Organ TransplantTRANSOSNCT02729142
Bone Microarchitecture in the Transplant Patient
A study testing Tibial cortical density evaluation in people with Organ Transplant, run by Hospices Civils de Lyon at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Organ Transplant
- What is being tested?
- Tibial cortical density evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 3 sitesFrance
- Study dates
- 7 Jun 2016to 8 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- No health cover
- Ongoing pregnancy
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Femme Mère Enfant
Bron
Hopital Edouard Herriot
Lyon
CHU Saint Etienne
Saint-Etienne
About this study
Official title: Longitudinal Monitoring of Bone Microarchitecture by High Resolution Peripheral Quantitative Computed Tomography of (HR-pQCT) 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.
Read more
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.
- Conditions
- Organ Transplant
- Being tested
- Tibial cortical density evaluation
- Keywords
- HRpQCT, transplant, bone microarchitecture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tibial cortical density evaluationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Tibial cortical density evaluation | Experimental | Not described Receives: Procedure: Tibial cortical density evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tibial cortical density measured by HR-pQCT
Measured: at 6 months
Secondary outcomes (25)
trabecular bone area measured by HR-pQCT
Measured: at 6 months
total bone area measured by HR-pQCT
Measured: at 6 months
trabecular number measured by HR-pQCT
Measured: at 6 months
trabecular thickness measured by HR-pQCT
Measured: at 6 months
trabecular separation measured by HR-pQCT
Measured: at 6 months
cortical perimeter measured by HR-pQCT
Measured: at 6 months
Evaluation of bone markers by measuring calcium
Measured: at 6 months
Evaluation of bone markers by measuring phosphate
Measured: at 6 months
Evaluation of bone markers by measuring alkaline reserve
Measured: at 6 months
Evaluation of bone markers by measuring PTH
Measured: at 6 months
Evaluation of bone markers by measuring 25OHD3
Measured: at 6 months
Evaluation of bone markers by measuring 1-25 OHD3
Measured: at 6 months
Evaluation of bone markers by measuring FGF23
Measured: at 6 months
Evaluation of bone markers by measuring CTX
Measured: at 6 months
Evaluation of bone markers by measuring total alkaline phosphatase
Measured: at 6 months
Evaluation of bone markers by measuring bone alkaline phosphatase
Measured: at 6 months
Evaluation of bone markers by measuring osteocalcin
Measured: at 6 months
Bone mineral density assessed by DXA
Measured: at 6 months
Fractures onset assessed by DXA
Measured: at 6 months
Cardiovascular events (death from cardiovascular cause, heart attack, stroke)
Measured: at 6 months
PTH
For kidney transplant only
Measured: Baseline
1-25 OHD
For kidney transplant only
Measured: Baseline
FGF 23
For kidney transplant only
Measured: Baseline
calcium
For kidney transplant only
Measured: Baseline
phosphate
For kidney transplant only
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study start7 Jun 2016
- Primary completion8 Oct 2020
- Study completion8 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Organ TransplantStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlene LEVI, Doctor, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729142
- Sponsor's protocol ID
- 69HCL14_0223
- Other IDs
- 2015-A00510-49
- Acronym
- TRANSOS
- Status last verified
- Nov 2020
- First submitted
- 25 Mar 2016
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
De Mul A, Leclerc AS, Ginhoux T, Levi C, Confavreux C, Aurelle M, Portefaix A, Bacchetta J. Changes in bone density and microarchitecture in adolescents undergoing a first kidney transplantation: a prospective study. Eur J Pediatr. 2024 Dec;183(12):5303-5312. doi: 10.1007/s00431-024-05777-z. Epub 2024 Oct 9.
PubMed 39384649
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Monitoring of Bone Microarchitecture by High Resolution Peripheral Quantitative Computed Tomography of (HR-pQCT) in the Transplant Patient
- ClinicalTrials.gov ID
- NCT02729142
- Acronym / sponsor ID
- TRANSOS / 69HCL14_0223
- Conditions
- Organ Transplant
- Keywords
- HRpQCT, transplant, bone microarchitecture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 7 Jun 2016 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tibial cortical density evaluation | Experimental | Procedure: Tibial cortical density evaluation |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- No health cover
- Ongoing pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tibial cortical density evaluationBone 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. | Procedure or surgery | Tibial cortical density evaluation |
Primary outcome
Tibial cortical density measured by HR-pQCT
Time frame: at 6 months
25 secondary outcomes
trabecular bone area measured by HR-pQCT
Time frame: at 6 months
total bone area measured by HR-pQCT
Time frame: at 6 months
trabecular number measured by HR-pQCT
Time frame: at 6 months
trabecular thickness measured by HR-pQCT
Time frame: at 6 months
trabecular separation measured by HR-pQCT
Time frame: at 6 months
cortical perimeter measured by HR-pQCT
Time frame: at 6 months
Evaluation of bone markers by measuring calcium
Time frame: at 6 months
Evaluation of bone markers by measuring phosphate
Time frame: at 6 months
Evaluation of bone markers by measuring alkaline reserve
Time frame: at 6 months
Evaluation of bone markers by measuring PTH
Time frame: at 6 months
Evaluation of bone markers by measuring 25OHD3
Time frame: at 6 months
Evaluation of bone markers by measuring 1-25 OHD3
Time frame: at 6 months
Evaluation of bone markers by measuring FGF23
Time frame: at 6 months
Evaluation of bone markers by measuring CTX
Time frame: at 6 months
Evaluation of bone markers by measuring total alkaline phosphatase
Time frame: at 6 months
Evaluation of bone markers by measuring bone alkaline phosphatase
Time frame: at 6 months
Evaluation of bone markers by measuring osteocalcin
Time frame: at 6 months
Bone mineral density assessed by DXA
Time frame: at 6 months
Fractures onset assessed by DXA
Time frame: at 6 months
Cardiovascular events (death from cardiovascular cause, heart attack, stroke)
Time frame: at 6 months
PTH
Time frame: Baseline
1-25 OHD
Time frame: Baseline
FGF 23
Time frame: Baseline
calcium
Time frame: Baseline
phosphate
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Results publication: PubMed 39384649De Mul A, Leclerc AS, Ginhoux T, Levi C, Confavreux C, Aurelle M, Portefaix A, Bacchetta J. Changes in bone density and microarchitecture in adolescents undergoing a first kidney transplantation: a prospective study. Eur J Pediatr. 2024 Dec;183(12):5303-5312. doi: 10.1007/s00431-024-05777-z. Epub 2024 Oct 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlene LEVI, Doctor principal investigator
Hospices Civils de Lyon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tibial cortical density evaluation in people with Organ Transplant, run by Hospices Civils de Lyon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tibial cortical density measured by HR-pQCT (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02729142, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.