[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585165":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":42,"responsibleParty":83,"collaborators":87,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":100,"sex":106,"minAge":107,"maxAge":11,"enrollmentInfo":108,"targetDuration":11,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":52,"whyStopped":11,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"University Hospital Bispebjerg and Frederiksberg","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Investigational Medicinal Product","ACTIVE_COMPARATOR",null,[13],"Drug: Ferric Derisomaltose",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Saline (NaCl 0,9 %) (placebo)",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Ferric Derisomaltose","The active intervention is a single dose of Ferric Derisomaltose, 20mg\u002Fkg body weight, diluted in 100 mL isotonic sodium chloride 0.9%",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Saline (NaCl 0,9 %) (placebo)","Single dose of 100 mL isotonic sodium chloride 0.9%",[15],[30],{"name":31,"affiliation":32,"role":33},"Nicolas Tekin Jones, MD","Copenhagen University Hospital Bispebjerg, Department of Orthopaedic Surgery and Traumatology","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":11,"email":38},"CONTACT","+4520491890","nicolas.tekin.jones@regionh.dk",{"name":40,"role":36,"phone":11,"phoneExt":11,"email":41},"Søren Overgaard, MD, DMSc","soeren.overgaard@regionh.dk",[43,50,68],{"facility":44,"status":45,"city":46,"state":11,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Department of Orthopedic Surgery and Traumatology, Bispebjerg, Copenhagen University Hospital","ACTIVE_NOT_RECRUITING","Copenhagen NV","2400","Denmark","DK",{"facility":51,"status":52,"city":53,"state":11,"zip":54,"country":48,"countryCode":49,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Department of Orthopedic Surgery and Traumatology, Herlev, Copenhagen University Hospital","RECRUITING","Herlev","2730",{"type":56,"coordinates":57},"Point",[58,59],12.43998,55.72366,{"lat":59,"lon":58},[62,66,67],{"name":63,"role":36,"phone":64,"phoneExt":11,"email":65},"Jens Peter Alva-Jørgensen, MD","+ 45 3868 3868","Jens.Peter.Alva-Joergensen@regionh.dk",{"name":31,"role":36,"phone":37,"phoneExt":11,"email":38},{"name":63,"role":33,"phone":11,"phoneExt":11,"email":11},{"facility":69,"status":52,"city":70,"state":11,"zip":71,"country":48,"countryCode":49,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Department of Orthopaedic Surgery, Odense and Svendborg University Hospital","Odense C","5000",{"type":56,"coordinates":73},[74,75],10.39538,55.40841,{"lat":75,"lon":74},[78,81,82],{"name":79,"role":36,"phone":64,"phoneExt":11,"email":80},"Bjarke Viberg, MD, PhD, Professor","bjarke.viberg@rsyd.dk",{"name":31,"role":36,"phone":37,"phoneExt":11,"email":38},{"name":79,"role":33,"phone":11,"phoneExt":11,"email":11},{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Soren Overgaard","Clinical Professor, DMSc",[88,89,91,93,96],{"name":5,"class":6},{"name":90,"class":6},"Copenhagen University Hospital at Herlev",{"name":92,"class":6},"Odense University Hospital",{"name":94,"class":95},"Musculoskeletal Statistics Unit, The Parker Institute","UNKNOWN",{"name":97,"class":6},"Svendborg Hospital","100585165","phase-4-the-effects-of-intravenous-iron-on-mobility-in-elderly-patients-following-hip-fracture-surgery-100585165",false,"NCT06898814","The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery","The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery: a Multicentre, Parallel Group, Randomised Controlled Trial","IronHip","Inclusion Criteria:\n\n1. 65 years of age or older\n2. Acute proximal femur fracture surgery\n3. A hemoglobin measurement ≤6.5 mmol\u002FL (10.5 g\u002FdL) on day 1 to 5 postoperatively\n4. Independent prefracture indoor walking ability, indoor NMS ≥ 2\n5. Ability to speak and understand Danish\n6. Able to provide informed consent on the participants own behalf\n\nExclusion Criteria:\n\n1. Known allergy to intravenous iron\n2. Residing permanently at a nursing home\n3. Hematological conditions with a risk of iron overload e.g. haemochromatosis, hemosiderosis, or where alternative treatments are necessary e.g. haematological malignancies\n4. Other contraindication to iron treatment, e.g. severe liver cirrhosis and hepatitis\n5. Severe uncontrolled infection as assessed by the responsible clinician (e.g. bacteraemia or sepsis)\n6. Plasma sodium levels below 125 or above 150 mmol\u002FL on the day of inclusion\n7. Renal replacement therapy\n8. Severe dementia assessed by physician\n9. Recent intravenous iron injection, 4 weeks prior to surgery\n10. Patient declared terminally ill\n11. Pathologic Fracture","ALL","65 Years",{"count":109,"type":110},210,"ESTIMATED","INTERVENTIONAL",[113],"PHASE4","The primary aim of this clinical trial is to investigate the effects of intravenous iron on recovery in mobility compared to the pre-fracture level in patients with a hip fracture\n\nThe main questions it aims to answer are:\n\nIt is hypothesize that intravenous iron will enhance gains in mobility and hereby recovery of mobility, increase hemoglobin (Hgb), lower fatigue, have a positive effect on skeletal muscles in the weeks and months after administration.\n\nThe primary objective is to compare the effect of a single dose of ferric derisomaltose (FDI) (20 mg\u002Fkg body weight) relative to placebo on patients' recovery of functional mobility, measured as the change from baseline in the New Mobility Score.\n\nParticipants will:\n\n\\- Receive either a single dose of intravenous FDI (20 mg\u002Fkg body weight) (and saline) or placebo (saline) at 1-5 days after surgery.\n\nThis trial will be conducted at three hospitals in Denmark, involving an anticipated 210 participants.",[116,117],"Hip Fracture","Anemia",[119,117,120,121,122,123],"Hip fracture","IV Iron","Mobility","Perioperative optimisation","Randomized Controlled Trial","2026-05-29",{"date":126,"type":127},"2026-06-01","ACTUAL",{"date":129,"type":127},"2025-06-09",{"date":131,"type":110},"2027-09-14",{"name":85,"class":6},3]