BoneAMICOSNCT05034848
Peripheral Artery Disease (PAD) : Its Effects on Bone
A study testing Assessment of BMD by DXA and HRpQCT in people with Bone and Peripheral Artery Disease, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone, Peripheral Artery Disease
- What is being tested?
- Assessment of BMD by DXA and HRpQCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2021to 19 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PAD patients defined by an Ankle brachial index < 0.9
- Written consent
- Patient affiliated with a social security organism
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Bone, Peripheral Artery Disease
- Being tested
- Assessment of BMD by DXA and HRpQCT
- Keywords
- bone, osteoporosis, peripheral artery disease, HRpQCT
- Medical subject headings
- Peripheral Arterial Disease, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of BMD by DXA and HRpQCTProcedure or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| PAD group | Other | PAD patients, diagnosis after undergoing an echo-doppler in the Vascular Medicine Department of Orleans regional Hospital Receives: Procedure: Assessment of BMD by DXA and HRpQCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 0
Secondary outcomes (8)
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.
Measured: Day 0
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 (%).
Measured: Day 0
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.
Measured: Day 0
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)
Measured: Day 0
Percentage of densitometric osteoporotic patients
percentage of densitometric osteoporotic patients in the population
Measured: Day 0
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.
Measured: Day 0
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%;
Measured: Day 0
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 (%).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start31 Mar 2021
- Primary completion19 May 2021
- Study completion19 May 2021
Why it stopped: no practitionner
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- observational, interventional, non comparative, prospective, monocentric open study
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric LESPESSAILLES, Dr, Principal investigator, CHR Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034848
- Sponsor's protocol ID
- CHRO-2018-13
- Acronym
- AMICOS
- Status last verified
- Dec 2022
- First submitted
- 19 Feb 2020
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19111489Collins 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.
PubMed 19380619Fehervari 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.
PubMed 23564349Gaudio 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.
PubMed 25672808
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Artery Disease (PAD) : Its Effects on Bone
- ClinicalTrials.gov ID
- NCT05034848
- Acronym / sponsor ID
- AMICOS / CHRO-2018-13
- Conditions
- Bone, Peripheral Artery Disease
- Keywords
- bone, osteoporosis, peripheral artery disease, HRpQCT
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no practitionner
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 19 May 2021 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- observational, interventional, non comparative, prospective, monocentric open study
| Arm | Type | Receives |
|---|---|---|
| PAD group | Other | Procedure: Assessment of BMD by DXA and HRpQCTPAD patients, diagnosis after undergoing an echo-doppler in the Vascular Medicine Department of Orleans regional Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PAD patients defined by an Ankle brachial index < 0.9
- Written consent
- Patient affiliated with a social security organism
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | PAD group |
Primary outcome
Bone Mineral Density (BMD) volumic values at the tibias of PAD (Peripheral Artery Disease) patients
Time frame: Day 0
BMD volumic values are BMD volumetric bone mineral density (mg HA/cm3)
8 secondary outcomes
Bone Mineral Density (BMD) measurement by DXA
Time frame: Day 0
Correlation between microstructural parameters and ankle brachial index results
Time frame: Day 0
Comparison between microstructural parameters at tibias
Time frame: Day 0
Correlation between Lipid and bone parameters
Time frame: Day 0
Percentage of densitometric osteoporotic patients
Time frame: Day 0
Evaluation of risk of fracture
Time frame: Day 0
Evaluation of cardiovascular risk
Time frame: Day 0
Correlation between microstructural parameters at tibias and radius
Time frame: Day 0
Results and safety
The study was stopped early (reason given: no practitionner). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Background: PubMed 19111489Breban 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.
- Background: PubMed 19380619Collins 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.
- Background: PubMed 23564349Fehervari 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.
- Background: PubMed 25672808Gaudio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric LESPESSAILLES, Dr principal investigator
CHR Orleans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of BMD by DXA and HRpQCT in people with Bone and Peripheral Artery Disease, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: no practitionner). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density (BMD) volumic values at the tibias of PAD (Peripheral Artery Disease) patients (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05034848, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.