Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function

NCT ID: NCT03716128

Last Updated: 2025-03-18

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

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-26

Study Completion Date

2027-10-31

Brief Summary

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The aim of the study is to

1. To describe the bone morphology in patients with reduced renal function and high or low parathyroid hormone (PTH) respectively.
2. To investigate if the non-invasive method 18-Fluoride Positron Emission Tomography (18F-PET) can describe the bone turnover and reflect the bone histomorphologic changes
3. To investigate if non-oxidized PTH reflects bone turnover

Detailed Description

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Patients with reduced renal function and suspected high turnover or low turnover bone disease are recruited.

A bone biopsy and a 18F-PET scan are performed and it is investigated if the 18F-PET can discriminate high turnover from low turnover bone disease

Conditions

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Renal Osteodystrophy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Low turnover bone disease

PTH\<150 pg/ml

18F-PET

Intervention Type DIAGNOSTIC_TEST

Bone biopsy and 18F-PET

High turnover bone disease

PTH\>300 pg/ml

18F-PET

Intervention Type DIAGNOSTIC_TEST

Bone biopsy and 18F-PET

Normal renal function

Patients under examination for prostate cancer

18F-PET

Intervention Type DIAGNOSTIC_TEST

Bone biopsy and 18F-PET

Interventions

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18F-PET

Bone biopsy and 18F-PET

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Bone biopsy

Eligibility Criteria

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Inclusion Criteria

-≥ 18 years

* estimated Glomerular Filtration Rate (eGFR) ≤ 20 ml/min/1,73m2
* PTH \< 150 pg/ml or PTH \> 300 pg/ml


-≥ 18 years

* eGFR \>= 60 ml/min
* under examination for c prostata
* Prostatic Specific Antigen (PSA) total \<40 µg/l

Exclusion:

* Former kidney disease
* ionized calcium or PTH outside normal range
* Known metabolic bone disease
* treatment with anticoagulants
* Disturbed thrombosis and hemostasis

Exclusion Criteria

* ongoing malignancy
* Allergy towards tetracyclin
* Pregnancy

Control Group:
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Universiteit Antwerpen

OTHER

Sponsor Role collaborator

Ditte Hansen

OTHER

Sponsor Role lead

Responsible Party

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Ditte Hansen

Associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Herlev Hospital

Herlev, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Ditte Hansen, PhD

Role: CONTACT

+4538683868

Facility Contacts

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Ditte Hansen, PhD

Role: primary

+4538683868

Other Identifiers

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H-17040409

Identifier Type: -

Identifier Source: org_study_id

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