NCT05034848

Brief Summary

Prevalence of PAD and osteoporosis (OP) both get higher with age. Clinical and epidemiologic evidence have showed an increased cardiovascular risk in OP and bone loss and fragility fractures in patient with cardiovascular disease. This study will examine the relationship between vascular disease in legs and sBMD and vBMD at trabecular and cortical sites and bone microarchitecture.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

February 19, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 31, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
Last Updated

December 29, 2022

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

February 19, 2020

Last Update Submit

December 27, 2022

Conditions

BonePeripheral Artery Disease

Keywords

boneosteoporosisperipheral artery diseaseHRpQCT

Outcome Measures

Primary Outcomes (1)

  • Bone Mineral Density (BMD) volumic values at the tibias of PAD (Peripheral Artery Disease) patients

    BMD volumic values are BMD volumetric bone mineral density (mg HA/cm3)

    Day 0

Secondary Outcomes (8)

  • Bone Mineral Density (BMD) measurement by DXA

    Day 0

  • Correlation between microstructural parameters and ankle brachial index results

    Day 0

  • Comparison between microstructural parameters at tibias

    Day 0

  • Correlation between Lipid and bone parameters

    Day 0

  • Percentage of densitometric osteoporotic patients

    Day 0

  • +3 more secondary outcomes

Study Arms (1)

PAD group

OTHER

PAD patients, diagnosis after undergoing an echo-doppler in the Vascular Medicine Department of Orleans regional Hospital

Procedure: Assessment of BMD by DXA and HRpQCT

Interventions

Assessment of BMD by DXA and HRpQCTPROCEDURE

* DXA : BMD assessment at the left hip, rachis and both legs * HRpQCT : Volumic Bone mineral density, cortical and trabecular parameters, at the non dominant radius and legs * Biological samples

PAD group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PAD patients defined by an Ankle brachial index \< 0.9
  • Written consent
  • Patient affiliated with a social security organism

You may not qualify if:

  • Age \< 18 years
  • Pregnancy or risk of pregnancy
  • Patients Under guardianship
  • Patient with known PAD who had been previously treated by surgery or endovascular pathway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR d'ORLEANS

Orléans, 45067, France

Location

Related Publications (4)

  • Breban S, Benhamou CL, Chappard C. Dual-energy X-ray absorptiometry assessment of tibial mid-third bone mineral density in young athletes. J Clin Densitom. 2009 Jan-Mar;12(1):22-7. doi: 10.1016/j.jocd.2008.10.009. Epub 2008 Dec 25.

    PMID: 19111489BACKGROUND

  • Collins TC, Ewing SK, Diem SJ, Taylor BC, Orwoll ES, Cummings SR, Strotmeyer ES, Ensrud KE; Osteoporotic Fractures in Men (MrOS) Study Group. Peripheral arterial disease is associated with higher rates of hip bone loss and increased fracture risk in older men. Circulation. 2009 May 5;119(17):2305-12. doi: 10.1161/CIRCULATIONAHA.108.820993. Epub 2009 Apr 20.

    PMID: 19380619BACKGROUND

  • Fehervari M, Sarkadi H, Krepuska M, Sotonyi P, Acsady G, Entz L, Lakatos P, Szeberin Z. Bone mineral density is associated with site-specific atherosclerosis in patients with severe peripheral artery disease. Calcif Tissue Int. 2013 Jul;93(1):55-61. doi: 10.1007/s00223-013-9727-5. Epub 2013 Apr 6.

    PMID: 23564349BACKGROUND

  • Gaudio A, Muratore F, Fiore V, Rapisarda R, Signorelli SS, Fiore CE. Decreased bone cortical density at the forearm in subjects with subclinical peripheral arterial disease. Osteoporos Int. 2015 Jun;26(6):1747-53. doi: 10.1007/s00198-015-3057-6. Epub 2015 Feb 12.

    PMID: 25672808BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial DiseaseOsteoporosis

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Eric LESPESSAILLES, Dr

    CHR Orleans

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: observational, interventional, non comparative, prospective, monocentric open study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2020

First Posted

September 5, 2021

Study Start

March 31, 2021

Primary Completion

May 19, 2021

Study Completion

May 19, 2021

Last Updated

December 29, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)