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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

NCT02368496 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-08-11

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

HR-pQCT

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Noel Peretti, Dr · Hospices Civils de Lyon - Hôpital Femme Mère Enfant

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-08-31
Completion
2016-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02368496 on ClinicalTrials.gov