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

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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

Tracking Information
First Submitted Date  ICMJE June 2, 2016
First Posted Date  ICMJE June 7, 2016
Last Update Posted Date June 29, 2016
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry) [ Time Frame: 24 months after inclusion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02792413 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Denosumab on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Female With Osteoporosis and Chronic Kidney Disease
Intervention  ICMJE
  • Drug: Denosumab
  • Drug: NaCl (placebo)
Study Arms  ICMJE
  • Experimental: Denosumab
    Denosumab 60 mg, subcutaneous injection every 6 months for 24 months
    Intervention: Drug: Denosumab
  • Placebo Comparator: Placebo
    NaCl 0.9% (1 mL), subcutaneous injection every 6 months for 24 months
    Intervention: Drug: NaCl (placebo)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 6, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 65 Years to 95 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02792413
Other Study ID Numbers  ICMJE UF9672
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Paul CRISTOL, Prof CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
PRS Account University Hospital, Montpellier
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP