Bone Markers in Pediatric IF (NCT05909228) | Clinical Trial Compass
CompletedNot Applicable
Bone Markers in Pediatric IF
Canada35 participantsStarted 2023-03-31
Plain-language summary
Poor bone health is a well-recognized but poorly understood complication in children with intestinal failure (IF) who are dependent on parenteral nutrition (PN). Previously, we showed that children with IF have decreased bone turnover markers. It is currently unknown if optimization of parenteral nutrition is related to improved bone turnover markers. Serum concentrations of bone markers (osteocalcin, bone-specific alkaline phosphatase and c-telopeptide) will be measured in 30 IF patients treated at a multidisciplinary intestinal rehabilitation and home PN program at the Hospital for Sick Children and compared to bone markers in 30 age- and sex-matched healthy controls.
Who can participate
Age range6 Weeks – 18 Years
SexALL
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Inclusion criteria
✓. Consent provided
✓. Age \< 18 years
✓. Suffering from IF needing PN providing at least 25% of calories for ≥6 weeks
✓. Medically stable with no acute changes in condition requiring hospitalization, or other intervention at home (for at least 3 months).
✓. Consent provided
✓. Age \< 18 years.
✓. On PN for \< 6 weeks
✓. Suffering from an acute clinical event, for example gastroenteritis, colds and flu
Exclusion criteria
✕. Any condition known to affect bone health (chronic disease, bone disease, history of malignancy, radiotherapy, steroid use, mental or physical disability)
✕. A positive history of fractures within the past 2 years
What they're measuring
1
Bone turnover markers - Osteocalcin
Timeframe: Baseline
2
Bone turnover markers - C-telopeptide
Timeframe: Baseline
3
Bone turnover markers - Bone-specific alkaline phosphatase