An observational study in Intestinal Failure, Osteoporosis and Metabolic Bone Disease, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 6 Weeks to 18 Years. Per ClinicalTrials.gov, last updated 2024-01-16.
Sponsored by The Hospital for Sick Children · Observational
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.
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 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.
64 studies on the registry are indexed under Intestinal Failure; 17 are open to participants now.
This study's enrollment of 35 is below the median of 60 across 19 observational studies indexed under Intestinal Failure.
Browse Intestinal Failure studies →The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children with intestinal failure on parenteral nutrition and healthy controls without parenteral nutrition.
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:
For healthy controls the inclusion criteria are as follows:
A patient who meets any of the following criteria will be excluded from participation in this study:
For healthy controls, the exclusion criteria are as follows:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children with intestinal failure on parenteral nutrition
Healthy controls without parenteral nutrition
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: DXA scan results will be collected when performed within 6 months of the blood draw for the bone markers.
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.
Time frame: Baseline
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.
Time frame: Intestinal failure and parenteral nutrition related factors
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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