Clinical trial NCT05034848: Peripheral Artery Disease (PAD) : Its Effects on Bone
Official title: Peripheral Artery Disease (PAD) : Its Effects on Bone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bone
Peripheral Artery Disease
Keywords: bone
osteoporosis
peripheral artery disease
HRpQCT
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: observational, interventional, non comparative, prospective, monocentric open study
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Bone Mineral Density (BMD) volumic values at the tibias of PAD (Peripheral Artery Disease) patients
timeFrame: Day 0
Secondary outcomes:
measure: Bone Mineral Density (BMD) measurement by DXA
timeFrame: Day 0
measure: Correlation between microstructural parameters and ankle brachial index results
timeFrame: Day 0
measure: Comparison between microstructural parameters at tibias
timeFrame: Day 0
measure: Correlation between Lipid and bone parameters
timeFrame: Day 0
measure: Percentage of densitometric osteoporotic patients
timeFrame: Day 0
measure: Evaluation of risk of fracture
timeFrame: Day 0
measure: Evaluation of cardiovascular risk
timeFrame: Day 0
measure: Correlation between microstructural parameters at tibias and radius
timeFrame: Day 0
Other outcomes:
Locations:
city: Orleans
country: France
facility: CHR d'ORLEANS
Study officials:
affiliation: CHR Orleans
name: Eric LESPESSAILLES, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.