[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100404514":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":128,"collaborators":25,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":25,"eligibilityCriteria":138,"healthyVolunteers":134,"sex":139,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":25,"studyType":145,"phases":146,"briefSummary":148,"conditions":149,"keywords":25,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Bispebjerg Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Denosumab treated group","EXPERIMENTAL","Participants will receive a 60 mg subcutaneous injection of Prolia upon randomization and on week 28 after the first injection provided remission of the Charcot foot has not been achieved by then",[13],"Drug: Denosumab Injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo treated group","PLACEBO_COMPARATOR","Participants will receive an injection of placebo (saline) instead of Prolia",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Denosumab Injection","Injections made subcutaneously per standard description",[9,15],null,[27],{"name":28,"affiliation":29,"role":30},"Ole Lander Svendsen, MD","Region Hovedstadens Apotek","STUDY_CHAIR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":25,"email":35},"CONTACT","+4521490547","Ole.Lander.Svendsen@regionh.dk",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Michael Zaucha Sørensen, MD","+4526836584","mzs@dadlnet.dk",[41,56,67,73,84,95,106,117],{"facility":42,"status":43,"city":44,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Steno Diabetes Center North","RECRUITING","Aalborg","Denmark","DK",{"type":48,"coordinates":49},"Point",[50,51],9.9187,57.048,{"lat":51,"lon":50},[54],{"name":55,"role":33,"phone":25,"phoneExt":25,"email":25},"Niels Ejskjær",{"facility":57,"status":43,"city":58,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Steno Diabetes Center Aarhus","Aarhus",{"type":48,"coordinates":60},[61,62],10.21076,56.15674,{"lat":62,"lon":61},[65],{"name":66,"role":33,"phone":25,"phoneExt":25,"email":25},"Christian Buhl",{"facility":5,"status":43,"city":68,"state":25,"zip":69,"country":45,"countryCode":46,"cosmosGeoPoint":25,"geoPoint":25,"contacts":70},"Copenhagen NV","2400",[71],{"name":72,"role":33,"phone":25,"phoneExt":25,"email":25},"Ole L Svendsen, Professor",{"facility":74,"status":43,"city":75,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Steno Diabetes Center Copenhagen","Gentofte Municipality",{"type":48,"coordinates":77},[78,79],12.54601,55.74903,{"lat":79,"lon":78},[82],{"name":83,"role":33,"phone":25,"phoneExt":25,"email":25},"Anne Rasmussen",{"facility":85,"status":43,"city":86,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Nordsjællands Hospital","Hillerød",{"type":48,"coordinates":88},[89,90],12.30081,55.92791,{"lat":90,"lon":89},[93],{"name":94,"role":33,"phone":25,"phoneExt":25,"email":25},"Peter Lommer",{"facility":96,"status":43,"city":97,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Hvidovre hospital","Hvidovre",{"type":48,"coordinates":99},[100,101],12.47708,55.64297,{"lat":101,"lon":100},[104],{"name":105,"role":33,"phone":25,"phoneExt":25,"email":25},"Ole Snorgaard",{"facility":107,"status":43,"city":108,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Zealand University Hospital","Køge",{"type":48,"coordinates":110},[111,112],12.18214,55.45802,{"lat":112,"lon":111},[115],{"name":116,"role":33,"phone":25,"phoneExt":25,"email":25},"Christoffer Hedetoft",{"facility":118,"status":43,"city":119,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Steno Diabetes Center Odense","Odense",{"type":48,"coordinates":121},[122,123],10.38831,55.39594,{"lat":123,"lon":122},[126],{"name":127,"role":33,"phone":25,"phoneExt":25,"email":25},"Lena Snogdal",{"type":129,"investigatorFullName":130,"investigatorTitle":131,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Ole Lander Svendsen","Professor","100404514","phase-3-the-denocharcot-trial-100404514",false,"NCT04547348","The DENOCHARCOT Trial","Efficacy of Treatment With DENOsumab of an Acute CHARCOT Foot in Patients With Diabetes. A Multicenter, Double-blind, Randomized, Placebo-controlled Trial.","Inclusion Criteria:\n\n* Age 18-80 years\n* Type 1 or type 2 diabetes (diagnosed diabetes for more than 3 months)\n* Diagnosed with acute Charcot foot defined as a unilateral red, swollen and warm foot, with a difference of skin temperature of more than 2 °C compared with the unaffected foot and with sign of Charcot on either x-rays of the foot, MRI, bone scintigram or PET\u002FCT.\n* Peripheral neuropathy: Previously diagnosed and\u002For biothesiometri: \\> 25 V or lack of sensation of 10 grams monofilament on 1. toe at the acute Charcot foot.\n\nExclusion Criteria:\n\n* Duration of the acute Charcot foot for more than 3 months (at the screening visit).\n* Existing foot ulcer on the affected foot\n* Previous acute or chronic Charcot of the affected foot\n* Planned surgery on the acute Charcot foot\n* Infection (cellulitis or osteomyelitis) of the affected foot (clinically and\u002For radiologically proven)\n* Previous midfoot or proximal to mid foot amputation of the affected foot\n* Hypocalcemia (Serum Calcium \\\u003C2.1 mmol\u002FL or Calcium ion \\\u003C 1.12 mmol\u002FL)\n* Vitamin D deficiency (Serum 25-hydroxyvitamin D \\\u003C 50 nmol\u002FL)\n* Renal failure (serum creatinine \\>200 mmol\u002FL or eGFR \\\u003C 30 ml\u002Fmin).\n* Treatment with Denosumab within the last 12 months. • Have a known hypersensitivity to Denosumab • History of osteonecrosis of the jaw.\n* Poor oral hygiene, which is defined as within 3 months of a tooth extraction, dental implants or mandibular surgery\n* Planned mandibular surgery or dental implants within the next 12 months.\n* Prior non-traumatic vertebral fracture\n* Treatment with medication known to affect bones within the last 12 months (such as bisphosphonates, Forsteo®, calcitonin, Protelos®, selective estrogen receptor modulators, glucocorticoids and sex hormones)\n* Active or chronic liver disease \\*Chronic liver disease is defined as clinical history of decompensated chronic liver disease (ascites, encephalopathy or variceal bleeding) \\*Acute Liver disease is defined as an INR of \\> 1.5 (in the absence of the use of Warfarin) and AST and ALT \\> 2 x ULN\n* History of inflammatory arthropathies (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, autoimmune arthropathy)\n* Pre-existing medical condition judged to preclude safe participation in the study\n* Current treatment with cytotoxic drugs or with systemically administered glucocorticoids\n* Abuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocol\n* Pregnancy, breast feeding or planning pregnancy or not using adequate contraceptive methods. The following contraceptive products are considered to be safe: Intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections).\n* Likely inability to comply with the visits because of planned activity\n* Use of any investigational product with the last month.\n* Use of any drug or any other reason which in the Investigator's opinion could interfere with the outcome of the treatment of the acute Charcot foot.\n* Cancer, or any clinically significant disease or disorder, except for conditions associated to the diabetes, which in the Investigator's opinion could interfere with the results of the trial","ALL","18 Years","80 Years",{"count":143,"type":144},38,"ESTIMATED","INTERVENTIONAL",[147],"PHASE3","The aim of the present trial is to assess the efficacy of treatment of acute Charcot foot in diabetes patients with Prolia® on clinical relevant Outcomes in a randomized, double blind, placebo-controlled trial.",[150,151],"Charcot Foot","Diabetes Mellitus","2024-08-06",{"date":154,"type":155},"2024-08-07","ACTUAL",{"date":157,"type":155},"2020-11-01",{"date":159,"type":144},"2026-10-01",{"name":130,"class":6},8]