[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513484":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":58,"collaborators":31,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":31,"enrollmentInfo":71,"targetDuration":31,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":31,"overallStatus":44,"whyStopped":31,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Leiden University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Denosumab","ACTIVE_COMPARATOR","Denosumab randomized at baseline and 3 months in a double-blinded fashion and in case of open label at 6 and 9 months",[13],"Drug: Denosumab 120 Mg\u002F1.7 Ml Inj",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo randomized at baseline and 3 months in a double-blinded fashion.",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Denosumab 120 Mg\u002F1.7 Ml Inj","Denosumab randomized at baseline and after 3 months at 6 and 9 months in case of open label",[9],[27],"Xgeva",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"placebo randomized at baseline and after 3 months",[15],null,[33],{"name":34,"affiliation":5,"role":35},"Natasha Appelman-Dijsktra, MD, PhD","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":31,"email":41},"Natasha Appelman-Dijkstra, MD, PhD","CONTACT","+31 625301410","n.m.appelman-dijkstra@lumc.nl",[43],{"facility":5,"status":44,"city":45,"state":31,"zip":31,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Leiden","Netherlands","NL",{"type":49,"coordinates":50},"Point",[51,52],4.49306,52.15833,{"lat":52,"lon":51},[55,56],{"name":38,"role":39,"phone":40,"phoneExt":31,"email":41},{"name":57,"role":35,"phone":31,"phoneExt":31,"email":31},"Natasha Appelman-Dijkstra",{"type":59,"investigatorFullName":57,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"SPONSOR_INVESTIGATOR","Principal investigator, Internist-Endocrinologist, MD, PhD","100513484","phase-4-denosumab-for-the-treatment-of-fibrous-dysplasiamccune-albright-syndrome-in-adults-defid-100513484",false,"NCT05966064","DEnosumab for the Treatment of FIbrous Dysplasia\u002FMcCune-Albright Syndrome in Adults (DeFiD)","DEnosumab for the Treatment of FIbrous Dysplasia\u002FMcCune-Albright Syndrome in Adults (DeFiD): a Randomized Double-blind Placebo-controlled Trial","DeFiD","Inclusion Criteria:\n\n* Symptomatic patients with established diagnosis of FD\u002FMAS and closed growth plates(\\>18 years)\n* Pain in the region of an FD localization, not responding to adequate pain treatment and without mechanical component e.g. impending fracture\n* Pain score from FD lesion for maximum or average pain on VAS ≥ 4\n* Increased lesional activity defined as increased bone turnover markers (ALP, P1NP or CTX) or increased activity on Na\\[18F\\]-PET\u002FCT or bone scintigraphy in at least one lesion\n* Normal levels of calcium, parathyroid hormone and vitamin D (supplementation is allowed)\n* Treated hypophosphatemia (defined as \\>0.7 at two separate measures)\n* good dental health (last check within the last 12 months)\n\nExclusion Criteria:\n\n* Active pregnancy wish, pregnancy or nursing\n* Pain not related to FD\n* Uncontrolled endocrine disease\n* Untreated vitamin D deficiency, hypocalcemia or hypophosphatemia\n* Previous use of bisphosphonates or Dmab \\\u003C 6 months before inclusion ('6 months wash out')\n* Previously reported severe side effects on Dmab\n* Inability to fulfil study requirements\n* Poor untreated dental health without intention to get treatment\n* Treatment with other bone influencing drugs, such as high doses corticosteroids","ALL","18 Years",{"count":72,"type":73},82,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","Fibrous Dysplasia\u002FMcCune-Albright syndrome (FD\u002FMAS) is a rare disease, consisting of the replacement of normal bone tissue with fibrous tissue. FD lesions may be isolated in one or more bones or may be associated with endocrinopathies in McCune-Albright syndrome. Bone lesions constitute of weak bone tissue, leading to higher risk of fractures, pain and decreased quality of life. There is no cure for FD lesions and current therapies failed to soothe patients' complaints or to display any effect on progression of the lesions on imaging. However, the RANKL-inhibitor Denosumab demonstrated encouraging results in mouse models and in off-label clinical use, leading to clinical, biochemical and radiographical improvements.\n\nStudy's aim is to investigate whether 3-monthly Denosumab will improve the clinical, radiological and biochemical manifestations of FD bone lesions.",[79,80],"Fibrous Dysplasia","McCune Albright Syndrome","2025-01-28",{"date":83,"type":84},"2025-01-29","ACTUAL",{"date":86,"type":84},"2023-06-13",{"date":88,"type":73},"2028-12",{"name":57,"class":6},1]