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Completed

NCT Number: NCT02729142

Bone Microarchitecture in the Transplant Patient

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.

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Key information

Conditions

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Femme Mère Enfant, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tibial cortical density evaluation

Procedure

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.

Primary outcomes

  1. Tibial cortical density measured by HR-pQCT

    Time frame: at 6 months

Secondary outcomes

  1. trabecular bone area measured by HR-pQCT

    Time frame: at 6 months

  2. total bone area measured by HR-pQCT

    Time frame: at 6 months

  3. trabecular number measured by HR-pQCT

    Time frame: at 6 months

  4. trabecular thickness measured by HR-pQCT

    Time frame: at 6 months

  5. trabecular separation measured by HR-pQCT

    Time frame: at 6 months

  6. cortical perimeter measured by HR-pQCT

    Time frame: at 6 months

  7. Evaluation of bone markers by measuring calcium

    Time frame: at 6 months

  8. Evaluation of bone markers by measuring phosphate

    Time frame: at 6 months

  9. Evaluation of bone markers by measuring alkaline reserve

    Time frame: at 6 months

  10. Evaluation of bone markers by measuring PTH

    Time frame: at 6 months

  11. Evaluation of bone markers by measuring 25OHD3

    Time frame: at 6 months

  12. Evaluation of bone markers by measuring 1-25 OHD3

    Time frame: at 6 months

  13. Evaluation of bone markers by measuring FGF23

    Time frame: at 6 months

  14. Evaluation of bone markers by measuring CTX

    Time frame: at 6 months

  15. Evaluation of bone markers by measuring total alkaline phosphatase

    Time frame: at 6 months

  16. Evaluation of bone markers by measuring bone alkaline phosphatase

    Time frame: at 6 months

  17. Evaluation of bone markers by measuring osteocalcin

    Time frame: at 6 months

  18. Bone mineral density assessed by DXA

    Time frame: at 6 months

  19. Fractures onset assessed by DXA

    Time frame: at 6 months

  20. Cardiovascular events (death from cardiovascular cause, heart attack, stroke)

    Time frame: at 6 months

  21. PTH

    Time frame: Baseline

    For kidney transplant only

  22. 1-25 OHD

    Time frame: Baseline

    For kidney transplant only

  23. FGF 23

    Time frame: Baseline

    For kidney transplant only

  24. calcium

    Time frame: Baseline

    For kidney transplant only

  25. phosphate

    Time frame: Baseline

    For kidney transplant only

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: TRANSOS

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 6, 2016
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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