[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100356442":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":31,"responsibleParty":58,"collaborators":12,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":12,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":12,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":12,"overallStatus":34,"whyStopped":12,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Main Study","NO_INTERVENTION","Up to 100 subjects, both non-CF volunteers and Cystic Fibrosis (CF) patients, will participate in a single study visit that will include a DEXA scan (if not completed as standard of care within 6 months prior to research visit), micro CT, and blood collection.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Denosomab Sub-study","EXPERIMENTAL","Approximately 10 subjects with CF that have completed the main study and have results which indicate bone disease are eligible to participate in the sub study. Subjects who consent will receive treatment with denosumab (60 mg\u002Fml via subcutaneous injection in the upper arm, upper thigh, or abdomen every 6 months) for up to 5 years. These subjects will be asked to return every 6 months for injections and annually (+\u002F- 6 months) for up to 5 years for a DEXA scan, micro CT, and blood collection.",[18],"Drug: Denosumab",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DRUG","Denosumab","treatment with denosumab every 6 months for up to 5 years",[14],[26],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Ashley Keller","CONTACT","2146482817","ashley.keller@utsouthwestern.edu",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"UT Southwestern Medical Center","RECRUITING","Dallas","Texas","75390","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-96.80667,32.78306,{"lat":44,"lon":43},[47,50,53,56],{"name":48,"role":28,"phone":49,"phoneExt":12,"email":30},"Ashley Keller, MPH","214-648-2817",{"name":51,"role":52,"phone":12,"phoneExt":12,"email":12},"Raksha Jain, MD, MSCI","PRINCIPAL_INVESTIGATOR",{"name":54,"role":55,"phone":12,"phoneExt":12,"email":12},"Dwight Towler, MD","SUB_INVESTIGATOR",{"name":57,"role":55,"phone":12,"phoneExt":12,"email":12},"Naim Maalouf, MD, PhD",{"type":52,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Raksha Jain","Associate Professor of Medicine","100356442","phase-4-markers-of-osteoporosis-in-cystic-fibrosis-100356442",false,"NCT03921060","Markers of Osteoporosis in Cystic Fibrosis","Cystic Fibrosis Main Study Inclusion Criteria:\n\n* Must have CF diagnosis confirmed by sweat test or genotype analysis\n* Subjects (and parents\u002Flegal guardians as applicable) must have the ability to read and write in English\n\nSub-study Exclusion Criteria:\n\n* No CF diagnosis\n* Men or women without osteoporosis\n* Less than 18 years of age\n* Unwilling to return annually for study visits for up to 5 years\n* Unwilling and\u002For medically unable to take denosumab",true,"ALL","18 Years","64 Years",{"count":72,"type":73},100,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","Main Study Up to 100 subjects, both non-CF volunteers and Cystic Fibrosis (CF) patients, will participate in a single study visit that will include a DEXA scan, micro CT, and blood collection.\n\nDenosumab (Prolia) Sub study Approximately 10 adult subjects with CF who participated in the main study and have results indicating bone disease will receive treatment with Denosumab for up to 5 years. They will be asked to return for repeat DEXA scans, micro CT, blood collection, and documenting of any adverse events.",[79],"Cystic Fibrosis","2026-04-30",{"date":82,"type":83},"2026-05-05","ACTUAL",{"date":85,"type":83},"2021-09-02",{"date":87,"type":73},"2027-07",{"name":5,"class":6},1]