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Status unknownNCT05234047HDENOBSUpdated Apr 14, 2022

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

An observational study in Osteoporosis and Chronic Kidney Disease 5D, sponsored by University Hospital, Montpellier. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-14.

Sponsored by University Hospital, Montpellier · Observational

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
21
Ages
18 Years and older
Sex
All
01

Study 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
Read the detailed description

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

  • on coronary calcification scores evolution (by multidetector computed tomography) after 24 months of follow-up
  • on abdominal aorta calcification scores evolution (by plain abdominal Xray) after 24 months of follow-up
  • 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 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
02

Conditions studied

  • Osteoporosis
  • Chronic Kidney Disease 5D

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03

In context

Osteoporosis

1,675 studies on the registry are indexed under Osteoporosis; 211 are open to participants now.

This study's planned enrollment of 21 is below the median of 180 across 461 observational studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 227 are open to participants now.

Browse University Hospital, Montpellier studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

CKD-5D patients with osteoporosis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
21 participants (estimated)
Patient registry
No

Groups and cohorts

  • CKD-5D patients receiving denosumab

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

Interventions

  • ProcedureMDCT (multidetector computed tomography)

    MDCT will be performed at inclusion and after 2 years

  • ProcedureDual-energy X-ray absorptiometry

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

06

What researchers measure

Primary outcomes

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

    Time frame: 24 months after inclusion

Secondary outcomes

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

    Time frame: 24 months after inclusion

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

    Time frame: 24 months after inclusion

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

    Time frame: 24 months after inclusion

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

    Time frame: 24 months after inclusion

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

    Time frame: 24 months after inclusion

  6. Variation of calcium at 6, 12, 18 and 24 months of follow-up

    Time frame: 6, 12, 18 and 24 months after inclusion]

  7. Variation of phosphorus at 6, 12, 18 et 24 months of follow-up

    Time frame: 6, 12, 18 and 24 months after inclusion

  8. Variation of bone remodeling at 6, 12, 18 et 24 months of follow-up

    Time frame: 6, 12, 18 and 24 months after inclusion

  9. Variation of inflammation at 6, 12, 18 et 24 months of follow-up

    Time frame: 6, 12, 18 and 24 months after inclusion

  10. Morbi-mortality at 24 months of follow-up

    Time frame: 24 months after inclusion]

  11. Adverse events occuring during the entire study

    Time frame: 24 months after inclusion]

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05234047
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Feb 10, 2022
Start date
May 2022 (estimated)
Primary completion
Feb 2025 (estimated)
Completion
Feb 2025 (estimated)
Last update
Apr 14, 2022

Study contacts

Jean-Paul CRISTOL, MD, PhD
Contact
jp-cristol@chu-montpellier.fr
+33 467 338315
Marion MORENA CARRERE, PhD
Contact
m-morenacarrere@chu-montpellier.fr
+33 411 759893

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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