[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605271":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":19,"collaborators":23,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":10,"studyType":50,"phases":10,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":59,"whyStopped":10,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":10},{"fullName":5,"class":6},"Aristotle University Of Thessaloniki","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients diagnosed with chronic hypoparathyroidism",null,"Patients ≥18 years of age, fluent in Greek language, diagnosed with chronic hypoparathyroidism (HP), on optimal treatment with calcium and active vitamin D metabolites. Chronic HP is defined when continuous therapy with calcium and vitamin D is required for \\>12 months.",[13],"Other: Questionnaire and Physical Exam",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Questionnaire and Physical Exam","Translation and validation of the existing HPES-Symptom and HPES-Impact Questionnaires in the Greek population",[9],{"type":20,"investigatorFullName":21,"investigatorTitle":22,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Panagiotis Anagnostis","Assistant Professor",[24,26,28,30,32,34],{"name":25,"class":6},"National and Kapodistrian University of Athens",{"name":27,"class":6},"424 General Military Hospital",{"name":29,"class":6},"General Hospital Of Thessaloniki Ippokratio",{"name":31,"class":6},"Laikο General Hospital, Athens",{"name":33,"class":6},"251 Hellenic Air Force & VA General Hospital",{"name":35,"class":6},"Hellenic Red Cross Hospital","100605271","translation-and-validation-of-the-hypoparathyroidism-patient-experience-scales-hpes-questionnaire-in-greek-100605271",false,"NCT07160348","Translation and Validation of the Hypoparathyroidism Patient Experience Scales (HPES) Questionnaire in Greek","Translation and Validation of the Hypoparathyroidism Patient Experience Scales (HPES) Questionnaire in Patients With Hypoparathyroidism for Use in the Greek Population","HPES","Inclusion Criteria:\n\nPatients should be ≥18 years of age, fluent in Greek language, diagnosed with chronic HP, on optimal treatment with calcium and active vitamin D metabolites. Chronic HP is defined when continuous therapy with calcium and vitamin D is required for \\>12 months.\n\nExclusion Criteria:\n\n1. Patients inadequately controlled with conventional therapy:\n\n   1. corrected serum Ca (cCa) ≤8 mg\u002Fdl or cCa ≤8.2 mg\u002Fdl with symptoms of hypocalcemia\n   2. serum P \\>5.5 mg\u002Fdl\n2. Age \\>80 years\n3. Presence of neoplastic disease\n4. Pregnancy\n5. Diagnosis of psychiatric disease or cognitive impairment\n6. Participants experiencing other comorbidities that may affect QoL\n7. Lack of informed consent","ALL","18 Years","80 Years",{"count":48,"type":49},200,"ESTIMATED","OBSERVATIONAL","This is a crossectional study that will be conducted at several tertiary centers in Greece.\n\nTo participate in the study, patients should be ≥18 years of age, fluent in Greek language, diagnosed with chronic HP, on optimal treatment with calcium and active vitamin D metabolites. Chronic HP is defined when continuous therapy with calcium and vitamin D is required for \\>12 months.\n\nExclusion criteria will include:\n\n1. Patients inadequately controlled with conventional therapy:\n\n   1. corrected serum Ca (cCa) ≤8 mg\u002Fdl or cCa ≤8.2 mg\u002Fdl with symptoms of hypocalcemia\n   2. serum P \\>5.5 mg\u002Fdl\n2. Age \\>80 years\n3. Presence of neoplastic disease\n4. Pregnancy\n5. Diagnosis of psychiatric disease or cognitive impairment\n6. Participants experiencing other comorbidities that may affect QoL\n7. Lack of informed consent The study will seek approval from the Ethics in Research Committee of its participating center. All participants will be informed about the objectives of the study and will sign an informed consent.\n\nThe HPES-Symptom was developed in accordance with the Food and Drug Administration guidance and best research practices for PRO measure development. The methodology used has been previously described.\n\nThe first step of the translation process requires two forward translations of the English version of the questionnaire. The translations will be done by two translators who are native speakers of the target (Greek) language and can understand the English version. Then a reconciled translation is made based on the two translations - that is, the chief investigator will review the two translations to achieve the best possible version by choosing one of the two translations or by combining them on the basis of their correctness, wording etc.\n\nThe next step requires translating the reconciled version back into English, again done by two translators who will be native speakers of English or at least will have a very good command of English.",[53],"Hypoparathyroidism",[55,56,57,58],"hypoparathyroidism","parathyroid hormone","palopegteriparatide","calcium metabolism disorders","NOT_YET_RECRUITING","2025-08-29",{"date":62,"type":63},"2025-09-08","ACTUAL",{"date":65,"type":49},"2025-10-01",{"date":67,"type":49},"2026-04-01",{"name":5,"class":6}]