Female With Osteoporosis and Chronic Kidney DiseasePhase 4HDENONCT02792413
Study Evaluating Denosumab on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease
A Phase 4 study testing Denosumab in people with Female With Osteoporosis and Chronic Kidney Disease, run by University Hospital, Montpellier at 9 sites in France.
Trial summary
Aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease females the effect of denosumab: 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… Read more about this study
- Who is it for?
- Ages 65 to 95 years, women only
- Conditions the study is for
- Female With Osteoporosis and Chronic Kidney Disease
- What is being tested?
- Denosumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 9 sitesFrance
- Study dates
- 19 Nov 2018to 10 Dec 2020
- Phase
- Phase 4
- 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 65 to 95 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Patient of 65 years or older
- Chronic kidney disease stage 5 patient, hemodialyzed with extracorporeal treatment for at least 3 months
- Patient with osteoporosis (history of bone fracture or T-scoring < -2.5 SD)
- PTH levels in the serum in agreement with the KDIGO guidelines, in the absence of treatment with Cinacalcet.
Who cannot join
- Cinacalcet treatment
- Calcium parameters (PTH, 25(OH) vitamin D3, Calcium) outside the KDIGO guidelines
- Suspicion of lower bone remodeling
- Hypersensibility to active substance or one of excipients of denosumab
- Patient with a cancer or myeloma
- Patient with severe heaptic cytolysis
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- Patients with severe teeth problems
- Patient positive for HIV
- Patient involved in another biomedical research
- Vulnerable patients (protected by the law, under guardianship, deprived of freedom)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Clinique Médipole Cabestany
Cabestany
CHL Castelnau Le Lez
Castelnau-le-Lez
CHU Lyon Sud, Nephrology department
Lyon
AP-HM, Nephrology department
Marseille
AIDER
Montpellier
CHU Montpellier, Nephrology department
Montpellier
CHU Nice, Nephrology department
Nice
CHU Nimes, Nephrology department
Nîmes
CH Perpignan, Nephrology department
Perpignan
About this study
Official title: Randomized Controlled Study Evaluating the Effect of a Biotherapy Treatment (Anti-RANKL Ligand Antibody: Denosumab) on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease
Aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease females the effect of denosumab:
- 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 coronary and abdominal aorta calcification scores evolution after 24 months of follow-up
- on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) 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 old osteoporotic chronic kidney disease females the effect of denosumab:
- 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 coronary and abdominal aorta calcification scores evolution (by multiple detector computed tomography and plain abdominal X-ray) after 24 months of follow-up
- on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) 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
- Being tested
- Denosumab, NaCl (placebo)
- Keywords
- osteoporosis, chronic kidney disease, anti-RANK ligand antibody, bone mineral density, vascular calcifications
- Medical subject headings
- Renal Insufficiency, Chronic, Osteoporosis, Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Patients will receive a subcutaneous injection of Denosumab every 6 months for the duration of the study. In addition, they will receive vitamin D and calcium (which is the normal treatment) for the duration of the study.
NaCl (placebo)Drug
Patients will receive a subcutaneous injection of NaCl every 6 months for the duration of the study. In addition, they will receive vitamin D and calcium (which is the normal treatment) for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Denosumab | Experimental | Denosumab 60 mg, subcutaneous injection every 6 months for 24 months Receives: Drug: Denosumab |
| Placebo | Placebo comparator | NaCl 0.9% (1 mL), subcutaneous injection every 6 months for 24 months Receives: Drug: NaCl (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)
Measured: 24 months after inclusion
Secondary outcomes (7)
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 coronary calcification scores after 24 months of follow-up
Measured: 24 months after inclusion
Relative variation of abdominal aorta calcification scores after 24 months of follow-up
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
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 posted7 Jun 2016 (estimated)
- Study start19 Nov 2018
- Primary completion10 Dec 2020
- Study completion10 Dec 2020
Why it stopped: Modified study and new deposit in RECHMPL21\_0451
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 Female With Osteoporosis and Chronic Kidney DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul CRISTOL, Prof, Principal investigator, CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792413
- Sponsor's protocol ID
- RECHMPL15_0496
- Other IDs
- UF 9676
- Acronym
- HDENO
- Status last verified
- Apr 2022
- First submitted
- 2 Jun 2016
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013424. doi: 10.1002/14651858.CD013424.pub2.
PubMed 34231877
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study Evaluating the Effect of a Biotherapy Treatment (Anti-RANKL Ligand Antibody: Denosumab) on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02792413
- Acronym / sponsor ID
- HDENO / RECHMPL15_0496
- Keywords
- osteoporosis, chronic kidney disease, anti-RANK ligand antibody, bone mineral density, vascular calcifications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Modified study and new deposit in RECHMPL21\_0451
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 7 Jun 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.
Aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease females the effect of denosumab:
- 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 coronary and abdominal aorta calcification scores evolution after 24 months of follow-up
- on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) 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 old osteoporotic chronic kidney disease females the effect of denosumab:
- 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 coronary and abdominal aorta calcification scores evolution (by multiple detector computed tomography and plain abdominal X-ray) after 24 months of follow-up
- on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab | Experimental | Drug: DenosumabDenosumab 60 mg, subcutaneous injection every 6 months for 24 months |
| Placebo | Placebo comparator | Drug: NaCl (placebo)NaCl 0.9% (1 mL), subcutaneous injection every 6 months for 24 months |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patient of 65 years or older
- Chronic kidney disease stage 5 patient, hemodialyzed with extracorporeal treatment for at least 3 months
- Patient with osteoporosis (history of bone fracture or T-scoring < -2.5 SD)
- PTH levels in the serum in agreement with the KDIGO guidelines, in the absence of treatment with Cinacalcet.
Key exclusion criteria (10 listed)
- Cinacalcet treatment
- Calcium parameters (PTH, 25(OH) vitamin D3, Calcium) outside the KDIGO guidelines
- Suspicion of lower bone remodeling
- Hypersensibility to active substance or one of excipients of denosumab
- Patient with a 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 |
|---|---|---|
| DenosumabPatients will receive a subcutaneous injection of Denosumab every 6 months for the duration of the study. In addition, they will receive vitamin D and calcium (which is the normal treatment) for the duration of the study. | Drug | Denosumab |
| NaCl (placebo)Patients will receive a subcutaneous injection of NaCl every 6 months for the duration of the study. In addition, they will receive vitamin D and calcium (which is the normal treatment) for the duration of the study. | Drug | Placebo |
Primary outcome
Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)
Time frame: 24 months after inclusion
7 secondary outcomes
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 coronary calcification scores after 24 months of follow-up
Time frame: 24 months after inclusion
Relative variation of abdominal aorta calcification scores after 24 months of follow-up
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
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
The study was stopped early (reason given: Modified study and new deposit in RECHMPL21\_0451). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Derived from this study: PubMed 34231877Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013424. doi: 10.1002/14651858.CD013424.pub2.
- Individual participant dataSharing planned: No
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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.
Jean-Paul CRISTOL, Prof principal investigator
CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Denosumab in people with Female With Osteoporosis and Chronic Kidney Disease, run by University Hospital, Montpellier at 9 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Modified study and new deposit in RECHMPL21\_0451). Results are not available in the source record.
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?
Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry) (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?
On the ClinicalTrials.gov record for NCT02792413, 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 9 Aug 2023.