NCT02368496

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

July 15, 2014

Last Update Submit

August 8, 2025

Conditions

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

Keywords

Long-term parenteral nutritionHR-pQCTDXABone trophicity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Trabecular and cortical BMD z score

    J0 (baseline)

  • BMD and BMC height z score after 1 year of parenteral nutrition (PN)

    1 year

Study Arms (1)

Children and young adults on long-term parenteral nutrition

EXPERIMENTAL

long-term parenteral nutrition : 2 years

Device: HR-pQCT

Interventions

HR-pQCTDEVICE
Children and young adults on long-term parenteral nutrition

Eligibility Criteria

Age9 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospices Civils de Lyon - Hôpital Femme Mère Enfant

Bron, 69500, France

Location

Hospices Civils de Lyon - Hôpital de la Croix-Rousse

Lyon, 69004, France

Location

Related Publications (1)

  • 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.

    PMID: 33911128RESULT

Study Officials

  • Noel Peretti, Dr

    Hospices Civils de Lyon - Hôpital Femme Mère Enfant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2014

First Posted

February 23, 2015

Study Start

March 1, 2014

Primary Completion

August 1, 2015

Study Completion

July 1, 2016

Last Updated

August 11, 2025

Record last verified: 2025-08

Locations

FR(2)