[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100402619":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":48,"centralContacts":53,"locations":62,"responsibleParty":143,"collaborators":147,"id":153,"slug":154,"hasResults":155,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":34,"eligibilityCriteria":159,"healthyVolunteers":155,"sex":160,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":34,"studyType":166,"phases":167,"briefSummary":169,"conditions":170,"keywords":175,"overallStatus":107,"whyStopped":34,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},{"fullName":5,"class":6},"Herlev Hospital","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Teriparatide","EXPERIMENTAL","Patients receive teriparatide 20 micrograms once daily for 18 months",[13,14,15,16,17],"Drug: Teriparatide","Diagnostic Test: DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET\u002FCT","Procedure: Bone biopsy","Diagnostic Test: Cardiac tests","Other: Blood and urine samples and physical examination",{"label":19,"type":6,"description":20,"interventionNames":21},"Controls","Controls receive no treatment with teriparatide",[14,15,16,17],[23,29,35,40,44],{"type":24,"name":9,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","20 micrograms",[9],[28],"Terrosa",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DIAGNOSTIC_TEST","DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET\u002FCT","All participants undergo DXA and VFA or X-ray scans 3 times during the study. Some participants (those connected to Herlev) are offered 18F NAF PET\u002FCT scans at baseline and after 12 months and some participants (those connected to Odense University Hospital and Aalborg University Hospital) are offered HR-pQCT scans at baseline and after 12 months. The 18F-NAF PET\u002FCT and HR-pQCT are optional, so it is not a must to have these procedures done to participate in the study.",[19,9],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":34},"PROCEDURE","Bone biopsy","All participants are invited to undergo a bone biopsy after 12 months, but it is not a must to have the procedure done to participate in the study.",[19,9],{"type":30,"name":41,"description":42,"armGroupLabels":43,"otherNames":34},"Cardiac tests","All participants are invited to undergo 24-hour blood pressure measurements and pulse wave measurements at baseline and after 18 months, but it is not a must to have these procedures done to participate in the study.",[19,9],{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":34},"Blood and urine samples and physical examination","All participants must undergo a physical examination and deliver blood and urine samples in order to participate in the study.",[19,9],[49],{"name":50,"affiliation":51,"role":52},"Ditte Hansen, MD, PhD","Department of Nephrology, Herlev and Gentofte Hospital","PRINCIPAL_INVESTIGATOR",[54,59],{"name":55,"role":56,"phone":57,"phoneExt":34,"email":58},"Sabina C Hauge, MD","CONTACT","+4528965887","sabina.chaudhary.hauge@regionh.dk",{"name":50,"role":56,"phone":60,"phoneExt":34,"email":61},"+4538682056","ditte.hansen.04@regionh.dk",[63,89,105,122],{"facility":64,"status":65,"city":66,"state":34,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Aalborg University Hospital","NOT_YET_RECRUITING","Aalborg","9000","Denmark","DK",{"type":71,"coordinates":72},"Point",[73,74],9.9187,57.048,{"lat":74,"lon":73},[77,81,84,85,87],{"name":78,"role":56,"phone":79,"phoneExt":34,"email":80},"Charlotte Strandhave, MD, PhD","+4597665500","charlotte.strandhave@rn.dk",{"name":82,"role":56,"phone":79,"phoneExt":34,"email":83},"My HS Svensson, MD, PhD","my.svensson@rn.dk",{"name":78,"role":52,"phone":34,"phoneExt":34,"email":34},{"name":82,"role":86,"phone":34,"phoneExt":34,"email":34},"SUB_INVESTIGATOR",{"name":88,"role":86,"phone":34,"phoneExt":34,"email":34},"Peter Vestergaard, MD, PhD",{"facility":90,"status":65,"city":91,"state":34,"zip":92,"country":68,"countryCode":69,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Steno Diabetes Center Copenhagen","Gentofte Municipality","2820",{"type":71,"coordinates":94},[95,96],12.54601,55.74903,{"lat":96,"lon":95},[99,103],{"name":100,"role":56,"phone":101,"phoneExt":34,"email":102},"Frederik Persson, MD, DMSc","+4539680800","frederik.persson@regionh.dk",{"name":104,"role":52,"phone":34,"phoneExt":34,"email":34},"Frederik Persson, MD, DMSc.",{"facility":106,"status":107,"city":108,"state":34,"zip":109,"country":68,"countryCode":69,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Herlev and Gentofte Hospital, Herlev Hospital","RECRUITING","Herlev","2730",{"type":71,"coordinates":111},[112,113],12.43998,55.72366,{"lat":113,"lon":112},[116,117,118,119,120],{"name":55,"role":56,"phone":57,"phoneExt":34,"email":58},{"name":50,"role":56,"phone":60,"phoneExt":34,"email":61},{"name":55,"role":86,"phone":34,"phoneExt":34,"email":34},{"name":50,"role":52,"phone":34,"phoneExt":34,"email":34},{"name":121,"role":86,"phone":34,"phoneExt":34,"email":34},"Jakob P Holm, MD, PhD",{"facility":123,"status":65,"city":124,"state":34,"zip":125,"country":68,"countryCode":69,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Odense University Hospital","Odense","5000",{"type":71,"coordinates":127},[128,129],10.38831,55.39594,{"lat":129,"lon":128},[132,136,140,141],{"name":133,"role":56,"phone":134,"phoneExt":34,"email":135},"Morten F Nielsen, MD, PhD","+4522877448","mmfnielsen@health.sdu.dk",{"name":137,"role":56,"phone":138,"phoneExt":34,"email":139},"Subagini Nagarajah, MD","+4528598621","subagininagarajah3@rsyd.dk",{"name":133,"role":52,"phone":34,"phoneExt":34,"email":34},{"name":142,"role":86,"phone":34,"phoneExt":34,"email":34},"Subagini Nagarajah, MD, PhD",{"type":144,"investigatorFullName":145,"investigatorTitle":146,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"SPONSOR_INVESTIGATOR","Ditte Hansen","MD, PhD",[148,149,150,152],{"name":123,"class":6},{"name":90,"class":6},{"name":151,"class":6},"Rigshospitalet, Denmark",{"name":64,"class":6},"100402619","phase-4-treatment-of-adynamic-bone-disorder-with-parathyroid-hormone-in-chronic-kidney-disease-100402619",false,"NCT04522622","Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease","Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Patients With Chronic Kidney Disease","Inclusion Criteria:\n\n* Age ≥18 years\n* CKD stage 4-5D (eGFR ≤29 ml\u002Fmin) according to Kidney Disease Improving Global Outcomes(KDIGO) definition\n* DXA scan with a T-score at the total hip, femoral neck or lumbar spine (L1-4) ≤-2 (or Z-score ≤-2) in a minimum of 2 vertebraes (for patients with active oral prednisolone treatment ≥ 5 mg\u002Fday for minimum 3 months the T-score or Z-score limit i \\\u003C -1) and\u002For former fragility fracture (vertebral, hip, for- or upper arm, ankle) assessed with VFA or x-ray of the columna\n* Patients with expected adynamic bone disorder, based on BSAP≤21 µg\u002Fl or biopsy-verified low bone turnover\n\nExclusion Criteria:\n\n* Hypercalcemia defined as sustained ionized calcium \\>1.35 mmol\u002Fl\n* Previous fracture withon the last 6 months \\*Patients may be rescreened after the 6 months\n* Previous calciphylaxis\n* Thyroid disturbances not adequately treated based on the opinion by the clinician \\*Patients may be rescreened after treatment optimization\n* Treatment with digoxin\n* Paget's disease or other metabolic bone disorders\n* Antiresorptive or bone anabolic medication during the last 24 months (for bisphosphonates it is only during the last 12 months)\n* Former or present malignant disease (except skin basal or planocellular carcinoma)\n* Previous external beam or implant radiation therapy to the skeleton\n* Patients who have undergone a kidney transplantation within the last 12 months\n* 25 hydroxyvitamin D2 and D3 \\\u003C50 nmol\u002Fl \\*Patients may be rescreened after correction\n* Inability to administer teriparatide\n* Reduced liver function \\*Alanine Aminotransferase (ALAT) \\>3x upper limit of normal or bilirubin \\> 2x upper limit of normal\n* Pregnancy, lactation or fertile women (post-menopausal females are not considered fertile) not using safe anticonception (the following contraceptive methods are considered appropriate: Intrauterine device (IUD) or hormonal anticontraceptive (oral contraceptives, implant, transdermal patches, vaginal ring or depot injection)).\n* Hypersensitivity to the active substance in teriparatide or to any of the excipients or content\n* Inability to provide informed consent\n* Medical conditions or treatments that may interfere with assessments of the outcomes of the trial\n* Drug or alcohol abuse\n* Unable to participate in a clinical study based on the judgement by the local investigator\n* For those participating in the bone biopsy procedure: 1) Hypersensitivity to any of the tetracyclines or to any of the excipients or content, 2) Treatment with anticoagulants (vitamin K antagonists, Non-vitamin K Antagonist Oral Anticoagulants (NOAC), unfractionated or low-molecular heparin or antiplatelet agents that, due to clinical indication can't be paused, 3) Disturbances in thrombosis and\u002For haemostasis\n* For those participating in pulse wave measurements: 1) Atrial fibrillation, 2) Aorta stenosis","ALL","18 Years","120 Years",{"count":164,"type":165},48,"ESTIMATED","INTERVENTIONAL",[168],"PHASE4","This study is a 1:1 randomized controlled trial with an intervention for 18 months and a follow up period of 12 months. The purpose of the study is to assess the safety and efficacy of recombinant human parathyroid hormone for treatment of adynamic bone disorder in patients with chronic kidney disease.",[171,172,173,174],"Adynamic Bone Disease","Chronic Kidney Diseases","Cardiac Disease","Chronic Kidney Disease-Mineral and Bone Disorder",[176,9],"Fracture risk","2024-04-19",{"date":179,"type":180},"2024-04-23","ACTUAL",{"date":182,"type":180},"2021-12-15",{"date":184,"type":165},"2027-09-01",{"name":145,"class":6},4]