Peripheral Artery Disease (PAD) : Its Effects on Bone

Peripheral Artery Disease Clinical Trial

— AMICOS  

Official title:

Peripheral Artery Disease (PAD) : Its Effects on Bone

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05034848
• Other study ID #: CHRO-2018-13
• Status: Terminated
• Phase: N/A
• Start date: March 31, 2021
• Est. completion date: May 19, 2021

Study information

• Verified date: December 2022
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 19, 2021
• Est. primary completion date: May 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Procedure:
• Assessment of BMD by DXA and HRpQCT
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

Locations

Country	Name	City	State
France	CHR d'ORLEANS	Orleans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Day 0
Secondary	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 (%).	Day 0
Secondary	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.	Day 0
Secondary	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)	Day 0
Secondary	Percentage of densitometric osteoporotic patients	percentage of densitometric osteoporotic patients in the population	Day 0
Secondary	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.	Day 0
Secondary	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%;	Day 0
Secondary	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 (%).	Day 0