Prevalence of Subclinical Vertebral Fractures in Rheumatoid Arthritis and Ankylosing Spondylitis

NCT06092775 | Unknown

• 1 other identifier: Vertebral fractures RA ,AS
• Study Type: observational
• Target: 93
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study of prevalence of subclinical vertebral fractures in Rheumatoid Arthritis and Ankylosing spondylitis

Conditions

Vertebral Fracture

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

RA group

DEXA scan X\_rays lumber, dorsal spine

Device: DEXA scan,X_ray

AS group

DEXA scan X\_rays lumber, dorsal spine

Device: DEXA scan,X_ray

Control group

DEXA scan X\_rays lumber, dorsal spine

Device: DEXA scan,X_ray

Interventions

DEXA scan,X_ray DEVICE

DEXA scan detect osteoporosis ,X\_ray show subclinical vertebral fractures

AS group; Control group; RA group

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

RA patients Age from 25 to 45 AS patients age from 25 to 45 Healthy people age from 25 to 45

You may qualify if:

• Patients fulfilling ACR/EULAR 2010 rheumatoid arthritis classification criteria.
• Patients diagnosed as ankylosing spondylitis according to ASAS criteria (2000). Age (18-50).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (15)

• 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.

  PMID: 34118911 BACKGROUND

• 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.

  PMID: 30039267 BACKGROUND

• 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.

  PMID: 33878877 BACKGROUND

• 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.

  PMID: 32605401 BACKGROUND

• 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.

  PMID: 28425085 BACKGROUND

• 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.

  PMID: 31691041 BACKGROUND

• 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.

  PMID: 34615639 BACKGROUND

• 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.

  PMID: 10371282 BACKGROUND

• 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.

  PMID: 18791749 BACKGROUND

• 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.

  PMID: 29390254 BACKGROUND

• 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.

  PMID: 26524708 BACKGROUND

• 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.

  PMID: 33459805 BACKGROUND

• 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.

  PMID: 26349789 BACKGROUND

• 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.

  PMID: 35501709 BACKGROUND

• 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.

  PMID: 23592710 BACKGROUND

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Doaa ABDELHAFEZ, Associte prof

  Yes

  STUDY DIRECTOR

• REEM RAMADAN, Dr

  Yes

  STUDY DIRECTOR

Central Study Contacts

BASMA NAGEH, RD

CONTACT

01070664417; bbsam6883@gmail.com

SAFAA MAHRAN, Prof

CONTACT

01003385106; safaa.mahran@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: October 23, 2023

Record last verified: 2023-10