Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-01 @ 10:01 PM
Study NCT ID:
NCT01457950
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2011-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
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': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).', 'description': 'SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.', 'eventGroups': [{'id': 'EG000', 'title': 'Randomized Phase: Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).', 'otherNumAtRisk': 69, 'otherNumAffected': 13, 'seriousNumAtRisk': 69, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Randomized Phase: Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).', 'otherNumAtRisk': 66, 'otherNumAffected': 11, 'seriousNumAtRisk': 66, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Open Label Denosumab 60 mg (Previously Randomized Denosumab)', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.', 'otherNumAtRisk': 60, 'otherNumAffected': 12, 'seriousNumAtRisk': 60, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Open Label Denosumab 60 mg (Previously Randomized Placebo)', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.', 'otherNumAtRisk': 63, 'otherNumAffected': 7, 'seriousNumAtRisk': 63, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Extradural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skull fractured base', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Traumatic lung injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Macular hole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.10', 'spread': '0.407', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '0.413', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.21', 'ciLowerLimit': '2.06', 'ciUpperLimit': '4.36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using the Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 6 - measure at Baseline) divided by the measure at Baseline \\* 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Efficacy (ITTE) Population: all participants who received one dose of study medication, and had a Baseline measure and at least one post-Baseline efficacy measure during the Double-Blind Treatment Phase.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.35', 'spread': '0.375', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '0.380', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 1', 'description': 'Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1 - measure at Baseline) divided by the measure at Baseline \\* 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITTE Population'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).'}], 'classes': [{'title': 'Total hip, Month 1, n=67, 63', 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.238', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.245', 'groupId': 'OG001'}]}]}, {'title': 'Total hip, Month 6, n=69, 64', 'categories': [{'measurements': [{'value': '2.23', 'spread': '0.245', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '0.254', 'groupId': 'OG001'}]}]}, {'title': 'Femoral neck, Month 1, n=67, 63', 'categories': [{'measurements': [{'value': '1.30', 'spread': '0.344', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.354', 'groupId': 'OG001'}]}]}, {'title': 'Fermoral neck, Month 6, n=69, 64', 'categories': [{'measurements': [{'value': '2.23', 'spread': '0.330', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '0.343', 'groupId': 'OG001'}]}]}, {'title': 'Trochanter, Month 1, n=67, 63', 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.380', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.392', 'groupId': 'OG001'}]}]}, {'title': 'Trochanter, Month n =69, 64', 'categories': [{'measurements': [{'value': '2.66', 'spread': '0.418', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.434', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1 and Month 6', 'description': 'Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covarience (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1/6 - measure at Baseline) divided by the measure at Baseline \\* 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITTE Population'}, {'type': 'SECONDARY', 'title': 'Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).'}], 'classes': [{'title': 's-CTx, Month 1, n=69, 66', 'categories': [{'measurements': [{'value': '-80.72', 'groupId': 'OG000', 'lowerLimit': '-88.62', 'upperLimit': '-73.50'}, {'value': '-14.48', 'groupId': 'OG001', 'lowerLimit': '-33.58', 'upperLimit': '-1.08'}]}]}, {'title': 's-CTx, Month 3, n=68, 65', 'categories': [{'measurements': [{'value': '-82.23', 'groupId': 'OG000', 'lowerLimit': '-89.00', 'upperLimit': '-73.67'}, {'value': '-27.49', 'groupId': 'OG001', 'lowerLimit': '-44.85', 'upperLimit': '-5.13'}]}]}, {'title': 's-CTx, Month 6, n=60, 63', 'categories': [{'measurements': [{'value': '-74.32', 'groupId': 'OG000', 'lowerLimit': '-84.09', 'upperLimit': '-65.33'}, {'value': '-21.21', 'groupId': 'OG001', 'lowerLimit': '-37.41', 'upperLimit': '3.44'}]}]}, {'title': 's-PINP, Month 1, n=69, 66', 'categories': [{'measurements': [{'value': '-18.75', 'groupId': 'OG000', 'lowerLimit': '-35.71', 'upperLimit': '-6.00'}, {'value': '-4.65', 'groupId': 'OG001', 'lowerLimit': '-17.86', 'upperLimit': '9.68'}]}]}, {'title': 's-PINP, Month 3, n=68, 65', 'categories': [{'measurements': [{'value': '-77.1', 'groupId': 'OG000', 'lowerLimit': '-83.54', 'upperLimit': '-68.57'}, {'value': '-21.57', 'groupId': 'OG001', 'lowerLimit': '-38.89', 'upperLimit': '-6.35'}]}]}, {'title': 's-PINP, Month 6, n=60, 63', 'categories': [{'measurements': [{'value': '-76.18', 'groupId': 'OG000', 'lowerLimit': '-81.27', 'upperLimit': '-61.89'}, {'value': '-21.05', 'groupId': 'OG001', 'lowerLimit': '-42.42', 'upperLimit': '-6.67'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Months 1, 3 and 6', 'description': 'Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline - measure at Baseline) divided by measure at Baseline \\* 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITTE Population. Only participants at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline up to Month 6', 'description': 'An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who received one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).'}], 'classes': [{'title': 'Albumin/globulin ratio, n=60, 63', 'categories': [{'measurements': [{'value': '0.020', 'spread': '0.1424', 'groupId': 'OG000'}, {'value': '0.052', 'spread': '0.1390', 'groupId': 'OG001'}]}]}, {'title': 'BUN/creatinine ratio, n=60, 63', 'categories': [{'measurements': [{'value': '-7.917', 'spread': '25.2917', 'groupId': 'OG000'}, {'value': '-4.063', 'spread': '27.3436', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).'}], 'classes': [{'title': 'Albumin, n=60,63', 'categories': [{'measurements': [{'value': '0.217', 'spread': '1.8964', 'groupId': 'OG000'}, {'value': '0.365', 'spread': '2.2598', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin, n=59, 63', 'categories': [{'measurements': [{'value': '1.153', 'spread': '5.8274', 'groupId': 'OG000'}, {'value': '1.778', 'spread': '5.6894', 'groupId': 'OG001'}]}]}, {'title': 'Mean corpuscle hemoglobin concentration, n=59, 63', 'categories': [{'measurements': [{'value': '-5.186', 'spread': '9.9264', 'groupId': 'OG000'}, {'value': '-6.857', 'spread': '9.4593', 'groupId': 'OG001'}]}]}, {'title': 'Total protein, n=60, 63', 'categories': [{'measurements': [{'value': '-0.050', 'spread': '2.9939', 'groupId': 'OG000'}, {'value': '-0.127', 'spread': '3.3864', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.', 'unitOfMeasure': 'Grams (G)/Liter (L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).'}], 'classes': [{'title': 'Alkaline phosphatase, n=60, 63', 'categories': [{'measurements': [{'value': '-24.283', 'spread': '15.9513', 'groupId': 'OG000'}, {'value': '-8.222', 'spread': '11.2127', 'groupId': 'OG001'}]}]}, {'title': 'Alanine amino transferase, n=60, 63', 'categories': [{'measurements': [{'value': '2.117', 'spread': '6.4047', 'groupId': 'OG000'}, {'value': '-0.397', 'spread': '8.8035', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate amino transferase, n=59, 63', 'categories': [{'measurements': [{'value': '1.034', 'spread': '4.4527', 'groupId': 'OG000'}, {'value': '-0.032', 'spread': '7.4962', 'groupId': 'OG001'}]}]}, {'title': 'Creatine kinase, n=60, 63', 'categories': [{'measurements': [{'value': '7.617', 'spread': '51.6658', 'groupId': 'OG000'}, {'value': '3.905', 'spread': '31.2052', 'groupId': 'OG001'}]}]}, {'title': 'Gamma glutamyl transferase, n=60, 63', 'categories': [{'measurements': [{'value': '-0.133', 'spread': '8.4381', 'groupId': 'OG000'}, {'value': '-2.143', 'spread': '7.9532', 'groupId': 'OG001'}]}]}, {'title': 'Lactate dehydraogenase, n=59, 63', 'categories': [{'measurements': [{'value': '6.119', 'spread': '18.1156', 'groupId': 'OG000'}, {'value': '3.889', 'spread': '20.4979', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.', 'unitOfMeasure': 'Internationational Units(IU)/Liter (L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants at the specified time points were analyzed. .'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).'}], 'classes': [{'title': 'Basophils, n=58, 63', 'categories': [{'measurements': [{'value': '-0.003', 'spread': '0.0131', 'groupId': 'OG000'}, {'value': '-0.006', 'spread': '0.0165', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils, n=58, 63', 'categories': [{'measurements': [{'value': '-0.019', 'spread': '0.1254', 'groupId': 'OG000'}, {'value': '-0.033', 'spread': '0.1309', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes, n=58, 63', 'categories': [{'measurements': [{'value': '-0.047', 'spread': '0.4096', 'groupId': 'OG000'}, {'value': '-0.206', 'spread': '0.5930', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes, n=58, 63', 'categories': [{'measurements': [{'value': '-0.033', 'spread': '0.1094', 'groupId': 'OG000'}, {'value': '-0.059', 'spread': '0.1324', 'groupId': 'OG001'}]}]}, {'title': 'Segmented neutrophils, n=58, 63', 'categories': [{'measurements': [{'value': '0.114', 'spread': '1.3382', 'groupId': 'OG000'}, {'value': '-0.213', 'spread': '1.0934', 'groupId': 'OG001'}]}]}, {'title': 'Total neutrophils, n=58, 63', 'categories': [{'measurements': [{'value': '0.114', 'spread': '1.3382', 'groupId': 'OG000'}, {'value': '-0.213', 'spread': '1.0934', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count, n=58, 63', 'categories': [{'measurements': [{'value': '1.621', 'spread': '31.7881', 'groupId': 'OG000'}, {'value': '-6.190', 'spread': '35.7874', 'groupId': 'OG001'}]}]}, {'title': 'White blood cell count, n=58, 63', 'categories': [{'measurements': [{'value': '0.014', 'spread': '1.4026', 'groupId': 'OG000'}, {'value': '-0.517', 'spread': '1.2003', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.', 'unitOfMeasure': '10^9 cells per liter (GI/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).'}], 'classes': [{'title': 'Direct bilirubin, n=60, 63', 'categories': [{'measurements': [{'value': '0.300', 'spread': '1.0301', 'groupId': 'OG000'}, {'value': '0.222', 'spread': '1.1974', 'groupId': 'OG001'}]}]}, {'title': 'Indirect bilirubin, n=60, 63', 'categories': [{'measurements': [{'value': '1.567', 'spread': '3.4757', 'groupId': 'OG000'}, {'value': '0.508', 'spread': '3.5372', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin, n=60, 63', 'categories': [{'measurements': [{'value': '1.867', 'spread': '3.8947', 'groupId': 'OG000'}, {'value': '0.730', 'spread': '3.8404', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, n=60, 63', 'categories': [{'measurements': [{'value': '2.037', 'spread': '6.4916', 'groupId': 'OG000'}, {'value': '0.940', 'spread': '5.1644', 'groupId': 'OG001'}]}]}, {'title': 'Uric acid, n=60, 63', 'categories': [{'measurements': [{'value': '11.500', 'spread': '38.9622', 'groupId': 'OG000'}, {'value': '0.159', 'spread': '40.9757', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.', 'unitOfMeasure': 'Micromole/liter (UMOL/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).'}], 'classes': [{'title': 'Calcium (corrected), n=1, 1', 'categories': [{'measurements': [{'value': '0.110', 'spread': 'NA', 'comment': 'Only one participant was analyzed; therefore, the standard deviation was undefined.', 'groupId': 'OG000'}, {'value': '0.000', 'spread': 'NA', 'comment': 'Only one participant was analyzed; therefore, the standard deviation was undefined.', 'groupId': 'OG001'}]}]}, {'title': 'Calcium, n=59, 63', 'categories': [{'measurements': [{'value': '-0.020', 'spread': '0.0890', 'groupId': 'OG000'}, {'value': '0.002', 'spread': '0.0768', 'groupId': 'OG001'}]}]}, {'title': 'Chloride, n=60, 63', 'categories': [{'measurements': [{'value': '-0.200', 'spread': '2.2981', 'groupId': 'OG000'}, {'value': '0.444', 'spread': '2.3264', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, n=60, 63', 'categories': [{'measurements': [{'value': '-0.873', 'spread': '2.5458', 'groupId': 'OG000'}, {'value': '-0.567', 'spread': '1.2118', 'groupId': 'OG001'}]}]}, {'title': 'Potassium, n=59, 63', 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.3900', 'groupId': 'OG000'}, {'value': '0.060', 'spread': '0.3476', 'groupId': 'OG001'}]}]}, {'title': 'Magnesium, n=60, 63', 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.0585', 'groupId': 'OG000'}, {'value': '0.009', 'spread': '0.0462', 'groupId': 'OG001'}]}]}, {'title': 'Sodium, n=60, 63', 'categories': [{'measurements': [{'value': '-0.400', 'spread': '2.1249', 'groupId': 'OG000'}, {'value': '0.095', 'spread': '1.9486', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus inorganic, n=60, 63', 'categories': [{'measurements': [{'value': '-0.072', 'spread': '0.1505', 'groupId': 'OG000'}, {'value': '-0.063', 'spread': '0.1695', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides, n=60, 63', 'categories': [{'measurements': [{'value': '-0.166', 'spread': '0.7155', 'groupId': 'OG000'}, {'value': '-0.156', 'spread': '0.6119', 'groupId': 'OG001'}]}]}, {'title': 'Urea/BUN, n=60, 63', 'categories': [{'measurements': [{'value': '-0.258', 'spread': '1.1878', 'groupId': 'OG000'}, {'value': '-0.119', 'spread': '1.4134', 'groupId': 'OG001'}]}]}, {'title': 'VLDL cholesterol calculation, n=59, 63', 'categories': [{'measurements': [{'value': '-0.098', 'spread': '0.2844', 'groupId': 'OG000'}, {'value': '-0.072', 'spread': '0.2810', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.', 'unitOfMeasure': 'Millimole/Liter (MMOL/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematocrit at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.009', 'spread': '0.0196', 'groupId': 'OG000'}, {'value': '0.013', 'spread': '0.0196', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.', 'unitOfMeasure': 'Proportion of RBCs in blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Corpuscle Hemoglobin at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.068', 'spread': '0.7111', 'groupId': 'OG000'}, {'value': '0.146', 'spread': '0.6696', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.', 'unitOfMeasure': 'Picograms (PG)/cell', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Corpuscular Volume at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.695', 'spread': '2.5000', 'groupId': 'OG000'}, {'value': '2.397', 'spread': '2.6368', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.', 'unitOfMeasure': 'Femtoliters (FL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Red Blood Cell Count at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.025', 'spread': '0.1844', 'groupId': 'OG000'}, {'value': '0.037', 'spread': '0.1920', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.', 'unitOfMeasure': '10^12 cells per liter (TI/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Red Cell Distribution Width at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.475', 'spread': '1.0256', 'groupId': 'OG000'}, {'value': '0.556', 'spread': '0.9242', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.', 'unitOfMeasure': 'percentage (%) of mean RBC volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).'}], 'classes': [{'title': 'Diastolic blood pressure, Low, n=60, 63', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure, High, n=60, 63', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure, Low, n=60, 63', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate, High, n=60, 63', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate, Low, n=60, 63', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Month 6', 'description': 'Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (\\<50 or \\>120 Bits Per Minutes \\[bpm\\]), Systolic Blood Pressure (\\>170 Millimeters of Mercury \\[mmHg\\] or \\<100 mmHg) and Heart rate (\\>110 mmHg or \\<50 mmHg) are summarized. Change from Baseline was calculated as the Month 6 value minus the Baseline value.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).'}], 'classes': [{'title': 'Neutralizing antibodies, Positive, n=0, 0', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'There were no binding antibody confirmed positive tests; therefore, neutralizing antibody testing was not performed.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'There were no binding antibody confirmed positive tests; therefore, neutralizing antibody testing was not performed.', 'groupId': 'OG001'}]}]}, {'title': 'Neutralizing antibodies, Negative, n=0, 0', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'There were no binding antibody confirmed positive tests; therefore, neutralizing antibody testing was not performed.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'There were no binding antibody confirmed positive tests; therefore, neutralizing antibody testing was not performed.', 'groupId': 'OG001'}]}]}, {'title': 'Binding antibodies, Positive, n=60, 63', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Binding antibodies, Negative, n=60, 63', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 6 was summarized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants at the specified time points were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Percent Change From Baseline in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Denosumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg to Open-Label Denosumab 60mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.62', 'spread': '3.776', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 - measure at Baseline) divided by the measure at Baseline \\* 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Open-Label (ITT-OL) Population: all participants from the ITT population in the Double-Blind Phase who continued into the Open-Label Extension Phase of the study and received denosumab at Month 6. Ony those participants with a value at Baseline and Month 12 were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Percent Change From Month 6 in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Open-Label Denosumab 60 mg', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.67', 'spread': '3.440', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6 and Month 12', 'description': 'Mean percent change from Month 6 in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by the measure at Month 6 \\* 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Denosumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg to Open-Label Denosumab 60mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}], 'classes': [{'title': 'Total hip', 'categories': [{'measurements': [{'value': '3.07', 'spread': '2.476', 'groupId': 'OG000'}]}]}, {'title': 'Femoral neck', 'categories': [{'measurements': [{'value': '3.39', 'spread': '3.158', 'groupId': 'OG000'}]}]}, {'title': 'Trochanter', 'categories': [{'measurements': [{'value': '3.39', 'spread': '4.653', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 - measure at Baseline) divided by the measure at Baseline \\* 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-OL Population. Ony those participants with a value at Baseline and Month 12 were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Percent Change From Month 6 in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Open-Label Denosumab 60 mg', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}], 'classes': [{'title': 'Total hip', 'categories': [{'measurements': [{'value': '1.46', 'spread': '1.701', 'groupId': 'OG000'}]}]}, {'title': 'Femoral neck', 'categories': [{'measurements': [{'value': '1.12', 'spread': '2.668', 'groupId': 'OG000'}]}]}, {'title': 'Trochanter', 'categories': [{'measurements': [{'value': '2.13', 'spread': '2.762', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6 and Month 12', 'description': 'Mean percent change from Month 6 in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by the measure at Month 6 \\* 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Denosumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg to Open-Label Denosumab 60mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}], 'classes': [{'title': 's-CTx', 'categories': [{'measurements': [{'value': '-63.36', 'groupId': 'OG000', 'lowerLimit': '-77.14', 'upperLimit': '-48.62'}]}]}, {'title': 's-PINP', 'categories': [{'measurements': [{'value': '-78.00', 'groupId': 'OG000', 'lowerLimit': '-84.31', 'upperLimit': '-66.67'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline - measure at Baseline) divided by measure at Baseline \\* 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-OL Population. Ony those participants with a value at Baseline and Month 12 were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Median Percent Change From Month 6 in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Open-Label Denosumab 60 mg', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}], 'classes': [{'title': 's-CTx', 'categories': [{'measurements': [{'value': '-50.90', 'groupId': 'OG000', 'lowerLimit': '-71.95', 'upperLimit': '-24.05'}]}]}, {'title': 's-PINP', 'categories': [{'measurements': [{'value': '-66.67', 'groupId': 'OG000', 'lowerLimit': '-76.82', 'upperLimit': '-55.65'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Month 6 and Month 12', 'description': 'Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by measure at Month 6 \\* 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) During the Open-Label Extension Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg to Open-Label Denosumab 60mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}, {'id': 'OG001', 'title': 'Placebo to Open-Label Denosumab 60 mg', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Month 6 to Month 12', 'description': 'An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-OL Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg to Open-Label Denosumab 60mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}, {'id': 'OG001', 'title': 'Placebo to Open-Label Denosumab 60 mg', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}], 'classes': [{'title': 'Albumin/globulin ratio, n=58, 60', 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.1473', 'groupId': 'OG000'}, {'value': '0.032', 'spread': '0.1621', 'groupId': 'OG001'}]}]}, {'title': 'BUN/creatinine ratio, n=58, 60', 'categories': [{'measurements': [{'value': '-5.776', 'spread': '24.4297', 'groupId': 'OG000'}, {'value': '2.500', 'spread': '27.7962', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Change from Baseline was calculated as the Month 12 value minus the Baseline value.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg to Open-Label Denosumab 60mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}, {'id': 'OG001', 'title': 'Placebo to Open-Label Denosumab 60 mg', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}], 'classes': [{'title': 'Albumin, n=58, 60', 'categories': [{'measurements': [{'value': '0.293', 'spread': '2.1110', 'groupId': 'OG000'}, {'value': '0.450', 'spread': '1.9866', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin, n=56, 60', 'categories': [{'measurements': [{'value': '1.411', 'spread': '5.7833', 'groupId': 'OG000'}, {'value': '2.033', 'spread': '6.0084', 'groupId': 'OG001'}]}]}, {'title': 'Mean corpuscle hemoglobin concentration, n=56, 60', 'categories': [{'measurements': [{'value': '-5.679', 'spread': '6.6143', 'groupId': 'OG000'}, {'value': '-6.650', 'spread': '7.7587', 'groupId': 'OG001'}]}]}, {'title': 'Total protein, n=58, 60', 'categories': [{'measurements': [{'value': '0.224', 'spread': '3.4946', 'groupId': 'OG000'}, {'value': '0.267', 'spread': '2.8216', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Change from Baseline was calculated as the Month 12 value minus the Baseline value.', 'unitOfMeasure': 'Grams (G)/Liter (L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg to Open-Label Denosumab 60mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}, {'id': 'OG001', 'title': 'Placebo to Open-Label Denosumab 60 mg', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}], 'classes': [{'title': 'Alkaline phosphatase, n=58, 60', 'categories': [{'measurements': [{'value': '-25.603', 'spread': '14.4780', 'groupId': 'OG000'}, {'value': '-23.767', 'spread': '15.7570', 'groupId': 'OG001'}]}]}, {'title': 'Alanine amino transferase, n=58, 60', 'categories': [{'measurements': [{'value': '1.810', 'spread': '7.9922', 'groupId': 'OG000'}, {'value': '-0.150', 'spread': '8.9288', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate amino transferase, n=58, 60', 'categories': [{'measurements': [{'value': '0.879', 'spread': '6.4293', 'groupId': 'OG000'}, {'value': '-0.467', 'spread': '6.2666', 'groupId': 'OG001'}]}]}, {'title': 'Creatine kinase, n=58, 60', 'categories': [{'measurements': [{'value': '-4.534', 'spread': '44.0690', 'groupId': 'OG000'}, {'value': '4.500', 'spread': '52.0731', 'groupId': 'OG001'}]}]}, {'title': 'Gamma glutamyl transferase, n=58, 60', 'categories': [{'measurements': [{'value': '0.4823', 'spread': '6.9541', 'groupId': 'OG000'}, {'value': '-0.600', 'spread': '9.4961', 'groupId': 'OG001'}]}]}, {'title': 'Lactate dehydraogenase, n=58, 60', 'categories': [{'measurements': [{'value': '-0.552', 'spread': '19.2237', 'groupId': 'OG000'}, {'value': '-1.217', 'spread': '24.7243', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Change from Baseline was calculated as the Month 12 value minus the Baseline value.', 'unitOfMeasure': 'Internationational Units(IU)/Liter (L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg to Open-Label Denosumab 60mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}, {'id': 'OG001', 'title': 'Placebo to Open-Label Denosumab 60 mg', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}], 'classes': [{'title': 'Basophils, n=54, 59', 'categories': [{'measurements': [{'value': '-0.004', 'spread': '0.0164', 'groupId': 'OG000'}, {'value': '-0.002', 'spread': '0.0148', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils, n=54, 59', 'categories': [{'measurements': [{'value': '0.024', 'spread': '0.1489', 'groupId': 'OG000'}, {'value': '0.019', 'spread': '0.1860', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes, n=54, 59', 'categories': [{'measurements': [{'value': '0.098', 'spread': '0.4436', 'groupId': 'OG000'}, {'value': '-0.089', 'spread': '0.5599', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes, n=54, 59', 'categories': [{'measurements': [{'value': '-0.009', 'spread': '0.1053', 'groupId': 'OG000'}, {'value': '-0.039', 'spread': '0.1443', 'groupId': 'OG001'}]}]}, {'title': 'Segmented neutrophils, n=54, 59', 'categories': [{'measurements': [{'value': '0.014', 'spread': '1.1748', 'groupId': 'OG000'}, {'value': '-0.259', 'spread': '1.2035', 'groupId': 'OG001'}]}]}, {'title': 'Total neutrophils, n=54, 59', 'categories': [{'measurements': [{'value': '0.014', 'spread': '1.1748', 'groupId': 'OG000'}, {'value': '-0.259', 'spread': '1.2035', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count, n=55, 60', 'categories': [{'measurements': [{'value': '-4.018', 'spread': '34.8215', 'groupId': 'OG000'}, {'value': '-4.233', 'spread': '37.7913', 'groupId': 'OG001'}]}]}, {'title': 'White blood cell count, n=54, 59', 'categories': [{'measurements': [{'value': '0.122', 'spread': '1.1618', 'groupId': 'OG000'}, {'value': '-0.369', 'spread': '1.3903', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Change from Baseline was calculated as the Month 12 value minus the Baseline value.', 'unitOfMeasure': '10^9 cells per liter (GI/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg to Open-Label Denosumab 60mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}, {'id': 'OG001', 'title': 'Placebo to Open-Label Denosumab 60 mg', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}], 'classes': [{'title': 'Direct bilirubin, n=58, 60', 'categories': [{'measurements': [{'value': '0.241', 'spread': '1.3548', 'groupId': 'OG000'}, {'value': '0.100', 'spread': '1.2980', 'groupId': 'OG001'}]}]}, {'title': 'Indirect bilirubin, n=58, 60', 'categories': [{'measurements': [{'value': '1.034', 'spread': '4.0391', 'groupId': 'OG000'}, {'value': '0.800', 'spread': '3.3385', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin, n=58, 60', 'categories': [{'measurements': [{'value': '1.276', 'spread': '4.6596', 'groupId': 'OG000'}, {'value': '0.900', 'spread': '3.5401', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, n=58, 60', 'categories': [{'measurements': [{'value': '0.948', 'spread': '5.1157', 'groupId': 'OG000'}, {'value': '-0.015', 'spread': '4.6216', 'groupId': 'OG001'}]}]}, {'title': 'Uric acid, n=58, 60', 'categories': [{'measurements': [{'value': '4.483', 'spread': '41.3870', 'groupId': 'OG000'}, {'value': '2.000', 'spread': '44.0647', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Change from Baseline was calculated as the Month 12 value minus the Baseline value.', 'unitOfMeasure': 'Micromole/liter (UMOL/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg to Open-Label Denosumab 60mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}, {'id': 'OG001', 'title': 'Placebo to Open-Label Denosumab 60 mg', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}], 'classes': [{'title': 'Calcium (corrected), n=0, 0', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Zero participants was analyzed; therefore, the mean and the standard deviation were undefined.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Zero participants was analyzed; therefore, the mean and the standard deviation were undefined.', 'groupId': 'OG001'}]}]}, {'title': 'Calcium, n=58, 60', 'categories': [{'measurements': [{'value': '-0.031', 'spread': '0.0944', 'groupId': 'OG000'}, {'value': '-0.004', 'spread': '0.0904', 'groupId': 'OG001'}]}]}, {'title': 'Chloride, n=58, 60', 'categories': [{'measurements': [{'value': '0.328', 'spread': '2.5573', 'groupId': 'OG000'}, {'value': '0.300', 'spread': '2.4446', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, n=58, 60', 'categories': [{'measurements': [{'value': '-0.760', 'spread': '2.9331', 'groupId': 'OG000'}, {'value': '-0.500', 'spread': '1.2985', 'groupId': 'OG001'}]}]}, {'title': 'Potassium, n=58, 60', 'categories': [{'measurements': [{'value': '0.047', 'spread': '0.4398', 'groupId': 'OG000'}, {'value': '0.045', 'spread': '0.3078', 'groupId': 'OG001'}]}]}, {'title': 'Magnesium, n=58, 60', 'categories': [{'measurements': [{'value': '0.009', 'spread': '0.0679', 'groupId': 'OG000'}, {'value': '0.004', 'spread': '0.0514', 'groupId': 'OG001'}]}]}, {'title': 'Sodium, n=58, 60', 'categories': [{'measurements': [{'value': '-0.172', 'spread': '2.1532', 'groupId': 'OG000'}, {'value': '0.067', 'spread': '2.2986', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus inorganic, n=58, 60', 'categories': [{'measurements': [{'value': '-0.153', 'spread': '0.1530', 'groupId': 'OG000'}, {'value': '-0.094', 'spread': '0.1981', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides, n=58, 60', 'categories': [{'measurements': [{'value': '-0.144', 'spread': '0.7716', 'groupId': 'OG000'}, {'value': '-0.033', 'spread': '0.8449', 'groupId': 'OG001'}]}]}, {'title': 'Urea/BUN, n=58, 60', 'categories': [{'measurements': [{'value': '-0.233', 'spread': '1.2183', 'groupId': 'OG000'}, {'value': '0.158', 'spread': '1.5771', 'groupId': 'OG001'}]}]}, {'title': 'VLDL cholesterol calculation, n=58, 59', 'categories': [{'measurements': [{'value': '-0.066', 'spread': '0.3539', 'groupId': 'OG000'}, {'value': '-0.044', 'spread': '0.3234', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Change from Baseline was calculated as the Month 12 value minus the Baseline value.', 'unitOfMeasure': 'Millimole/Liter (MMOL/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Hematocrit at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg to Open-Label Denosumab 60mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}, {'id': 'OG001', 'title': 'Placebo to Open-Label Denosumab 60 mg', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.010', 'spread': '0.0182', 'groupId': 'OG000'}, {'value': '0.014', 'spread': '0.0185', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Change from Baseline was calculated as the Month 12 value minus the Baseline value.', 'unitOfMeasure': 'Proportion of RBCs in blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Mean Corpuscle Hemoglobin at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg to Open-Label Denosumab 60mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}, {'id': 'OG001', 'title': 'Placebo to Open-Label Denosumab 60 mg', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.304', 'spread': '0.7632', 'groupId': 'OG000'}, {'value': '-0.310', 'spread': '0.5058', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Change from Baseline was calculated as the Month 12 value minus the Baseline value.', 'unitOfMeasure': 'Picograms (PG)/cell)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Red Blood Cell Count at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg to Open-Label Denosumab 60mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}, {'id': 'OG001', 'title': 'Placebo to Open-Label Denosumab 60 mg', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.086', 'spread': '0.1634', 'groupId': 'OG000'}, {'value': '0.103', 'spread': '0.1904', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Change from Baseline was calculated as the Month 12 value minus the Baseline value.', 'unitOfMeasure': '10^12 cells per liter (TI/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Red Cell Distribution Width at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg to Open-Label Denosumab 60mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}, {'id': 'OG001', 'title': 'Placebo to Open-Label Denosumab 60 mg', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.007', 'spread': '0.7897', 'groupId': 'OG000'}, {'value': '0.203', 'spread': '0.8718', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Change from Baseline was calculated as the Month 12 value minus the Baseline value.', 'unitOfMeasure': 'percentage (%) of mean RBC volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg to Open-Label Denosumab 60mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}, {'id': 'OG001', 'title': 'Placebo to Open-Label Denosumab 60 mg', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}], 'classes': [{'title': 'Diastolic blood pressure, High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure, Low', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure, High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure, Low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate, High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate, Low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Month 12', 'description': 'Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (\\<50 or \\>120 Bits Per Minutes \\[bpm\\]), Systolic Blood Pressure (\\>170 Millimeters of Mercury \\[mmHg\\] or \\<100 mmHg) and Heart rate (\\>110 mmHg or \\<50 mmHg) are summarized. Change from Baseline was calculated as the Month 12 value minus the Baseline value.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg to Open-Label Denosumab 60mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}, {'id': 'OG001', 'title': 'Placebo to Open-Label Denosumab 60 mg', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}], 'classes': [{'title': 'Neutralizing antibodies, Positive, n=0, 0', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'There were no binding antibody confirmed positive tests; therefore, neutralizing antibody testing was not performed.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'There were no binding antibody confirmed positive tests; therefore, neutralizing antibody testing was not performed.', 'groupId': 'OG001'}]}]}, {'title': 'Neutralizing antibodies, Negative, n=0, 0', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'There were no binding antibody confirmed positive tests; therefore, neutralizing antibody testing was not performed.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'There were no binding antibody confirmed positive tests; therefore, neutralizing antibody testing was not performed.', 'groupId': 'OG001'}]}]}, {'title': 'Binding antibodies, Positive, n=58, 61', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Binding antibodies, Negative, n=58, 61', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 12 was summarized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).'}, {'id': 'FG002', 'title': 'Denosumab 60 mg to Open-Label Denosumab 60mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}, {'id': 'FG003', 'title': 'Placebo to Open-Label Denosumab 60 mg', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.'}], 'periods': [{'title': 'Double-Blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Completed the 6 Month Assessment', 'achievements': [{'comment': '"Completed 6 month assessment" refers to par. that completed at least one 6 month assessment.', 'groupId': 'FG000', 'numSubjects': '62'}, {'comment': '"Completed 6 month assessment" refers to par. that completed at least one 6 month assessment.', 'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '"Completed" refers to par. that did not have a withdraw reason at the 6 month visit.', 'groupId': 'FG000', 'numSubjects': '60'}, {'comment': '"Completed" refers to par. that did not have a withdraw reason at the 6 month visit.', 'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Continuation Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Open-Label Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This study consisted of a screening phase of up to 2.5 months, a six-month Double-Blind Treatment Phase and a six-month Open-Label Extension Phase. 371 participants (par.) were screened, 135 par. entered the Double-Blind Treatment Phase, and 123 par. continued into the Open-Label Extension Phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Denosumab 60 mg', 'description': 'Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \\[IU\\]).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.0', 'spread': '4.86', 'groupId': 'BG000'}, {'value': '66.0', 'spread': '4.77', 'groupId': 'BG001'}, {'value': '66.5', 'spread': '4.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '135', '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/Ethnicity, Customized', 'classes': [{'title': 'Asian - East Asian Heritage', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '135', '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': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-17', 'studyFirstSubmitDate': '2011-10-20', 'resultsFirstSubmitDate': '2013-08-22', 'studyFirstSubmitQcDate': '2011-10-20', 'lastUpdatePostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-08-22', 'studyFirstPostDateStruct': {'date': '2011-10-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean Percent Change From Baseline in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Denosumab', 'timeFrame': 'Baseline and Month 12', 'description': 'Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 - measure at Baseline) divided by the measure at Baseline \\* 100.'}, {'measure': 'Mean Percent Change From Month 6 in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Placebo', 'timeFrame': 'Month 6 and Month 12', 'description': 'Mean percent change from Month 6 in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by the measure at Month 6 \\* 100.'}, {'measure': 'Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Denosumab', 'timeFrame': 'Baseline and Month 12', 'description': 'Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 - measure at Baseline) divided by the measure at Baseline \\* 100.'}, {'measure': 'Mean Percent Change From Month 6 in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Placebo', 'timeFrame': 'Month 6 and Month 12', 'description': 'Mean percent change from Month 6 in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by the measure at Month 6 \\* 100.'}, {'measure': 'Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Denosumab', 'timeFrame': 'Baseline and Month 12', 'description': 'Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline - measure at Baseline) divided by measure at Baseline \\* 100.'}, {'measure': 'Median Percent Change From Month 6 in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Placebo', 'timeFrame': 'Month 6 and Month 12', 'description': 'Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by measure at Month 6 \\* 100.'}, {'measure': 'Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) During the Open-Label Extension Phase', 'timeFrame': 'From Month 6 to Month 12', 'description': 'An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.'}, {'measure': 'Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 12', 'timeFrame': 'Baseline and Month 12', 'description': 'Change from Baseline was calculated as the Month 12 value minus the Baseline value.'}, {'measure': 'Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12', 'timeFrame': 'Baseline and Month 12', 'description': 'Change from Baseline was calculated as the Month 12 value minus the Baseline value.'}, {'measure': 'Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12', 'timeFrame': 'Baseline and Month 12', 'description': 'Change from Baseline was calculated as the Month 12 value minus the Baseline value.'}, {'measure': 'Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12', 'timeFrame': 'Baseline and Month 12', 'description': 'Change from Baseline was calculated as the Month 12 value minus the Baseline value.'}, {'measure': 'Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12', 'timeFrame': 'Baseline and Month 12', 'description': 'Change from Baseline was calculated as the Month 12 value minus the Baseline value.'}, {'measure': 'Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12', 'timeFrame': 'Baseline and Month 12', 'description': 'Change from Baseline was calculated as the Month 12 value minus the Baseline value.'}, {'measure': 'Change From Baseline in Hematocrit at Month 12', 'timeFrame': 'Baseline and Month 12', 'description': 'Change from Baseline was calculated as the Month 12 value minus the Baseline value.'}, {'measure': 'Change From Baseline in Mean Corpuscle Hemoglobin at Month 12', 'timeFrame': 'Baseline and Month 12', 'description': 'Change from Baseline was calculated as the Month 12 value minus the Baseline value.'}, {'measure': 'Change From Baseline in Red Blood Cell Count at Month 12', 'timeFrame': 'Baseline and Month 12', 'description': 'Change from Baseline was calculated as the Month 12 value minus the Baseline value.'}, {'measure': 'Change From Baseline in Red Cell Distribution Width at Month 12', 'timeFrame': 'Baseline and Month 12', 'description': 'Change from Baseline was calculated as the Month 12 value minus the Baseline value.'}, {'measure': 'Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12', 'timeFrame': 'Baseline and Month 12', 'description': 'Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (\\<50 or \\>120 Bits Per Minutes \\[bpm\\]), Systolic Blood Pressure (\\>170 Millimeters of Mercury \\[mmHg\\] or \\<100 mmHg) and Heart rate (\\>110 mmHg or \\<50 mmHg) are summarized. Change from Baseline was calculated as the Month 12 value minus the Baseline value.'}, {'measure': 'Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12', 'timeFrame': 'Month 12', 'description': 'Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 12 was summarized.'}], 'primaryOutcomes': [{'measure': 'Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': 'Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using the Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 6 - measure at Baseline) divided by the measure at Baseline \\* 100.'}], 'secondaryOutcomes': [{'measure': 'Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1', 'timeFrame': 'Baseline and Month 1', 'description': 'Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1 - measure at Baseline) divided by the measure at Baseline \\* 100.'}, {'measure': 'Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6', 'timeFrame': 'Baseline, Month 1 and Month 6', 'description': 'Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covarience (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1/6 - measure at Baseline) divided by the measure at Baseline \\* 100.'}, {'measure': 'Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6', 'timeFrame': 'Baseline, Months 1, 3 and 6', 'description': 'Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline - measure at Baseline) divided by measure at Baseline \\* 100.'}, {'measure': 'Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE)', 'timeFrame': 'From Baseline up to Month 6', 'description': 'An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.'}, {'measure': 'Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.'}, {'measure': 'Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.'}, {'measure': 'Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.'}, {'measure': 'Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.'}, {'measure': 'Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.'}, {'measure': 'Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.'}, {'measure': 'Change From Baseline in Hematocrit at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.'}, {'measure': 'Change From Baseline in Mean Corpuscle Hemoglobin at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.'}, {'measure': 'Change From Baseline in Mean Corpuscular Volume at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.'}, {'measure': 'Change From Baseline in Red Blood Cell Count at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.'}, {'measure': 'Change From Baseline in Red Cell Distribution Width at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': 'Change from Baseline was calculated as the Month 6 value minus the Baseline value.'}, {'measure': 'Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': 'Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (\\<50 or \\>120 Bits Per Minutes \\[bpm\\]), Systolic Blood Pressure (\\>170 Millimeters of Mercury \\[mmHg\\] or \\<100 mmHg) and Heart rate (\\>110 mmHg or \\<50 mmHg) are summarized. Change from Baseline was calculated as the Month 6 value minus the Baseline value.'}, {'measure': 'Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab', 'timeFrame': 'Month 6', 'description': 'Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 6 was summarized.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['denosumab', 'Republic of Korea', 'dual energy x-ray absorptiometry'], 'conditions': ['Osteoporosis, Postmenopausal']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Korean postmenopausal women with osteoporosis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ambulatory Korean postmenopausal women with osteoporosis\n* greater than 5 years postmenopausal\n* aged 60 to 90 years old\n* absolute bone mineral density value consistent with a T-score less than -2.5 and greater than or equal to - 4.0 at the either the lumbar spine or total hip, as measured by dual energy x-ray absorptiometry. Subjects with a T-score less than -4.0 are at very high risk for fracture and will be excluded.\n\nExclusion Criteria:\n\n* previous or current metabolic bone disease, Paget's or Cushing's disease, or hyperprolactinemia\n* current hypo- or hyperparathyroidism or hypo- or hyperthyroidism unless on stable thyroid replacement therapy and TSH level meets criteria\n* rheumatoid arthritis\n* cirrhosis of the liver or unstable liver disease or ALT or AST greater than or equal to 2.0 times the upper limit of normal, or alkaline phosphatase and bilirubin greater than or equal to 1.5 times the upper limit of normal\n* medications used to treat osteoporosis, defined for type and duration of use, and including IV and oral bisphosphonates\n* medications that affect bone metabolism including parathyroid hormone or derivatives; anabolic steroids or testosterone; glucocorticosteroids; systemic hormone replacement therapy; selective estrogen receptor modulators; tibolone, calcitonin, and calcitriol or vitamin D derivatives; other bone active drugs including anticonvulsives (but not benzodiazepines) and heparin; chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, and gonadotropin-releasing hormone agonists\n* malignancy within 5 years except certain resected types\n* malabsorption syndrome or gastrointestinal disorders associated with malabsorption\n* abnormal calcium level\n* vitamin D deficiency\n* any laboratory abnormality that will prevent the subject from completing the study or interfere with interpretation of study results\n* severe renal impairment or on dialysis\n* impaired immune system or subject is taking immunosuppressants\n* oral or dental conditions including current or past history of osteomyelitis or osteonecrosis of the jaw; active dental or jaw condition with requires oral surgery; planned invasive dental procedure; un-healed dental or oral surgery\n* any disorder that compromises the ability of the subject to give written informed consent or to comply with study procedures\n* any physical or psychiatric disorder that will prevent the subject from completing the study or interferes with study results\n* known to have tested positive for HIV\n* less than two lumbar vertebrae evaluable for DXA measurements\n* height, weight, or girth that may preclude accurate DXA measurements\n* drug or alcohol abuse within 12 months that interferes with understanding or completing the study\n* known sensitivity to mammalian cell-derived drug products\n* use of an investigational drug or device within 30 days of enrollment or currently receiving other investigational agent(s)"}, 'identificationModule': {'nctId': 'NCT01457950', 'briefTitle': 'A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Six Month Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study With a Six Month Open-Label Extension to Evaluate the Efficacy and Safety of Denosumab in Korean Postmenopausal Women With Osteoporosis', 'orgStudyIdInfo': {'id': '114163'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'denosumab 60mg subcutaneous injection, single dose at the start of the 6-month double-blind phase', 'interventionNames': ['Drug: denosumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2', 'description': 'placebo subcutaneous injection, single dose at the start of the 6-month double-blind phase', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'open-label phase follows the double-blind phase, denosumab 60mg subcutaneous injection, single dose at the start of the 6-month open-label phase', 'interventionNames': ['Drug: open-label denosumab']}], 'interventions': [{'name': 'denosumab', 'type': 'DRUG', 'description': 'double-blind phase: 60mg subcutaneous injection, single dose', 'armGroupLabels': ['Arm 1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'double-blind phase: placebo subcutaneous injection, single dose', 'armGroupLabels': ['Arm 2']}, {'name': 'open-label denosumab', 'type': 'DRUG', 'description': 'open-label phase: 60mg subcutaneous injection, single dose', 'armGroupLabels': ['Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '602-739', 'city': 'Busan', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '501-757', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '100-380', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Songpa-gu, Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '443-721', 'city': 'Suwon', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}