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Bone Microarchitecture in the Transplant Patient (TRANSOS)

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ClinicalTrials.gov Identifier: NCT02729142
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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.


Condition or disease Intervention/treatment Phase
Organ Transplant Procedure: Tibial cortical density evaluation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Longitudinal Monitoring of Bone Microarchitecture by High Resolution Peripheral Quantitative Computed Tomography of (HR-pQCT) in the Transplant Patient
Actual Study Start Date : June 7, 2016
Actual Primary Completion Date : October 8, 2020
Actual Study Completion Date : October 8, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Tibial cortical density evaluation Procedure: Tibial 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.


Outcome Measures
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Primary Outcome Measures :
  1. Tibial cortical density measured by HR-pQCT [ Time Frame: at 6 months ]

Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729142


Locations
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France
Hôpital Femme Mère Enfant
Bron, France
Hopital Edouard Herriot
Lyon, France
CHU Saint Etienne
Saint-Étienne, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Charlene LEVI, Doctor Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02729142    
Other Study ID Numbers: 69HCL14_0223
2015-A00510-49 ( Other Identifier: IDRCB )
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020
Keywords provided by Hospices Civils de Lyon:
HRpQCT
transplant
bone microarchitecture