Metabolic Bone DiseaseNCT01603472
Markers of Bone Disease in Children on Parenteral Nutrition
An observational study of Metabolic Bone Disease, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 weeks to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Bone Disease
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children on long term PN and childen not on PN.
Who may be able to join
- For Cases on Long-term PN:
- On PN for ≥ 6 consecutive weeks
- Willingness to participate in the study
- For Control Subjects:
- Healthy as assessed by history and physical exam.
- Growing normally
- Are not on medications known to affect bone metabolism eg. Corticosteroids.
- Never received PN in the past
Who cannot join
- For Cases on Long-term PN
- Patients who are on PN for shorter than 6 weeks
- Patients on hemodialysis
- For Control Subjects
- Subjects who are not able to be matched to a case/subject on long-term PN for age and gender
- Positive history of fractures
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Markers of Parenteral Nutrition (PN) Associated Metabolic Bone Disease in Children on Long-Term PN for Intestinal Failure.
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.
- Conditions
- Metabolic Bone Disease
- Keywords
- pediatric, parenteral nutrition, bone disease, long-term PN
- Medical subject headings
- Bone Diseases, Metabolic, Hyperphagia, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum osteocalcin
Measured: Over 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Bone DiseaseStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Rare Disease Foundation, Vancouver, Canada
- Responsible party
- Principal investigator, Glenda Courtney-Martin, The Hospital for Sick Children
- Investigators
- Glenda Courtney-Martin, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603472
- Sponsor's protocol ID
- 1000028242
- Status last verified
- Jul 2013
- First submitted
- 18 May 2012
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers of Parenteral Nutrition (PN) Associated Metabolic Bone Disease in Children on Long-Term PN for Intestinal Failure.
- ClinicalTrials.gov ID
- NCT01603472
- Acronym / sponsor ID
- 1000028242
- Conditions
- Metabolic Bone Disease
- Keywords
- pediatric, parenteral nutrition, bone disease, long-term PN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Rare Disease Foundation, Vancouver, Canada
- Study start
- May 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 22 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children on long term PN and childen not on PN.
Key inclusion criteria (8 listed)
- On PN for ≥ 6 consecutive weeks
- Willingness to participate in the study
- Healthy as assessed by history and physical exam.
- Growing normally
- Are not on medications known to affect bone metabolism eg. Corticosteroids.
Key exclusion criteria (7 listed)
- For Cases on Long-term PN
- Patients who are on PN for shorter than 6 weeks
- Patients on hemodialysis
- For Control Subjects
- Subjects who are not able to be matched to a case/subject on long-term PN for age and gender
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
serum osteocalcin
Time frame: Over 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenda Courtney-Martin principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Bone Disease, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum osteocalcin (time frame: Over 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2013.