APOSTrophe Study (Parenteral Nutrition and Bone Trophicity) Impact of a Long-term Parenteral Nutrition on Bone Metabolism Measured by High Resolution Peripheral Quantitative Computer Tomography (HR-pQCT) in Children and Young Adults

Study Overview
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Brief Summary
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Recent progress in parenteral nutrition has contributed to improve vital prognosis and to reduce morbidity in patients with severe intestinal failure. Currently, home parenteral nutrition is the only alternative to prolonged hospitalization for those patients. However, long-term parenteral nutrition can result in complications especially in bone, such as osteopenia or osteomalacia, then increasing the risk of fractures. Children are especially at risk because of bone growth and peak mineralization acquisition during puberty. Moreover, frequency and risk factors of those complications are not well documented for children. Dual-energy X-ray Absorptiometry (DXA) is considered as the golden standard for bone mineralization measurement. In pediatrics, this technique has some limits such as the underestimation of Bone Mineral Density (BMD) in short stature, the overestimation of the BMD in tall children, and the inability to distinguish cortical from trabecular bone or to evaluate the bone microarchitecture. HR-pQCT, High Resolution peripheral Quantitative Computed Tomography enables noninvasive assessment of bone microarchitecture (virtual bone biopsy) using a radiation similar to DXA. However this technique has never been validated in patients with long-term parenteral nutrition. During the usual follow-up of the patients, HR-pQCT will be the only exam which will come in addition to the routine medical tests.

Official Title
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Parenteral Nutrition and Bone Trophicity

Conditions
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Long-term Parenteral Nutrition (2 Years) in Children and Adults

Intervention / Treatment
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* Device: HR-pQCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who's receiving a long-term parenteral nutrition (over 2 years) Patient between 9 and 30 years of age (children big enough to stay immobile for 3 min during the measurement) Affiliation to the Social Security System Informed consent form signed by parents and assent given by the patient Exclusion Criteria: Patient presenting a bone disease which is not directly related to the parenteral nutrition. Long-term corticotherapy ( over 6 months of therapy) Inability to keep the leg or the arm immobile for 3 min Patient not affiliated to a Social Security System Patient participating to another interventional study Pregnant patient or patient who desires pregnancy All situation that the physician estimated that is not compatible with the study

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Children and young adults on long-term parenteral nutrition<br>long-term parenteral nutrition : 2 years | Device: HR-pQCT<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density (BMD) and Bone mineral contain (BMC) height z-score at baseline | BMD and BMC z scores (after correction for the height) will be measured by High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) and compared to those measured in a control group (healthy subjects matched on age and sex). The same measurements will be also compared with those obtained by Dual-energy X Ray (DXA) but in this case each subject will be considered as his own control. | J0 (baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trabecular and cortical BMD z score | Trabecular and cortical BMD (height) z score measured by HR-pQCT for patients under parenteral nutrition at baseline will be compared to those of the control group | J0 (baseline) | 
| BMD and BMC height z score after 1 year of parenteral nutrition (PN) | BMD and BMC (height) z score measured by HR-pQCT and DXA after one year of PN will be compared, for each subject, to the measurements recorded at baseline | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DXA, Long-term parenteral nutrition, HR-pQCT, Bone trophicity