Peripheral Artery Disease (PAD) : Its Effects on Bone (AMICOS)
Primary Purpose
Bone, Peripheral Artery Disease
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Assessment of BMD by DXA and HRpQCT
Sponsored by
About this trial
This is an interventional diagnostic trial for Bone focused on measuring bone, osteoporosis, peripheral artery disease, HRpQCT
Eligibility Criteria
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
Sites / Locations
- CHR d'ORLEANS
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PAD group
Arm Description
PAD patients, diagnosis after undergoing an echo-doppler in the Vascular Medicine Department of Orleans regional Hospital
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Bone Mineral Density (BMD) measurement by DXA
Relations between areal BMD results (DXA) at the hip and lumbar spine and the ankle brachial index measured at the two legs.
Correlation between microstructural parameters and ankle brachial index results
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 (%).
Comparison between microstructural parameters at tibias
comparison between bone microarchitecture parameters at the tibia: the parameters will be compared between the most severely limb and the contralateral one.
Correlation between Lipid and bone parameters
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)
Percentage of densitometric osteoporotic patients
percentage of densitometric osteoporotic patients in the population
Evaluation of risk of fracture
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.
Evaluation of cardiovascular risk
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
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 (%).
Full Information
NCT ID
NCT05034848
First Posted
February 19, 2020
Last Updated
December 27, 2022
Sponsor
Centre Hospitalier Régional d'Orléans
1. Study Identification
Unique Protocol Identification Number
NCT05034848
Brief Title
Peripheral Artery Disease (PAD) : Its Effects on Bone
Acronym
AMICOS
Official Title
Peripheral Artery Disease (PAD) : Its Effects on Bone
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
no practitionner
Study Start Date
March 31, 2021 (Actual)
Primary Completion Date
May 19, 2021 (Actual)
Study Completion Date
May 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone, Peripheral Artery Disease
Keywords
bone, osteoporosis, peripheral artery disease, HRpQCT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
observational, interventional, non comparative, prospective, monocentric open study
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PAD group
Arm Type
Other
Arm Description
PAD patients, diagnosis after undergoing an echo-doppler in the Vascular Medicine Department of Orleans regional Hospital
Intervention Type
Procedure
Intervention Name(s)
Assessment of BMD by DXA and HRpQCT
Intervention Description
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
Primary Outcome Measure Information:
Title
Bone Mineral Density (BMD) volumic values at the tibias of PAD (Peripheral Artery Disease) patients
Description
BMD volumic values are BMD volumetric bone mineral density (mg HA/cm3)
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Bone Mineral Density (BMD) measurement by DXA
Description
Relations between areal BMD results (DXA) at the hip and lumbar spine and the ankle brachial index measured at the two legs.
Time Frame
Day 0
Title
Correlation between microstructural parameters and ankle brachial index results
Description
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 (%).
Time Frame
Day 0
Title
Comparison between microstructural parameters at tibias
Description
comparison between bone microarchitecture parameters at the tibia: the parameters will be compared between the most severely limb and the contralateral one.
Time Frame
Day 0
Title
Correlation between Lipid and bone parameters
Description
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)
Time Frame
Day 0
Title
Percentage of densitometric osteoporotic patients
Description
percentage of densitometric osteoporotic patients in the population
Time Frame
Day 0
Title
Evaluation of risk of fracture
Description
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.
Time Frame
Day 0
Title
Evaluation of cardiovascular risk
Description
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%;
Time Frame
Day 0
Title
Correlation between microstructural parameters at tibias and radius
Description
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 (%).
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric LESPESSAILLES, Dr
Organizational Affiliation
CHR Orleans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'ORLEANS
City
Orleans
ZIP/Postal Code
45067
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19111489
Citation
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.
Results Reference
background
PubMed Identifier
19380619
Citation
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.
Results Reference
background
PubMed Identifier
23564349
Citation
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.
Results Reference
background
PubMed Identifier
25672808
Citation
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.
Results Reference
background
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Peripheral Artery Disease (PAD) : Its Effects on Bone
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