Diagnosing bone disease in patients with kidney issues
Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function Can 18F-PET Replace Bone Histomorphometry
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 |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev Hospital Academic / other |
| Locations | 1 site (Herlev) |
| Trial ID | NCT03716128 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with reduced renal function and specific PTH levels.
Not a fit: Patients with ongoing malignancies, allergies to tetracycline, or those who are pregnant may not benefit from this study.
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 performed: While the use of 18F-PET in this context is relatively novel, similar imaging techniques have shown promise in other studies assessing bone health.
Eligibility criteria
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 this trial is running
Herlev
- Herlev Hospital — Herlev, Denmark (Recruiting)
Study contacts
- Study coordinator: Ditte Hansen, PhD
- Email: ditte.hansen.04@regionh.dk
- Phone: +4538683868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.