Vertebral Fracture Clinical Trial
Official title:
Prevalence of Subclinical Vertebral Fractures in Rheumatoid Arthritis and Ankylosing Spondylitis in Egyptian Patients and Its Relation to Some Clinical Data
Study of prevalence of subclinical vertebral fractures in Rheumatoid Arthritis and Ankylosing spondylitis
Status | Not yet recruiting |
Enrollment | 93 |
Est. completion date | January 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 45 Years |
Eligibility | Inclusion Criteria: - Patients fulfilling ACR/EULAR 2010 rheumatoid arthritis classification criteria. Patients diagnosed as ankylosing spondylitis according to ASAS criteria (2000). Age (18-50). Exclusion Criteria: - Patient with other autoimmune Rheumatic disease other than RA and AS. Infections including hepatitis C or B, HIV, tuberculosis. RA and AS patients with known vertebral fractures. Malignancy, hypogonadism, thyroid problems, chronic kidney disease, Hypoparathyroidism, Type 1 DM. Pregnancy and breast-feeding. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Bot SD, Caspers M, Van Royen BJ, Toussaint HM, Kingma I. Biomechanical analysis of posture in patients with spinal kyphosis due to ankylosing spondylitis: a pilot study. Rheumatology (Oxford). 1999 May;38(5):441-3. doi: 10.1093/rheumatology/38.5.441. — View Citation
Compston J, Cooper A, Cooper C, Gittoes N, Gregson C, Harvey N, Hope S, Kanis JA, McCloskey EV, Poole KES, Reid DM, Selby P, Thompson F, Thurston A, Vine N; National Osteoporosis Guideline Group (NOGG). UK clinical guideline for the prevention and treatment of osteoporosis. Arch Osteoporos. 2017 Dec;12(1):43. doi: 10.1007/s11657-017-0324-5. Epub 2017 Apr 19. — View Citation
Guanabens N, Olmos JM, Hernandez JL, Cerda D, Hidalgo Calleja C, Martinez Lopez JA, Arboleya L, Aguilar Del Rey FJ, Martinez Pardo S, Ros Vilamajo I, Suris Armangue X, Grados D, Beltran Audera C, Suero-Rosario E, Gomez Gracia I, Salmoral Chamizo A, Martin-Esteve I, Florez H, Naranjo A, Castaneda S, Ojeda Bruno S, Garcia Carazo S, Garcia Vadillo A, Lopez Vives L, Martinez-Ferrer A, Borrell Panos H, Aguado Acin P, Castellanos-Moreira R, Tebe C, Gomez-Vaquero C; OsteoResSer Working Group of the Spanish Society of Rheumatology. Vertebral fractures are increased in rheumatoid arthritis despite recent therapeutic advances: a case-control study. Osteoporos Int. 2021 Jul;32(7):1333-1342. doi: 10.1007/s00198-021-05824-7. Epub 2021 Jan 18. — View Citation
Hu Z, Zhang L, Lin Z, Zhao C, Xu S, Lin H, Zhang J, Li W, Chu Y. Prevalence and risk factors for bone loss in rheumatoid arthritis patients from South China: modeled by three methods. BMC Musculoskelet Disord. 2021 Jun 12;22(1):534. doi: 10.1186/s12891-021-04403-5. — View Citation
Kendler DL, Bauer DC, Davison KS, Dian L, Hanley DA, Harris ST, McClung MR, Miller PD, Schousboe JT, Yuen CK, Lewiecki EM. Vertebral Fractures: Clinical Importance and Management. Am J Med. 2016 Feb;129(2):221.e1-10. doi: 10.1016/j.amjmed.2015.09.020. Epub 2015 Oct 30. — View Citation
Navarro-Compan V, Sepriano A, El-Zorkany B, van der Heijde D. Axial spondyloarthritis. Ann Rheum Dis. 2021 Dec;80(12):1511-1521. doi: 10.1136/annrheumdis-2021-221035. Epub 2021 Oct 6. — View Citation
Phuan-Udom R, Lektrakul N, Katchamart W. The association between 10-year fracture risk by FRAX and osteoporotic fractures with disease activity in patients with rheumatoid arthritis. Clin Rheumatol. 2018 Oct;37(10):2603-2610. doi: 10.1007/s10067-018-4218-8. Epub 2018 Jul 23. — View Citation
Radner H, Neogi T, Smolen JS, Aletaha D. Performance of the 2010 ACR/EULAR classification criteria for rheumatoid arthritis: a systematic literature review. Ann Rheum Dis. 2014 Jan;73(1):114-23. doi: 10.1136/annrheumdis-2013-203284. Epub 2013 Apr 16. — View Citation
Raterman HG, Bultink IE, Lems WF. Osteoporosis in patients with rheumatoid arthritis: an update in epidemiology, pathogenesis, and fracture prevention. Expert Opin Pharmacother. 2020 Oct;21(14):1725-1737. doi: 10.1080/14656566.2020.1787381. Epub 2020 Jul 1. — View Citation
Schousboe JT. Epidemiology of Vertebral Fractures. J Clin Densitom. 2016 Jan-Mar;19(1):8-22. doi: 10.1016/j.jocd.2015.08.004. Epub 2015 Sep 5. — View Citation
Tavassoli S, Rajaei A, Emam MM, Farsad F. Evaluating the Value-Added of the Trabecular Bone Score in Patients with Rheumatoid Arthritis. Arch Iran Med. 2021 Mar 1;24(3):193-198. doi: 10.34172/aim.2021.30. — View Citation
Tong JJ, Xu SQ, Zong HX, Pan MJ, Teng YZ, Xu JH. Prevalence and risk factors associated with vertebral osteoporotic fractures in patients with rheumatoid arthritis. Clin Rheumatol. 2020 Feb;39(2):357-364. doi: 10.1007/s10067-019-04787-9. Epub 2019 Nov 5. Erratum In: Clin Rheumatol. 2020 Jun;39(6):2023. — View Citation
Tu PH, Liu ZH, Yeap MC, Liu YT, Li YC, Huang YC, Lin TM, Chen CC. Spinal cord injury and spinal fracture in patients with ankylosing spondylitis. BMC Emerg Med. 2022 May 2;22(1):73. doi: 10.1186/s12873-022-00635-3. — View Citation
Westerveld LA, Verlaan JJ, Oner FC. Spinal fractures in patients with ankylosing spinal disorders: a systematic review of the literature on treatment, neurological status and complications. Eur Spine J. 2009 Feb;18(2):145-56. doi: 10.1007/s00586-008-0764-0. Epub 2008 Sep 13. — View Citation
Zhang M, Li XM, Wang GS, Tao JH, Chen Z, Ma Y, Li XP. The association between ankylosing spondylitis and the risk of any, hip, or vertebral fracture: A meta-analysis. Medicine (Baltimore). 2017 Dec;96(50):e8458. doi: 10.1097/MD.0000000000008458. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of prevalence of subclinical vertebral fractures in RA ,AS and control group | Detection of prevalence of subclinical vertebral fractures in RA, AS and control group | Baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06367582 -
SPINE BONE CEMENTS OUTCOMES
|
||
Terminated |
NCT00748631 -
Treatment of Malignant Vertebral Fractures With Percutaneous Balloon Kyphoplasty.
|
N/A | |
Completed |
NCT00463905 -
Evaluation of the Impact of a Case-finding Strategy for Vertebral Fractures
|
N/A | |
Completed |
NCT03885466 -
Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis
|
N/A | |
Active, not recruiting |
NCT05283148 -
Sickle Cell Disease (SCD) Bone Pain Study
|
N/A | |
Completed |
NCT03839732 -
Observer Variability in Scoring Abdominal Aortic Calcifications and Vertebral Morphometry
|
||
Recruiting |
NCT04609150 -
Vertebral Fat Quantitative MRI as a Marker of Bone Fragility in Multiple Myeloma (MYELOMEFRAGIQUANTI)
|
||
Completed |
NCT03263585 -
Treatment With a Spinal Orthosis Compared to Equipment Group Training and a Control Group
|
N/A | |
Completed |
NCT02536898 -
Norwegian Capture the Fracture Initiative
|
N/A | |
Completed |
NCT01963039 -
A Trial of Vertebroplasty for Painful Chronic Osteoporotic Vertebral Fractures (Vertos V)
|
N/A | |
Completed |
NCT01120197 -
Study of Effect of Exercise With Osteoporosis and Vertebral Fracture
|
N/A | |
Recruiting |
NCT04821739 -
RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures
|
N/A | |
Completed |
NCT05071625 -
CT Guided Percutaneous Vertebroplasty for Vertebral Non-union Following Posterior Fixation
|
||
Recruiting |
NCT04533217 -
Examination of Vertebroplasty in Addition to Regular Treatment of Patients With Multiple Myeloma.
|
N/A | |
Completed |
NCT05227976 -
Patient Education With or Without Physical Training or Mindfulness and Medical Yoga in Established Spinal Osteoporosis
|
N/A | |
Completed |
NCT04980131 -
Application of 3-Dimensional Printing Guide Template and Pointed Lotus-style Regulator
|
N/A | |
Completed |
NCT01839682 -
Evaluation of Outcomes of DFine StabiliT Kyphoplasty in Vertebral Compression Fractures Due to Osteoporosis
|
N/A | |
Not yet recruiting |
NCT06449742 -
A Prospective Observational Study of Artificial Intelligence Morphometric Evaluation of Vertebral Fractures
|
||
Completed |
NCT03617094 -
Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures
|
N/A | |
Active, not recruiting |
NCT01374412 -
Investigation of Bone Defects and Microcirculation With Computed Tomography and Magnetic Resonance Imaging
|