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

Primary Purpose

Female With Osteoporosis and Chronic Kidney Disease

Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Denosumab
NaCl (placebo)
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female With Osteoporosis and Chronic Kidney Disease focused on measuring osteoporosis, chronic kidney disease, anti-RANK ligand antibody, bone mineral density, vascular calcifications

Eligibility Criteria

65 Years - 95 Years (Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Denosumab

Placebo

Arm Description

Denosumab 60 mg, subcutaneous injection every 6 months for 24 months

NaCl 0.9% (1 mL), subcutaneous injection every 6 months for 24 months

Outcomes

Primary Outcome Measures

Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)

Secondary Outcome Measures

Relative variation of lumbar bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)
Relative variation of coronary calcification scores after 24 months of follow-up
Relative variation of abdominal aorta calcification scores after 24 months of follow-up
Variation of calcium at 6, 12, 18 and 24 months of follow-up
Variation of phosphorus at 6, 12, 18 et 24 months of follow-up
Morbi-mortality at 24 months of follow-up
Adverse events occuring during the entire study

Full Information

First Posted
June 2, 2016
Last Updated
August 8, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02792413
Brief Title
Study Evaluating Denosumab on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease
Acronym
HDENO
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Modified study and new deposit in RECHMPL21_0451
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
December 10, 2020 (Actual)
Study Completion Date
December 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female With Osteoporosis and Chronic Kidney Disease
Keywords
osteoporosis, chronic kidney disease, anti-RANK ligand antibody, bone mineral density, vascular calcifications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Denosumab
Arm Type
Experimental
Arm Description
Denosumab 60 mg, subcutaneous injection every 6 months for 24 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
NaCl 0.9% (1 mL), subcutaneous injection every 6 months for 24 months
Intervention Type
Drug
Intervention Name(s)
Denosumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
NaCl (placebo)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)
Time Frame
24 months after inclusion
Secondary Outcome Measure Information:
Title
Relative variation of lumbar bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)
Time Frame
24 months after inclusion
Title
Relative variation of coronary calcification scores after 24 months of follow-up
Time Frame
24 months after inclusion
Title
Relative variation of abdominal aorta calcification scores after 24 months of follow-up
Time Frame
24 months after inclusion
Title
Variation of calcium at 6, 12, 18 and 24 months of follow-up
Time Frame
6, 12, 18 and 24 months after inclusion
Title
Variation of phosphorus at 6, 12, 18 et 24 months of follow-up
Time Frame
6, 12, 18 and 24 months after inclusion
Title
Morbi-mortality at 24 months of follow-up
Time Frame
24 months after inclusion
Title
Adverse events occuring during the entire study
Time Frame
24 months after inclusion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Paul CRISTOL, Prof
Organizational Affiliation
CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Médipole Cabestany
City
Cabestany
Country
France
Facility Name
CHL Castelnau Le Lez
City
Castelnau-le-Lez
Country
France
Facility Name
CHU Lyon Sud, Nephrology department
City
Lyon
Country
France
Facility Name
AP-HM, Nephrology department
City
Marseille
Country
France
Facility Name
AIDER
City
Montpellier
Country
France
Facility Name
CHU Montpellier, Nephrology department
City
Montpellier
Country
France
Facility Name
CHU Nice, Nephrology department
City
Nice
Country
France
Facility Name
CHU Nimes, Nephrology department
City
Nimes
Country
France
Facility Name
CH Perpignan, Nephrology department
City
Perpignan
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34231877
Citation
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.
Results Reference
derived

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

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