NCT05234047

Brief Summary

Aim of this study is to evaluate in a population of osteoporotic chronic kidney disease patients the effect of denosumab:

  • on coronary artery calcification scores evolution after 24 months of followup
  • on abdominal aorta calcification scores evolution after 24 months of followup
  • 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 parameters of bone remodelling 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

2.8 years

First QC Date

January 31, 2022

Last Update Submit

April 13, 2022

Conditions

OsteoporosisChronic Kidney Disease 5D

Outcome Measures

Primary Outcomes (1)

  • Relative variation of coronary calcification scores after 24 months of follow-up

    24 months after inclusion

Secondary Outcomes (11)

  • Relative variation of abdominal aorta calcification scores after 24 months of follow-up

    24 months after inclusion

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

    24 months after inclusion

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

    24 months after inclusion

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

    24 months after inclusion

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

    24 months after inclusion

  • +6 more secondary outcomes

Study Arms (1)

CKD-5D patients receiving denosumab

Procedure: MDCT (multidetector computed tomography)Procedure: Dual-energy X-ray absorptiometry

Interventions

MDCT (multidetector computed tomography)PROCEDURE

MDCT will be performed at inclusion and after 2 years

CKD-5D patients receiving denosumab
Dual-energy X-ray absorptiometryPROCEDURE

DXA will be performed at inclusion, 1 and 2 years after inclusion

CKD-5D patients receiving denosumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CKD-5D patients with osteoporosis

You may qualify if:

  • Chronic kidney disease stage 5D patient, hemodialyzed with extracorporeal treatment for at least 3 months
  • Osteoporosis

You may not qualify if:

  • Pregnancy or breastfeeeding female
  • Current corticoid treatment
  • PTH and Calcium outside the KDIGO guidelines
  • Adynamic bone disease suspicion
  • Cancer or myeloma
  • Serious hepatic cytolysis
  • Serious dental troubles
  • Positive HIV serology
  • Hypersensibility to active substance or one of excipients of denosumab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoporosis

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Central Study Contacts

Jean-Paul CRISTOL, MD, PhD

CONTACT

+33 467 338315jp-cristol@chu-montpellier.fr

Marion MORENA CARRERE, PhD

CONTACT

+33 411 759893m-morenacarrere@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 10, 2022

Study Start

May 1, 2022

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

April 14, 2022

Record last verified: 2022-04