Prevalence of Subclinical Vertebral Fractures in Rheumatoid Arthritis and Ankylosing Spondylitis

NCT ID: NCT06092775

Last Updated: 2023-10-23

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-31

Study Completion Date

2025-01-31

Brief Summary

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

Detailed Description

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Detection of the prevalence of subclinical vertebral fractures in Rheumatoid Arthritis and Ankylosing spondylitis Study the relation between vertebral fractures and some clinical data like demographics data, disease duration and disease severity

Conditions

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Vertebral Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RA group

DEXA scan X\_rays lumber, dorsal spine

DEXA scan,X_ray

Intervention Type DEVICE

DEXA scan detect osteoporosis

,X\_ray show subclinical vertebral fractures

AS group

DEXA scan X\_rays lumber, dorsal spine

DEXA scan,X_ray

Intervention Type DEVICE

DEXA scan detect osteoporosis

,X\_ray show subclinical vertebral fractures

Control group

DEXA scan X\_rays lumber, dorsal spine

DEXA scan,X_ray

Intervention Type DEVICE

DEXA scan detect osteoporosis

,X\_ray show subclinical vertebral fractures

Interventions

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DEXA scan,X_ray

DEXA scan detect osteoporosis

,X\_ray show subclinical vertebral fractures

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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BASMA ZARIEF NAGEH FAHMY

Resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Doaa ABDELHAFEZ, Associte prof

Role: STUDY_DIRECTOR

Yes

REEM RAMADAN, Dr

Role: STUDY_DIRECTOR

Yes

Central Contacts

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BASMA NAGEH, RD

Role: CONTACT

01070664417

SAFAA MAHRAN, Prof

Role: CONTACT

01003385106

References

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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.

Reference Type BACKGROUND
PMID: 34118911 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30039267 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33878877 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32605401 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28425085 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31691041 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34615639 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10371282 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18791749 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29390254 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26524708 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33459805 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26349789 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35501709 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23592710 (View on PubMed)

Other Identifiers

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Vertebral fractures RA ,AS

Identifier Type: -

Identifier Source: org_study_id

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