Study Evaluating Denosumab on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease (HDENO)

August 8, 2023 updated by: University Hospital, Montpellier

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Cabestany, France
        • Clinique Médipole Cabestany
      • Castelnau-le-Lez, France
        • CHL Castelnau Le Lez
      • Lyon, France
        • CHU Lyon Sud, Nephrology department
      • Marseille, France
        • AP-HM, Nephrology department
      • Montpellier, France
        • AIDER
      • Montpellier, France
        • CHU Montpellier, Nephrology department
      • Nice, France
        • CHU Nice, Nephrology department
      • Nimes, France
        • CHU Nimes, Nephrology department
      • Perpignan, France
        • CH Perpignan, Nephrology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

61 years to 91 years (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Denosumab
Denosumab 60 mg, subcutaneous injection every 6 months for 24 months
Drug: Denosumab
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.
Placebo Comparator: Placebo
NaCl 0.9% (1 mL), subcutaneous injection every 6 months for 24 months
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)
Time Frame: 24 months after inclusion
24 months after inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Relative variation of lumbar bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)
Time Frame: 24 months after inclusion
24 months after inclusion
Relative variation of coronary calcification scores after 24 months of follow-up
Time Frame: 24 months after inclusion
24 months after inclusion
Relative variation of abdominal aorta calcification scores after 24 months of follow-up
Time Frame: 24 months after inclusion
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
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
6, 12, 18 and 24 months after inclusion
Morbi-mortality at 24 months of follow-up
Time Frame: 24 months after inclusion
24 months after inclusion
Adverse events occuring during the entire study
Time Frame: 24 months after inclusion
24 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean-Paul CRISTOL, Prof, CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECHMPL15_0496
  • UF 9676 (Other Identifier: Montpellier University Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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