E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Kidney Disease - Mineral and Bone Disorder (CKD-MBD), especially renal osteodystofi. |
Chronic Kidney Disease - Mineral and Bone Disorder (CKD-MBD), især renal osteodystofi. |
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E.1.1.1 | Medical condition in easily understood language |
Examination of the disturbances of bone and mineral metabolism, that occurs in patients with chronic kidney disease. The project has emphasis of bone metabolism. |
Undersøgelse af de forstyrrelse i knogle- og mineralmetabolismen, der ses hos patienter med kronisk nyresygdom. Projektet har særlig vægt på knoglemetabolismen. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065404 |
E.1.2 | Term | Combined positron emission tomogram and computerised tomogram |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10022891 |
E.1.2 | Term | Investigations |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066622 |
E.1.2 | Term | Chronic hemodialysis |
E.1.2 | System Organ Class | 100000004865 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate 18 F-NaF PET/CT in combination with biomarkers for classification of subtypes of renal osteodystrophy in patients treated with hemodialysis. This is compared to the golden standard (bone biopsy with double tetracycline labeling). |
At undersøge om 18F-NaF PET/CT i kombination med biomarkører kan klassificere undertyperne af renal osteodystrofi ved hæmodialysepatienter sammenlignet med golden standard (dobbelt tetracyklinmærket knoglebiopsi)
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age 30-80 years
Chronic hemodialysis |
Mænd og kvinder 30-80 år
Kronisk hæmodialyse
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E.4 | Principal exclusion criteria |
Medical treatment with systemic corticosteroid
Inability to give informed consent
Pregnancy and lactation
Not radically treated cancer disease
Alcohol or drugs abuse
Within three months: bone fracture, AMI or TCI, parathyroidektomi or kidney transplantation
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Behandling med systemisk binyrebarkhormon
Manglende evne til at afgive informeret samtykke
Graviditet eller amning
Ikke radikalt behandlet cancersygdom
Alkoholmisbrug
Stofmisbrug
Inden for tre måneder: knoglebrud, AMI eller TCI, nyretransplantation eller parathyroidektomi |
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E.5 End points |
E.5.1 | Primary end point(s) |
SUVmaks (Sandard value uptake) and Ki |
SUVmaks (Sandard value uptake) og Ki |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of the trial, when all subjects have completed and the blood samples, bone biopsy and PET/CT-scans are analyzed |
I slutningen af forsøget, når alle forsøgspersoner er afsluttet og blodprøver, knoglebiopsi og PET/CT-skanninger analyseret |
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E.5.2 | Secondary end point(s) |
Bone biopsy: BFR/BS, Ac.F, O.th, Mlt, BV/TV
Biomarkers: bALP, FGF23, osteocalcin, OPG/sRANKL ratio
PET/CT: SUVmean, SUVpeak, SUVa50, MAV, total bone volume and calciumscore
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Knoglebiopsi: BFR/BS, Ac.F, O.th, Mlt, BV/TV
Biomarkørerne: bALP, FGF23, osteocalcin, OPG/sRANKL ratio
PET/CT: SUVmean, SUVpeak, MAV, total knoglevolumen og kalkscore
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the end of the trial, when all subjects have completed and the blood samples, bone biopsy and PET/CT-scans are analyzed |
I slutningen af forsøget, når alle forsøgspersoner er afsluttet og blodprøver, knoglebiopsi og PET/CT-skanninger analyseret |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |