A study of non-invasive diagnostic techniques in renal osteodystrophy: 18F-sodiumfluoride positron emission tomography and serum non-oxidized PTH compared to bone histomorphometry

Completed

Conditions: renal osteodystrophy
10005959
10029149

Registration Number: NL-OMON48097

Lead Sponsor: Amsterdam UMC, locatie VUmc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is 1) the association between bone turnover as assessed with<br /><br>18F-NaF PET and bone turnover as assessed by bone histomorphometry. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>associations of total PTH and non-oxidized PTH with bone turnover as measured<br /><br>with bone histomor-phometry; associations of bone turnover as measured with<br /><br>18F-NaF PET and nonoxidized PTH measurements with conventional serum bone<br /><br>turnover markers.</p><br>