Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01245-40 | Other Identifier | (N°ID-RCB) France: Agence Nationale de Sécurité du Médicament et des produits de santé |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children and young adults on long-term parenteral nutrition | Experimental | long-term parenteral nutrition : 2 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR-pQCT | Device |
|
| 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) |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Noel Peretti, Dr | Hospices Civils de Lyon - Hôpital Femme Mère Enfant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon - Hôpital Femme Mère Enfant | Bron | 69500 | France | |||
| Hospices Civils de Lyon - Hôpital de la Croix-Rousse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33911128 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| Lyon |
| 69004 |
| France |