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AzTrials

Vertebral FractureNCT06092775

Prevalence of Subclinical Vertebral Fractures in Rheumatoid Arthritis and Ankylosing Spondylitis

An observational study of Vertebral Fracture, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Study of prevalence of subclinical vertebral fractures in Rheumatoid Arthritis and Ankylosing spondylitis Read more about this study

Who is it for?
Ages 25 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Vertebral Fracture
What is being tested?
DEXA scan,X_ray
Type of treatment
Medical device
How many people
93 participants
Where
No sites listed yet
Study dates
Dec 2023to Jan 2025
Phase
Observational
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 25 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: RA patients Age from 25 to 45 AS patients age from 25 to 45 Healthy people age from 25 to 45

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

BASMA NAGEH, RD contact

01070664417

bbsam6883@gmail.com

SAFAA MAHRAN, Prof contact

01003385106

safaa.mahran@aun.edu.eg

About this study

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

Read the detailed description

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

Being tested
DEXA scan,X_ray
Medical subject headings
Spinal Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DEXA scan,X_rayDevice

    DEXA scan detect osteoporosis

    ,X_ray show subclinical vertebral fractures

Study groups in NCT06092775
Study groupRoleWhat they receive
RA groupDEXA scan X_rays lumber, dorsal spine
Receives: Device: DEXA scan,X_ray
AS groupDEXA scan X_rays lumber, dorsal spine
Receives: Device: DEXA scan,X_ray
Control groupDEXA scan X_rays lumber, dorsal spine
Receives: Device: DEXA scan,X_ray

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study startDec 2023 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionJan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
93 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06092775
Sponsor's protocol ID
Vertebral fractures RA ,AS
Status last verified
Oct 2023
First submitted
16 Oct 2023
Last updated
23 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34118911

  • 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.

    PubMed 30039267

  • 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.

    PubMed 33878877

  • 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.

    PubMed 32605401

  • 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.

    PubMed 28425085

  • 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.

    PubMed 31691041

  • 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.

    PubMed 34615639

  • 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.

    PubMed 10371282

  • 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.

    PubMed 18791749

  • 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.

    PubMed 29390254

  • 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.

    PubMed 26524708

  • 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.

    PubMed 33459805

  • 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.

    PubMed 26349789

  • 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.

    PubMed 35501709

  • 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.

    PubMed 23592710

Questions about this trial

What is this clinical trial studying?

An observational study of Vertebral Fracture, run by Assiut University.

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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact BASMA NAGEH, RD (01070664417, bbsam6883@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of prevalence of subclinical vertebral fractures in RA ,AS and control group (time frame: Baseline). 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 NCT06092775, which also lists 15 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 23 Oct 2023.

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