To assess accuracy of 18F-sodiumfluoride (NaF) positron emission tomography (PET) and serum non-oxidized parathyroid hormone (PTH) as an accurate, reliable and easy applicable diagnostic tools for the assessment of bone turnover in chronic kidney…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is 1) the association between bone turnover as assessed with
18F-NaF PET and bone turnover as assessed by bone histomorphometry.
Secondary outcome
associations of total PTH and non-oxidized PTH with bone turnover as measured
with bone histomor-phometry; associations of bone turnover as measured with
18F-NaF PET and nonoxidized PTH measurements with conventional serum bone
turnover markers.
Background summary
Renal osteodystrophy is characterized by abnormalities in bone turnover,
mineralization, and volume in the setting of chronic kidney disease. Knowledge
regarding the underlying bone disorder, in particular the bone turnover rate,
is essential in the treatment choice. However, current non-invasive diagnostic
tests cannot discriminate accurately between high and low bone turnover.
Transiliac bone biopsy is the gold standard but has limitations including being
invasive, being limited to one skeletal site and requiring considerable
expertise. Thus, reliable noninvasive techniques to classify bone turnover in
renal osteo-dystrophy are of utmost importance.
Study objective
To assess accuracy of 18F-sodiumfluoride (NaF) positron emission tomography
(PET) and serum non-oxidized parathyroid hormone (PTH) as an accurate, reliable
and easy applicable diagnostic tools for the assessment of bone turnover in
chronic kidney disease (CKD) patients.
Study design
Cross-sectional study. Patients will be recruited from the outpatient clinic of
nephrology in the AUMC locations AMC and VUMC.
Intervention
Non-oxidized PTH, 18F-NaF PET and other bone marker turnovers (BTMs) compared
to histomorpho-metric bone biopsy as the gold standard
Study burden and risks
Sixteen patients referred to undergo a living kidney transplant will be
included. Patients will undergo dual energy X-ray absorptiometry (DXA), 18F-NaF
PET and fasting blood sampling to assess classical bone turnover markers and
non-oxidized PTH. Transiliac bone biopsy will be performed after the
transplanta-tion procedure at the contralateral side under general anaesthesia
(and after administration of oral tet-racycline). Therefore, participants will
experience minimal discomfort from the biopsy procedure. Imag-ing studies and
blood withdrawal will be performed on one day at one location to limit hospital
visits as much as possible. Participating in this study has low risks of
radiation damage (total amount approxi-mately 6 mSv, maximum amount allowed per
year 10 mSv).
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
- Written informed consent
- Aged 18 years and above
- Planned to undergo a living-donor kidney transplantation, related or unrelated
- 25-hydroxyvitamin D concentrations > 50 nmol/L
Exclusion criteria
- Pregnant or lactating women, or subjects who intend to become pregnant within
the study period
- Serious mental impairment i.e. preventing to understand the study protocol or
comply with the study aim; potentially unreliable patients and those judged by
the investigator to be unsuitable for the study
- Active, not previously treated, malignancy. Malignancies > 1 year in the
medical history and treated with curative intention is not considered an
exclusion criterium
- Presence of diseases known to influence bone metabolism (other than CKD MBD)
such as active or chronic liver failure or cirrhosis or thyroid disease (other
than benign, euthyroid nodules)
- Known allergic reaction for tetracycline antibiotics.
- Current use of calcimimetics
- Previous parathyreoidectomy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Nederlandse Trial Register |
| CCMO | NL70466.029.19 |