Ignite Creation Date:
2024-05-06 @ 8:23 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02729142
Status:
COMPLETED
Last Update Posted:
2020-11-16
First Post:
2016-03-25
Brief Title:
Bone Microarchitecture in the Transplant Patient
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Longitudinal Monitoring of Bone Microarchitecture by High Resolution Peripheral Quantitative Computed Tomography of HR-pQCT in the Transplant Patient
Status:
COMPLETED
Status Verified Date:
2020-11
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:
TRANSOS
Brief Summary:
The optimal management of calcium and phosphate metabolism regulation in chronic kidney disease CKD is important in preventing fracture risk and vascular calcification and thus morbidity and mortality global and vascular
Kidney transplant in a CKD context usually with a pre-existing underlying renal osteodystrophy malnutrition chronic inflammation hypogonadism and immunosuppression protocols still often made up of high-dose corticosteroid therapy are all theoretical factors of post-transplantation bone disease For other solid organ transplants even though there is generally no underlying renal osteodystrophy before the transplant the proportion of osteoporotic patients at the time of transplant is substantial The bone risk in the immediate post-transplant period is notable
Patients follow-up is based on biological radiological and histological tools Bone densitometry DXA is used to measure bone mass However recent international recommendations do not consider DXA as a valid tool to assess bone health in CKD patients Moreover it is less informative than peripheral quantitative tomography resolution HR-pQCT This latest technique available in Lyon and Saint-Etienne is more precise allowing a three-dimensional study of the trabecular microarchitecture and compartmental volumetric bone density total cortical trabecular while similar to DXA in terms of radiation less than 5 μSv The prevention of cardiovascular risk factors is also part of the daily care of patients with a regular cardiac monitoring heart ultrasound and vascular blood pressure Doppler of the supra-aortic trunks
TRANSOS study aims to evaluate in a prospective cohort longitudinal follow-up of 6 months the bone status in patients receiving solid organ transplantation in the University Hospitals of Lyon and Saint-Etienne using DXA and HR-pQCT at baseline and month 6 in combination with classical biological and cardiovascular monitoring Transplantation is an important activity in these two hospitals and this protocol provides the same bone follow-up for all solid organ transplants with a reliable efficient non-invasive and low-dose radiation tool
The primary objective of TRANSOS study is to evaluate changes in tibial cortical density between the baseline and the 6th month post-transplant measured by HR-pQCT
Kidney transplant in a CKD context usually with a pre-existing underlying renal osteodystrophy malnutrition chronic inflammation hypogonadism and immunosuppression protocols still often made up of high-dose corticosteroid therapy are all theoretical factors of post-transplantation bone disease For other solid organ transplants even though there is generally no underlying renal osteodystrophy before the transplant the proportion of osteoporotic patients at the time of transplant is substantial The bone risk in the immediate post-transplant period is notable
Patients follow-up is based on biological radiological and histological tools Bone densitometry DXA is used to measure bone mass However recent international recommendations do not consider DXA as a valid tool to assess bone health in CKD patients Moreover it is less informative than peripheral quantitative tomography resolution HR-pQCT This latest technique available in Lyon and Saint-Etienne is more precise allowing a three-dimensional study of the trabecular microarchitecture and compartmental volumetric bone density total cortical trabecular while similar to DXA in terms of radiation less than 5 μSv The prevention of cardiovascular risk factors is also part of the daily care of patients with a regular cardiac monitoring heart ultrasound and vascular blood pressure Doppler of the supra-aortic trunks
TRANSOS study aims to evaluate in a prospective cohort longitudinal follow-up of 6 months the bone status in patients receiving solid organ transplantation in the University Hospitals of Lyon and Saint-Etienne using DXA and HR-pQCT at baseline and month 6 in combination with classical biological and cardiovascular monitoring Transplantation is an important activity in these two hospitals and this protocol provides the same bone follow-up for all solid organ transplants with a reliable efficient non-invasive and low-dose radiation tool
The primary objective of TRANSOS study is to evaluate changes in tibial cortical density between the baseline and the 6th month post-transplant measured by HR-pQCT
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 |
|---|---|---|---|
| 2015-A00510-49 | OTHER | IDRCB | None |