Peripheral Artery Disease (PAD) : Its Effects on Bone

Not Applicable

Terminated

• Conditions: Bone; Peripheral Artery Disease
• Interventions: Procedure: Assessment of BMD by DXA and HRpQCT

• Registration Number: NCT05034848
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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.

Detailed 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

Study Timeline

• Study First Submitted: 2020-02-19
• Study Start: 2021-03-31
• Primary Completion: 2021-05-19
• Study Completion: 2021-05-19
• Study First Submitted QC: 2021-09-02
• Study First Posted: 2021-09-05
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-27
• Last Update Posted: 2022-12-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density (BMD) volumic values at the tibias of PAD (Peripheral Artery Disease) patients	Day 0	BMD volumic values are BMD volumetric bone mineral density (mg HA/cm3)

Secondary Outcome Measures

Name	Time	Method
Bone Mineral Density (BMD) measurement by DXA	Day 0	Relations between areal BMD results (DXA) at the hip and lumbar spine and the ankle brachial index measured at the two legs.
Comparison between microstructural parameters at tibias	Day 0	comparison between bone microarchitecture parameters at the tibia: the parameters will be compared between the most severely limb and the contralateral one.
Percentage of densitometric osteoporotic patients	Day 0	percentage of densitometric osteoporotic patients in the population
Correlation between Lipid and bone parameters	Day 0	We will study the relation between lipidic and bone parameters. Potential correlations between on the one hand (lipid parameters: total and HDL-cholesterol, triglyceridemia, LDL-cholesterol calculation) and on the other hand bone parameters: vBMD volumetric bone mineral density (mg HA/cm3) Ct.BMD: cortical volumetric bone mineral density (mg/cm3); Tb.BMD: trabecular volumetric bone mineral density (mg HA/cm3)
Evaluation of cardiovascular risk	Day 0	Cardiovascular risk assessment using the SCORE tool (Systematic Coronary Risk Estimation).; Four levels of risk are defined: * Very high cardiovascular risk ≥ 10%; * High risk, which includes subjects with major or particularly high risk factors (familial hypercholesterolemia, severe hypertension, etc.) and those with a score between 5 and 10%; * Moderate risk, which concerns patients with a score between 1 and 5%; * Low risk, which includes subjects with a score \< 1%;
Correlation between microstructural parameters at tibias and radius	Day 0	comparison between bone microarchitecture at the tibia and of the radius.; The following micro structural parameters assessed by HRpQCT at tibias and radius will be : * Dtrab : volumetric trabecular bone mineral density (mg HA/ cm3),; * Dinn : inner trabecular bone density (mg HA/cm3),; * Dmeta: metatrabecular bone density (mg HA/cm3),; * Dcort: volumetric cortical bone mineral density (mg HA/cm3),; * D100: total volumetric bone mineral density (mg HA/cm3),; * Tb.Th: trabecular thickness (mm),; * Tb.N: trabecular number (mm-1); * Tb.Sp: trabecular separation (mm),; * Ct.Th: cortical thickness (mm); * Tb1.NSD: intra-distribution individual separation (mm),; * BV / TV: trabecular bone volume (%).
Correlation between microstructural parameters and ankle brachial index results	Day 0	The following micro structural parameters assessed by HRpQCT at both tibias will be : * Dtrab : volumetric trabecular bone mineral density (mg HA/ cm3),; * Dinn : inner trabecular bone density (mg HA/cm3),; * Dmeta: metatrabecular bone density (mg HA/cm3),; * Dcort: volumetric cortical bone mineral density (mg HA/cm3),; * D100: total volumetric bone mineral density (mg HA/cm3),; * Tb.Th: trabecular thickness (mm),; * Tb.N: trabecular number (mm-1); * Tb.Sp: trabecular separation (mm),; * Ct.Th: cortical thickness (mm); * Tb1.NSD: intra-distribution individual separation (mm),; * BV / TV: trabecular bone volume (%).
Evaluation of risk of fracture	Day 0	The risk of fracture at 10 years will be evaluate by the Fracture Risk Assessment Tool (FRAX) survey.; The FRAX® tool was developed by the then WHO Collaborating Centre for Metabolic Bone Diseases (1991-2010) at the University of Sheffield. It was launched in 2008 following approximately 10 years of meta-analyses of a variety of risk factors for osteoporotic fracture. Although not the only fracture prediction tool available, FRAX® is the only risk calculator which has been calibrated to rates of fracture and mortality per individual country and has been shown to identify a risk amenable to available treatments.

Trial Locations

Locations (1)

CHR d'ORLEANS; 🇫🇷 Orleans, France