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Peripheral Artery Disease (PAD) : Its Effects on Bone (AMICOS)

C

Centre Hospitalier Régional d'Orléans

Status

Terminated

Conditions

Peripheral Artery Disease
Bone

Treatments

Procedure: Assessment of BMD by DXA and HRpQCT

Study type

Interventional

Funder types

Other

Identifiers

NCT05034848
CHRO-2018-13

Details and patient eligibility

About

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.

Full description

The primary goal of our study is to determinate if presence of PAD is associated with lower sBMD and vBMD values at the tibias, assuming that BMD should be more alterate in the predominant vascular impairement site.

Our secondary objectives are to :

  • determine if severity of PAD quantified by ankle brachial index ABI is associated to a decrease of BMD values defined by T-Score at the left hip, spine and legs, but also with volumetric values, assessed by HRpQCT at the non dominant radius and at both tibias.
  • determine the prevalence of osteoporosis in our population
  • To evaluate the relationships between ;
  • lipids and bone parameters
  • vit D and parathormone with PAD severity
  • levels of physical activity and both vascular and bone impairments

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

2 participants in 1 patient group

PAD group
Other group
Description:
PAD patients, diagnosis after undergoing an echo-doppler in the Vascular Medicine Department of Orleans regional Hospital
Treatment:
Procedure: Assessment of BMD by DXA and HRpQCT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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