Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
Study NCT ID:
NCT03716128
Status:
RECRUITING
Last Update Posted:
2025-03-18
First Post:
2018-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012080', 'term': 'Chronic Kidney Disease-Mineral and Bone Disorder'}], 'ancestors': [{'id': 'D012279', 'term': 'Rickets'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}, {'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Bone Biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2018-09-26', 'studyFirstSubmitQcDate': '2018-10-20', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Can 18F-PET-CT describe bone formation rate?', 'timeFrame': 'The bone biopsy and 18F-PET will be performed during two month for each participant', 'description': 'The ROC curve for 18F uptake by bone measured as bone plasma clearance (ki) to descriminate between high and low bone turnover measured as bone formation rate'}, {'measure': 'Can non-oxidized PTH describe bone formation rate?', 'timeFrame': 'Blood sample and bone biopsy will be performed during two month for each participant', 'description': 'The relation between non-oxidized PTH in ng/L and bone turnover in bone biopsy described as bone formation rate'}], 'secondaryOutcomes': [{'measure': 'Can 18F-PET-CT describe mineral apposition rate?', 'timeFrame': 'The bone biopsy and 18F-PET will be performed during two month for each participant', 'description': 'The ROC curve for 18F uptake by bone measured as bone plasma clearance (ki) to descriminate between high and low bone turnover measured as mineral apposition rate'}, {'measure': 'Can non-oxidized PTH describe mineral apposition rate?', 'timeFrame': 'Blood sample and bone biopsy will be performed during two month for each participant', 'description': 'The relation between non-oxidized PTH in ng/L and bone turnover in bone biopsy described as mineral apposition rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Osteodystrophy']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to\n\n1. To describe the bone morphology in patients with reduced renal function and high or low parathyroid hormone (PTH) respectively.\n2. To investigate if the non-invasive method 18-Fluoride Positron Emission Tomography (18F-PET) can describe the bone turnover and reflect the bone histomorphologic changes\n3. To investigate if non-oxidized PTH reflects bone turnover', 'detailedDescription': 'Patients with reduced renal function and suspected high turnover or low turnover bone disease are recruited.\n\nA bone biopsy and a 18F-PET scan are performed and it is investigated if the 18F-PET can discriminate high turnover from low turnover bone disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients under investigation for prostate cancer are recruited as bone healthy controls Patients with reduced renal function and suspected high or low bone turnover are recruited for bone biopsy, blood and urin samples and 18F-PET scan', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients with reduced renal function:\n\nInclusion Criteria:\n\n-≥ 18 years\n\n* estimated Glomerular Filtration Rate (eGFR) ≤ 20 ml/min/1,73m2\n* PTH \\< 150 pg/ml or PTH \\> 300 pg/ml\n\nExclusion Criteria:\n\n* ongoing malignancy\n* Allergy towards tetracyclin\n* Pregnancy\n\nControl Group:\n\nInclusion Criteria:\n\n-≥ 18 years\n\n* eGFR \\>= 60 ml/min\n* under examination for c prostata\n* Prostatic Specific Antigen (PSA) total \\<40 µg/l\n\nExclusion:\n\n* Former kidney disease\n* ionized calcium or PTH outside normal range\n* Known metabolic bone disease\n* treatment with anticoagulants\n* Disturbed thrombosis and hemostasis'}, 'identificationModule': {'nctId': 'NCT03716128', 'briefTitle': 'Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function Can 18F-PET Replace Bone Histomorphometry', 'orgStudyIdInfo': {'id': 'H-17040409'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low turnover bone disease', 'description': 'PTH\\<150 pg/ml', 'interventionNames': ['Diagnostic Test: 18F-PET']}, {'label': 'High turnover bone disease', 'description': 'PTH\\>300 pg/ml', 'interventionNames': ['Diagnostic Test: 18F-PET']}, {'label': 'Normal renal function', 'description': 'Patients under examination for prostate cancer', 'interventionNames': ['Diagnostic Test: 18F-PET']}], 'interventions': [{'name': '18F-PET', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Bone biopsy'], 'description': 'Bone biopsy and 18F-PET', 'armGroupLabels': ['High turnover bone disease', 'Low turnover bone disease', 'Normal renal function']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Ditte Hansen, PhD', 'role': 'CONTACT', 'email': 'ditte.hansen.04@regionh.dk', 'phone': '+4538683868'}], 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'centralContacts': [{'name': 'Ditte Hansen, PhD', 'role': 'CONTACT', 'email': 'ditte.hansen.04@regionh.dk', 'phone': '+4538683868'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ditte Hansen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'Universiteit Antwerpen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Ditte Hansen', 'investigatorAffiliation': 'Herlev Hospital'}}}}