Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577350
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Osteosarcopenia in Axial Spondyloarthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Frequency of Osteosarcopenia and Its Relationship With Demographic and Clinical Factors in Axial Spondyloarthritis
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Axial spondyloarthritis is a chronic inflammatory disease affecting the spine sacroiliac joints entheses and sometimes peripheral joints with a close link to HLAB27 Typical features include inflammatory back pain limited spinal mobility and sacroiliitis The term axial spondyloarthritis AxSpA includes both Ankylosing Spondylitis AS where sacroiliitis is diagnosed by X-rays and non-radiographic AxSpA where sacroiliitis is diagnosed via magnetic resonance imaging MRI
Osteoporosis is common in AS patients and sarcopenia may also develop due to inflammation and immobilization Osteosarcopenia the co-occurrence of osteoporosis and sarcopenia might have an impact on morbidity and mortality of AxSpA patients
This cross-sectional study aims to determine the frequency of osteosarcopenia in AxSpA patients and to investigate its relationship with various demographic and clinical factors A control group with similar age and gender distribution will be recruited to evaluate osteosarcopenia Our hypothesis is that osteosarcopenia will be more frequent in the AxSpA group compared to the control group The study will also identify the demographic and clinical factors associated with osteosarcopenia in AxSpa
Osteoporosis is common in AS patients and sarcopenia may also develop due to inflammation and immobilization Osteosarcopenia the co-occurrence of osteoporosis and sarcopenia might have an impact on morbidity and mortality of AxSpA patients
This cross-sectional study aims to determine the frequency of osteosarcopenia in AxSpA patients and to investigate its relationship with various demographic and clinical factors A control group with similar age and gender distribution will be recruited to evaluate osteosarcopenia Our hypothesis is that osteosarcopenia will be more frequent in the AxSpA group compared to the control group The study will also identify the demographic and clinical factors associated with osteosarcopenia in AxSpa
Detailed Description:
Ankylosing Spondylitis AS is a chronic inflammatory disease of unknown etiology that affects the spine sacroiliac joints entheses regions and sometimes peripheral joints Its typical findings include inflammatory back pain limited spinal mobility and radiographic sacroiliitis The term axial spondyloarthritis AxSpA describes a chronic inflammatory disease affecting the axial skeleton including the spine and sacroiliac joints It encompasses both patients with definite AS diagnosis with radiographic X-ray sacroiliitis and patients with non-radiographic AxSpA whose sacroiliitis detected by MRI Osteoporosis is among the clinical findings of AS Similarly sarcopenia may develop in AS patients due to both inflammation and immobilization Osteosarcopenia is a clinical syndrome that includes both osteoporosis and sarcopenia Osteosarcopenia may be a significant cause of morbidity and mortality in AxSpA patients
This study aims to determine the frequency of osteosarcopenia in patients with AxSpA and to investigate its relationship with demographic and various clinical parameters To determine the presence of osteoporosis bone mineral density BMD measurement will be performed using Dual-energy X-ray absorptiometry DXA WHO definition for the diagnosis of osteoporosis will be used A T score at or below -25 at the lumbal andor hip region is defined as osteoporosis Subsequently to determine the presence of sarcopenia patients will be assessed according to the European Working Group on Sarcopenia in Older People EWGSOP2 algorithm through measurements of muscle strength muscle mass quantity or quality and physical performance Skeletal muscle mass or quality will be measured by appendicular skeletal muscle mass ASM using both DXA and bioelectrical impedance analysis BIA Skeletal muscle strength will be measured by grip strength and physical performance by gait speed EWGSOP2 cut-off points will be used for low muscle strength grip strength low muscle quantity ASMheight2 and low physical performance gait speed Then the sarcopenia diagnosis probable confirmed severe will be made according to the 2018 operational definition of sarcopenia by EWGSOP2 A healthy control group with similar age and gender distribution will be recruited to evaluate osteosarcopenia and compare with the patient group After determining the presence of osteosarcopenia in AxSpA the relationship between osteosarcopenia sarcopenia and osteoporosis and demographicclinical parameters including age gender physical activity disease duration medications used biological vs non-biological disease activity spinal mobility radiological involvement and functional status will be investigated
There has been no prior study on investigating osteosarcopenia in AxSpA We expect a higher frequency osteosarcopenia in the AxSpA group compared to the control group Additionally the relationship between osteosarcopenia and clinical parameters will be demonstrated thus increasing the attention and awareness of patients at high risk for developing osteosarcopenia and facilitating early steps in treatment
This study aims to determine the frequency of osteosarcopenia in patients with AxSpA and to investigate its relationship with demographic and various clinical parameters To determine the presence of osteoporosis bone mineral density BMD measurement will be performed using Dual-energy X-ray absorptiometry DXA WHO definition for the diagnosis of osteoporosis will be used A T score at or below -25 at the lumbal andor hip region is defined as osteoporosis Subsequently to determine the presence of sarcopenia patients will be assessed according to the European Working Group on Sarcopenia in Older People EWGSOP2 algorithm through measurements of muscle strength muscle mass quantity or quality and physical performance Skeletal muscle mass or quality will be measured by appendicular skeletal muscle mass ASM using both DXA and bioelectrical impedance analysis BIA Skeletal muscle strength will be measured by grip strength and physical performance by gait speed EWGSOP2 cut-off points will be used for low muscle strength grip strength low muscle quantity ASMheight2 and low physical performance gait speed Then the sarcopenia diagnosis probable confirmed severe will be made according to the 2018 operational definition of sarcopenia by EWGSOP2 A healthy control group with similar age and gender distribution will be recruited to evaluate osteosarcopenia and compare with the patient group After determining the presence of osteosarcopenia in AxSpA the relationship between osteosarcopenia sarcopenia and osteoporosis and demographicclinical parameters including age gender physical activity disease duration medications used biological vs non-biological disease activity spinal mobility radiological involvement and functional status will be investigated
There has been no prior study on investigating osteosarcopenia in AxSpA We expect a higher frequency osteosarcopenia in the AxSpA group compared to the control group Additionally the relationship between osteosarcopenia and clinical parameters will be demonstrated thus increasing the attention and awareness of patients at high risk for developing osteosarcopenia and facilitating early steps in treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None