Ignite Creation Date:
2024-05-06 @ 3:45 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02368496
Status:
COMPLETED
Last Update Posted:
2016-07-21
First Post:
2014-07-15
Brief Title:
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
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Parenteral Nutrition and Bone Trophicity
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-A01245-40 | OTHER | NID-RCB France Agence Nationale de Sécurité du Médicament et des produits de santé | None |