[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606105":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":54,"collaborators":23,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":23,"enrollmentInfo":68,"targetDuration":23,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":38,"whyStopped":23,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Herlev Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PTH intensive target","EXPERIMENTAL","Intensive parathyroid hormone target (within interval of lower and upper normal limits = 2,0 - 8,5 µmol\u002FL). In the intensive PTH target group, treatment will be initiated as soon as the PTH rise above the upper limit of normal. Participants in this group will receive treatment to lower PTH level (activated vitamin D, phosphate binder, native vitamin D and calcimetics).\n\nPTH will be measured as intact PTH with Atellica IM PTH assay at Herlev Hospital laboratory (normal range 2,0 - 8,5 µmol\u002FL).",[13],"Other: Treat to target",{"label":15,"type":10,"description":16,"interventionNames":17},"PTH liberal target","Liberal parathyroid hormone target (\\\u003C 5 x upper normal limit = 42,5 µmol\u002FL). In the liberal PTH target group, treatment will not be initiated until PTH rise above five times the upper limit of normal. This is expected to be a small part of the participants.\n\nThe cut-off for the liberal PTH target (\\\u003C5 x upper normal limit) was discussed in the national CKD-MBD group. It is chosen to allow the clinician initiate treatment if PTH reaches unusually high levels, no studies have focussed on PTH-targets before, consequently the cut-off is chosen as part of the pragmatic design.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Treat to target","Participants will receive treatment from a \"toolbox\" depending on the situation to reach the PTH target. Available medication is mirroring what is used in the outpatient clinic setting already (native vitamin D, activated vitamin D, phosphate binders, calcimetics).",[9,15],null,[25],{"name":26,"affiliation":27,"role":28},"Ditte Hansen, Medical doctor, professor","Department of Nephrology, Herlev Hospital","STUDY_DIRECTOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":23,"email":34},"Freja S Hassager, Medical doctor","CONTACT","0045+22554707","freja.staehr.hassager.01@regionh.dk",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Department of Nephrology, outpatient clinic, Herlev Hospital","RECRUITING","Herlev","Capital Region","2730","Denmark","DK",{"type":45,"coordinates":46},"Point",[47,48],12.43998,55.72366,{"lat":48,"lon":47},[51,52],{"name":31,"role":32,"phone":33,"phoneExt":23,"email":34},{"name":31,"role":53,"phone":23,"phoneExt":23,"email":23},"PRINCIPAL_INVESTIGATOR",{"type":53,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":57,"oldNameTitle":23,"oldOrganization":23},"Freja Stæhr Hassager","Medical doctor","Herlev and Gentofte Hospital","100606105","the-effect-of-regulation-of-parathyroid-hormone-in-patients-with-chronic-kidney-disease-to-investigate-the-change-in-bone-mineral-density-100606105",false,"NCT07171216","The Effect of REgulation of PArathyroId hoRmone in Patients With Chronic Kidney Disease to Investigate the Change in Bone Mineral Density","The Effect of REgulation of PArathyroId hoRmone in Patients With Chronic Kidney Disease to Investigate the Change in Bone Mineral Density (Biskjoldbruskkirtelhormon og knogletæthed Hos Patienter Med Kronisk Nyresygdom)","REPAIR-CKD","Inclusion Criteria:\n\n1. ≥50 years of age at screening\n2. CKD G4-5nonD (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m2) based on local laboratory assessment of serum creatinine and eGFR estimated by the CKD-EPI formula)\n3. Plasma PTH \\> upper normal limit of local laboratory reference range (\\> 8,5µmol\u002FL) and\u002For treated with active vitamin D (Alphacalcidol) or calcimetics (Cinacalcet) initially\n4. Written informed consent\n\nExclusion Criteria:\n\n1. Patients who have received a kidney transplant\n2. Patients receiving treatment with specific anti-osteoporosis medication (denosumab\u002Fbisphosphonates) (because of the profound effect on calcium\u002Fphosphate fluxes and BMD)","ALL","50 Years",{"count":69,"type":70},70,"ESTIMATED","INTERVENTIONAL",[73],"NA","The prevalence of chronic kidney disease (CKD) in the adult population is estimated to 10%. CKD increases risk of bone fractures, cardiovascular disease and death. The main role of parathyroid hormone (PTH) is to regulate mineral metabolism, including the calcium and phosphate homeostasis. PTH increases as the kidney function declines, and at end stage kidney disease almost all patients have disturbances in the mineral metabolism. Decreasing bone mineral density is associated with risk of fracture, both in background population and in patients with CKD.\n\nFor decades, treatment with activated vitamin D, phosphate binders, and calcium supplements has been used for patients with chronic kidney disease and elevated parathyroid hormone, but treatment targets have varied greatly over the years, reflecting the lack of randomized clinical trials with clinical important end points.\n\nThe purpose of The REPAIR-CKD trial is to determine if treatment of hyperparathyroidism improves the bone mineral density in patients with chronic kidney disease.\n\nDuring this trial it will also be evaluated if it is feasible to obtain a difference in PTH levels when targeting two different levels of PTH.\n\nFurther this trial will explore if a difference in PTH influences on arterial stiffness, muscle mass, muscle function, bone histology and health related quality of life.",[76],"Chronic Kidney Disease Mineral and Bone Disorder",[78,79,80,81],"parathyroid hormone","chronic kidney disease","randomized clinical trial","Activated vitamin D","2026-01-05",{"date":84,"type":85},"2026-01-06","ACTUAL",{"date":87,"type":85},"2025-11-20",{"date":89,"type":70},"2027-09-01",{"name":5,"class":6},1]