OsteoporosisHDENOBSNCT05234047
Study Evaluating Denosumab on Vascular and Bone Metabolism in Osteoporotic Chronic Kidney Disease (HDENOBS)
An observational study of Osteoporosis and Chronic Kidney Disease 5D, run by University Hospital, Montpellier.
Trial summary
Aim of this study is to evaluate in a population of osteoporotic chronic kidney disease patients the effect of denosumab: on coronary artery calcification scores evolution after 24 months of followup on abdominal aorta calcification scores evolution after 24 months of followup on bone mineral density (femoral T-score)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis, Chronic Kidney Disease 5D
- What is being tested?
- MDCT (multidetector computed tomography) and Dual-energy X-ray absorptiometry
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Feb 2025
- 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: CKD-5D patients with osteoporosis
Who may be able to join
- Chronic kidney disease stage 5D patient, hemodialyzed with extracorporeal treatment for at least 3 months
- Osteoporosis
Who cannot join
- Pregnancy or breastfeeeding female
- Current corticoid treatment
- PTH and Calcium outside the KDIGO guidelines
- Adynamic bone disease suspicion
- Cancer or myeloma
- Serious hepatic cytolysis
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- Serious dental troubles
- Positive HIV serology
- Hypersensibility to active substance or one of excipients of denosumab
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Observational Study Evaluating the Effect of a Biotherapy Treatment (Anti- RANKL Ligand Antibody: Denosumab) on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease Patients
Aim of this study is to evaluate in a population of osteoporotic chronic kidney disease patients the effect of denosumab:
- on coronary artery calcification scores evolution after 24 months of followup
- on abdominal aorta calcification scores evolution after 24 months of followup
- on bone mineral density (femoral T-score) at 24 months
- on bone mineral density evolution (femoral T-score) after 24 months of follow-up
- on bone mineral density evolution (lumbar T-score) after 24 months of follow-up
- on parameters of bone remodelling after 24 months of follow-up
- on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up
- the tolerance after 24 months of follow-up
Read the detailed description
Aim of this study is to evaluate in a population of osteoporotic chronic kidney disease patients the effect of denosumab:
- on coronary calcification scores evolution (by multidetector computed tomography) after 24 months of follow-up
- on abdominal aorta calcification scores evolution (by plain abdominal Xray) after 24 months of follow-up
- on bone mineral density (femoral T-score) (by bone densitometry) at 24 months
- on bone mineral density evolution (femoral T-score) (by bone densitometry) after 24 months of follow-up
- on bone mineral density evolution (lumbar T-score) (by bone densitometry) after 24 months of follow-up
- on parameters of bone remodelling after 24 months of follow-up
- on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up
- the tolerance after 24 months of follow-up
- Conditions
- Osteoporosis, Chronic Kidney Disease 5D
- Being tested
- MDCT (multidetector computed tomography), Dual-energy X-ray absorptiometry
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDCT (multidetector computed tomography)Procedure or surgery
MDCT will be performed at inclusion and after 2 years
Dual-energy X-ray absorptiometryProcedure or surgery
DXA will be performed at inclusion, 1 and 2 years after inclusion
| Study group | Role | What they receive |
|---|---|---|
| CKD-5D patients receiving denosumab | Not described Receives: Procedure: MDCT (multidetector computed tomography); Procedure: Dual-energy X-ray absorptiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative variation of coronary calcification scores after 24 months of follow-up
Measured: 24 months after inclusion
Secondary outcomes (11)
Relative variation of abdominal aorta calcification scores after 24 months of follow-up
Measured: 24 months after inclusion
Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)
Measured: 24 months after inclusion
Relative variation of lumbar bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)
Measured: 24 months after inclusion
Relative variation of radius bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)
Measured: 24 months after inclusion
Relative variation of whole body bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)
Measured: 24 months after inclusion
Variation of calcium at 6, 12, 18 and 24 months of follow-up
Measured: 6, 12, 18 and 24 months after inclusion]
Variation of phosphorus at 6, 12, 18 et 24 months of follow-up
Measured: 6, 12, 18 and 24 months after inclusion
Variation of bone remodeling at 6, 12, 18 et 24 months of follow-up
Measured: 6, 12, 18 and 24 months after inclusion
Variation of inflammation at 6, 12, 18 et 24 months of follow-up
Measured: 6, 12, 18 and 24 months after inclusion
Morbi-mortality at 24 months of follow-up
Measured: 24 months after inclusion]
Adverse events occuring during the entire study
Measured: 24 months after inclusion]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study startMay 2022 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234047
- Sponsor's protocol ID
- RECHMPL21_0451
- Acronym
- HDENOBS
- Status last verified
- Apr 2022
- First submitted
- 31 Jan 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Evaluating the Effect of a Biotherapy Treatment (Anti- RANKL Ligand Antibody: Denosumab) on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT05234047
- Acronym / sponsor ID
- HDENOBS / RECHMPL21_0451
- Conditions
- Osteoporosis, Chronic Kidney Disease 5D
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 10 Feb 2022 (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.
Aim of this study is to evaluate in a population of osteoporotic chronic kidney disease patients the effect of denosumab:
- on coronary artery calcification scores evolution after 24 months of followup
- on abdominal aorta calcification scores evolution after 24 months of followup
- on bone mineral density (femoral T-score) at 24 months
- on bone mineral density evolution (femoral T-score) after 24 months of follow-up
- on bone mineral density evolution (lumbar T-score) after 24 months of follow-up
- on parameters of bone remodelling after 24 months of follow-up
- on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up
- the tolerance after 24 months of follow-up
Detailed description
Aim of this study is to evaluate in a population of osteoporotic chronic kidney disease patients the effect of denosumab:
- on coronary calcification scores evolution (by multidetector computed tomography) after 24 months of follow-up
- on abdominal aorta calcification scores evolution (by plain abdominal Xray) after 24 months of follow-up
- on bone mineral density (femoral T-score) (by bone densitometry) at 24 months
- on bone mineral density evolution (femoral T-score) (by bone densitometry) after 24 months of follow-up
- on bone mineral density evolution (lumbar T-score) (by bone densitometry) after 24 months of follow-up
- on parameters of bone remodelling after 24 months of follow-up
- on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up
- the tolerance after 24 months of follow-up
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CKD-5D patients receiving denosumab | – | Procedure: MDCT (multidetector computed tomography), Procedure: Dual-energy X-ray absorptiometry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CKD-5D patients with osteoporosis
Key inclusion criteria (2 listed)
- Chronic kidney disease stage 5D patient, hemodialyzed with extracorporeal treatment for at least 3 months
- Osteoporosis
Key exclusion criteria (9 listed)
- Pregnancy or breastfeeeding female
- Current corticoid treatment
- PTH and Calcium outside the KDIGO guidelines
- Adynamic bone disease suspicion
- Cancer or myeloma
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 |
|---|---|---|
| MDCT (multidetector computed tomography)MDCT will be performed at inclusion and after 2 years | Procedure or surgery | CKD-5D patients receiving denosumab |
| Dual-energy X-ray absorptiometryDXA will be performed at inclusion, 1 and 2 years after inclusion | Procedure or surgery | CKD-5D patients receiving denosumab |
Primary outcome
Relative variation of coronary calcification scores after 24 months of follow-up
Time frame: 24 months after inclusion
11 secondary outcomes
Relative variation of abdominal aorta calcification scores after 24 months of follow-up
Time frame: 24 months after inclusion
Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)
Time frame: 24 months after inclusion
Relative variation of lumbar bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)
Time frame: 24 months after inclusion
Relative variation of radius bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)
Time frame: 24 months after inclusion
Relative variation of whole body bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)
Time frame: 24 months after inclusion
Variation of calcium at 6, 12, 18 and 24 months of follow-up
Time frame: 6, 12, 18 and 24 months after inclusion]
Variation of phosphorus at 6, 12, 18 et 24 months of follow-up
Time frame: 6, 12, 18 and 24 months after inclusion
Variation of bone remodeling at 6, 12, 18 et 24 months of follow-up
Time frame: 6, 12, 18 and 24 months after inclusion
Variation of inflammation at 6, 12, 18 et 24 months of follow-up
Time frame: 6, 12, 18 and 24 months after inclusion
Morbi-mortality at 24 months of follow-up
Time frame: 24 months after inclusion]
Adverse events occuring during the entire study
Time frame: 24 months after inclusion]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Chronic Kidney Disease 5D, run by University Hospital, Montpellier.
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 9 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: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Paul CRISTOL, MD, PhD (+33 467 338315, jp-cristol@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative variation of coronary calcification scores after 24 months of follow-up (time frame: 24 months after inclusion). 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 14 Apr 2022.