Renal Osteodystrophy Clinical Trial
— BoneXOfficial title:
Systematic Study of Parameters of Chronic Kidney Disease Mineral and Bone Disorder (CKD-MBD)
Bone and mineral disease is a key problem in patients with kidney disease. The available clinical parameters are non-specific, unproven for the assessment of the bone metabolism and do not reflect the complexity and diversity of the underlying bone pathology. The aim of this study is to use bone histology, novel bone markers and bone imaging results to establish a reliable decision model (diagnostic tool) that can be used to guide the individual therapy.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 2019 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with kidney disease who have an indication for a bone biopsy, based on clinical, laboratory and radiologic findings Exclusion Criteria: - known malignant bone or bone marrow disease |
Country | Name | City | State |
---|---|---|---|
Germany | Hannover Medical School | Hannover |
Lead Sponsor | Collaborator |
---|---|
Hannover Medical School | University of Jena |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of a diagnostic model (derived from the non-invasive radiologic and blood parameters of the bone) in relation to the 'gold standard' bone biopsy result | After determining the AUC, sensitivity, specificity and optimal cutpoint for each parameter, a logistic regression model is created which gives the probability of the underlying bone diagnosis as a single probability value. In this cross-sectional studies each patient gets a one-time assessment of radiologic and blood parameters of bone metabolism obtained within one week. Accuracy is described by the performance measures sensitivity, specificity, area under the curve, negative and positive predictive values. |
cross-sectional study, one week |
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