Bone Markers in Pediatric IF

Completed

• Conditions: Metabolic Bone Disease; Intestinal Failure; Osteoporosis

• Registration Number: NCT05909228
• Lead Sponsor: The Hospital for Sick Children

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 Timeline

• Study Start: 2023-03-31
• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-06-09
• Study First Posted: 2023-06-18
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone turnover markers - Bone-specific alkaline phosphatase	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	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	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 Outcome Measures

Name	Time	Method
Intestinal failure and parenteral nutrition related factors	Intestinal failure and parenteral nutrition related factors	Association of intestinal failure and parenteral nutrition related factors such as parenteral nutrition dependency index (%) with serum osteocalcin, C-telopeptide and bone-specific alkaline phosphatase levels.
Bone health	DXA scan results will be collected when performed within 6 months of the blood draw for the bone markers.	Association of serum osteocalcin, C-telopeptide and bone-specific alkaline phosphatase with bone mineral density Z-scores for lumber spine and total body less head obtained from DXA scans performed as standard clinical care.

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada