Bone Markers in Pediatric IF

Osteoporosis Clinical Trial

Official title:

Bone Turnover Markers in Children With Intestinal Failure After Optimization of Parenteral Nutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05909228
• Other study ID #: 1000080417
• Status: Completed
• Start date: March 31, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2024
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Gender: All
• Age group: 6 Weeks to 18 Years

Eligibility

Inclusion criteria are as follows:

In order to be eligible to participate in this study, a patient must meet all of the following criteria at time of inclusion:

1. Consent provided

2. Age < 18 years

3. Suffering from IF needing PN providing at least 25% of calories for =6 weeks

4. Medically stable with no acute changes in condition requiring hospitalization, or other intervention at home (for at least 3 months).

For healthy controls the inclusion criteria are as follows:

1. Consent provided

2. Age < 18 years.

A patient who meets any of the following criteria will be excluded from participation in this study:

1. On PN for < 6 weeks

2. Suffering from an acute clinical event, for example gastroenteritis, colds and flu

3. Suffering from sepsis on antibiotics

4. On medication known to affect bone metabolism, for example steroids

5. Having a history of fracture within the last 12 months.

For healthy controls, the exclusion criteria are as follows:

1. Any condition known to affect bone health (chronic disease, bone disease, history of malignancy, radiotherapy, steroid use, mental or physical disability)

2. A positive history of fractures within the past 2 years

3. Poor growth (weight- and height-for-age below - 2 or above + 2 standard deviation score using the WHO growth charts).

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Intestinal Failure
• Metabolic Bone Disease
• Osteoporosis

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone turnover markers - Osteocalcin	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.	Baseline
Primary	Bone turnover markers - C-telopeptide	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.	Baseline
Primary	Bone turnover markers - Bone-specific alkaline phosphatase	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.	Baseline
Secondary	Bone health	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.	DXA scan results will be collected when performed within 6 months of the blood draw for the bone markers.
Secondary	Intestinal failure and parenteral nutrition related factors	Association of intestinal failure and parenteral nutrition related factors such as duration of parenteral nutrition (y) with serum osteocalcin, C-telopeptide and bone-specific alkaline phosphatase levels.	Baseline
Secondary	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.	Intestinal failure and parenteral nutrition related factors