Clinical trial NCT02368496: 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
Official title: Parenteral Nutrition and Bone Trophicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long-term Parenteral Nutrition (2 Years) in Children and Adults
Keywords: Long-term parenteral nutrition
HR-pQCT
DXA
Bone trophicity
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-02-23
Enrollment: 17
Sex: ALL
Minimum age (years): 9
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Bone mineral density (BMD) and Bone mineral contain (BMC) height z-score at baseline
timeFrame: J0 (baseline)
Secondary outcomes:
measure: Trabecular and cortical BMD z score
timeFrame: J0 (baseline)
measure: BMD and BMC height z score after 1 year of parenteral nutrition (PN)
timeFrame: 1 year
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital de la Croix-Rousse
Study officials:
affiliation: Hospices Civils de Lyon - Hôpital Femme Mère Enfant
name: Noel Peretti, Dr
role: PRINCIPAL_INVESTIGATOR
References: