Skip to content

Bone Microarchitecture in the Transplant Patient

Longitudinal Monitoring of Bone Microarchitecture by High Resolution Peripheral Quantitative Computed Tomography of (HR-pQCT) in the Transplant Patient

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02729142
Acronym
TRANSOS
Enrollment
137
Registered
2016-04-06
Start date
2016-06-07
Completion date
2020-10-08
Last updated
2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Organ Transplant

Keywords

HRpQCT, transplant, bone microarchitecture

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.

Interventions

PROCEDURETibial cortical density evaluation

Bone evaluation in transplant patients will be performed by HR-pQCT at baseline (either within 6 months before surgery or within 15 days following surgery) and 6 months post-intervention in order to assess its evolution.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient over 10 year-old * Patient receiving a first solid organ transplant within involved hospitals (Lyon, Saint Etienne): kidney, heart, kidney-pancreas, lung * Informed consent signed by the patients or their parents (minors)

Exclusion criteria

* No health cover * Ongoing pregnancy

Design outcomes

Primary

MeasureTime frame
Tibial cortical density measured by HR-pQCTat 6 months

Secondary

MeasureTime frameDescription
Evaluation of bone markers by measuring 25OHD3at 6 months
Evaluation of bone markers by measuring 1-25 OHD3at 6 months
Evaluation of bone markers by measuring FGF23at 6 months
Evaluation of bone markers by measuring CTXat 6 months
Evaluation of bone markers by measuring total alkaline phosphataseat 6 months
Evaluation of bone markers by measuring bone alkaline phosphataseat 6 months
Evaluation of bone markers by measuring osteocalcinat 6 months
Bone mineral density assessed by DXAat 6 months
Fractures onset assessed by DXAat 6 months
Cardiovascular events (death from cardiovascular cause, heart attack, stroke)at 6 months
PTHBaselineFor kidney transplant only
1-25 OHDBaselineFor kidney transplant only
Evaluation of bone markers by measuring PTHat 6 months
calciumBaselineFor kidney transplant only
phosphateBaselineFor kidney transplant only
cortical perimeter measured by HR-pQCTat 6 months
Evaluation of bone markers by measuring calciumat 6 months
Evaluation of bone markers by measuring phosphateat 6 months
Evaluation of bone markers by measuring alkaline reserveat 6 months
trabecular bone area measured by HR-pQCTat 6 months
total bone area measured by HR-pQCTat 6 months
trabecular number measured by HR-pQCTat 6 months
trabecular thickness measured by HR-pQCTat 6 months
trabecular separation measured by HR-pQCTat 6 months
FGF 23BaselineFor kidney transplant only

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026