Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02792413
Recruitment Status : Unknown
Verified June 2016 by University Hospital, Montpellier.
Recruitment status was:  Not yet recruiting
First Posted : June 7, 2016
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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

Condition or disease Intervention/treatment Phase
Female With Osteoporosis and Chronic Kidney Disease Drug: Denosumab Drug: NaCl (placebo) Phase 4

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : September 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab

Arm Intervention/treatment
Experimental: Denosumab
Denosumab 60 mg, subcutaneous injection every 6 months for 24 months
Drug: Denosumab
Placebo Comparator: Placebo
NaCl 0.9% (1 mL), subcutaneous injection every 6 months for 24 months
Drug: NaCl (placebo)



Primary Outcome Measures :
  1. 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 Measures :
  1. Relative variation of lumbar bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry) [ Time Frame: 24 months after inclusion ]
  2. Relative variation of coronary calcification scores after 24 months of follow-up [ Time Frame: 24 months after inclusion ]
  3. Relative variation of abdominal aorta calcification scores after 24 months of follow-up [ Time Frame: 24 months after inclusion ]
  4. Variation of calcium at 6, 12, 18 and 24 months of follow-up [ Time Frame: 6, 12, 18 and 24 months after inclusion ]
  5. Variation of phosphorus at 6, 12, 18 et 24 months of follow-up [ Time Frame: 6, 12, 18 and 24 months after inclusion ]
  6. Morbi-mortality at 24 months of follow-up [ Time Frame: 24 months after inclusion ]
  7. Adverse events occuring during the entire study [ Time Frame: 24 months after inclusion ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years to 95 Years   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient female of 65 years or older
  • Chronic kidney disease stage 5 patient, hemodialyzed with extracorporeal treatment for at least 3 months
  • History of vertebral fracture

Exclusion Criteria:

  • Cinacalcet treatment
  • Substitutive hormonal treatment
  • Calcium phosphate balance (PTH, 25(OH) vitamin D3, Calcium, phosphate) outside the KDIGO guidelines
  • Hypersensibility to active substance or one of excipients of denosumab

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792413


Contacts
Layout table for location contacts
Contact: Jean-Paul CRISTOL, Prof +33(0)4 67 33 83 15 jp-cristol@chu-montpellier.fr
Contact: Marion MORENA, PhD +33(0)4 11 75 98 93 m-morenacarrere@chu-montpellier.fr

Locations
Layout table for location information
France
CHU Lyon Sud, Nephrology department Not yet recruiting
Lyon, France
Contact: Denis Fouque, Prof         
Sub-Investigator: Denis Fouque, Prof         
AP-HM, Nephrology department Not yet recruiting
Marseille, France
Contact: Philippe Brunet, Prof         
Sub-Investigator: Philippe Brunet, Prof         
AIDER Not yet recruiting
Montpellier, France
Contact: Lotfi Chalabi, Dr         
Sub-Investigator: Lotfi Chalabi, Dr         
CHU Montpellier, Nephrology department Not yet recruiting
Montpellier, France
Contact: Georges Mourad, Prof         
Sub-Investigator: Georges Mourad, Prof         
Sub-Investigator: Hélène Leray-Moragues, Dr         
Sub-Investigator: Leila Chenine, Dr         
CHU Nice, Nephrology department Not yet recruiting
Nice, France
Contact: Vincent Esnault, Prof         
Sub-Investigator: Vincent Esnault, Prof         
CHU Nimes, Nephrology department Not yet recruiting
Nimes, France
Contact: Pascal Reboul, Dr         
Sub-Investigator: Pascal Reboul, Dr         
CH Perpignan, Nephrology department Not yet recruiting
Perpignan, France
Contact: Carlos Vela, Dr         
Sub-Investigator: Carlos Vela, Dr         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Layout table for investigator information
Principal Investigator: Jean-Paul CRISTOL, Prof CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE

Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02792413     History of Changes
Other Study ID Numbers: UF9672
First Posted: June 7, 2016    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Montpellier:
osteoporosis
chronic kidney disease
anti-RANK ligand antibody
bone mineral density
vascular calcifications
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Physiological Effects of Drugs
Bone Density Conservation Agents