Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-29 @ 12:23 PM
Study NCT ID:
NCT05909228
Status:
COMPLETED
Last Update Posted:
2024-01-16
First Post:
2023-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Markers in Pediatric IF
Sponsor:
The Hospital for Sick Children
Organization:
Study Overview
Official Title:
Bone Turnover Markers in Children With Intestinal Failure After Optimization of Parenteral Nutrition
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: