Renal Osteodystrophy Clinical Trial
Official 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.
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.
In this study bone histology parameters including results of tetracycline labeling will be
compared to non-invasive parameters of bone metabolism (e.g. sclerostin, calciprotein
particles) and bone structure obtained by imaging (e.g. bone density).
The aim of the study is to establish a reliable decision model (diagnostic tool) with these
non-invasive parameters that can be used to guide the individual therapy. The decision model
will be based on single calculations of the area under the curve for each parameter,
including determination of the optimal cutpoint, sensitivity and specificity. These results
will be integrated in a multivariate logistic regression analysis. The resulting model will
enable to calculate the individual probability of the underlying bone diagnosis as a single
value (without a specific dimension).
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