[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529009":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":30,"studyPopulation":44,"armGroups":45,"interventions":30,"overallOfficials":52,"centralContacts":56,"locations":62,"responsibleParty":172,"collaborators":174,"id":177,"slug":30,"hasResults":178,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":178,"sex":183,"minAge":184,"maxAge":185,"enrollmentInfo":186,"targetDuration":189,"studyType":190,"phases":30,"briefSummary":191,"conditions":192,"keywords":30,"overallStatus":65,"whyStopped":30,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},{"fullName":5,"class":6},"BioMarin Pharmaceutical","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":30,"otherOutcomes":30},[9,13,16,19,22,25,28,31,35,38],{"measure":10,"description":11,"timeFrame":12},"Height","sitting and standing measured in centimetres","Retrospective data and prospective data for up to 5 years starting from time of study enrolment",{"measure":14,"description":15,"timeFrame":12},"Weight","measured in kilograms",{"measure":17,"description":18,"timeFrame":12},"Body Mass Index","measured in kg\u002Fm2",{"measure":20,"description":21,"timeFrame":12},"Head Circumference","measured in centimeters",{"measure":23,"description":24,"timeFrame":12},"Annualized growth velocity (AGV)","measured in centimeters\u002Fyear",{"measure":26,"description":27,"timeFrame":12},"Medical diagnoses by age","Clinical examination and\u002For radiological assessment",{"measure":29,"description":30,"timeFrame":12},"Surgical procedures and\u002For medical interventions by age",null,{"measure":32,"description":33,"timeFrame":34},"Changes in physical functioning","assessed using the Mobility and Upper Extremity Patient-Reported Outcomes Measurement Information System (PROMIS) tools","every 6 months starting from time of study enrolment up to 5 years",{"measure":36,"description":37,"timeFrame":34},"Changes in health-related quality of life (HRQoL)","assessed using the Pediatric Quality of Life Inventory (PedsQL)",{"measure":39,"description":40,"timeFrame":34},"Adherence to treatment with VOXZOGO™ (vosoritide), if prescribed","assessed using a medication adherence questionnaire to capture the number of missed doses in the prior month. Parent(ObsRO) version for all participants enrolled ages 5-13 years",{"allocation":30,"interventionModel":30,"interventionModelDescription":30,"primaryPurpose":30,"observationalModel":42,"timePerspective":43,"maskingInfo":30},"COHORT","OTHER","The primary study population will include individuals with achondroplasia regardless of their treatment status with VOXZOGO™. Whilst individuals may change status from untreated to treated during the prospective period of the study (or vice versa), for the purposes of recruitment targets they will only be counted once, based on their treated status at the point of enrollment",[46,49],{"label":47,"type":30,"description":48,"interventionNames":30},"Primary Pediatric Cohort","≤13 years old at time of enrollment. This is an observational study.",{"label":50,"type":30,"description":51,"interventionNames":30},"Secondary Adolescent and Adult Cohort","≥14 years old at time of enrollment. This is an observational study.",[53],{"name":54,"affiliation":5,"role":55},"Medical Director, MD","STUDY_DIRECTOR",[57],{"name":58,"role":59,"phone":60,"phoneExt":30,"email":61},"Trial Specialist","CONTACT","1-800-938-4587","medinfo@bmrn.com",[63,82,94,107,120,133,146,159],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"UCSF","RECRUITING","Oakland","California","94609","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-122.2708,37.80437,{"lat":75,"lon":74},[78,80],{"name":79,"role":59,"phone":30,"phoneExt":30,"email":30},"Hind Al Saif",{"name":79,"role":81,"phone":30,"phoneExt":30,"email":30},"PRINCIPAL_INVESTIGATOR",{"facility":83,"status":65,"city":84,"state":67,"zip":85,"country":69,"countryCode":70,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"PicnicHealth","San Francisco","94107",{"type":72,"coordinates":87},[88,89],-122.41942,37.77493,{"lat":89,"lon":88},[92],{"name":83,"role":59,"phone":30,"phoneExt":30,"email":93},"hello@picnichealth.com",{"facility":95,"status":65,"city":96,"state":97,"zip":98,"country":69,"countryCode":70,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Johns Hopkins University (JHU)","Baltimore","Maryland","21205",{"type":72,"coordinates":100},[101,102],-76.61219,39.29038,{"lat":102,"lon":101},[105],{"name":106,"role":59,"phone":30,"phoneExt":30,"email":30},"Julie Hoover-Fong",{"facility":108,"status":65,"city":109,"state":110,"zip":111,"country":69,"countryCode":70,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Piedmont Health","Statesville","North Carolina","28625",{"type":72,"coordinates":113},[114,115],-80.8873,35.78264,{"lat":115,"lon":114},[118],{"name":119,"role":59,"phone":30,"phoneExt":30,"email":30},"Samuel Hughes",{"facility":121,"status":65,"city":122,"state":123,"zip":124,"country":69,"countryCode":70,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"University of Cincinnati","Cincinnati","Ohio","45229",{"type":72,"coordinates":126},[127,128],-84.51439,39.12711,{"lat":128,"lon":127},[131],{"name":132,"role":59,"phone":30,"phoneExt":30,"email":30},"Laurie Bailey",{"facility":134,"status":65,"city":135,"state":136,"zip":137,"country":69,"countryCode":70,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Sanford Health","Sioux Falls","South Dakota","57115",{"type":72,"coordinates":139},[140,141],-96.72796,43.54369,{"lat":141,"lon":140},[144],{"name":145,"role":59,"phone":30,"phoneExt":30,"email":30},"Isum Ward",{"facility":147,"status":65,"city":148,"state":149,"zip":150,"country":69,"countryCode":70,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Baylor College of Medicine","Houston","Texas","77030-2316",{"type":72,"coordinates":152},[153,154],-95.36327,29.76328,{"lat":154,"lon":153},[157],{"name":158,"role":59,"phone":30,"phoneExt":30,"email":30},"Carlos Bacino",{"facility":160,"status":65,"city":161,"state":162,"zip":163,"country":69,"countryCode":70,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"University of Wisconsin","Madison","Wisconsin","53726",{"type":72,"coordinates":165},[166,167],-89.40123,43.07305,{"lat":167,"lon":166},[170],{"name":171,"role":59,"phone":30,"phoneExt":30,"email":30},"Janet Legare",{"type":173,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[175],{"name":83,"class":176},"UNKNOWN","100529009",false,"NCT06168201","VIrtual STudy in Achondroplasia for the US (VISTA)","VISTA","Inclusion Criteria:\n\n* Physician diagnosis of achondroplasia\n* Age at time of enrollment:\n\nPrimary Pediatric Cohort: ≤13 years old Secondary Adolescent and Adult Cohort: ≥14 years old\n\n* Receiving medical care in the United States\n* Complete PicnicHealth's onboarding process, including signing informed consent and authorization for medical record retrieval\n\nExclusion Criteria:\n\n* Lack of any medical records","ALL","0 Months","18 Years",{"count":187,"type":188},170,"ESTIMATED","5 Years","OBSERVATIONAL","This is an observational study of individuals with achondroplasia in the United States. The primary study population consists of pediatric individuals treated and untreated with VOXZOGO™. Study enrollment started in February 2023. The projected total duration of the study is approximately 5 years at minimum from start of study recruitment in February 2023, with the duration of individual prospective follow-up differing depending on the time of enrollment. The study duration may be extended based on decisions by the study sponsor.\n\nData will be collected in two formats for the primary pediatric study population:\n\n1. Participant-mediated access to electronic health records(including medical imaging, when available) which will enable retrospective and prospective collection of secondary data reflecting real-life treatment use and clinical care. .\n2. Primary data collection of Clinical Outcome Assessments (COAs) and questionnaire data.\n\nData will be collected in the following format for the adult cohort:\n\n\\- Participant-mediated access to electronic health records (including medical imaging, when available) which will enable retrospective and prospective collection of secondary data reflecting real-life treatment use and clinical care.\n\nThe primary study population will include approximately 150 pediatric individuals with achondroplasia regardless of their treatment status with VOXZOGO™. Individuals may change status from untreated to treated during the prospective period of the study (or vice versa) however they will only be counted once, based on their treated status at the point of enrollment.\n\nThe secondary study population will include 20 adolescent and adult participants.",[193],"Achondroplasia","2026-06-29",{"date":196,"type":197},"2026-06-30","ACTUAL",{"date":199,"type":197},"2023-02-21",{"date":201,"type":188},"2028-02",{"name":5,"class":6},8]