Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT05972551
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2023-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010013', 'term': 'Osteogenesis Imperfecta'}], 'ancestors': [{'id': 'D010009', 'term': 'Osteochondrodysplasias'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C557282', 'term': 'romosozumab'}, {'id': 'D004164', 'term': 'Diphosphonates'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-08-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2023-07-24', 'studyFirstSubmitQcDate': '2023-07-24', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Clinical Fractures', 'timeFrame': '12 months', 'description': 'Clinical fractures include clinical vertebral fractures and nonvertebral fractures.'}, {'measure': 'Number of Any Fractures', 'timeFrame': '12 months', 'description': 'Fractures include new and worsening vertebral compression fractures, whether clinically silent or manifest, and nonvertebral fractures.'}, {'measure': 'Change from Baseline in Lumbar Spine BMD Z-score at 12 Months, as assessed by DXA', 'timeFrame': 'Baseline and 12 months'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in lumbar spine BMD Z-score at 6 months and 12 months, as assessed by DXA', 'timeFrame': 'Baseline, 6 months, and 12 months'}, {'measure': 'Change from Baseline in Total Hip BMD Z-score at 6 Months and at 12 Months, as assessed by DXA', 'timeFrame': 'Baseline, 6 months, and 12 months'}, {'measure': 'Change from Baseline in Femoral Neck BMD Z-score at 6 Months and at 12 Months, as assessed by DXA', 'timeFrame': 'Baseline, 6 months, and 12 months'}, {'measure': 'Number of Participants with Any Fractures', 'timeFrame': '12 months'}, {'measure': 'Number of Participants with Clinical Fractures', 'timeFrame': '12 months'}, {'measure': 'Number of Participants with New or Worsening Vertebral Fractures', 'timeFrame': '12 months'}, {'measure': 'Number of Participants with Nonvertebral Fractures', 'timeFrame': '12 months'}, {'measure': 'Number of Participants with Long Bone Fractures', 'timeFrame': '12 months'}, {'measure': 'Number of New or Worsening Vertebral Fractures', 'timeFrame': '12 months'}, {'measure': 'Number of Nonvertebral Fractures', 'timeFrame': '12 months'}, {'measure': 'Number of Long Bone Fractures', 'timeFrame': '12 months'}, {'measure': 'Change from Baseline in Child Health Questionnaire - Parent Version (CHQ-PF-50) Physical Summary Score', 'timeFrame': 'Baseline and 12 months', 'description': 'The CHQ-PF-50 measures how a child\'s condition affects their ability to function in daily life. The CHQ-PF-50 measures 50 items in the following domains: physical functioning, role/social limitations - physical, general health perceptions, bodily pain/discomfort, family activities, role/social limitations - emotional/behavioral, parent impact - time, parent impact - emotion, self-esteem, mental health, behavior, family cohesion, change in health.\n\nEach item is rated on a scale from "without any difficulty" to "unable to do". Total scores for each item are transformed to 0 - 100 scale, with lower scores indicating worse health states. Higher change from baseline scores indicate better or more positive health states.'}, {'measure': 'Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Score', 'timeFrame': 'Baseline and 12 months', 'description': 'The CHAQ measures how a child\'s condition affects their ability to function in daily life. The CHAQ measures 50 items in the following domains: physical functioning, role/social limitations - physical, general health perceptions, bodily pain/discomfort, family activities, role/social limitations emotional/behavioral, self-esteem, mental health, behavior, family cohesion, change in health.\n\nEach item is rated on a scale from "without any difficulty" to "unable to do". Total scores for each item are transformed to 0 - 100 scale, with lower scores indicating worse health states. Higher change from baseline scores indicate better or more positive health states.'}, {'measure': 'Change from Baseline in the Wong-Baker Faces Pain Rating Scale', 'timeFrame': 'Baseline and 12 months', 'description': 'The Wong-Baker Faces Pain Rating Scale is a horizontal pain scale that consists of six hand-drawn faces that range from a smiling "no hurt" face with a score of 0 to a crying "hurts worst" face with a score of 10. Greater change from baseline scores indicate greater pain experienced by the participant.'}, {'measure': 'Serum Concentration of Romosozumab', 'timeFrame': 'Day 1 to Month 12'}, {'measure': 'Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs) at 12 Months', 'timeFrame': '12 months', 'description': 'Any clinically signification change from baseline in laboratory values and vital signs after first dose will be recorded as a TEAE.'}, {'measure': 'Number of Participants who Experience TEAEs from Month 12 to Month 15', 'timeFrame': 'Month 12 to Month 15', 'description': 'Any clinically signification change from baseline in laboratory values and vital signs after first dose will be recorded as a TEAE.'}, {'measure': 'Number of Participants with Anti-drug Antibodies (ADA) to Romosozumab', 'timeFrame': 'Up to 15 months'}, {'measure': 'Number of Participants who Experience TEAEs at 15 Months', 'timeFrame': '15 months', 'description': 'Any clinically signification change from baseline in laboratory values and vital signs after first dose will be recorded as a TEAE.'}, {'measure': 'Number of Participants with a Narrowing from Baseline to 6 Months in the Intracranial Nerve Tract in the Cranium and Vault of the Skull', 'timeFrame': 'Baseline and 6 months', 'description': 'Measured in a subset of participants who receive cranial nerve computerized tomography (CT) scans.'}, {'measure': 'Number of Participants with a Narrowing from Baseline to 12 Months in the Intracranial Nerve Tract in the Cranium and Vault of the Skull', 'timeFrame': 'Baseline and 12 months', 'description': 'Measured in a subset of participants who receive cranial nerve CT scans.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteogenesis Imperfecta', 'Romosozumab', 'EVENITY®', 'Bisphosphonates'], 'conditions': ['Osteogenesis Imperfecta']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures.\n\nOR\n\n* Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.\n* Ambulatory male and female children and adolescents, age 5 to \\<18 years, including ambulatory with assistance as defined in the pediatric osteogenesis imperfecta (OI) population.\n* Clinical diagnosis of OI, defined as clinical history consistent with type I, III, or IV OI as determined by presence of expected phenotype (examples include: facial shape, voice, blue sclera, dentinogenesis imperfecta, typical radiographic features, fracture pattern) and lack of additional features unrelated to type I, III, or IV OI (eg, blindness, mental retardation, neuropathy, and craniosynostosis).\n\n o If familial, also must be autosomal dominant.\n* Meets at least one of the following:\n\n * 3 or more fractures within the previous 2 years, or\n * 1 or more nonvertebral fracture(s) within the previous 2 years and at least 1 prevalent vertebral fracture, or\n * 2 or more prevalent vertebral fractures.\n\nExclusion Criteria:\n\nDisease Related\n\n* History of an electrophoresis pattern inconsistent with type I, III or IV OI.\n* History of known mutation in a gene other than collagen type I alpha 1/collagen type I alpha 2 (COL1A1/COL1A2) causing OI or other metabolic bone disease.\n* History of congenital dislocation of the radial head, interosseous membrane calcification, or exuberant callus formation."}, 'identificationModule': {'nctId': 'NCT05972551', 'briefTitle': 'Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 3, Open-Label, Multicenter, Randomized Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta', 'orgStudyIdInfo': {'id': '20200105'}, 'secondaryIdInfos': [{'id': '2023-503294-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Romosozumab', 'description': 'Participants will receive romosozumab once a month (QM) for 12 months.', 'interventionNames': ['Drug: Romosozumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care Bisphosphonate', 'description': 'Participants will receive bisphosphonates per local standard of care treatment regimens, as determined by the investigator for 12 months.', 'interventionNames': ['Drug: Bisphosphonate']}], 'interventions': [{'name': 'Romosozumab', 'type': 'DRUG', 'otherNames': ['EVENITY®'], 'description': 'Subcutaneous (SC) injection', 'armGroupLabels': ['Romosozumab']}, {'name': 'Bisphosphonate', 'type': 'DRUG', 'description': 'Administration determined by investigator according to the local standard of care', 'armGroupLabels': ['Standard of Care Bisphosphonate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Childrens Hospital of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Phoenix Childrens Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of California, Los Angeles Interventional Clinical Trials', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Nemours Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '32827', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Nemours Childrens Hospital', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of South Florida - Carol and Frank Morsani Center for Advanced Health Care', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Kennedy Krieger Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Boston Childrens Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'TERMINATED', 'country': 'United States', 'facility': 'Mayo Clinic Childrens Center', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '55101', 'city': 'Saint Paul', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Gillette Childrens Hospital and Clinic Saint Paul', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '37212-3157', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Monash Childrens Hospital', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '6909', 'city': 'Nedlands', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Perth Childrens Hospital', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '4020', 'city': 'Linz', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Kepler Universitaetsklinikum GmbH', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Leuven - Campus Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'K1H 8L1', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Childrens Hospital of Eastern Ontario', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire Sainte Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '518053', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The University of Hong Kong-Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Tongji Hospital , Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The First Bethune Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '250021', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Shandong Provincial Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '610044', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'West China Hospital Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '200233', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Shanghai Sixth Peoples Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '33076', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '75743', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hopital Necker Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '50937', 'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitaetsklinikum Koeln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '97074', 'city': 'Würzburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitaetsklinikum Wuerzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '1094', 'city': 'Budapest', 'status': 'RECRUITING', 'country': 'Hungary', 'facility': 'Semmelweis Egyetem', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '700-0013', 'city': 'Okayama', 'state': 'Okayama-ken', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Okayama Saiseikai Outpatient Center Hospital', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '700-8558', 'city': 'Okayama', 'state': 'Okayama-ken', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Okayama University Hospital', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '594-1101', 'city': 'Izumi-shi', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Osaka Womens and Childrens Hospital'}, {'zip': '157-8535', 'city': 'Setagaya-ku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'National Center for Child Health and Development'}, {'zip': '31-530', 'city': 'Krakow', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Centermed Krakow Sp zoo', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '91-738', 'city': 'Lodz', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny UMeds', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '93-338', 'city': 'Lodz', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Instytut Centrum Zdrowia Matki Polki', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '35-326', 'city': 'Rzeszów', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Centrum Medyczne Medyk Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'zip': '43-100', 'city': 'Tychy', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Szpital Miejski w Tychach Spolka z ograniczona odpowiedzialnoscia', 'geoPoint': {'lat': 50.13717, 'lon': 18.96641}}, {'zip': '833 40', 'city': 'Bratislava', 'status': 'RECRUITING', 'country': 'Slovakia', 'facility': 'Narodny ustav detskych chorob', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '48903', 'city': 'Barakaldo', 'state': 'Basque Country', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital de Cruces', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitari Vall d Hebron', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08950', 'city': 'Esplugues de Llorbregat', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Sant Joan de Deu'}, {'zip': '28905', 'city': 'Getafe', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Getafe', 'geoPoint': {'lat': 40.30571, 'lon': -3.73295}}, {'zip': '46026', 'city': 'Valencia', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitari i Politecnic La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '28009', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Infantil Niño Jesus', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '4031', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'Universitaets-Kinderspital beider Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '1011', 'city': 'Lausanne', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': '06500', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '34890', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara Universitesi Tip Fakultesi Hastanesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '35100', 'city': 'Izmir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Ege Universitesi Tip Fakultesi Hastanesi', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '61080', 'city': 'Trabzon', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Karadeniz Teknik Universitesi Tip Fakultesi', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}, {'zip': 'G51 4TF', 'city': 'Glasgow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth University Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal Manchester Childrens Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'centralContacts': [{'name': 'Amgen Call Center', 'role': 'CONTACT', 'email': 'medinfo@amgen.com', 'phone': '866-572-6436'}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'ipdSharingStatementModule': {'url': 'http://www.amgen.com/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}