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Markers of Bone Disease in Children on Parenteral Nutrition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01603472
Recruitment Status : Completed
First Posted : May 22, 2012
Last Update Posted : July 29, 2013
Rare Disease Foundation, Vancouver, Canada
Information provided by (Responsible Party):
Glenda Courtney-Martin, The Hospital for Sick Children

Brief Summary:
Parenteral nutrition (PN) is the provision of nutrients via the intravenous route. Parenteral nutrition associated metabolic bone disease (MBD) was first described in children in the 1980s. Since then, there has been little to no research into the underlying relationship and as a result, little evidence on which to base clinical care. In adults, MBD is associated with increased fractures. At the Hospital for Sick children in Toronto, an intestinal failure program has been set up since 2003. This is the only intestinal failure program in Canada and receives country wide referrals. Most of the patients have short bowel syndrome (SBS) and require PN for prolonged periods, or for life. About 90% of these patients have MBD, and some have had bone fractures. An understanding of the etiology of MBD would provide information to guide care, and prevent this condition. Funding for this area of research however is challenging because intestinal failure requiring long term PN is a rare condition, accounting for approximately 200 - 300 children in all of Canada. The goal of this study therefore is to gather pilot data on markers of MBD in children on long term PN, and to compare these markers to age and gender matched control patients who are fed by mouth or feeding tube. The information gathered from this study will help us begin to understand what is actually happening in the bones of children on long term PN and will form the basis for future studies and improved clinical care.

Condition or disease
Metabolic Bone Disease

Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Markers of Parenteral Nutrition (PN) Associated Metabolic Bone Disease in Children on Long-Term PN for Intestinal Failure.
Study Start Date : May 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Diseases
U.S. FDA Resources

Subjects on Parenteral Nutrition
cases are those on Parenteral Nutrition >6 weeks for intestinal failure.
Subjects not on Parenteral Nutrion
Controls are those who have never been on PN but can be fed via a feeding tube

Primary Outcome Measures :
  1. serum osteocalcin [ Time Frame: Over 8 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children on long term PN and childen not on PN.


For Cases on Long-term PN:

  1. On PN for ≥ 6 consecutive weeks
  2. Willingness to participate in the study

For Control Subjects:

  1. Healthy as assessed by history and physical exam.
  2. Growing normally
  3. Are not on medications known to affect bone metabolism eg. Corticosteroids.
  4. Never received PN in the past


For Cases on Long-term PN

  1. Patients who are on PN for shorter than 6 weeks
  2. Patients on hemodialysis

For Control Subjects

  1. Subjects who are not able to be matched to a case/subject on long-term PN for age and gender
  2. Positive history of fractures
  3. Subjects who are unable to participate because of fear of giving blood or unable to come to the hospital for sick children for blood draws.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01603472

Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, MG 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Rare Disease Foundation, Vancouver, Canada
Principal Investigator: Glenda Courtney-Martin The Hospital for Sick Children

Responsible Party: Glenda Courtney-Martin, Academic &Clinical Specialist, Project Investigator, The Hospital for Sick Children Identifier: NCT01603472     History of Changes
Other Study ID Numbers: 1000028242
First Posted: May 22, 2012    Key Record Dates
Last Update Posted: July 29, 2013
Last Verified: July 2013

Keywords provided by Glenda Courtney-Martin, The Hospital for Sick Children:
parenteral nutrition
bone disease
long-term PN

Additional relevant MeSH terms:
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Metabolic Diseases