- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02556216
Systematic Study of Parameters of Chronic Kidney Disease Mineral and Bone Disorder (CKD-MBD) (BoneX)
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Margret Patecki, MD
- Phone Number: 6320 +49 511-532
- Email: patecki.margret@mh-hannover.de
Study Contact Backup
- Name: Wilfried Gwinner, MD
- Phone Number: 6230 +49 511-532
- Email: gwinner.wilfried@mh-hannover.de
Study Locations
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Hannover, Germany, 30625
- Recruiting
- Hannover Medical School
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Contact:
- Elisabeth Bahlmann, Study Nurse
- Phone Number: +49-511-532-3000
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Principal Investigator:
- Margret Patecki, MD
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Sub-Investigator:
- Wilfried Gwinner, Prof. Dr.
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Sub-Investigator:
- Armin Koch, Prof. Dr.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
cross-sectional study, one week
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Margret Patecki, MD, Hannover Medical School
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Urologic Diseases
- Endocrine System Diseases
- Renal Insufficiency
- Nutrition Disorders
- Musculoskeletal Diseases
- Parathyroid Diseases
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Bone Diseases, Metabolic
- Calcium Metabolism Disorders
- Rickets
- Vitamin D Deficiency
- Hyperparathyroidism, Secondary
- Hyperparathyroidism
- Kidney Diseases
- Renal Insufficiency, Chronic
- Bone Diseases
- Chronic Kidney Disease-Mineral and Bone Disorder
Other Study ID Numbers
- S 061-10.027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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