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 (APOSTROPHE)

Parenteral Nutrition and Bone Trophicity

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.

Study Overview

• Status: Completed
• Conditions: Long-term Parenteral Nutrition (2 Years) in Children and Adults
• Intervention / Treatment: Device: HR-pQCT

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Hospices Civils de Lyon - Hôpital Femme Mère Enfant
  • Lyon, France, 69004
    • Hospices Civils de Lyon - Hôpital de la Croix-Rousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Noel Peretti, Dr, Hospices Civils de Lyon - Hôpital Femme Mère Enfant

Publications and helpful links

General Publications

• Louazon T, Poinsot P, Restier L, Belmalih A, Loras-Duclaux I, Marotte S, Heissat S, Barnoud D, Chambrier C, Confavreux CB, Lachaux A, Bacchetta J, Peretti N. A prospective case-control pilot study to evaluate bone microarchitecture in children and teenagers on long-term parenteral nutrition using HR-pQCT. Sci Rep. 2021 Apr 28;11(1):9151. doi: 10.1038/s41598-021-88366-6.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: February 16, 2015
• First Posted (Estimated): February 23, 2015

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: DXA; HR-pQCT; Long-term parenteral nutrition; Bone trophicity
• Other Study ID Numbers: 2013.825; 2013-A01245-40 (Other Identifier: (N°ID-RCB) France: Agence Nationale de Sécurité du Médicament et des produits de santé)