Viewing Study NCT00486434

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Ignite Creation Date: 2025-12-25 @ 2:21 AM
Ignite Modification Date: 2026-03-12 @ 12:38 PM
Study NCT ID: NCT00486434
Status: COMPLETED
Last Update Posted: 2019-04-26
First Post: 2007-06-13
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Lithuania']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bjr@nordicbioscience.com', 'phone': '+4522901317', 'title': 'Bente Juel Riis, Medical Director', 'organization': 'Nordic Bioscience A/S'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From baseline until 30 days following the end of study.', 'description': 'The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Active Arm', 'description': '0.8mg SMC021 Oral Calcitonin tablet twice daily', 'otherNumAtRisk': 585, 'otherNumAffected': 548, 'seriousNumAtRisk': 585, 'seriousNumAffected': 100}, {'id': 'EG001', 'title': 'Placebo Arm', 'description': '1 SMC021 Placebo tablet twice daily', 'otherNumAtRisk': 584, 'otherNumAffected': 520, 'seriousNumAtRisk': 584, 'seriousNumAffected': 88}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 93}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 104}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 24}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 59}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 52}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 55}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 52}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 52}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 30}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypercholesterolemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 36}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 30}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 20}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Viral infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bone graft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 7}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Benign breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Coronary artery dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 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and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Uterine leimyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cauda equina syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urethral prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urinary retension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Prostatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Uterine haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Peau d´orange', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abscess drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Appendicectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardial pacemaker insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastric bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lipoma excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Radical hysterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Thyroidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 584, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '584', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': '0.8mg SMC021 Oral Calcitonin tablet twice daily'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': '1 SMC021 Placebo tablet twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.188', 'spread': '0.5626', 'groupId': 'OG000'}, {'value': '-0.198', 'spread': '0.5069', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 24 months', 'description': 'The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criteria. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criteria were met. The outcome was measured as a change in JSW from baseline to month 24.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.'}, {'type': 'PRIMARY', 'title': 'Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '584', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': '0.8mg SMC021 Oral Calcitonin tablet twice daily'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': '1 SMC021 Placebo tablet twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-124.0', 'groupId': 'OG000', 'lowerLimit': '-391', 'upperLimit': '218'}, {'value': '-109.0', 'groupId': 'OG001', 'lowerLimit': '-410', 'upperLimit': '349'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Change from baseline to 24 months', 'description': 'WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.'}, {'type': 'PRIMARY', 'title': 'Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '584', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': '0.8mg SMC021 Oral Calcitonin tablet twice daily'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': '1 SMC021 Placebo tablet twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-390.0', 'groupId': 'OG000', 'lowerLimit': '-1307', 'upperLimit': '783'}, {'value': '-299.5', 'groupId': 'OG001', 'lowerLimit': '-1342', 'upperLimit': '915'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Change from baseline to 24 months', 'description': 'WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the degree of difficulty for performing each daily function listed in the questionnaire. 0 is no difficulty (best), 100 is extreme difficulty (worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 1700. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less difficulty).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.'}, {'type': 'SECONDARY', 'title': 'Changes in Biochemical Markers of Bone & Cartilage Metabolism.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '584', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': '0.8mg SMC021 Oral Calcitonin tablet twice daily'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': '1 SMC021 Placebo tablet twice daily'}], 'classes': [{'title': 'Serum CTX-I (ng/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '578', 'groupId': 'OG000'}, {'value': '577', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.358', 'spread': '68.1153', 'groupId': 'OG000'}, {'value': '62.883', 'spread': '65.7225', 'groupId': 'OG001'}]}]}, {'title': 'Serum Osteocalcin (ng/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '578', 'groupId': 'OG000'}, {'value': '577', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.134', 'spread': '22.1368', 'groupId': 'OG000'}, {'value': '1.785', 'spread': '22.8324', 'groupId': 'OG001'}]}]}, {'title': '24-h urine CTX-I/creatinine (µg/mmol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'OG000'}, {'value': '571', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.959', 'spread': '50.0723', 'groupId': 'OG000'}, {'value': '8.311', 'spread': '55.4934', 'groupId': 'OG001'}]}]}, {'title': '24-h urine CTX-II/creatinine (ng/mmol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'OG000'}, {'value': '571', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.484', 'spread': '56.4879', 'groupId': 'OG000'}, {'value': '11.266', 'spread': '49.6250', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Month 24', 'description': 'The central laboratory analyzed serum CTX-I (S-Crosslaps, Elecsys) and osteocalcin as well as urine CTX-I/creatinine and CTX-II/creatinine. It was originally planned that serum CTX-II would be measured, but this was not done.', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. The number analyzed in some rows differs from the overall number analyzed due to missing values from patients who prematurely discontinued.'}, {'type': 'SECONDARY', 'title': 'Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '584', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': '0.8mg SMC021 Oral Calcitonin tablet twice daily'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': '1 SMC021 Placebo tablet twice daily'}], 'classes': [{'title': 'Total osteophytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.784', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.754', 'groupId': 'OG001'}]}]}, {'title': 'Total JSN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.45', 'spread': '1.063', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '0.990', 'groupId': 'OG001'}]}]}, {'title': 'Total cyst/erosions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.83', 'spread': '1.204', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '1.327', 'groupId': 'OG001'}]}]}, {'title': 'Total osteophytes, JSN and cyst/erosions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.68', 'spread': '2.682', 'groupId': 'OG000'}, {'value': '1.84', 'spread': '2.714', 'groupId': 'OG001'}]}]}, {'title': 'AUSCAN total score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-51.5', 'spread': '265.13', 'groupId': 'OG000'}, {'value': '-38.1', 'spread': '272.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 24', 'description': 'To assess disease progression of OA affected joints, X-rays of both hands were performed \\& assessed by two central readers (at Synarc). Hand OA was assessed by calculating total score for osteophytes, cyst erosion, \\& joint space narrowing, each of which were based on sum of left and right hand X-ray analysis with possible scores of 0-66. The overall total score (possible range 0-198) was also used. Higher scores (closer to 66 or to 198 when using overall total score) imply a worse outcome. Hand analyses were based on double readings, and the mean was used in the analyses.\n\nThe AUStralian/CANadian Osteoarthritis Hand Index (AUSCAN) questionnaire was also used for assessment of hand OA. It measures pain (5 questions), stiffness (1 question) and difficulties with daily activities (9 questions) through a visual analogue scale (0-100mm; 0 = lowest score; 100 = highest score). Lower AUSCAN scores represent a better outcome. Change (from baseline to month 24) in these scores was calculated.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'About 15% of the ITT population had hand OA at baseline and only these subjects were included in the X-ray assessments.The AUSCAN questionnaire was administered to all the patients at sites in Denmark, the Czech Republic, and Romania.'}, {'type': 'SECONDARY', 'title': 'Nature and # of AEs Monitored Continuously During Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '584', 'groupId': 'OG001'}, {'value': '1169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': '0.8mg SMC021 Oral Calcitonin tablet twice daily'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': '1 SMC021 Placebo tablet twice daily'}, {'id': 'OG002', 'title': 'Total', 'description': 'Total number of subjects between the two groups'}], 'classes': [{'title': 'Any primary system organ class', 'categories': [{'measurements': [{'value': '548', 'groupId': 'OG000'}, {'value': '520', 'groupId': 'OG001'}, {'value': '1068', 'groupId': 'OG002'}]}]}, {'title': 'Blood and lymphatic system disorders', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'Cardiac disorders', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}]}, {'title': 'Congenital, familial and genetic disorders', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Ear and labyrinth disorders', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Endocrine disorders', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Eye disorders', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal disorders', 'categories': [{'measurements': [{'value': '268', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '418', 'groupId': 'OG002'}]}]}, {'title': 'General disorders and administration site condit.', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}]}, {'title': 'Hepatobiliary disorders', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Immune system disorders', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Infections and infestations', 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '480', 'groupId': 'OG002'}]}]}, {'title': 'Injury, poisoning and procedural complications', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}]}, {'title': 'Investigations', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}]}, {'title': 'Metabolism and nutrition disorders', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}]}, {'title': 'Musculoskeletal and connective tissue disorders', 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}, {'value': '498', 'groupId': 'OG002'}]}]}, {'title': 'Neoplasms benign, malignant and unspecified', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}, {'title': 'Nervous system disorders', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}]}, {'title': 'Psychiatric disorders', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}]}, {'title': 'Renal and urinary disorders', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'Reproductive system and breast disorders', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory, thoracic and mediastinal disorders', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}]}, {'title': 'Skin and subcutaneous tissue disorders', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}]}]}, {'title': 'Surgical and medical procedures', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}]}, {'title': 'Vascular disorders', 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '252', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to Month 24', 'description': 'Adverse events were by system organ class of all patients.', 'unitOfMeasure': 'Number of AEs by system organ class', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. A patient with multiple occurrences of a TEAE under one treatment is counted only once in the AE category for that treatment.'}, {'type': 'SECONDARY', 'title': 'Disease Progression in the Knee Evaluated by MRI.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': '0.8mg SMC021 Oral Calcitonin tablet twice daily'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': '1 SMC021 Placebo tablet twice daily'}], 'classes': [{'title': 'Total cartilage volume m12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.90', 'spread': '10.104', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '9.283', 'groupId': 'OG001'}]}]}, {'title': 'Total cartilage volume m24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.79', 'spread': '10.352', 'groupId': 'OG000'}, {'value': '1.94', 'spread': '9.257', 'groupId': 'OG001'}]}]}, {'title': 'Total cartilage thickness m12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9921', 'spread': '7.05068', 'groupId': 'OG000'}, {'value': '0.4343', 'spread': '6.90177', 'groupId': 'OG001'}]}]}, {'title': 'Total cartilage thickness m24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1777', 'spread': '6.22356', 'groupId': 'OG000'}, {'value': '2.2467', 'spread': '7.09590', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Month 24', 'description': 'Disease progression in the signal knee (cartilage volume and thickness) were evaluated by magnetic resonance imaging (MRI). MRIs were performed for patients from the sites in Ballerup, Denmark, the Czech Republic, and Romania using a quality controlled low-field 0.18T C-Span scanner from Esaote dedicated to the imaging of extremities. The same solenoid coil was used for all patients at a given site.', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MRIs were performed for patients from the sites in Ballerup, Denmark, the Czech Republic, and Romania.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Arm', 'description': '0.8mg SMC021 Oral Calcitonin tablet twice daily'}, {'id': 'FG001', 'title': 'Placebo Arm', 'description': '1 SMC021 Placebo tablet twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '588'}, {'groupId': 'FG001', 'numSubjects': '588'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '394'}, {'groupId': 'FG001', 'numSubjects': '454'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '134'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Personal reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '588', 'groupId': 'BG000'}, {'value': '588', 'groupId': 'BG001'}, {'value': '1176', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Arm', 'description': '0.8mg SMC021 Oral Calcitonin tablet twice daily'}, {'id': 'BG001', 'title': 'Placebo Arm', 'description': '1 SMC021 Placebo tablet twice daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '293', 'groupId': 'BG000'}, {'value': '321', 'groupId': 'BG001'}, {'value': '614', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '295', 'groupId': 'BG000'}, {'value': '267', 'groupId': 'BG001'}, {'value': '562', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.1', 'spread': '6.84', 'groupId': 'BG000'}, {'value': '63.9', 'spread': '6.41', 'groupId': 'BG001'}, {'value': '64.0', 'spread': '6.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '418', 'groupId': 'BG000'}, {'value': '386', 'groupId': 'BG001'}, {'value': '804', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Hong Kong', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}, {'title': 'Estonia', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '370', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '739', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-25', 'studyFirstSubmitDate': '2007-06-13', 'resultsFirstSubmitDate': '2012-03-28', 'studyFirstSubmitQcDate': '2007-06-13', 'lastUpdatePostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-05-25', 'studyFirstPostDateStruct': {'date': '2007-06-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months.', 'timeFrame': 'Change from baseline to 24 months', 'description': 'The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criteria. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criteria were met. The outcome was measured as a change in JSW from baseline to month 24.'}, {'measure': 'Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee', 'timeFrame': 'Change from baseline to 24 months', 'description': 'WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain).'}, {'measure': 'Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee.', 'timeFrame': 'Change from baseline to 24 months', 'description': 'WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the degree of difficulty for performing each daily function listed in the questionnaire. 0 is no difficulty (best), 100 is extreme difficulty (worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 1700. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less difficulty).'}], 'secondaryOutcomes': [{'measure': 'Changes in Biochemical Markers of Bone & Cartilage Metabolism.', 'timeFrame': 'From Baseline to Month 24', 'description': 'The central laboratory analyzed serum CTX-I (S-Crosslaps, Elecsys) and osteocalcin as well as urine CTX-I/creatinine and CTX-II/creatinine. It was originally planned that serum CTX-II would be measured, but this was not done.'}, {'measure': 'Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months', 'timeFrame': 'Baseline and Month 24', 'description': 'To assess disease progression of OA affected joints, X-rays of both hands were performed \\& assessed by two central readers (at Synarc). Hand OA was assessed by calculating total score for osteophytes, cyst erosion, \\& joint space narrowing, each of which were based on sum of left and right hand X-ray analysis with possible scores of 0-66. The overall total score (possible range 0-198) was also used. Higher scores (closer to 66 or to 198 when using overall total score) imply a worse outcome. Hand analyses were based on double readings, and the mean was used in the analyses.\n\nThe AUStralian/CANadian Osteoarthritis Hand Index (AUSCAN) questionnaire was also used for assessment of hand OA. It measures pain (5 questions), stiffness (1 question) and difficulties with daily activities (9 questions) through a visual analogue scale (0-100mm; 0 = lowest score; 100 = highest score). Lower AUSCAN scores represent a better outcome. Change (from baseline to month 24) in these scores was calculated.'}, {'measure': 'Nature and # of AEs Monitored Continuously During Study', 'timeFrame': 'From Baseline to Month 24', 'description': 'Adverse events were by system organ class of all patients.'}, {'measure': 'Disease Progression in the Knee Evaluated by MRI.', 'timeFrame': 'From Baseline to Month 24', 'description': 'Disease progression in the signal knee (cartilage volume and thickness) were evaluated by magnetic resonance imaging (MRI). MRIs were performed for patients from the sites in Ballerup, Denmark, the Czech Republic, and Romania using a quality controlled low-field 0.18T C-Span scanner from Esaote dedicated to the imaging of extremities. The same solenoid coil was used for all patients at a given site.'}]}, 'conditionsModule': {'keywords': ['Osteoarthritis, oral salmon calcitonin, treatment, efficacy, tolerability'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '32249039', 'type': 'DERIVED', 'citation': 'Bihlet AR, Bjerre-Bastos JJ, Andersen JR, Byrjalsen I, Karsdal MA, Bay-Jensen AC. Clinical and biochemical factors associated with risk of total joint replacement and radiographic progression in osteoarthritis: Data from two phase III clinical trials. Semin Arthritis Rheum. 2020 Dec;50(6):1374-1381. doi: 10.1016/j.semarthrit.2020.03.002. Epub 2020 Mar 15.'}, {'pmid': '31481084', 'type': 'DERIVED', 'citation': 'Bihlet AR, Byrjalsen I, Bay-Jensen AC, Andersen JR, Christiansen C, Riis BJ, Karsdal MA. Associations between biomarkers of bone and cartilage turnover, gender, pain categories and radiographic severity in knee osteoarthritis. Arthritis Res Ther. 2019 Sep 3;21(1):203. doi: 10.1186/s13075-019-1987-7.'}, {'pmid': '29343266', 'type': 'DERIVED', 'citation': 'Bihlet AR, Byrjalsen I, Bay-Jensen AC, Andersen JR, Christiansen C, Riis BJ, Valter I, Karsdal MA, Hochberg MC. Identification of pain categories associated with change in pain in patients receiving placebo: data from two phase 3 randomized clinical trials in symptomatic knee osteoarthritis. BMC Musculoskelet Disord. 2018 Jan 17;19(1):17. doi: 10.1186/s12891-018-1938-5.'}, {'pmid': '25582279', 'type': 'DERIVED', 'citation': 'Karsdal MA, Byrjalsen I, Alexandersen P, Bihlet A, Andersen JR, Riis BJ, Bay-Jensen AC, Christiansen C; CSMC021C2301/2 investigators. Treatment of symptomatic knee osteoarthritis with oral salmon calcitonin: results from two phase 3 trials. Osteoarthritis Cartilage. 2015 Apr;23(4):532-43. doi: 10.1016/j.joca.2014.12.019. Epub 2015 Jan 9.'}, {'pmid': '20932224', 'type': 'DERIVED', 'citation': 'Henriksen K, Bay-Jensen AC, Christiansen C, Karsdal MA. Oral salmon calcitonin--pharmacology in osteoporosis. Expert Opin Biol Ther. 2010 Nov;10(11):1617-29. doi: 10.1517/14712598.2010.526104. Epub 2010 Oct 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoarthritis of the knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '51 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Medical history and symptoms of knee osteoarthritis\n\nExclusion Criteria:\n\n* Any other disease or medication affecting the bone or cartilage.\n* Any clinical signs or laboratory evidence diseases, which in the Investigator's opinion would preclude the participant from adhering to the Protocol or completing the trial.\n\nOther protocol defined inclusion/exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT00486434', 'briefTitle': 'Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nordic Bioscience A/S'}, 'officialTitle': 'A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Subjects With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'CSMC021C2301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'SMC021 Oral Calcitonin, 0.8 mg twice daily during 24 months', 'interventionNames': ['Drug: SMC021 Oral Calcitonin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'SMC021 Placebo, orally twice daily during 24 months', 'interventionNames': ['Drug: SMC021 Placebo']}], 'interventions': [{'name': 'SMC021 Oral Calcitonin', 'type': 'DRUG', 'description': '0.8mg SMC021 (Oral Calcitoinin) twice daily', 'armGroupLabels': ['1']}, {'name': 'SMC021 Placebo', 'type': 'DRUG', 'description': 'Placebo orally, twice daily', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53002', 'city': 'Pardubice', 'country': 'Czechia', 'facility': 'CCBR Czech', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'CCBR Aalborg', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '2750', 'city': 'Ballerup Municipality', 'country': 'Denmark', 'facility': 'CCBR Ballerup', 'geoPoint': {'lat': 55.73165, 'lon': 12.36328}}, {'zip': '7100', 'city': 'Vejle', 'country': 'Denmark', 'facility': 'CCBR Vejle', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}, {'zip': '10128', 'city': 'Tallinn', 'country': 'Estonia', 'facility': 'CCBR Estonia', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'CCBR Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '15-461', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Centrum Osteoporozy i Chorób Kostno Stawowych, ul. Waryńskiego 6/2', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '04703', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'CCBR Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '030463', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'CCBR Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}], 'overallOfficials': [{'name': 'Bente J Riis, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Nordic Bioscience A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nordic Bioscience A/S', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}