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

NCT02556216 | Unknown

• 1 other identifier: S 061-10.027
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Osteodystrophy

Keywords

bone biopsy; bone density

Outcome Measures

Primary Outcomes (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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic kidney disease (including kidney transplanted patients) with mineral and bone disease

You may qualify if:

• Patients with kidney disease who have an indication for a bone biopsy, based on clinical, laboratory and radiologic findings

You may not qualify if:

• known malignant bone or bone marrow disease

Sponsors & Collaborators

• Hannover Medical School: lead
• University of Jena: collaborator

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood; urine, bone tissue

MeSH Terms

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder

Condition Hierarchy (Ancestors)

Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Margret Patecki, MD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margret Patecki, MD

CONTACT

+49 511-532; patecki.margret@mh-hannover.de

Wilfried Gwinner, MD

CONTACT

+49 511-532; gwinner.wilfried@mh-hannover.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: September 22, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: July 1, 2019
• Last Updated: February 27, 2018

Record last verified: 2018-02

Locations

DE (1)