Hypoparathyroidism Patient Experience Scale (HPES) Symptom - Cognitive Domain score, a disease-specific patient reported outcome, at 26 weeks of treatment. The measure uses a scale of 0-100 and values represent the change in scores from baseline. A decrease in HPES score denotes an improvement in hypoparathyroidism disease related cognitive symptoms.'}, {'measure': 'Change From Baseline to Week 26 in HPES Impact - Physical Functioning Domain Score', 'timeFrame': '26 weeks', 'description': 'Change from baseline in Hypoparathyroidism Patient Experience Scale (HPES) Impact - Physical Functioning Domain score, a disease-specific patient reported outcome, at 26 weeks of treatment. The measure uses a scale of 0-100 and values represent the change in scores from baseline. A decrease in HPES score denotes an improvement in physical functioning health-related quality of life.'}, {'measure': 'Change From Baseline to Week 26 in HPES Impact - Daily Life Domain Score', 'timeFrame': '26 weeks', 'description': 'Change from baseline in Hypoparathyroidism Patient Experience Scale (HPES) Impact - Daily Life Domain score, a disease-specific patient reported outcome, at 26 weeks of treatment. The measure uses a scale of 0-100 and values represent the change in scores from baseline. A decrease in HPES score denotes an improvement in daily health-related quality of life.'}, {'measure': 'Change From Baseline to Week 26 in SF-36 Physical Functioning Subscale Score', 'timeFrame': '26 weeks', 'description': 'Change from baseline in the 36-item Short Form Survey (SF-36) Physical Functioning subscale score, a generic health survey, at 26 weeks of treatment. The Physical Functioning subscale uses a range of 19-57.6 and values represent the change in scores from baseline. An increase in SF-36 score denotes an improvement in physical functioning health-related quality of life.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypoparathyroidism', 'Parathyroid Hormone', 'TransCon PTH', 'PTH(1-34)', 'Prodrug', 'Sustained Release', 'Parathyroid Hormone Replacement Therapy', 'Palopegteriparatide'], 'conditions': ['Hypoparathyroidism', 'Endocrine System Diseases', 'Parathyroid Diseases']}, 'referencesModule': {'references': [{'pmid': '39136801', 'type': 'DERIVED', 'citation': 'Brod M, Pfeiffer KM, Beck JF, Smith A. Measuring treatment impacts on symptoms in adults with hypoparathyroidism: findings from the PaTHway trial. J Patient Rep Outcomes. 2024 Aug 13;8(1):94. doi: 10.1186/s41687-024-00757-1.'}, {'pmid': '38691316', 'type': 'DERIVED', 'citation': 'Rejnmark L, Gosmanova EO, Khan AA, Makita N, Imanishi Y, Takeuchi Y, Sprague S, Shoback DM, Kohlmeier L, Rubin MR, Palermo A, Schwarz P, Gagnon C, Tsourdi E, Zhao C, Makara MA, Ominsky MS, Lai B, Ukena J, Sibley CT, Shu AD. Palopegteriparatide Treatment Improves Renal Function in Adults with Chronic Hypoparathyroidism: 1-Year Results from the Phase 3 PaTHway Trial. Adv Ther. 2024 Jun;41(6):2500-2518. doi: 10.1007/s12325-024-02843-8. Epub 2024 Apr 30.'}]}, 'descriptionModule': {'briefSummary': 'During the first 26 weeks of the trial, participants will be randomly assigned to one of two groups: one group will receive TransCon PTH and one group will receive placebo. All subjects will start with study drug at a dose of 18 mcg/day and will be individually and progressively titrated to an optimal dose in dose increments of 3 mcg/day. TransCon PTH or placebo will be administered as a subcutaneous injection using a pre-filled injection pen. Neither trial participants nor their doctors will know who has been assigned to each group. After the 26 weeks, participants will continue in the trial as part of a long-term extension study. During the extension, all participants will receive TransCon PTH, with the dose adjusted to their individual needs. This is a global trial that will be conducted in the United States, Canada, Germany, Denmark, Norway, Italy, and Hungary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males and females, ≥18 years of age\n2. Subjects with postsurgical chronic HP, or auto-immune, genetic, or idiopathic HP for at least 26 weeks. Diagnosis of HP is established based on historic hypocalcemia in the setting of inappropriately low serum PTH levels\n3. Requirement for doses of SoC (e.g., calcitriol, alfacalcidol, calcium supplements) at or above a minimum threshold:\n\n * For countries other than Japan: requirement for a dose of calcitriol ≥0.5 μg/day, or alfacalcidol ≥1.0 μg/day and (elemental) calcium ≥800 mg/day (e.g., calcium citrate, calcium carbonate etc.) for at least 12 weeks prior to Screening. In addition, the dose of calcitriol, or alfacalcidol, or calcium should be stable for at least 5 weeks prior to Screening\n * For Japan: requirement for a dose of calcitriol ≥1.0 μg/day, or alfacalcidol ≥2.0 μg/day for at least 12 weeks prior to Screening. In addition, the dose of calcitriol or alfacalcidol should be stable for at least 5 weeks prior to Screening. In Japan only (due to local practice and dietary patterns), there is no requirement to exceed a minimum dose of calcium supplements\n4. Optimization of supplements prior to randomization to achieve the target serum levels of:\n\n * 25(OH) vitamin D levels of 20-80 ng/mL (49-200 nmol/L) and\n * Magnesium level in the normal range, or just below the normal range and\n * Albumin-adjusted or ionized sCa level in the normal range, or just below the normal range\n5. The subject demonstrates a 24-hour uCa excretion of ≥125 mg/24h (on a sample collected within 52 weeks prior to Screening or during the Screening Period)\n6. BMI 17- 40 kg/m2 at Screening\n7. If ≤25 years of age, radiological evidence of epiphyseal closure based on X-ray of nondominant wrist and hand\n8. Thyroid-stimulating hormone (TSH) within normal laboratory limits within the 6 weeks prior to Visit 1; if on suppressive therapy for a history of thyroid cancer, TSH level must be ≥0.2 mIU/mL\n9. If treated with thyroid hormone replacement therapy, the dose must have been stable for at least 5 weeks prior to Screening\n10. eGFR ≥30 mL/min/1.73 m2 during Screening\n11. Able to perform daily subcutaneous self-injections of study drug (or have a designee to perform injections) via a pre-filled injection pen\n12. Able and willing to provide written and signed informed consent in accordance with GCP\n\nExclusion Criteria:\n\n1. Impaired responsiveness to PTH (pseudohypoparathyroidism) which is characterized as PTH-resistance, with elevated PTH levels in the setting of hypocalcemia\n2. Any disease that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels other than HP, such as active hyperthyroidism; Paget disease of bone; severe hypomagnesemia; type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus (HbA1C \\>9%, documented HbA1C result drawn within 12 weeks prior to Screening is acceptable); severe and chronic liver, or renal disease; Cushing syndrome; multiple myeloma; active pancreatitis; malnutrition; rickets; recent prolonged immobility; active malignancy (other than low-risk well differentiated thyroid cancer or basal cell skin cancer); active hyperparathyroidism; parathyroid carcinoma within 5 years prior to Screening; acromegaly; or multiple endocrine neoplasia types 1 and 2\n3. High risk thyroid cancer within 2 years, requiring suppression of TSH \\<0.2 mIU/mL\n4. Use of loop diuretics, phosphate binders (other than calcium supplements), digoxin, lithium, methotrexate, biotin \\>30 μg/day, or systemic corticosteroids (other than as replacement therapy)\n5. Use of thiazide diuretic within 4 weeks prior to the 24-hour urine collection scheduled to occur within 1 week prior to Visit 1\n6. Use of PTH-like drugs (whether commercially available or through participation in an investigational trial), including PTH(1-84), PTH(1-34), or other N-terminal fragments or analogs of PTH or PTH-related protein, within 4 weeks prior to Screening\n7. Use of other drugs known to influence calcium and bone metabolism, such as calcitonin, fluoride tablets (\\>0.5 mg/day), strontium, or cinacalcet hydrochloride, within 12 weeks prior to Screening\n8. Use of osteoporosis therapies known to influence calcium and bone metabolism, i.e., bisphosphonate (oral or intravenous \\[IV\\]), denosumab, raloxifene, or romosozumab therapies within 2 years prior to Screening\n9. Non-hypocalcemic seizure disorder with a history of a seizure within 26 weeks prior to Screening\n10. Increased risk for osteosarcoma, such as those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, hereditary disorders predisposing to osteosarcoma, or with a prior history of substantial external beam or implant radiation therapy involving the skeleton\n11. Pregnant or lactating women\n12. Male who has a female partner who intends to become pregnant or is of childbearing potential and is unwilling to use adequate contraceptive methods during the trial\n13. Diagnosed drug or alcohol dependence within 3 years prior to Screening\n14. Disease processes that adversely affect gastrointestinal absorption, including but not limited to short bowel syndrome, significant small bowel resection, gastric bypass, tropical sprue, active celiac disease, active ulcerative colitis, active Crohn's disease, gastroparesis and AIRE gene mutations with malabsorption\n15. Chronic or severe cardiac disease within 26 weeks prior to Screening including but not limited to congestive heart failure, myocardial infarction, severe or uncontrolled arrhythmias, bradycardia (resting heart rate \\<48 beats/minute, unless chronic and asymptomatic), symptomatic hypotension or systolic BP \\<80 mm Hg or diastolic \\<40 mm Hg or poorly controlled hypertension (systolic BP \\>165 mm Hg or diastolic \\>95 mm Hg). In the absence of a prior history of hypertension, an isolated BP \\>165/95 in the setting of white coat hypertension/anxiety may not be exclusionary and a measurement can be repeated prior to randomization\n16. Cerebrovascular accident within 5 years prior to Screening\n17. Within 26 weeks prior to Screening: acute colic due to nephrolithiasis, or acute gout. Subjects with asymptomatic renal stones are permitted\n18. Participation in any other interventional trial in which receipt of investigational drug or device occurred within 8 weeks (or within 5.5 times the half-life of the investigational drug (whichever comes first) prior to Screening\n19. Any disease or condition that, in the opinion of the investigator, may require treatment or make the subject unlikely to fully complete the trial, or any condition that presents undue risk from the investigational product or procedures, including treated malignancies that are likely to recur within the approximate 3.5-year duration of the trial\n20. Known allergy or sensitivity to PTH or any of the excipients \\[metacresol, mannitol, succinic acid, NaOH/(HCl)\\]\n21. Likely to be non-compliant with respect to trial conduct\n22. Any other reason that in the opinion of the investigator would prevent the subject from completing participation or following the trial schedule"}, 'identificationModule': {'nctId': 'NCT04701203', 'acronym': 'PaTHway', 'briefTitle': 'A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Adults With Hypoparathyroidism', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascendis Pharma A/S'}, 'officialTitle': 'PaTHway TRIAL: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, With an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults With Hypoparathyroidism', 'orgStudyIdInfo': {'id': 'TCP-304'}, 'secondaryIdInfos': [{'id': '2020-003380-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TransCon PTH', 'description': 'TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose', 'interventionNames': ['Combination Product: TransCon PTH']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for TransCon PTH delivered once daily by subcutaneous injection', 'interventionNames': ['Combination Product: Placebo']}], 'interventions': [{'name': 'TransCon PTH', 'type': 'COMBINATION_PRODUCT', 'description': 'TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.', 'armGroupLabels': ['TransCon PTH']}, {'name': 'Placebo', 'type': 'COMBINATION_PRODUCT', 'description': 'Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '89511', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '76132', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L6M 1M1', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'G1V 4G2', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '2100', 'city': 'Copenhagen', 'state': 'Capital Region', 'country': 'Denmark', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '8200', 'city': 'Aarhus', 'state': 'Central Jutland', 'country': 'Denmark', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '6720', 'city': 'Szeged', 'state': 'Csongrád megye', 'country': 'Hungary', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '1083', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '40138', 'city': 'Bologna', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '00128', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '56126', 'city': 'Pisa', 'state': 'Piacenza', 'country': 'Italy', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '0176', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Aimee D Shu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ascendis Pharma A/S Medical Monitor/Medical Expert'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascendis Pharma Bone Diseases A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}