Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
Study NCT ID:
NCT03716128
Status:
RECRUITING
Last Update Posted:
2025-03-18
First Post:
2018-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function
Sponsor:
Ditte Hansen
Organization:
Study Overview
Official Title:
Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function Can 18F-PET Replace Bone Histomorphometry
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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:
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: