Chronic Renal FailureTRIFIRNCT03356522
Study of Trabecular Bone Score (TBS) as a Fracture Risk Factor in Chronic Renal Failure
An observational study of Chronic Renal Failure and Kidney Transplant Patients, run by Rennes University Hospital at 1 site in France.
Trial summary
Observational study Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Renal Failure, Kidney Transplant Patients
- How many people
- 206 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2016to 30 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Kidney failure patients and kidney transplant patients
Who may be able to join
- 1st population: kidney failure patients at stage 4-5, age> 40 years, non-dialyzed, ungrafted.
- 2nd population: kidney transplant patients, age> 40, first kidney transplant.
Who cannot join
- Pregnant women.
- Incapable adults (tutelage, guardianship, safeguard of justice).
- Persons deprived of liberty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TRIFIR : Study of Trabecular Bone Score (TBS) as a Fracture Risk Factor in Chronic Renal Failure
Observational study
Read the detailed description
The Trabecular Bone Score (TBS) is a recent imaging tool that indirectly studies bone microarchitecture from 2-dimensional images of lumbar biphotonic absorptiometry (DXA). His interest is demonstrated in the evaluation of the fracture risk of the general population. The study of its interest in chronic renal failure is ongoing, only 3 studies have been published to our knowledge.
Osteopathy of chronic renal failure is a complex phenomenon involving bone remodeling disorders, mineralization, mass and bone microarchitecture. In the renal transplant population, certain factors, such as anti-rejection therapy, are also involved.
The impact of fragility fractures induced by these disorders of bone metabolism is a major public health issue due to the resulting morbidity and mortality, with mortality doubling in comparison to the general population after a hip fracture.
The bone osteopathy assessment of chronic renal failure is the bone biopsy, however its realization is very limited because of its invasiveness.
Although initially Bone Densitometry was not recommended in the evaluation of the fracture risk of chronic renal failure by KDIGO (Kidney Disease Improvement Global Outcomes) of 2009, many works published since plead in favor of its realization for the fracture risk assessment, in combination with the clinical data of the Fracture Risk Assessment Tool (FRAX), as should be recommended in the next KDIGO. Indeed, the decrease in bone density in chronic renal failure is associated with an increased risk of fracture.
Clinical parameters, of course, also play an important role in the evaluation of the fracture risk of chronic renal insufficiency, be it the items taken into account in FRAX, certain factors related to chronic kidney disease, or even transplantation. kidney transplant.
To our knowledge, only three studies on the association of TBS with fracture risk of chronic renal failure have been published. In particular, they show a significant association between the decrease in TBS and the incident fracture risk, independently of bone density and FRAX, in a population of kidney transplant recipients, and chronic renal insufficiency in stage 3 or 4.
According to KDIGO 2009, the only biomarkers recommended in the evaluation of osteopathy chronic renal failure are parathyroid hormone (PTH) and bone-specific alkaline phosphatase (BAP), although there is no established threshold for significant increase in fracture risk . However, there is little data on other bone remodeling markers such as the Procollagen type 1 N-terminal propeptide (P1NP) and the C-terminal telopeptide of type 1 collagen (CTX). Some studies indicate, however, that they may be of interest in evaluation of osteopathy of chronic renal failure .
- Conditions
- Chronic Renal Failure, Kidney Transplant Patients
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of Trabecular Bone Score (TBS)
Measured: Baseline
Secondary outcomes (4)
Evaluation of bone remodeling markers
Biological markers: parathyroid hormone (PTH)
Measured: Baseline
Evaluation of bone remodeling markers
Biological markers: Bone-specific Alkaline Phosphatase (BAP)
Measured: Baseline
Evaluation of bone remodeling markers
Biological markers: Procollagen type 1 N-terminal propeptide (P1NP)
Measured: Baseline
Evaluation of bone remodeling markers
Biological markers: C-terminal telopeptide of type I collagen (CTX)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start1 Feb 2016
- Primary completion30 Apr 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal Guggenbuhl, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356522
- Sponsor's protocol ID
- 35RC16_3029_TRIFIR
- Acronym
- TRIFIR
- Status last verified
- Nov 2017
- First submitted
- 16 Nov 2017
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRIFIR : Study of Trabecular Bone Score (TBS) as a Fracture Risk Factor in Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT03356522
- Acronym / sponsor ID
- TRIFIR / 35RC16_3029_TRIFIR
- Conditions
- Chronic Renal Failure, Kidney Transplant Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 29 Nov 2017 (actual)
- 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.
Observational study
Detailed description
The Trabecular Bone Score (TBS) is a recent imaging tool that indirectly studies bone microarchitecture from 2-dimensional images of lumbar biphotonic absorptiometry (DXA). His interest is demonstrated in the evaluation of the fracture risk of the general population. The study of its interest in chronic renal failure is ongoing, only 3 studies have been published to our knowledge.
Osteopathy of chronic renal failure is a complex phenomenon involving bone remodeling disorders, mineralization, mass and bone microarchitecture. In the renal transplant population, certain factors, such as anti-rejection therapy, are also involved.
The impact of fragility fractures induced by these disorders of bone metabolism is a major public health issue due to the resulting morbidity and mortality, with mortality doubling in comparison to the general population after a hip fracture.
The bone osteopathy assessment of chronic renal failure is the bone biopsy, however its realization is very limited because of its invasiveness.
Although initially Bone Densitometry was not recommended in the evaluation of the fracture risk of chronic renal failure by KDIGO (Kidney Disease Improvement Global Outcomes) of 2009, many works published since plead in favor of its realization for the fracture risk assessment, in combination with the clinical data of the Fracture Risk Assessment Tool (FRAX), as should be recommended in the next KDIGO. Indeed, the decrease in bone density in chronic renal failure is associated with an increased risk of fracture.
Clinical parameters, of course, also play an important role in the evaluation of the fracture risk of chronic renal insufficiency, be it the items taken into account in FRAX, certain factors related to chronic kidney disease, or even transplantation. kidney transplant.
To our knowledge, only three studies on the association of TBS with fracture risk of chronic renal failure have been published. In particular, they show a significant association between the decrease in TBS and the incident fracture risk, independently of bone density and FRAX, in a population of kidney transplant recipients, and chronic renal insufficiency in stage 3 or 4.
According to KDIGO 2009, the only biomarkers recommended in the evaluation of osteopathy chronic renal failure are parathyroid hormone (PTH) and bone-specific alkaline phosphatase (BAP), although there is no established threshold for significant increase in fracture risk . However, there is little data on other bone remodeling markers such as the Procollagen type 1 N-terminal propeptide (P1NP) and the C-terminal telopeptide of type 1 collagen (CTX). Some studies indicate, however, that they may be of interest in evaluation of osteopathy of chronic renal failure .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney failure patients and kidney transplant patients
Key inclusion criteria (2 listed)
- 1st population: kidney failure patients at stage 4-5, age> 40 years, non-dialyzed, ungrafted.
- 2nd population: kidney transplant patients, age> 40, first kidney transplant.
Key exclusion criteria (3 listed)
- Pregnant women.
- Incapable adults (tutelage, guardianship, safeguard of justice).
- Persons deprived of liberty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Value of Trabecular Bone Score (TBS)
Time frame: Baseline
4 secondary outcomes
Evaluation of bone remodeling markers
Time frame: Baseline
Evaluation of bone remodeling markers
Time frame: Baseline
Evaluation of bone remodeling markers
Time frame: Baseline
Evaluation of bone remodeling markers
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 29 Nov 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.
Pascal Guggenbuhl principal investigator
Rennes University Hospital
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 Renal Failure and Kidney Transplant Patients, run by Rennes University Hospital 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 2 inclusion and 3 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 29 Nov 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?
Value of Trabecular Bone Score (TBS) (time frame: Baseline). 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 29 Nov 2017.