[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520642":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":50,"centralContacts":55,"locations":61,"responsibleParty":78,"collaborators":35,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":35,"enrollmentInfo":89,"targetDuration":35,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":35,"overallStatus":64,"whyStopped":35,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 - ROMO 12 months, ZOL 12 months","ACTIVE_COMPARATOR","90 patients 12 months of romosozumab (ROMO) followed by 12 months of zoledronate (ZOL)",[13,14],"Drug: Romosozumab","Drug: Zoledronate",{"label":16,"type":10,"description":17,"interventionNames":18},"Group 2 - ROMO 6 months, ZOL 12 months, ROMO 6 months","90 patients 6 months of romosozumab followed by 12 months of zoledronate and lastly 6 months of romosozumab.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Group 3 - ROMO 6 months, ZOL 18 months","90 patients 6 months of romosozumab followed by 18 months of zoledronate\n\n.",[13,14],[24,31,36,40,43,47],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Romosozumab","Romosozumab 210 mg\u002F2.34 ml from baseline to month 11",[9],[30],"Evenity",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Zoledronate","5 mg\u002F100 ml at month 12",[9],null,{"type":25,"name":26,"description":37,"armGroupLabels":38,"otherNames":39},"210 mg\u002F2.34 ml from baseline to month 5 and from month 18 to month 23",[16],[30],{"type":25,"name":32,"description":41,"armGroupLabels":42,"otherNames":35},"5 mg\u002F100 ml at month 6",[16],{"type":25,"name":26,"description":44,"armGroupLabels":45,"otherNames":46},"210 mg\u002F2.34 ml from baseline to month 5",[20],[30],{"type":25,"name":32,"description":48,"armGroupLabels":49,"otherNames":35},"5 mg\u002F100 ml at month 5 and month 18",[20],[51],{"name":52,"affiliation":53,"role":54},"Bente Langdahl, MD, Professor, DMSc, PhD,","Department of Endocrinology and Internal medicin, Aarhus University Hospital","STUDY_DIRECTOR",[56],{"name":57,"role":58,"phone":59,"phoneExt":35,"email":60},"Vivi Makinen, MD","CONTACT","78450000","vivmaa@rm.dk",[62],{"facility":63,"status":64,"city":65,"state":35,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Department of Endrocinology and Internal Medicine","RECRUITING","Aarhus","8000","Denmark","DK",{"type":70,"coordinates":71},"Point",[72,73],10.21076,56.15674,{"lat":73,"lon":72},[76],{"name":77,"role":58,"phone":59,"phoneExt":35,"email":60},"Vivi Mäkinen",{"type":79,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100520642","phase-4-the-optimised-use-of-romozosumab-study-100520642",false,"NCT06059222","The Optimised Use of Romozosumab Study","OPTIMIST","Inclusion Criteria:\n\n* Postmenopausal women (postmenopausal for at least two years)\n* BMD T-score \\\u003C -2.5 at lumbar spine, total hip, or femoral neck\n* Osteoporotic fracture within the last 3 years at the spine, hip, pelvis, humerus or forearm after the age of 50 years.\n\nExclusion Criteria:\n\n* Osteoporosis treatment including hormone replacement therapy within the last 5 years\n* Metabolic bone disease\n* Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, liver dysfunction (baseline phosphatase higher than twice upper limit), rheumatism, severe COPD (chronic obstructive pulmonary disease), hypopituitarism, Cushing's disease\n* Ongoing treatment with glucocorticoids (systemic)\n* Estimated glomerular filtration rate (eGFR) \\\u003C 35 mL\u002Fmin\n* Contraindications for zoledronate according to the Supplementary protection certificates (SPC)\n* Contraindications for romosozumab according to the SPC\n* For the subgroup with Jamshidi biopsies contraindications for local anaesthetics according to the SPC\n* For the subgroup with Jamshidi biopsies contraindications for tetracycline or doxycykline according to the SPC","FEMALE","50 Years",{"count":90,"type":91},270,"ESTIMATED","INTERVENTIONAL",[94],"PHASE4","OPTIMIST is a two-year, randomised, active controlled, open-label, multicentre intervention trial. OPTIMIST includes 3 treatment groups each comprising combinations of romosozumab (ROMO) and zoledronate (ZOL) treatment used in standard doses (210 mg monthly (sc) and 5 mg yearly (iv), respectively).\n\nThe study will investigate if it is possible to maximize the effect of romosozumab by giving it in 2 periods of 6 months interrupted by zoledronate for 12 months compared to romosozumab for 12 months uninterrupted followed by zoledronate for 12 months. The investigators will also evaluate if 6 months of romosozumab followed by 18 months of zoledronate is non-inferior to the standard regimen of romosozumab for 12 months followed by zoledronate for 12 months.",[97],"Osteoporosis","2026-07-01",{"date":100,"type":101},"2026-07-02","ACTUAL",{"date":103,"type":101},"2023-10-02",{"date":105,"type":91},"2032-08-31",{"name":5,"class":6},1]