Study Evaluating Denosumab on Vascular and Bone Metabolis... | NCT05234047

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

NCT05234047

Sponsor

University Hospital, Montpellier

Status

Unknown status

Last Update Posted

Apr 14, 2022Actual

Enrollment

21Estimated

Phase

Not provided

Conditions

Osteoporosis
Chronic Kidney Disease 5D

Interventions

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

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2022Estimated

Primary Completion Date

Feb 2025Estimated

Completion Date

Feb 2025Estimated

First Submitted Date

Jan 31, 2022

First Submission Date that Met QC Criteria

Jan 31, 2022

First Posted Date

Feb 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2022

Last Update Posted Date

Apr 14, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

21Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CKD-5D patients receiving denosumab			Procedure: MDCT (multidetector computed tomography) Procedure: Dual-energy X-ray absorptiometry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MDCT (multidetector computed tomography)	Procedure	MDCT will be performed at inclusion and after 2 years	CKD-5D patients receiving denosumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relative variation of coronary calcification scores after 24 months of follow-up		24 months after inclusion

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

CKD-5D patients with osteoporosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

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

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015502	Absorptiometry, Photon

Ancestor Terms

ID	Term
D011859	Radiography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided