Diagnosing bone disease in patients with kidney issues
Official title: Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function Can 18F-PET Replace Bone Histomorphometry
Run by Herlev Hospital · NCT03716128 · Data updated 2026-11-12
This study is testing if a special imaging scan can help doctors better understand bone health in patients with kidney problems and different levels of parathyroid hormone.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Herlev Hospital Academic / other |
| Locations | 1 site (Herlev) |
| Status | Recruiting |
| Started | September 26, 2018 |
| Main results expected | October 2027 |
| Study ends | October 2027 |
| Registry record updated | March 18, 2025 |
| Trial ID | NCT03716128 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with reduced renal function and specific PTH levels.
✕Probably not a fit
Patients with ongoing malignancies, allergies to tetracycline, or those who are pregnant may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to characterize bone morphology in patients with reduced renal function and varying levels of parathyroid hormone (PTH). It investigates the use of 18-Fluoride Positron Emission Tomography (18F-PET) as a non-invasive method to assess bone turnover and its correlation with bone histomorphologic changes. Patients with suspected high or low turnover bone disease will undergo a bone biopsy and an 18F-PET scan to determine the effectiveness of this imaging technique in differentiating between the two conditions.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for renal osteodystrophy, allowing for better-targeted treatments.
How similar studies have gone: While the use of 18F-PET in this context is relatively novel, similar imaging techniques have shown promise in other studies assessing bone health.
Who can join: the full rules
Show full inclusion / exclusion criteria
Patients with reduced renal function: Inclusion Criteria: -≥ 18 years * estimated Glomerular Filtration Rate (eGFR) ≤ 20 ml/min/1,73m2 * PTH \< 150 pg/ml or PTH \> 300 pg/ml Exclusion Criteria: * ongoing malignancy * Allergy towards tetracyclin * Pregnancy Control Group: Inclusion Criteria: -≥ 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
Where it's running
-
Herlev Hospital
Herlev, Denmark Recruiting
Study contacts
- Study coordinator: Ditte Hansen, PhD
- Email: ditte.hansen.04@regionh.dk
- Phone: +4538683868
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.