Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT04664959
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2020-12-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}], 'ancestors': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069448', 'term': 'Denosumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sbregistry@samsung.com', 'phone': '+82-32-728-0371', 'title': 'Director of Clinical Trials', 'organization': 'Samsung Bioepis Co., Ltd'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Overall Period (18 months)', 'eventGroups': [{'id': 'EG000', 'title': 'SB16', 'description': 'Subjects were randomly assigned to receive SB16 subcutaneously 60 mg at Months 0 and 6. At Month 12, subjects who received SB16 in the Main period continued to receive SB16, but they also followed the randomisation procedure to maintain blinding.', 'otherNumAtRisk': 225, 'deathsNumAtRisk': 225, 'otherNumAffected': 116, 'seriousNumAtRisk': 225, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Prolia Overall', 'description': 'Prolia Overall include subjects who had randomised to Prolia at Month 0 and had re-randomisation (Prolia+SB16 or Prolia+Prolia) at Month 12. Prolia+SB16 and Prolia+Prolia may not add up to Prolia Overall.', 'otherNumAtRisk': 231, 'deathsNumAtRisk': 231, 'otherNumAffected': 107, 'seriousNumAtRisk': 231, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Prolia+SB16', 'description': 'Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6. At Month 12, subjects who received Prolia in the Main period of the SB16-3001 study were randomised again in a 1:1 ratio to either continue on Prolia (Prolia+Prolia) or were transitioned to SB16 (Prolia+SB16).', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 46, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Prolia+Prolia', 'description': 'Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6. At Month 12, subjects who received Prolia in the Main period of the SB16-3001 study were randomised again in a 1:1 ratio to either continue on Prolia (Prolia+Prolia) or were transitioned to SB16 (Prolia+SB16).', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 49, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Adrenal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urethral caruncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intervertebral discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Lumbar Spine BMD at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SB16', 'description': 'Subjects were randomly assigned to receive SB16 subcutaneously 60 mg at Months 0 and 6.'}, {'id': 'OG001', 'title': 'Prolia', 'description': 'Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.63', 'spread': '0.250', 'groupId': 'OG000'}, {'value': '5.30', 'spread': '0.254', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 12', 'unitOfMeasure': '%Change of BMD', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SB16', 'description': 'Subjects were randomly assigned to receive SB16 subcutaneously 60 mg at Months 0 and 6.'}, {'id': 'FG001', 'title': 'Prolia', 'description': 'Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6.'}, {'id': 'FG002', 'title': 'SB16+SB16', 'description': 'Subjects were randomly assigned to receive SB16 subcutaneously 60 mg at Months 0 and 6. At Month 12, subjects who received SB16 in the Main period continued to receive SB16, but they also followed the randomisation procedure to maintain blinding.'}, {'id': 'FG003', 'title': 'Prolia+SB16', 'description': 'Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6. At Month 12, subjects who received Prolia in the Main period of the SB16-3001 study were randomised again in a 1:1 ratio to either continue on Prolia (Prolia+Prolia) or were transitioned to SB16 (Prolia+SB16).'}, {'id': 'FG004', 'title': 'Prolia+Prolia', 'description': 'Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6. At Month 12, subjects who received Prolia in the Main period of the SB16-3001 study were randomised again in a 1:1 ratio to either continue on Prolia (Prolia+Prolia) or were transitioned to SB16 (Prolia+SB16).'}], 'periods': [{'title': 'Main Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '225'}, {'groupId': 'FG001', 'numSubjects': '232'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '206'}, {'groupId': 'FG001', 'numSubjects': '201'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Transition Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '206'}, {'groupId': 'FG003', 'numSubjects': '100'}, {'groupId': 'FG004', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '206'}, {'groupId': 'FG003', 'numSubjects': '99'}, {'groupId': 'FG004', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'BG000'}, {'value': '232', 'groupId': 'BG001'}, {'value': '457', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SB16', 'description': 'Subjects were randomly assigned to receive SB16 subcutaneously 60 mg at Months 0 and 6.'}, {'id': 'BG001', 'title': 'Prolia', 'description': 'Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6.'}, {'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': '89', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '273', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.5', 'spread': '5.87', 'groupId': 'BG000'}, {'value': '66.3', 'spread': '6.03', 'groupId': 'BG001'}, {'value': '66.4', 'spread': '5.95', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '225', 'groupId': 'BG000'}, {'value': '232', 'groupId': 'BG001'}, {'value': '457', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '415', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-03', 'size': 8163076, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-11-19T03:21', 'hasProtocol': True}, {'date': '2023-01-31', 'size': 9148082, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-11-19T03:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 457}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-10', 'studyFirstSubmitDate': '2020-12-10', 'resultsFirstSubmitDate': '2024-11-25', 'studyFirstSubmitQcDate': '2020-12-10', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-25', 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Lumbar Spine BMD at Month 12', 'timeFrame': 'Baseline and Month 12'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postmenopausal Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '39243386', 'type': 'DERIVED', 'citation': 'Langdahl B, Chung YS, Plebanski R, Czerwinski E, Dokoupilova E, Supronik J, Rosa J, Mydlak A, Rowinska-Osuch A, Baek KH, Urboniene A, Mordaka R, Ahn S, Rho YH, Ban J, Eastell R. Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12. J Clin Endocrinol Metab. 2025 May 19;110(6):e1951-e1958. doi: 10.1210/clinem/dgae611.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK, PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.', 'detailedDescription': 'Subjects will be randomised in a 1:1 ratio to receive either SB16 or Prolia®. At Month 12, subjects in Prolia® treatment group will be randomised again in a 1:1 ratio to either continue on Prolia® treatment or be transitioned to SB16 treatment. Investigational product (60 mg in 1 mL of SB16 or Prolia®) will be given subcutaneously every 6 months up to Month 12, and the last assessment will be done at Month 18.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women who are 55 to 80 years of age at Screening\n* Ambulatory and visually unimpaired to participate in the study at Screening, in the opinion of the Investigator\n* Absolute BMD consistent with T-score at the total hip or lumbar spine of -4 and -2.5 at Screening\n* At least three evaluable vertebrae within L1 to L4, one evaluable femoral neck, and one evaluable hip joint for BMD measurement at Screening\n* Biologic naïve at Screening\n* Body weight of 50 kg and 90 kg at Screening\n\nExclusion Criteria:\n\n* One severe or more than two moderate vertebral fractures on spinal X-ray according to Genant classification at Screening\n* History of hip fracture or bilateral hip replacement at Screening\n* Uncorrected vitamin D deficiency at Screening\n* Hypercalcemia or hypocalcaemia at Screening\n* Inadequate haematological function at Screening\n* Inadequate renal or hepatic function at Screening\n* Known allergic reactions, hypersensitivity, or intolerance to denosumab or to any ingredients of the IP, including latex allergy or hereditary problems of fructose intolerance at Screening\n* May not tolerate long-term calcium or vitamin D supplementation or subject with malabsorption of calcium or vitamin D supplements, in the opinion of the Investigator, at Screening\n* Use of any of the medications that can affect BMD\n* Use of any non-biologic IP that is not indicated for osteoporosis from another study or use of an investigational device at Screening\n* Non-osteoporosis medical conditions that can affect BMD at Screening\n* Any clinically significant disease or disorder or laboratory abnormality which, in the opinion of the Investigator, would prevent the subject from completing the study or the interpretation of the study results at Screening and Randomisation'}, 'identificationModule': {'nctId': 'NCT04664959', 'briefTitle': 'A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Samsung Bioepis Co., Ltd.'}, 'officialTitle': 'A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Compare the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Between SB16 (Proposed Denosumab Biosimilar) and Prolia® in Postmenopausal Women With Osteoporosis', 'orgStudyIdInfo': {'id': 'SB16-3001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SB16 (Proposed Denosumab Biosimilar)', 'description': 'Subjects randomised into SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously every 6 months.', 'interventionNames': ['Drug: SB16 (Proposed Denosumab Biosimilar)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prolia® (Denosumab)', 'description': 'Subjects randomised into Prolia® group will receive Prolia® (60 mg in 1 mL) subcutaneously every 6 months.\n\nAt Month 12, subjects in Prolia® treatment group will be re-randomised in a 1:1 ratio to either continue on Prolia® treatment or be transitioned to SB16 treatment. After re-randomisation, subjects transited to SB16 group will receive SB16, and subjects remaining in Prolia® group will continue to receive Prolia® at Month 12.', 'interventionNames': ['Drug: SB16 (Proposed Denosumab Biosimilar)', 'Drug: Prolia® (Denosumab)']}], 'interventions': [{'name': 'SB16 (Proposed Denosumab Biosimilar)', 'type': 'DRUG', 'description': 'Subjects randomised into SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously every 6 months.\n\nAt Month 12, subjects transited from Prolia® group to SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously.', 'armGroupLabels': ['Prolia® (Denosumab)', 'SB16 (Proposed Denosumab Biosimilar)']}, {'name': 'Prolia® (Denosumab)', 'type': 'DRUG', 'description': 'Subjects randomised into Prolia® group will receive Prolia® (60 mg in 1 mL) subcutaneously every 6 months.', 'armGroupLabels': ['Prolia® (Denosumab)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Krakow', 'country': 'Poland', 'facility': 'SB Investigative Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lodz', 'country': 'Poland', 'facility': 'SB Investigative Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Siedlce', 'country': 'Poland', 'facility': 'SB Investigative Site', 'geoPoint': {'lat': 52.16772, 'lon': 22.29006}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'SB Investigative Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Zamość', 'country': 'Poland', 'facility': 'SB Investigative Site', 'geoPoint': {'lat': 50.72314, 'lon': 23.25196}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Bioepis Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}