Bone Turnover Markers in Children With Intestinal Failure After Optimization of Parenteral Nutrition
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Bone turnover markers - Bone-specific alkaline phosphatase
Study Overview
Brief 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.
Detailed Description
It is currently unknown if optimization of PN mixtures leads to a measurable change in bone turnover markers. Our hypothesis is that bone turnover markers of children with IF whose PN has been optimized will not differ from those of healthy control subjects, with a positive effect on bone mineral density.
Our aims are:
- To measure bone turnover markers in children with IF on long-term PN and compare them with age- and sex-matched healthy children who never received PN
- To evaluate if changes in bone turnover markers are related to changes in bone mineral density measured by Dual energy X-ray absorptiometry (DXA)
- To identify IF- and PN-related factors associated with bone health
To be able to answer these aims, bone markers in children with IF will be compared to bone markers in healthy controls, age- and sex-matched.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 6 Weeks to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Bone turnover markers - Bone-specific alkaline phosphatase
Time Frame: Baseline
To measure serum bone-specific alkaline phosphatase levels in children with intestinal failure on long-term parenteral nutrition and compare them with age- and sex-matched healthy children who never received parenteral nutrition.
Bone turnover markers - Osteocalcin
Time Frame: Baseline
To measure serum osteocalcin levels in children with intestinal failure on long-term parenteral nutrition and compare them with age- and sex-matched healthy children who never received parenteral nutrition.
Bone turnover markers - C-telopeptide
Time Frame: Baseline
To measure serum C-telopeptide levels in children with intestinal failure on long-term parenteral nutrition and compare them with age- and sex-matched healthy children who never received parenteral nutrition.
Secondary Outcomes
- Intestinal failure and parenteral nutrition related factors(Intestinal failure and parenteral nutrition related factors)
- Bone health(DXA scan results will be collected when performed within 6 months of the blood draw for the bone markers.)
Investigators
Glenda Courtney-Martin
Principal Investigator
The Hospital for Sick Children