renal osteodystrophy
Conditions
Interventions
Non-oxidized PTH, 18F-NaF PET and other bone marker turnovers (BTMs) compared
to histomorpho-metric bone biopsy as the gold standard
Sponsors
Amsterdam UMC, locatie VUmc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is 1) the association between bone turnover as assessed with 18F-NaF PET and bone turnover as assessed by bone histomorphometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed