Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2021-03-31
2021-05-19
Brief Summary
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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
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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
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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PAD group
PAD patients, diagnosis after undergoing an echo-doppler in the Vascular Medicine Department of Orleans regional Hospital
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Written consent
* Patient affiliated with a social security organism
Exclusion Criteria
* Pregnancy or risk of pregnancy
* Patients Under guardianship
* Patient with known PAD who had been previously treated by surgery or endovascular pathway
18 Years
ALL
No
Sponsors
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Centre Hospitalier Régional d'Orléans
OTHER
Responsible Party
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Principal Investigators
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Eric LESPESSAILLES, Dr
Role: PRINCIPAL_INVESTIGATOR
CHR Orleans
Locations
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CHR d'ORLEANS
Orléans, , France
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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CHRO-2018-13
Identifier Type: -
Identifier Source: org_study_id