Systematic Study of Parameters of Chronic Kidney Disease Mineral and Bone Disorder (CKD-MBD) (BoneX)
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|ClinicalTrials.gov Identifier: NCT02556216|
Recruitment Status : Recruiting
First Posted : September 22, 2015
Last Update Posted : February 27, 2018
|Condition or disease|
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).
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Systematic Study of Parameters of Chronic Kidney Disease Mineral and Bone Disorder (CKD-MBD)|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||July 2019|
- 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 [ Time Frame: cross-sectional study, one week ]
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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556216
|Contact: Margret Patecki, MD||+49 511-532 ext firstname.lastname@example.org|
|Contact: Wilfried Gwinner, MD||+49 511-532 ext email@example.com|
|Hannover Medical School||Recruiting|
|Hannover, Germany, 30625|
|Contact: Elisabeth Bahlmann, Study Nurse +49-511-532-3000|
|Principal Investigator: Margret Patecki, MD|
|Sub-Investigator: Wilfried Gwinner, Prof. Dr.|
|Sub-Investigator: Armin Koch, Prof. Dr.|
|Principal Investigator:||Margret Patecki, MD||Hannover Medical School|