Chronic Kidney DiseasesTRANSBONENCT02523209
Analysis of Bone Microarchitecture With HR-pQCT of Patients With Chronic Kidney Disease (CKD) Candidates for Renal Transplantation
An observational study of Chronic Kidney Diseases and Hyperparathyroidism, Secondary, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
While the duration of renal transplant function has increased over the last decade kidney transplanted patients (KTP) still exhibit a fracture risk 4 times higher than in the general population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Hyperparathyroidism, Secondary
- What is being tested?
- HR-pQCT and DEXA
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Apr 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with end stage renal disease
Who may be able to join
- Serum parathyroidal Hormon (PTH ) > 65pg/ml
- Stage 5 or 5D Chronic Kidney Disease patients
- Patient registered (or on the verge of being registered) on the KT waiting list at St-Etienne Hospital, France
- Written consent of patient
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Bone Microarchitecture With HR-pQCT of Patients With Chronic Kidney Disease (CKD) Candidates for Renal Transplantation - A Monocentric Study
While the duration of renal transplant function has increased over the last decade kidney transplanted patients (KTP) still exhibit a fracture risk 4 times higher than in the general population. Fracture risk remains increased despite the improvement of immunosuppressive therapies (IST) that allowed the reduction of steroid administration. Potential explanations for this could be 1) that Chronic Kidney Disease (CKD) induces renal osteodystrophy that occurs before kidney transplanted, impairs bone metabolism and promotes bone fragility ; 2) that kidney transplanted patients are older and older (14% of kidney transplanted patients were older than 70 in 2011 in France), ageing being a major risk factor for fractures 3) IST, besides steroid, may have deleterious effects on bone and 4) that secondary hyperparathyroidism, a risk factor of fractures, persists after kidney transplanted . Thus, the pathophysiology and epidemiology of bone fragility of kidney transplanted patient remains insufficiently characterized. Despite these data, and contrarily to what is done for patients candidates for cardiac transplantation, there is no general consensus for performing bone evaluation before kidney transplanted . Thus it's necessary to individualize the management of bone fragility and prevent fractures according to strategies that remain to be defined, provided that patients at risk are better detected.
Read the detailed description
Bone fragility is determined by quantitative parameters (bone mass) and qualitative parameters including macro- and micro-architecture (especially cortical porosity and thickness). The Dual Energy X-ray Absorptiometry (DEXA ) measurement of Bone Mineral Density (BMD) is a robust predictor of fracture risk in the non-uremic population. Micro and macro-architecture can be measured with High Resolution peripheral micro Computerized Tomography (HRpQCT) at the ankle and the wrist . Some recent studies suggested that HRpQCT could be a better fracture predictor than DEXA in uremic populations. In this context, the aim of our project is to describe in a cross sectional study the bone status of CKD patients, candidates for kidney transplanted . It will be 1) calculated the prevalence of cortical osteoporosis as assessed by cortical thickness at the ankle and the wrist (primary end point), 2) analyzed other HRpQCT microarchitecture quantitative parameters and 3) defined the biological and clinical factors associated with bone degradation (secondary endpoints). This population will be compared to age and sex matched normal subjects (collaboration with Pr Rizzoli, Geneva, Switzerland). The DEXA and HRpQCT will be compared for detection of patients at risk for fracture.
- Being tested
- HR-pQCT, DEXA
- Keywords
- Osteoporosis, chronic kidney disease, kidney transplantation, fracture risk
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperparathyroidism, Secondary, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR-pQCTDevice
HR-pQCT (High Resolution peripheral micro Computerized Tomography) is a device used for 3D bone measurements at the tibia and the radius levels in humans.
DEXADevice
The Lunar DEXA (Dual Energy X-ray Absorptiometry) is a third generation multi-captor DEXA (Dual Energy X-ray Absorptiometry) device that allows short duration measurements ( <15 min). It measures Bone Mineral Density at the spine (L1-L4) and the femoral neck
| Study group | Role | What they receive |
|---|---|---|
| Bone quality and quantity | measure of bone quality and quantity parameters by HRpQCT and by DEXA Receives: Device: HR-pQCT; Device: DEXA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with cortical osteoporosis
A Cortical osteoporosis is a composite outcome measured with two devices : HR-pQCT and DEXA parameters measured with HR-pQCT on ankle (tibia) and wrist (radius) are : Cortical thickness (mm). Parameters measured with DEXA on spine and femoral neck are : Bone Mineral Density (BMD, g/cm2)
Measured: Day1
Secondary outcomes (1)
clinical and biological factors associated with bone degradation
clinical and biological factors are a composite outcome : Clinical parameters measured are : dialysis vintage, age, transplantation history , sex, Immunosuppressive Therapies, steroid dose, parathyroidectomy history, Biological parameters measured are Calcium, Phosphorus, Parathormone, bicarbonates, albumin, Bone alkaline phosphatase.
Bone degradation is a composite measure : parameters measured with HR-pQCT on ankle (tibia) and wrist (radius) are :
Cortical thickness (mm), Total mineral volumetric density (mg/ccm HA), trabecular mineral volumetric density (mg/ccm HA), Cortical mineral volumetric density (mg/ccm HA), Trabecular Number (1/mm), Trabecular thickness (mm), Trabecular Separation (mm), Mean distance between trabecular (mm) Parameters measured with DEXA on spine and femoral neck are : Bone Mineral Density (BMD, g/cm2), T-Score, Z-Score, Trabecular bone score (TBS).
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startSep 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Hélène LAFAGE-PROUST, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523209
- Sponsor's protocol ID
- 1408080
- Acronym
- TRANSBONE
- Status last verified
- May 2017
- First submitted
- 15 Jul 2015
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Bone Microarchitecture With HR-pQCT of Patients With Chronic Kidney Disease (CKD) Candidates for Renal Transplantation - A Monocentric Study
- ClinicalTrials.gov ID
- NCT02523209
- Acronym / sponsor ID
- TRANSBONE / 1408080
- Keywords
- Osteoporosis, chronic kidney disease, kidney transplantation, fracture risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 14 Aug 2015 (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.
While the duration of renal transplant function has increased over the last decade kidney transplanted patients (KTP) still exhibit a fracture risk 4 times higher than in the general population. Fracture risk remains increased despite the improvement of immunosuppressive therapies (IST) that allowed the reduction of steroid administration. Potential explanations for this could be 1) that Chronic Kidney Disease (CKD) induces renal osteodystrophy that occurs before kidney transplanted, impairs bone metabolism and promotes bone fragility ; 2) that kidney transplanted patients are older and older (14% of kidney transplanted patients were older than 70 in 2011 in France), ageing being a major risk factor for fractures 3) IST, besides steroid, may have deleterious effects on bone and 4) that secondary hyperparathyroidism, a risk factor of fractures, persists after kidney transplanted . Thus, the pathophysiology and epidemiology of bone fragility of kidney transplanted patient remains insufficiently characterized. Despite these data, and contrarily to what is done for patients candidates for cardiac transplantation, there is no general consensus for performing bone evaluation before kidney transplanted . Thus it's necessary to individualize the management of bone fragility and prevent fractures according to strategies that remain to be defined, provided that patients at risk are better detected.
Detailed description
Bone fragility is determined by quantitative parameters (bone mass) and qualitative parameters including macro- and micro-architecture (especially cortical porosity and thickness). The Dual Energy X-ray Absorptiometry (DEXA ) measurement of Bone Mineral Density (BMD) is a robust predictor of fracture risk in the non-uremic population. Micro and macro-architecture can be measured with High Resolution peripheral micro Computerized Tomography (HRpQCT) at the ankle and the wrist . Some recent studies suggested that HRpQCT could be a better fracture predictor than DEXA in uremic populations. In this context, the aim of our project is to describe in a cross sectional study the bone status of CKD patients, candidates for kidney transplanted . It will be 1) calculated the prevalence of cortical osteoporosis as assessed by cortical thickness at the ankle and the wrist (primary end point), 2) analyzed other HRpQCT microarchitecture quantitative parameters and 3) defined the biological and clinical factors associated with bone degradation (secondary endpoints). This population will be compared to age and sex matched normal subjects (collaboration with Pr Rizzoli, Geneva, Switzerland). The DEXA and HRpQCT will be compared for detection of patients at risk for fracture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone quality and quantity | – | Device: HR-pQCT, Device: DEXAmeasure of bone quality and quantity parameters by HRpQCT and by DEXA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with end stage renal disease
Key inclusion criteria (4 listed)
- Serum parathyroidal Hormon (PTH ) > 65pg/ml
- Stage 5 or 5D Chronic Kidney Disease patients
- Patient registered (or on the verge of being registered) on the KT waiting list at St-Etienne Hospital, France
- Written consent of patient
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| HR-pQCTHR-pQCT (High Resolution peripheral micro Computerized Tomography) is a device used for 3D bone measurements at the tibia and the radius levels in humans. | Device | Bone quality and quantity |
| DEXAThe Lunar DEXA (Dual Energy X-ray Absorptiometry) is a third generation multi-captor DEXA (Dual Energy X-ray Absorptiometry) device that allows short duration measurements ( <15 min). It measures Bone Mineral Density at the spine (L1-L4) and the femoral neck | Device | Bone quality and quantity |
Primary outcome
Number of patients with cortical osteoporosis
Time frame: Day1
A Cortical osteoporosis is a composite outcome measured with two devices : HR-pQCT and DEXA parameters measured with HR-pQCT on ankle (tibia) and wrist (radius) are : Cortical thickness (mm). Parameters measured with DEXA on spine and femoral neck are : Bone Mineral Density (BMD, g/cm2)
1 secondary outcome
clinical and biological factors associated with bone degradation
Time frame: day 1
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 31 May 2017.
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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.
Marie-Hélène LAFAGE-PROUST, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Hyperparathyroidism, Secondary, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site 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 4 inclusion and 1 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 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of patients with cortical osteoporosis (time frame: Day1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2017.