[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621089":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":83,"collaborators":21,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":21,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":21,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":39,"whyStopped":21,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Amgen","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care","OTHER","Participants who completed romosozumab trial 20200105 will continue to receive standard of care treatment (calcium and vitamin D), as determined by the investigator and local guidance. No investigational drug product will be administered in this trial as this is a safety follow-up.",[13,14],"Dietary Supplement: Vitamin D","Dietary Supplement: Calcium",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DIETARY_SUPPLEMENT","Vitamin D","Participants are recommended to receive Vitamin D supplements as standard of care treatment, per investigator discretion and local guidance.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Calcium","Participants are recommended to receive Calcium supplements as standard of care treatment, per investigator discretion and local guidance.",[9],[27],{"name":28,"affiliation":5,"role":29},"MD","STUDY_DIRECTOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":21,"email":35},"Amgen Call Center","CONTACT","866-572-6436","medinfo@amgen.com",[37,51,62,71],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":21},"Indiana University","RECRUITING","Indianapolis","Indiana","46202","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-86.15804,39.76838,{"lat":49,"lon":48},{"facility":52,"status":39,"city":53,"state":21,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":61,"contacts":21},"Universitaetsklinikum Koeln","Cologne","50937","Germany","DE",{"type":46,"coordinates":58},[59,60],6.95,50.93333,{"lat":60,"lon":59},{"facility":63,"status":39,"city":64,"state":21,"zip":65,"country":55,"countryCode":56,"cosmosGeoPoint":66,"geoPoint":70,"contacts":21},"Universitaetsklinikum Wuerzburg","Würzburg","97074",{"type":46,"coordinates":67},[68,69],9.95121,49.79391,{"lat":69,"lon":68},{"facility":72,"status":39,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":82,"contacts":21},"Okayama Saiseikai Outpatient Center Hospital","Okayama","Okayama-ken","700-0013","Japan","JP",{"type":46,"coordinates":79},[80,81],133.93333,34.65,{"lat":81,"lon":80},{"type":84,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100621089","phase-3-pediatric-safety-follow-up-study-of-prior-treatment-with-romosozumab-for-osteogenesis-imperfecta-100621089",false,"NCT07366086","Pediatric Safety Follow-up Study of Prior Treatment With Romosozumab for Osteogenesis Imperfecta","Multicenter, Safety Follow-up Study to Assess Safety of Prior Treatment With Romosozumab in Children and Adolescents With Osteogenesis Imperfecta","Inclusion Criteria:\n\n\\- Participant has provided informed consent\u002Fassent prior to initiation of any trial specific activities\u002Fprocedures.\n\nOR 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\u002For guidelines prior to any trial-specific activities\u002Fprocedures being initiated.\n\n\\- Participant was randomized to the romosozumab arm and completed Trial 20200105 through the Month 15 Visit, regardless of whether they received investigational product (romosozumab) until the last protocol-specified dose or ended investigational product early.\n\nExclusion Criteria:\n\n* Currently receiving treatment in another investigational device or drug trial, or less than 2 years since ending treatment on another investigational device or drug trial(ies) with the exception of trial 20200105. Other investigational procedures while participating in this trial are excluded.\n* Participant likely to not be available to complete all protocol-required trial visits or procedures, and\u002For to comply with all required trial procedures to the best of the participant and investigator's knowledge.","ALL","5 Years","19 Years",{"count":96,"type":97},71,"ESTIMATED","INTERVENTIONAL",[100],"PHASE3","The primary objective of this trial is to evaluate the safety of romosozumab in participants with osteogenesis imperfecta (OI) that have completed Study 20200105, regardless of whether they received investigational product (romosozumab) until the last protocol-specified dose or ended investigational product early.",[103],"Osteogenesis Imperfecta",[105,106],"Romosozumab","EVENITY","2026-06-18",{"date":109,"type":110},"2026-06-22","ACTUAL",{"date":112,"type":110},"2026-03-18",{"date":114,"type":97},"2028-04-19",{"name":5,"class":6},4]