Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-03 @ 4:27 AM
Study NCT ID:
NCT01348269
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2011-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077211', 'term': 'Zoledronic Acid'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'l-seefried.klh@uni-wuerzburg.de', 'phone': '+499318033590', 'title': 'Dr. Lothar Seefried', 'organization': 'University Hospital Wuerzburg - Department of Orthopaedics (Clinical Study Unit)'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Zoledronic Acid', 'description': 'single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 34, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo', 'description': 'placebo with vitamin D 1000 IU/d (NaCl Solution)', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 11, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blepharospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Renal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Skin discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rheumatic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Post-traumatic neck syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reduction of the Edema Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid', 'description': 'single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo with vitamin D 1000 IU/d (NaCl Solution)'}], 'classes': [{'categories': [{'measurements': [{'value': '64.53', 'spread': '41.92', 'groupId': 'OG000'}, {'value': '23.97', 'spread': '46.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.006', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'T-test (with MITT, omitting outlier value of one patient in placebo group)'}, {'pValue': '=0.015', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Mann-Whitney-Test'}], 'paramType': 'MEAN', 'timeFrame': 'Week 6 after administration of a single intravenous dose of zoledronic acid (5 mg)', 'description': 'The volume of the edema in cm³ is defined as biometric data measured by the use of MRI before and six weeks after treatment. Edema volume at screening was set to 100%. Edema volume six weeks after study drug administration was provdied as percentage reduction compared to the value at screening', 'unitOfMeasure': 'percentage of edema volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reduction of Pain (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid', 'description': 'single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo with vitamin D 1000 IU/d (NaCl Solution)'}], 'classes': [{'categories': [{'measurements': [{'value': '25.5', 'spread': '22.7', 'groupId': 'OG000'}, {'value': '25.6', 'spread': '24.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessment at week 3', 'description': 'Reduction of pain as measured by a Visual Analog Scale (VAS). Range 0-100 with higher values indicating worse pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Reporting group'}, {'type': 'SECONDARY', 'title': 'Reduction of Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid', 'description': 'single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo with vitamin D 1000 IU/d (NaCl Solution)'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'spread': '28.7', 'groupId': 'OG000'}, {'value': '38.5', 'spread': '30.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessment at week 6', 'description': 'Reduction of pain as measured by a visual analog scale (VAS). Range 0-100. Higher values indicating worse pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Reporting group'}, {'type': 'SECONDARY', 'title': 'Quality of Life (Qualeffo-41 Questionnaire)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid', 'description': 'single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo with vitamin D 1000 IU/d (NaCl Solution)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessment at week 3', 'description': 'Quality of life as measured by the Qualeffo-41 questionnaire - a quality of life questionnaire in patients with fractures of the European Foundation for Osteoporosis Higher values indicate worse quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Reporting group'}, {'type': 'SECONDARY', 'title': 'Quality of Life (Qualeffo-41 Questionnaire)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid', 'description': 'single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo with vitamin D 1000 IU/d (NaCl Solution)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessment at week 6', 'description': 'Quality of life as measured by the Qualeffo-41 questionnaire - a quality of life questionnaire in patients with vertebral fractures of the European Foundation for Osteoporosis', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Reporting group'}, {'type': 'SECONDARY', 'title': 'Subjective Estimation of Medical Condition (PDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid', 'description': 'single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo with vitamin D 1000 IU/d (NaCl Solution)'}], 'classes': [{'categories': [{'measurements': [{'value': '14.8', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '20.5', 'spread': '7.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessment at week 3', 'description': "Subjective estimation of medical condition as assessed by PDI (Pain Disability Index). Range 0-70. The higher the index the greater the person's disability due to pain.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Reporting group'}, {'type': 'SECONDARY', 'title': 'Subjective Estimation of Medical Condition (PDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid', 'description': 'single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo with vitamin D 1000 IU/d (NaCl Solution)'}], 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '18.8', 'spread': '7.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessment at week 6', 'description': 'Subjective estimation of medical condition as assessed by PDI (Pain Disability Index)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Reporting group'}, {'type': 'SECONDARY', 'title': 'Number of Additional Medicinal Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid', 'description': 'single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo with vitamin D 1000 IU/d (NaCl Solution)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessment at week 3', 'description': 'Number of additional medicinal visits until week 3', 'unitOfMeasure': 'Number of additional medicinal visits', 'reportingStatus': 'POSTED', 'populationDescription': 'Reporting group'}, {'type': 'SECONDARY', 'title': 'Number of Additional Medicinal Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid', 'description': 'single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo with vitamin D 1000 IU/d (NaCl Solution)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessment at week 6', 'description': 'Aggregated number of unscheduled medicinal visits', 'unitOfMeasure': 'Medicinal Visits', 'reportingStatus': 'POSTED', 'populationDescription': 'Reporting Group'}, {'type': 'SECONDARY', 'title': 'Number of Days of Illness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid', 'description': 'single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo with vitamin D 1000 IU/d (NaCl Solution)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.24', 'spread': '5.02', 'groupId': 'OG000'}, {'value': '3.00', 'spread': '7.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessment at week 6', 'description': 'Aggregated number of days of illness i.e. sick leave from work, assessed until week 6', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Reporting group'}, {'type': 'SECONDARY', 'title': 'Number of Days of Illness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid', 'description': 'single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo with vitamin D 1000 IU/d (NaCl Solution)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.94', 'spread': '4.10', 'groupId': 'OG000'}, {'value': '3.14', 'spread': '4.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessment at week 6', 'description': 'Number of days of illness assessed until week 6', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Reporting group'}, {'type': 'SECONDARY', 'title': 'Number of Aseptic Bone Necrosis and Fatigue Fractures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid', 'description': 'single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo with vitamin D 1000 IU/d (NaCl Solution)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline until end of study (week 12)', 'description': 'Assessment of number of patients withaseptic bone necrosis and/or fatigue fractures.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Reporting group'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events as a Measure of Safety and Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid', 'description': 'single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo with vitamin D 1000 IU/d (NaCl Solution)'}], 'classes': [{'title': 'Serum Calcium', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serum Phosphate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serum Alkaline Phosphatase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gamma-GT', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serum Creatinine', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'C-reactives protein', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 3, 6', 'description': 'including changes in the following parameters according to DVO guidelines: Calcium, Phosphate, Creatinin-Clearance (Cockcroft-Gault), Alkaline Phosphatase, γGT, CRP', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Reporting Group'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zoledronic Acid', 'description': 'single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'placebo with vitamin D 1000 IU/d (NaCl Solution)'}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment | Core Study (Until Week 6)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Follow-up (Until Week 12)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Surgical intervention - not study related', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Subsequent follow-up treatment required', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zoledronic Acid', 'description': 'single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'placebo with vitamin D 1000 IU/d (NaCl Solution)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Severity of disease', 'classes': [{'categories': [{'title': 'mild', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'moderate', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'severe', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Pain (VAS)', 'classes': [{'categories': [{'measurements': [{'value': '36.9', 'spread': '27.4', 'groupId': 'BG000'}, {'value': '34.1', 'spread': '21.1', 'groupId': 'BG001'}, {'value': '34.9', 'spread': '24.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Unidimensonal scale to rate pain. Range 0-100. Higher values indicate more pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Qualeffo-41', 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '2.2', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '2.1', 'spread': '0.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Quality of life questionnaire in patients with fractures. Answers are standardized so that 1 represents the best and 5 (or 3, or 4) represents the worst quality of life. Lower values indicate better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Subjective estimation of medical condition (Paian Disability Index)', 'classes': [{'categories': [{'measurements': [{'value': '20.8', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '21.3', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '20.8', 'spread': '13.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Pain Disability Index (PDI) is an instrument to measure the impact that pain has on the ability of a person to participate in life activities. Score range 0-70 with higher values indicating greater disability due to pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2015-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2011-05-02', 'resultsFirstSubmitDate': '2022-08-26', 'studyFirstSubmitQcDate': '2011-05-04', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-09', 'studyFirstPostDateStruct': {'date': '2011-05-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of the Edema Area', 'timeFrame': 'Week 6 after administration of a single intravenous dose of zoledronic acid (5 mg)', 'description': 'The volume of the edema in cm³ is defined as biometric data measured by the use of MRI before and six weeks after treatment. Edema volume at screening was set to 100%. Edema volume six weeks after study drug administration was provdied as percentage reduction compared to the value at screening'}], 'secondaryOutcomes': [{'measure': 'Reduction of Pain (VAS)', 'timeFrame': 'Assessment at week 3', 'description': 'Reduction of pain as measured by a Visual Analog Scale (VAS). Range 0-100 with higher values indicating worse pain.'}, {'measure': 'Reduction of Pain', 'timeFrame': 'Assessment at week 6', 'description': 'Reduction of pain as measured by a visual analog scale (VAS). Range 0-100. Higher values indicating worse pain.'}, {'measure': 'Quality of Life (Qualeffo-41 Questionnaire)', 'timeFrame': 'Assessment at week 3', 'description': 'Quality of life as measured by the Qualeffo-41 questionnaire - a quality of life questionnaire in patients with fractures of the European Foundation for Osteoporosis Higher values indicate worse quality of life'}, {'measure': 'Quality of Life (Qualeffo-41 Questionnaire)', 'timeFrame': 'Assessment at week 6', 'description': 'Quality of life as measured by the Qualeffo-41 questionnaire - a quality of life questionnaire in patients with vertebral fractures of the European Foundation for Osteoporosis'}, {'measure': 'Subjective Estimation of Medical Condition (PDI)', 'timeFrame': 'Assessment at week 3', 'description': "Subjective estimation of medical condition as assessed by PDI (Pain Disability Index). Range 0-70. The higher the index the greater the person's disability due to pain."}, {'measure': 'Subjective Estimation of Medical Condition (PDI)', 'timeFrame': 'Assessment at week 6', 'description': 'Subjective estimation of medical condition as assessed by PDI (Pain Disability Index)'}, {'measure': 'Number of Additional Medicinal Visits', 'timeFrame': 'Assessment at week 3', 'description': 'Number of additional medicinal visits until week 3'}, {'measure': 'Number of Additional Medicinal Visits', 'timeFrame': 'Assessment at week 6', 'description': 'Aggregated number of unscheduled medicinal visits'}, {'measure': 'Number of Days of Illness', 'timeFrame': 'Assessment at week 6', 'description': 'Aggregated number of days of illness i.e. sick leave from work, assessed until week 6'}, {'measure': 'Number of Days of Illness', 'timeFrame': 'Assessment at week 6', 'description': 'Number of days of illness assessed until week 6'}, {'measure': 'Number of Aseptic Bone Necrosis and Fatigue Fractures', 'timeFrame': 'Baseline until end of study (week 12)', 'description': 'Assessment of number of patients withaseptic bone necrosis and/or fatigue fractures.'}, {'measure': 'Number of Participants With Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': 'Week 3, 6', 'description': 'including changes in the following parameters according to DVO guidelines: Calcium, Phosphate, Creatinin-Clearance (Cockcroft-Gault), Alkaline Phosphatase, γGT, CRP'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bone marrow edema', 'Aclasta'], 'conditions': ['Bone Marrow Edema']}, 'descriptionModule': {'briefSummary': 'The primary aim is to test the reduction of bone marrow edema syndrome after a singular intravenous treatment with Zoledronic Acid within 6 weeks compared to placebo. The volume of the edema is defined as biometric data measured by the use of MRT before and six weeks after treatment. The hypothesis has to be checked whether Zoledronic Acid is efficient in the treatment of painful bone marrow edema. A statistically significant reduction of the edema in the MRT is considered as evidence for efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men: age over ≥ 18 years or women: age over ≥ 18 years with finished reproductivity according to the following definition:\n* ≥ 12 month persistent natural (spontaneous) amenorrhoea (women aged \\<50: additionally: FSH \\>40MIE/ml and estrogen deficiency of \\<30pg/ml or a negative estrogen test)\n* status post hysterectomy and / or bilateral oophorectomy\n* finished reproduction planning\n* secure diagnosis of bone marrow edema using MRT\n* current osteologic basic laboratory values (≤ 4 weeks before V2) according to DVO criteria\n* presence of an personally signed informed consent for the participation in the study\n\nExclusion Criteria:\n\n* \\- subchondral bone loss or already occurred cartilage damage due to the bone marrow edema\n* reactive bone marrow edema with advanced arthrotic changes in the adjacent joint (grade III and IV according to Kellgren and Lawrence)\n* patients with edematous changes in bone marrow due to the diagnosis of M. Sudeck / algodystrophy / Complex Regional Pain Syndrome (CRPS)\n* patients with known hypo- and hyperparathyroidism, osteogenesis imperfecta, osteomalacia, M. Paget or another systemic skeletal diseases, except osteoporosis\n* patients with bone necrosis in the painful skeletal region\n* patients with infectious process at the affected bone or the adjacent joint and adjacent soft parts, respectively\n* patients with diagnosed or assumed rheumatoid arthritis, Lupus erythematodes, collagenosis or vasculitides\n* patients with advanced renal insufficiency (GFR according to Cockcroft\n\n / Gault ≤ 40 ml/min/KO)\n* patients with malignant diseases with osseous manifestation in anamnesis/history\n* status post malignant basic/primary disease with large dosed chemotherapy\n* current or massive dose therapy completed before less than 6 weeks (\\>7.5mg prednisolon equivalent) with glucocorticoids\n* patients with a malignant tumor disease within the past 5 years, independent from the affected organ system and independent from the implemented treatment, the presence of a relapse or metastatic invasion, except basal cell carcinoma and squamous-cell carcinoma of the skin Current treatment due to uveitis\n* vague/ambiguous hyper- or hypocalcemia, hyper- or hypophosphatemia\n* etiological vague/ambiguous AP-increase\n* symptomatic renal calculus or nephrocalcinosis within 2 years before V2\n* recent fracture within the last 3 months independent of the localisation\n* non consolidated fractures\n* previous treatment with i.v. bisphosphonates within the last 12 months\n* previous treatment with oral bisphosphonates within the last 12 months and longer than 3 months\n* pre-treatment with prostacyclin analogs (Ilomedin® / Iloprost®) within the past 6 months\n* Current treatment due to inflammatory diseases of the jaw area as well as planned tooth extractions or tooth extractions less than 6 months ago or oral surgery implant treatment\n* pregnancy or nursing period\n* patients immediately involved in the conduction of the trial and relatives\n* patients with current proceedings related to the bone marrow edema\n* patients for which the participation in the study carries an increased risk under consideration of the health condition due to the assessment of the investigator\n* participation in another clinical trial within 30 days before study start or during the trial\n* participation of patient who might be dependent on the investigator, also the spouse, parents or children'}, 'identificationModule': {'nctId': 'NCT01348269', 'acronym': 'ZoMARS', 'briefTitle': 'Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Wuerzburg University Hospital'}, 'officialTitle': 'A Prospective, Bi-centric,Randomized, Primary Double-blind, Placebo-controlled Phase III Study to Assess the Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome', 'orgStudyIdInfo': {'id': 'CZOL446HDE38T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aclasta', 'interventionNames': ['Drug: Aclasta']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NaCl Solution', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aclasta', 'type': 'DRUG', 'description': '1 x intravenous non-current drip (infusion)', 'armGroupLabels': ['Aclasta']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'NaCl Solution', 'armGroupLabels': ['NaCl Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97074', 'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Orthopedic Center for Musculoskeletal Research, Orthopedic Department, University of Wuerzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '97080', 'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Department of trauma, hand, reconstructive and plastic, University of Wuerzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'overallOfficials': [{'name': 'Rainer Meffert, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of trauma, hand, reconstructive and plastic, University of Wuerzburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Crolll Gmbh', 'class': 'OTHER'}, {'name': 'University of Wuerzburg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Lothar Seefried', 'investigatorFullName': 'Dr. Lothar Seefried', 'investigatorAffiliation': 'Orthopaedische Klinik Koenig-Ludwig-Haus'}}}}