Renal OsteodystrophyBoneXNCT02556216
Systematic Study of Parameters of Chronic Kidney Disease Mineral and Bone Disorder (CKD-MBD)
An observational study of Renal Osteodystrophy, run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Osteodystrophy
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic kidney disease (including kidney transplanted patients) with mineral and bone disease
Who may be able to join
- Patients with kidney disease who have an indication for a bone biopsy, based on clinical, laboratory and radiologic findings
Who cannot join
- known malignant bone or bone marrow disease
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hannover Medical School
Hanover, 30625
Elisabeth Bahlmann, Study Nurse, +49-511-532-3000
Margret Patecki, MD
About this study
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.
Read the 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).
- Conditions
- Renal Osteodystrophy
- Keywords
- bone biopsy; bone density
- Medical subject headings
- Chronic Kidney Disease-Mineral and Bone Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: cross-sectional study, one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal OsteodystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- University of Jena
- Responsible party
- Sponsor
- Investigators
- Margret Patecki, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556216
- Sponsor's protocol ID
- S 061-10.027
- Acronym
- BoneX
- Status last verified
- Feb 2018
- First submitted
- 6 Aug 2015
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Study of Parameters of Chronic Kidney Disease Mineral and Bone Disorder (CKD-MBD)
- ClinicalTrials.gov ID
- NCT02556216
- Acronym / sponsor ID
- BoneX / S 061-10.027
- Conditions
- Renal Osteodystrophy
- Keywords
- bone biopsy; bone density
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- University of Jena
- Study start
- Feb 2015
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic kidney disease (including kidney transplanted patients) with mineral and bone disease
Key inclusion criteria (1 listed)
- Patients with kidney disease who have an indication for a bone biopsy, based on clinical, laboratory and radiologic findings
Key exclusion criteria (1 listed)
- known malignant bone or bone marrow disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margret Patecki, MD principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Osteodystrophy, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margret Patecki, MD (+49 511-532 ext. 6320, patecki.margret@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018.