ClinicalTrials.gov
ClinicalTrials.gov Menu

Systematic Study of Parameters of Chronic Kidney Disease Mineral and Bone Disorder (CKD-MBD) (BoneX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02556216
Recruitment Status : Recruiting
First Posted : September 22, 2015
Last Update Posted : February 27, 2018
Sponsor:
Collaborator:
University of Jena
Information provided by (Responsible Party):
Hannover Medical School

Brief Summary:
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.

Condition or disease
Renal Osteodystrophy

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 : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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
blood; urine, bone tissue


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic kidney disease (including kidney transplanted patients) with mineral and bone disease
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Margret Patecki, MD +49 511-532 ext 6320 patecki.margret@mh-hannover.de
Contact: Wilfried Gwinner, MD +49 511-532 ext 6230 gwinner.wilfried@mh-hannover.de

Locations
Germany
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.         
Sponsors and Collaborators
Hannover Medical School
University of Jena
Investigators
Principal Investigator: Margret Patecki, MD Hannover Medical School

Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT02556216     History of Changes
Other Study ID Numbers: S 061-10.027
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Hannover Medical School:
bone biopsy; bone density

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Bone Diseases
Chronic Kidney Disease-Mineral and Bone Disorder
Urologic Diseases
Renal Insufficiency
Musculoskeletal Diseases
Rickets
Bone Diseases, Metabolic
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hyperparathyroidism, Secondary
Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases