Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT01377467
Status:
COMPLETED
Last Update Posted:
2016-05-26
First Post:
2011-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Denosumab for Prevention of Osteoporosis in Renal Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069448', 'term': 'Denosumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rudolf.wuethrich@usz.ch', 'phone': '+41 44 255 33 84', 'title': 'Prof. Rudolf P. Wüthrich', 'organization': 'University Hospital Zürich'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Denosumab', 'description': '60 mg denosumab s.c. at baseline and after 6 months\n\nDenosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months', 'otherNumAtRisk': 46, 'otherNumAffected': 45, 'seriousNumAtRisk': 46, 'seriousNumAffected': 31}, {'id': 'EG001', 'title': 'Control', 'description': 'No treatment', 'otherNumAtRisk': 44, 'otherNumAffected': 44, 'seriousNumAtRisk': 44, 'seriousNumAffected': 29}], 'otherEvents': [{'term': 'Urinary tract infections', 'notes': 'Cystitis (bladder infection)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 39, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 19, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Hypocalcemia', 'notes': 'Transient, asymptomatic hypocalcemia defined as total serum calcium \\<1.9 mmol/L', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Aphtous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Exanthema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Muscle pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Neck/back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Fecal blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}], 'seriousEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Transplant pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'CMV viremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Flu-like disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Acute rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Skin cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Diabetes (post-transplant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Surgical intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Functional decline of transplant function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Transplant ureter stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Peripheral arterial vascular disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Transplant artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Uterus myomatosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Retinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Bilateral nephrectomy of polycystic kidneys', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Neck/back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Generalized weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Ureteral leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Choledocholithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Infection without focus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Transplant reflux testing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Selective ureteral sampling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Urethral stricture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab', 'description': '60 mg denosumab s.c. at baseline and after 6 months\n\nDenosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.059', 'ciLowerLimit': '3.137', 'ciUpperLimit': '6.980', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.967', 'estimateComment': 'Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.', 'groupDescription': 'We calculated that a sample size of 43 patients per group would provide a statistical power of 86% to detect a 4% difference in the percentage change of areal BMD at the total lumbar spine at 12 months, using a two-sided t-test with an α-level of 0.05 and assuming a mean ± SD change of 4 ± 6% in the denosumab group and 0 ± 6% in the control group. To account for a dropout rate of 5%, it was planned to randomize a total of 90 patients.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and month 12', 'description': 'The total lumbar spine BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention-to-treat (ITT) population was used for the primary efficacy analysis, i.e. all subjects were included that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).'}, {'type': 'SECONDARY', 'title': 'Percent Change in BMD at the Total Hip From Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab', 'description': '60 mg denosumab s.c. at baseline and after 6 months\n\nDenosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '4.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.035', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.895', 'ciLowerLimit': '0.132', 'ciUpperLimit': '3.659', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.887', 'estimateComment': 'Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and month 12', 'description': 'The total hip BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).'}, {'type': 'SECONDARY', 'title': 'Percent Change in BMD at the Femoral Neck From Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab', 'description': '60 mg denosumab s.c. at baseline and after 6 months\n\nDenosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '6.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.380', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.059', 'ciLowerLimit': '-1.329', 'ciUpperLimit': '3.447', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.201', 'estimateComment': 'Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and month 12', 'description': 'The total femoral neck BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention-to-treat (ITT) was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).'}, {'type': 'SECONDARY', 'title': 'Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab', 'description': '60 mg denosumab s.c. at baseline and after 6 months\n\nDenosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.567', 'ciLowerLimit': '2.975', 'ciUpperLimit': '6.178', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.806', 'estimateComment': 'Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and month 6', 'description': 'The total lumbar spine BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention-to-treat was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).'}, {'type': 'SECONDARY', 'title': 'Percent Change in BMD at the Total Hip From Baseline to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab', 'description': '60 mg denosumab s.c. at baseline and after 6 months\n\nDenosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.756', 'ciLowerLimit': '0.440', 'ciUpperLimit': '3.072', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.662', 'estimateComment': 'Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and month 6', 'description': 'The total hip BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).'}, {'type': 'SECONDARY', 'title': 'Percent Change in BMD at the Femoral Neck From Baseline to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab', 'description': '60 mg denosumab s.c. at baseline and after 6 months\n\nDenosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '5.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.064', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.035', 'ciLowerLimit': '-0.122', 'ciUpperLimit': '4.193', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.085', 'estimateComment': 'Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and month 6', 'description': 'The femoral neck BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).'}, {'type': 'SECONDARY', 'title': 'Beta-CTX at Baseline and Months 3, 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab', 'description': '60 mg denosumab s.c. at baseline and after 6 months\n\nDenosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '0.635', 'groupId': 'OG000', 'lowerLimit': '0.508', 'upperLimit': '0.741'}, {'value': '0.772', 'groupId': 'OG001', 'lowerLimit': '0.665', 'upperLimit': '0.878'}]}]}, {'title': 'month 3', 'categories': [{'measurements': [{'value': '0.129', 'groupId': 'OG000', 'lowerLimit': '0.037', 'upperLimit': '0.221'}, {'value': '0.590', 'groupId': 'OG001', 'lowerLimit': '0.498', 'upperLimit': '0.682'}]}]}, {'title': 'month 6', 'categories': [{'measurements': [{'value': '0.204', 'groupId': 'OG000', 'lowerLimit': '0.077', 'upperLimit': '0.330'}, {'value': '0.612', 'groupId': 'OG001', 'lowerLimit': '0.485', 'upperLimit': '0.739'}]}]}, {'title': 'month 12', 'categories': [{'measurements': [{'value': '0.389', 'groupId': 'OG000', 'lowerLimit': '0.154', 'upperLimit': '0.623'}, {'value': '0.794', 'groupId': 'OG001', 'lowerLimit': '0.559', 'upperLimit': '1.028'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'between-subjects effect', 'ciNumSides': 'TWO_SIDED', 'paramValue': '10.466', 'estimateComment': 'Within-subjects effect: p=0.007. Time\\*treatment interaction: p=0.002. The a priori threshold for statistical significance is \\<0.05.', 'statisticalMethod': 'repeated measures GLM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, month 3, month 6, and month 12', 'description': 'Blood concentrations of beta-CTX (microgram/L)', 'unitOfMeasure': 'microgram/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.'}, {'type': 'SECONDARY', 'title': 'P1NP at Baseline and Months 3, 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab', 'description': '60 mg denosumab s.c. at baseline and after 6 months\n\nDenosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '61.222', 'groupId': 'OG000', 'lowerLimit': '47.974', 'upperLimit': '74.470'}, {'value': '77.808', 'groupId': 'OG001', 'lowerLimit': '64.399', 'upperLimit': '91.217'}]}]}, {'title': 'month 3', 'categories': [{'measurements': [{'value': '40.976', 'groupId': 'OG000', 'lowerLimit': '19.801', 'upperLimit': '62.152'}, {'value': '108.699', 'groupId': 'OG001', 'lowerLimit': '87.266', 'upperLimit': '130.13'}]}]}, {'title': 'month 6', 'categories': [{'measurements': [{'value': '35.347', 'groupId': 'OG000', 'lowerLimit': '11.525', 'upperLimit': '59.169'}, {'value': '107.072', 'groupId': 'OG001', 'lowerLimit': '82.962', 'upperLimit': '131.18'}]}]}, {'title': 'month 12', 'categories': [{'measurements': [{'value': '57.953', 'groupId': 'OG000', 'lowerLimit': '33.685', 'upperLimit': '82.221'}, {'value': '132.439', 'groupId': 'OG001', 'lowerLimit': '107.876', 'upperLimit': '157.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'between-subjects effect', 'ciNumSides': 'TWO_SIDED', 'paramValue': '275622.016', 'estimateComment': 'Within-subjects effect: p\\<0.001. Time\\*treatment interaction: p=0.012. The a priori threshold for statistical significance is \\<0.05.', 'statisticalMethod': 'repeated measures GLM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, month 3, month 6, and month 12', 'description': 'Blood concentrations of P1NP were measured in microgram/L', 'unitOfMeasure': 'microgram/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For this endpoints, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Blood Levels of Calcium (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab', 'description': '60 mg denosumab s.c. at baseline and after 6 months\n\nDenosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '2.320', 'groupId': 'OG000', 'lowerLimit': '2.245', 'upperLimit': '2.395'}, {'value': '2.317', 'groupId': 'OG001', 'lowerLimit': '2.247', 'upperLimit': '2.386'}]}]}, {'title': 'month 0.5', 'categories': [{'measurements': [{'value': '2.131', 'groupId': 'OG000', 'lowerLimit': '2.049', 'upperLimit': '2.214'}, {'value': '2.405', 'groupId': 'OG001', 'lowerLimit': '2.329', 'upperLimit': '2.481'}]}]}, {'title': 'month 1', 'categories': [{'measurements': [{'value': '2.293', 'groupId': 'OG000', 'lowerLimit': '2.231', 'upperLimit': '2.356'}, {'value': '2.444', 'groupId': 'OG001', 'lowerLimit': '2.387', 'upperLimit': '2.502'}]}]}, {'title': 'month 2', 'categories': [{'measurements': [{'value': '2.420', 'groupId': 'OG000', 'lowerLimit': '2.355', 'upperLimit': '2.485'}, {'value': '2.480', 'groupId': 'OG001', 'lowerLimit': '2.419', 'upperLimit': '2.540'}]}]}, {'title': 'month 3', 'categories': [{'measurements': [{'value': '2.404', 'groupId': 'OG000', 'lowerLimit': '2.327', 'upperLimit': '2.481'}, {'value': '2.461', 'groupId': 'OG001', 'lowerLimit': '2.390', 'upperLimit': '2.532'}]}]}, {'title': 'month 6', 'categories': [{'measurements': [{'value': '2.463', 'groupId': 'OG000', 'lowerLimit': '2.404', 'upperLimit': '2.522'}, {'value': '2.453', 'groupId': 'OG001', 'lowerLimit': '2.399', 'upperLimit': '2.508'}]}]}, {'title': 'month 12', 'categories': [{'measurements': [{'value': '2.480', 'groupId': 'OG000', 'lowerLimit': '2.421', 'upperLimit': '2.538'}, {'value': '2.509', 'groupId': 'OG001', 'lowerLimit': '2.455', 'upperLimit': '2.563'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'between-subjects effect', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.717', 'estimateComment': 'Within-subjects effect: p\\<0.001. Time\\*treatment interaction: p\\<0.001. The a priori threshold for statistical significance is \\<0.05.', 'statisticalMethod': 'repeated measures GLM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, months 0.5, 1, 2, 3, 6, 12', 'description': 'Blood levels of calcium (mmol/L) were measured at baseline and at months 0.5, 1, 2, 3, 6, and 12', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For this endpoints, an available case analysis was performed, thus all randomised patients with valid data at all time points were included.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Blood Levels of Phosphate (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab', 'description': '60 mg denosumab s.c. at baseline and after 6 months\n\nDenosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '0.582', 'groupId': 'OG000', 'lowerLimit': '0.506', 'upperLimit': '0.657'}, {'value': '0.586', 'groupId': 'OG001', 'lowerLimit': '0.514', 'upperLimit': '0.657'}]}]}, {'title': 'month 0.5', 'categories': [{'measurements': [{'value': '0.525', 'groupId': 'OG000', 'lowerLimit': '0.436', 'upperLimit': '0.613'}, {'value': '0.714', 'groupId': 'OG001', 'lowerLimit': '0.631', 'upperLimit': '0.798'}]}]}, {'title': 'month 1', 'categories': [{'measurements': [{'value': '0.605', 'groupId': 'OG000', 'lowerLimit': '0.519', 'upperLimit': '0.691'}, {'value': '0.726', 'groupId': 'OG001', 'lowerLimit': '0.645', 'upperLimit': '0.807'}]}]}, {'title': 'month 2', 'categories': [{'measurements': [{'value': '0.726', 'groupId': 'OG000', 'lowerLimit': '0.659', 'upperLimit': '0.793'}, {'value': '0.812', 'groupId': 'OG001', 'lowerLimit': '0.749', 'upperLimit': '0.875'}]}]}, {'title': 'month 3', 'categories': [{'measurements': [{'value': '0.742', 'groupId': 'OG000', 'lowerLimit': '0.673', 'upperLimit': '0.812'}, {'value': '0.776', 'groupId': 'OG001', 'lowerLimit': '0.711', 'upperLimit': '0.842'}]}]}, {'title': 'month 6', 'categories': [{'measurements': [{'value': '0.804', 'groupId': 'OG000', 'lowerLimit': '0.727', 'upperLimit': '0.880'}, {'value': '0.849', 'groupId': 'OG001', 'lowerLimit': '0.777', 'upperLimit': '0.921'}]}]}, {'title': 'month 12', 'categories': [{'measurements': [{'value': '0.842', 'groupId': 'OG000', 'lowerLimit': '0.737', 'upperLimit': '0.948'}, {'value': '0.902', 'groupId': 'OG001', 'lowerLimit': '0.802', 'upperLimit': '1.002'}]}]}], 'analyses': [{'pValue': '0.068', 'groupIds': ['OG000', 'OG001'], 'paramType': 'between-subjects effect', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.707', 'estimateComment': 'Within-subjects effect: p\\<0.001. Time\\*treatment interaction: p=0.047. The a priori threshold for statistical significance is \\<0.05.', 'statisticalMethod': 'repeated measures GLM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, months 0.5, 1, 2, 3, 6, 12', 'description': 'Blood levels of phosphate (mmol/L) were measured at baseline and at months 0.5, 1, 2, 3, 6, 12', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For this endpoints, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Blood Levels of PTH (ng/L) at Baseline and Months 3, 6, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab', 'description': '60 mg denosumab s.c. at baseline and after 6 months\n\nDenosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '163.110', 'groupId': 'OG000', 'lowerLimit': '115.906', 'upperLimit': '210.314'}, {'value': '147.300', 'groupId': 'OG001', 'lowerLimit': '100.096', 'upperLimit': '194.504'}]}]}, {'title': 'month 3', 'categories': [{'measurements': [{'value': '173.573', 'groupId': 'OG000', 'lowerLimit': '130.141', 'upperLimit': '217.004'}, {'value': '111.563', 'groupId': 'OG001', 'lowerLimit': '68.131', 'upperLimit': '154.994'}]}]}, {'title': 'month 6', 'categories': [{'measurements': [{'value': '157.043', 'groupId': 'OG000', 'lowerLimit': '117.092', 'upperLimit': '196.993'}, {'value': '99.420', 'groupId': 'OG001', 'lowerLimit': '59.469', 'upperLimit': '139.371'}]}]}, {'title': 'month 12', 'categories': [{'measurements': [{'value': '106.650', 'groupId': 'OG000', 'lowerLimit': '85.078', 'upperLimit': '128.222'}, {'value': '100.705', 'groupId': 'OG001', 'lowerLimit': '79.133', 'upperLimit': '122.277'}]}]}], 'analyses': [{'pValue': '0.114', 'groupIds': ['OG000', 'OG001'], 'paramType': 'between-subjects effect', 'ciNumSides': 'TWO_SIDED', 'paramValue': '99952.126', 'estimateComment': 'Within-subjects effect: p\\<0.001. 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The a priori threshold for statistical significance is \\<0.05.', 'statisticalMethod': 'repeated measures GLM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and months 3, 6, and 12', 'description': 'Blood levels of PTH (ng/L) were measured at baseline and at months 3, 6, and 12', 'unitOfMeasure': 'ng/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': '25-OH-vitamin D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab', 'description': '60 mg denosumab s.c. at baseline and after 6 months\n\nDenosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '17.378', 'groupId': 'OG000', 'lowerLimit': '14.690', 'upperLimit': '20.067'}, {'value': '18.058', 'groupId': 'OG001', 'lowerLimit': '15.336', 'upperLimit': '20.779'}]}]}, {'title': 'month 3', 'categories': [{'measurements': [{'value': '21.632', 'groupId': 'OG000', 'lowerLimit': '19.604', 'upperLimit': '23.659'}, {'value': '22.903', 'groupId': 'OG001', 'lowerLimit': '20.850', 'upperLimit': '24.955'}]}]}, {'title': 'month 6', 'categories': [{'measurements': [{'value': '24.395', 'groupId': 'OG000', 'lowerLimit': '21.418', 'upperLimit': '27.373'}, {'value': '26.728', 'groupId': 'OG001', 'lowerLimit': '23.713', 'upperLimit': '29.742'}]}]}, {'title': 'month 12', 'categories': [{'measurements': [{'value': '28.546', 'groupId': 'OG000', 'lowerLimit': '25.890', 'upperLimit': '31.202'}, {'value': '28.358', 'groupId': 'OG001', 'lowerLimit': '25.669', 'upperLimit': '31.046'}]}]}], 'analyses': [{'pValue': '0.578', 'groupIds': ['OG000', 'OG001'], 'paramType': 'between-subjects effect', 'ciNumSides': 'TWO_SIDED', 'paramValue': '84.830', 'estimateComment': 'Within-subjects effect: p\\<0.001. 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'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Trabecular Volumetric Bone Mineral Densitiy (Tb.vBMD) at the Distal Radius', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab', 'description': '60 mg denosumab s.c. at baseline and after 6 months\n\nDenosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '4.1'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-9.4', 'upperLimit': '3.1'}]}]}], 'analyses': [{'pValue': '0.108', 'groupIds': ['OG000', 'OG001'], 'paramType': 'z value', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.640', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and month 12', 'description': 'Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Cortical Thickness (Ct.Th) at the Distal Radius', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab', 'description': '60 mg denosumab s.c. at baseline and after 6 months\n\nDenosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'No treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '2.0'}, {'value': '-3.6', 'groupId': 'OG001', 'lowerLimit': '-7.7', 'upperLimit': '-1.3'}]}]}], 'analyses': [{'pValue': '0.048', 'groupIds': ['OG000', 'OG001'], 'paramType': 'z value', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.991', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and month 12', 'description': 'Cortical thickness was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mm.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Denosumab', 'description': '60 mg denosumab s.c. at baseline and after 6 months\n\nDenosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months'}, {'id': 'FG001', 'title': 'Control', 'description': 'No treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were recruited from June 20, 2011, to May 2, 2014. Patients were randomized after 15.7 ± 6.4 days after transplantation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Denosumab', 'description': '60 mg denosumab s.c. at baseline and after 6 months\n\nDenosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months'}, {'id': 'BG001', 'title': 'Control', 'description': 'No treatment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.9', 'spread': '16.0', 'groupId': 'BG000'}, {'value': '52.9', 'spread': '14.0', 'groupId': 'BG001'}, {'value': '50.9', 'spread': '15.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Switzerland', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of osteopenic patients', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of osteoporotic patients', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Randomized patients with a functioning graft'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-26', 'studyFirstSubmitDate': '2011-06-20', 'resultsFirstSubmitDate': '2016-01-22', 'studyFirstSubmitQcDate': '2011-06-20', 'lastUpdatePostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-23', 'studyFirstPostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood Levels of Calcium (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12', 'timeFrame': 'baseline, months 0.5, 1, 2, 3, 6, 12', 'description': 'Blood levels of calcium (mmol/L) were measured at baseline and at months 0.5, 1, 2, 3, 6, and 12'}, {'measure': 'Blood Levels of Phosphate (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12', 'timeFrame': 'baseline, months 0.5, 1, 2, 3, 6, 12', 'description': 'Blood levels of phosphate (mmol/L) were measured at baseline and at months 0.5, 1, 2, 3, 6, 12'}, {'measure': 'Blood Levels of PTH (ng/L) at Baseline and Months 3, 6, and 12', 'timeFrame': 'baseline and months 3, 6, and 12', 'description': 'Blood levels of PTH (ng/L) were measured at baseline and at months 3, 6, and 12'}, {'measure': '25-OH-vitamin D3', 'timeFrame': 'baseline, months 3, 6, and 12', 'description': 'Blood levels of 25-OH-vitamin D3 were measured as microgramm/L'}, {'measure': '1,25-(OH)2 Vitamin D3', 'timeFrame': 'baseline, months 3, 6, and 12', 'description': 'Blood levels of 1,25-(OH)2 vitamin D3 were measured as ng/L'}, {'measure': 'Percent Change From Baseline in Total Volumetric Bone Mineral Densitiy (Tot.vBMD) at the Distal Tibia', 'timeFrame': 'Baseline and month 12', 'description': 'Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3.'}, {'measure': 'Percent Change From Baseline in Cortical Volumetric Bone Mineral Densitiy (Ct.vBMD) at the Distal Tibia', 'timeFrame': 'Baseline and month 12', 'description': 'Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3.'}, {'measure': 'Percent Change From Baseline in Trabecular Volumetric Bone Mineral Densitiy (Tb.vBMD) at the Distal Tibia', 'timeFrame': 'Baseline and month 12', 'description': 'Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3.'}, {'measure': 'Percent Change From Baseline in Cortical Thickness (Ct.Th) at the Distal Tibia', 'timeFrame': 'Baseline and month 12', 'description': 'Cortical thickness was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mm.'}, {'measure': 'Percent Change From Baseline in Total Volumetric Bone Mineral Densitiy (Tot.vBMD) at the Distal Radius', 'timeFrame': 'Baseline and month 12', 'description': 'Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3.'}, {'measure': 'Percent Change From Baseline in Cortical Volumetric Bone Mineral Densitiy (Ct.vBMD) at the Distal Radius', 'timeFrame': 'Baseline and month 12', 'description': 'Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3.'}, {'measure': 'Percent Change From Baseline in Trabecular Volumetric Bone Mineral Densitiy (Tb.vBMD) at the Distal Radius', 'timeFrame': 'Baseline and month 12', 'description': 'Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3.'}, {'measure': 'Percent Change From Baseline in Cortical Thickness (Ct.Th) at the Distal Radius', 'timeFrame': 'Baseline and month 12', 'description': 'Cortical thickness was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mm.'}], 'primaryOutcomes': [{'measure': 'Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12', 'timeFrame': 'Baseline and month 12', 'description': 'The total lumbar spine BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite'}], 'secondaryOutcomes': [{'measure': 'Percent Change in BMD at the Total Hip From Baseline to Month 12', 'timeFrame': 'Baseline and month 12', 'description': 'The total hip BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite'}, {'measure': 'Percent Change in BMD at the Femoral Neck From Baseline to Month 12', 'timeFrame': 'Baseline and month 12', 'description': 'The total femoral neck BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite'}, {'measure': 'Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 6', 'timeFrame': 'Baseline and month 6', 'description': 'The total lumbar spine BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite.'}, {'measure': 'Percent Change in BMD at the Total Hip From Baseline to Month 6', 'timeFrame': 'Baseline and month 6', 'description': 'The total hip BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite'}, {'measure': 'Percent Change in BMD at the Femoral Neck From Baseline to Month 6', 'timeFrame': 'Baseline and month 6', 'description': 'The femoral neck BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite'}, {'measure': 'Beta-CTX at Baseline and Months 3, 6 and 12', 'timeFrame': 'baseline, month 3, month 6, and month 12', 'description': 'Blood concentrations of beta-CTX (microgram/L)'}, {'measure': 'P1NP at Baseline and Months 3, 6 and 12', 'timeFrame': 'baseline, month 3, month 6, and month 12', 'description': 'Blood concentrations of P1NP were measured in microgram/L'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoporosis', 'Osteopenia', 'Denosumab', 'Transplantation', 'Kidney'], 'conditions': ['Osteoporosis', 'Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '26713403', 'type': 'RESULT', 'citation': 'Bonani M, Frey D, Brockmann J, Fehr T, Mueller TF, Saleh L, von Eckardstein A, Graf N, Wuthrich RP. Effect of Twice-Yearly Denosumab on Prevention of Bone Mineral Density Loss in De Novo Kidney Transplant Recipients: A Randomized Controlled Trial. Am J Transplant. 2016 Jun;16(6):1882-91. doi: 10.1111/ajt.13692. Epub 2016 Feb 29.'}, {'pmid': '39382091', 'type': 'DERIVED', 'citation': 'Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to examine the effect of denosumab on lumbar spine bone mineral density (BMD) after one year of treatment in newly transplanted renal allograft recipients. Secondary endpoints include BMD changes at the total hip and the femoral neck, changes in body height, changes in bone mineral metabolism parameters, incidence of fractures, and allograft function at one year. Safety measurements include the occurrence of rejection episodes, infectious complications, graft loss and mortality.\n\n* Trial with medicinal product', 'detailedDescription': 'Renal allograft recipients are at high risk to suffer a substantial loss of bone mineral density (BMD) within the first year after kidney transplantation. This loss of BMD correlates with an increased risk for the development of osteoporosis or worsening of pre-existing osteopenia/osteoporosis, heightening the risk for the subsequent occurrence of fractures. Renal allograft recipients are often treated with calcium and vitamin D preparations to prevent BMD loss. The addition of bisphosphonates can further improve BMD. However, bisphosphonates are potentially nephrotoxic and promote adynamic bone disease, and are therefore not regularly prescribed.\n\nReceptor Activator of Nuclear factor- Kappa-B Ligand (RANKL) is a key molecule mediating development, activity, and survival of osteoclasts. Osteoporosis results in part from increased osteoclastic bone resorption, and therefore the inhibition of RANKL activity has become an obvious therapeutic strategy to prevent bone mineral density (BMD) loss and the development of osteoporosis.\n\nThe novel anti-osteoporotic drug denosumab (trade name Prolia®) is a fully human monoclonal antibody against RANKL. By inhibiting the development and the activity as well as reducing the survival of osteoclasts it decreases bone resorption and increases bone density.\n\nThe hypothesis of the present study is that denosumab has a beneficial effect on the loss of BMD in the first year after renal transplantation. The preservation of BMD is a surrogate parameter, generally predicting subsequent improvements in the occurrence rate of fractures. The hypothesis will be tested by studying the effect of denosumab on BMD in newly transplanted renal allograft recipients.\n\nThe purpose of the present trial is to study the effect of denosumab on BMD in kidney allograft recipients. The study participants will be treated for 1 year, receiving a total of 2 injections of the standard 60 mg dose at baseline and at 6 months.\n\nNinety sequential renal allograft recipients will be randomized 1:1 to receive two subcutaneous 60 mg denosumab injections within 14 days and 6 months following renal transplantation, or no treatment. All patients will also receive oral standard treatment with 1000 mg calcium plus 800 IU vitamin D.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'The key inclusion criteria are:\n\n1. Male or female adult de novo kidney, kidney-pancreas or kidney-islet, or kidney-liver transplant recipients\n2. Functioning graft within 28 days after transplantation (creatinine having decreased to \\<200 micromol/l without the need for dialysis)\n3. Being on standard triple immunosuppression including a calcineurin antagonist (cyclosporine or tacrolimus), mycophenolate (MMF or MPA) and steroids, with or without induction treatment with basiliximab or anti-thymocyte globulin\n\nKey exclusion criteria are:\n\n1. Age \\<18 years\n2. Rising creatinine after initial drop \\<200 micromol/l or creatinine \\>200 micromol/l at baseline\n3. Evidence of early acute rejection, either suspected clinically and/or proven by biopsy\n4. Presence of severe osteoporosis as evidenced by a T score \\<-4 at the hip, femoral neck or any of the 4 vertebrae L1 to L4\n5. Evidence of severe hyper- or hypoparathyroidism (iPTH \\>800 ng/l or \\<10 ng/l)\n6. Hypocalcemia (total calcium \\<1.8 mmol/l) or hypercalcemia (total calcium \\>2.7 mmol/l)\n7. Steroid-free de novo immunosuppression scheme'}, 'identificationModule': {'nctId': 'NCT01377467', 'acronym': 'POSTOP', 'briefTitle': 'Denosumab for Prevention of Osteoporosis in Renal Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'A Phase 3, Investigator-initiated, Randomized, Open-label Single-center Study of the Effect of Denosumab on the Prevention of Bone Mineral Density Loss After Renal Transplantation', 'orgStudyIdInfo': {'id': 'UZH-NEP 2.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Denosumab', 'description': '60 mg denosumab s.c. at baseline and after 6 months', 'interventionNames': ['Drug: Denosumab (Prolia)']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No treatment'}], 'interventions': [{'name': 'Denosumab (Prolia)', 'type': 'DRUG', 'otherNames': ['Prolia'], 'description': '60 mg s.c. injection at baseline and after 6 months', 'armGroupLabels': ['Denosumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Division of Nephrology, University Hospital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Rudolf P Wuthrich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Nephrology, University Hospital, Zurich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rudolf Wuethrich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor and Director', 'investigatorFullName': 'Rudolf Wuethrich', 'investigatorAffiliation': 'University of Zurich'}}}}