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

NCT ID: NCT02556216

Last Updated: 2018-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Renal Osteodystrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Jena

OTHER

Sponsor Role collaborator

Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margret Patecki, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

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Hannover Medical School

Hanover, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Margret Patecki, MD

Role: CONTACT

+49 511-532 ext. 6320

Wilfried Gwinner, MD

Role: CONTACT

+49 511-532 ext. 6230

Facility Contacts

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Elisabeth Bahlmann, Study Nurse

Role: primary

+49-511-532-3000

Other Identifiers

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S 061-10.027

Identifier Type: -

Identifier Source: org_study_id

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