Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2026-01-02 @ 2:09 AM
Study NCT ID:
NCT00478569
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2007-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adherence to PTH(1-84) Treatment (FP-002-IM)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'interventionBrowseModule': {'meshes': [{'id': 'D010281', 'term': 'Parathyroid Hormone'}], 'ancestors': [{'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialregistry@tpna.com', 'phone': '800-778-2860', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'Any study related publication will be multi-center or single-center publications. All proposed site publications and presentations will be submitted to (sponsor) NPS Pharmaceuticals for review in advance of publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24 months', 'description': 'At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Parathyroid Hormone (PTH) (1-84)', 'description': 'PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.', 'otherNumAtRisk': 1170, 'otherNumAffected': 276, 'seriousNumAtRisk': 1170, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Motion sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Panophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 66}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Reflux gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood calcium abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood pressure systolic increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 123}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mobility decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Burning sensation mucosal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypercalciuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lipoatrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash papulosquamous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood calcium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1170, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Discontinued Before 6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1170', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Parathyroid Hormone (PTH) (1-84)', 'description': 'PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'A participant was defined as "permanently discontinued" if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1170', 'groupId': 'OG000'}, {'value': '1170', 'groupId': 'OG001'}, {'value': '1170', 'groupId': 'OG002'}, {'value': '1170', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 Months'}, {'id': 'OG001', 'title': '12 Months'}, {'id': 'OG002', 'title': '18 Months'}, {'id': 'OG003', 'title': '24 Months'}], 'classes': [{'title': 'Permanently discontinued', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '284', 'groupId': 'OG002'}, {'value': '525', 'groupId': 'OG003'}]}]}, {'title': 'Temporarily discontinued', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Ongoing', 'categories': [{'measurements': [{'value': '898', 'groupId': 'OG000'}, {'value': '847', 'groupId': 'OG001'}, {'value': '709', 'groupId': 'OG002'}, {'value': '375', 'groupId': 'OG003'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}, {'value': '268', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From enrollment to 3, 12, 18, and 24 months', 'description': 'A participant was defined as "permanently discontinued" if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards. A participant was defined as "temporarily discontinued" if treatment with PTH(1-84) was not ongoing at the time point but was then ongoing at a future time point. This was the case when a participant or investigator wanted to pause the treatment for a length of time (e.g. because of an adverse event or interruption). Therefore, a participant was defined as still "ongoing" during the trial if treatment with PTH(1-84) had not been permanently or temporarily discontinued at that time point. A participant was only defined as "missing" or "unknown" if they attended the relevant visit and there was no result or "unknown" was entered as the result. Results for months 3, 12, 18 and 24 are cumulative data up until that time point.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'SECONDARY', 'title': 'Duration of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1156', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Parathyroid Hormone (PTH) (1-84)', 'description': 'PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '35'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Duration of treatment was defined as the last known date that PTH(1-84) was taken minus the first date that PTH(1-84) was taken plus one. In the calculation of duration, no adjustment was made for the prescribed dose frequency or for periods of temporary discontinuation due to adverse drug reactions (ADRs) or temporary patient suspension of treatment.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for whom data were available'}, {'type': 'SECONDARY', 'title': 'Treatment Compliance by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1170', 'groupId': 'OG000'}, {'value': '1170', 'groupId': 'OG001'}, {'value': '1170', 'groupId': 'OG002'}, {'value': '1170', 'groupId': 'OG003'}, {'value': '1170', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '3 Months'}, {'id': 'OG001', 'title': '6 Months'}, {'id': 'OG002', 'title': '12 Months'}, {'id': 'OG003', 'title': '18 Months'}, {'id': 'OG004', 'title': '24 Months'}], 'classes': [{'title': 'Compliant', 'categories': [{'measurements': [{'value': '875', 'groupId': 'OG000'}, {'value': '845', 'groupId': 'OG001'}, {'value': '800', 'groupId': 'OG002'}, {'value': '721', 'groupId': 'OG003'}, {'value': '558', 'groupId': 'OG004'}]}]}, {'title': 'Non-compliant', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '93', 'groupId': 'OG004'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}, {'value': '360', 'groupId': 'OG003'}, {'value': '519', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From enrollment to 3, 6, 12, 18, and 24 months', 'description': "A participant was defined as compliant if the participant took the treatment as prescribed by the Physician, i.e. complied with the Physician's advice and followed the treatment regimen prescribed. A participant whose dose frequency and treatment length were changed during treatment, e.g. in response to a raised serum calcium level, was regarded as fully compliant if the revised treatment regimen was adhered to.\n\nData on compliance were obtained at each visit and relate to the period since the previous recorded visit.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Parathyroid Hormone (PTH) (1-84)', 'description': 'PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1170'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '761'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '409'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 120 investigative sites in Austria, Denmark, Germany, Greece, Ireland, the Netherlands, Spain, and the United Kingdom from 1 April 2007 to 6 March 2013.', 'preAssignmentDetails': 'Participants with a diagnosis of osteoporosis and prescribed parathyroid hormone (PTH)(1-84) in a normal clinical setting were enrolled in this non-interventional study for 24 months observation. 1179 participants were enrolled however for 9 patients the data was missing.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1170', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Parathyroid Hormone (PTH) (1-84)', 'description': 'PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.3', 'spread': '9.05', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '1149', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Although the indication in the Summary of Product characteristics is only females, some males were initially enrolled in countries where the PTH treatment is reimbursed.', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '1165', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'African', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'categories': [{'measurements': [{'value': '158', 'groupId': 'BG000'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '246', 'groupId': 'BG000'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '300', 'groupId': 'BG000'}]}]}, {'title': 'Ireland', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '272', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '156.3', 'spread': '7.98', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '63.4', 'spread': '12.25', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '25.9', 'spread': '4.59', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age at Onset of Menopause', 'classes': [{'categories': [{'measurements': [{'value': '47.9', 'spread': '5.49', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Total number of menopausal participants at baseline was 1148.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age at Onset of Menopause by Category', 'classes': [{'title': '≤ 45 years', 'categories': [{'measurements': [{'value': '283', 'groupId': 'BG000'}]}]}, {'title': '> 45 years', 'categories': [{'measurements': [{'value': '749', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Total number of menopausal participants at baseline was 1148, respectively.', 'unitOfMeasure': 'participants'}, {'title': 'Type of Menopause', 'classes': [{'title': 'Surgical', 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}]}]}, {'title': 'Natural', 'categories': [{'measurements': [{'value': '966', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Total number of menopausal participants at baseline was 1148.', 'unitOfMeasure': 'participants'}, {'title': 'Calcium and/or Vitamin D Supplement', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '1046', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Time Since Starting PTH(1-84)', 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '15.52', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PTH (1-84) Dosing Frequency', 'classes': [{'title': 'Once Daily', 'categories': [{'measurements': [{'value': '1162', 'groupId': 'BG000'}]}]}, {'title': 'Every Other Day', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Family History of Osteoporosis', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '223', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '896', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Alcohol Consumption', 'classes': [{'title': 'Never', 'categories': [{'measurements': [{'value': '709', 'groupId': 'BG000'}]}]}, {'title': 'Occasionally', 'categories': [{'measurements': [{'value': '385', 'groupId': 'BG000'}]}]}, {'title': 'Daily', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Current Smoker', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '1057', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Past Smoker', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '159', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '1009', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Glucocorticosteroid Use', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '1038', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Total Hip Bone Mineral Density (BMD)', 'classes': [{'categories': [{'measurements': [{'value': '0.680', 'spread': '0.1239', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Measured by dual energy X-ray absorptiometry (DXA). The total number of participants for whom baseline hip BMD data was available was 654.', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Hip T-score', 'classes': [{'categories': [{'measurements': [{'value': '-2.46', 'spread': '0.965', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'T-score is the bone mineral density (BMD) at the site when compared to the young normal reference mean; a healthy thirty-year-old.\n\nNormal is a T-score of -1.0 or higher; Osteopenia is defined as between -1.0 and -2.5 Osteoporosis is defined as -2.5 or lower.\n\nThe total number of participants for whom Baseline hip T-score data was available was 812.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Spine Bone Mineral Density (BMD)', 'classes': [{'categories': [{'measurements': [{'value': '0.763', 'spread': '0.1480', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The total number of participants for whom baseline spine bone mineral density data was available was 738.', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Spine T-score', 'classes': [{'categories': [{'measurements': [{'value': '-3.10', 'spread': '1.130', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The total number of participants for whom Baseline spine T-score data was available was 954.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Participants With at Least One Fracture', 'classes': [{'categories': [{'measurements': [{'value': '904', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Was Patient/relative/helper instructed in PTH(1-84) (self) injection technique?', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '1167', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1179}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-29', 'studyFirstSubmitDate': '2007-05-23', 'resultsFirstSubmitDate': '2014-04-29', 'studyFirstSubmitQcDate': '2007-05-23', 'lastUpdatePostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-29', 'studyFirstPostDateStruct': {'date': '2007-05-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Discontinued Before 6 Months of Treatment', 'timeFrame': '6 months', 'description': 'A participant was defined as "permanently discontinued" if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment', 'timeFrame': 'From enrollment to 3, 12, 18, and 24 months', 'description': 'A participant was defined as "permanently discontinued" if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards. A participant was defined as "temporarily discontinued" if treatment with PTH(1-84) was not ongoing at the time point but was then ongoing at a future time point. This was the case when a participant or investigator wanted to pause the treatment for a length of time (e.g. because of an adverse event or interruption). Therefore, a participant was defined as still "ongoing" during the trial if treatment with PTH(1-84) had not been permanently or temporarily discontinued at that time point. A participant was only defined as "missing" or "unknown" if they attended the relevant visit and there was no result or "unknown" was entered as the result. Results for months 3, 12, 18 and 24 are cumulative data up until that time point.'}, {'measure': 'Duration of Treatment', 'timeFrame': '24 months', 'description': 'Duration of treatment was defined as the last known date that PTH(1-84) was taken minus the first date that PTH(1-84) was taken plus one. In the calculation of duration, no adjustment was made for the prescribed dose frequency or for periods of temporary discontinuation due to adverse drug reactions (ADRs) or temporary patient suspension of treatment.'}, {'measure': 'Treatment Compliance by Visit', 'timeFrame': 'From enrollment to 3, 6, 12, 18, and 24 months', 'description': "A participant was defined as compliant if the participant took the treatment as prescribed by the Physician, i.e. complied with the Physician's advice and followed the treatment regimen prescribed. A participant whose dose frequency and treatment length were changed during treatment, e.g. in response to a raised serum calcium level, was regarded as fully compliant if the revised treatment regimen was adhered to.\n\nData on compliance were obtained at each visit and relate to the period since the previous recorded visit."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Clinical Use of PTH(1-84)']}, 'descriptionModule': {'briefSummary': 'The primary objective is:\n\n1\\) to describe adherence (and the main factors influencing adherence) to PTH(1-84) treatment when prescribed in a normal clinical setting.\n\nThe secondary objectives are:\n\n1. to describe the demographics and clinical characteristics of the patients that in a normal clinical setting are started on a treatment regimen with PTH(1-84)\n2. to describe (using available data) the long term treatment effectiveness during the 24 months following initiation of PTH(1-84) treatment in a normal clinical setting\n3. to monitor safety for 24 months following initiation of PTH(1-84) treatment in a patient in a normal clinical setting.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Postmenopausal women with osteoporosis and a high risk of fractures prescribed PTH(1-84) in a normal clinical setting.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* According to the current Summary of Product Characteristics (SmPC)\n* PTH(1-84) treatment initiated within one month preceding enrolment\n* The patient's written informed consent to direct access and data processing must be obtained.\n\nExclusion Criteria:\n\n* According to the current SmPC\n* The patient cannot participate in a clinical trial with PTH (all other trials allowed)."}, 'identificationModule': {'nctId': 'NCT00478569', 'briefTitle': 'Adherence to PTH(1-84) Treatment (FP-002-IM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Adherence to PTH(1-84) Treatment in Europe. A Non-interventional Cohort Study Collecting Safety Information and Examining Reasons and Predictors for Adherence to PTH(1-84) Treatment in Usual Clinical Settings', 'orgStudyIdInfo': {'id': 'FP-002-IM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Parathyroid Hormone (PTH) (1-84)', 'description': 'PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.', 'interventionNames': ['Drug: Parathyroid Hormone (PTH) (1-84)']}], 'interventions': [{'name': 'Parathyroid Hormone (PTH) (1-84)', 'type': 'DRUG', 'otherNames': ['Preotact'], 'description': 'Adherence to PTH(1-84) treatment in Usual Clinical Settings', 'armGroupLabels': ['Parathyroid Hormone (PTH) (1-84)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Roskilde', 'country': 'Denmark', 'facility': 'Nycomed', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}], 'overallOfficials': [{'name': 'Medical Director, Clinical Science', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}