Magnetic Resonance Imaging in High Risk Patients for the Development of Diffuse Idiopathic Skeletal Hyperostosis (DISH)

NCT03237455 | Unknown

• 1 other identifier: 0102-17-EMC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Diffuse idiopathic skeletal hyperostosis (DISH) is a poorly understood, systemic condition characterized by progressive calcification and ossification of ligaments and entheses. The current classification criteria allow diagnosing the disease in its late course, when significant bony overgrowth already involves the vertebral column and the appendicular skeleton. The research of the pathogenic mechanisms in DISH, is significantly hampered by the late diagnosis resulting from this definition.Based on recent MRI studies in both axial spondyloarthritis (axSpA) and in DISH, it seems that changes similar to the classical early inflammatory changes described in axSpA, can be detected in patients with DISH. We therefore hypothesize, that patients with metabolic syndrome without radiographic evidence for spinal DISH, might exhibit early MRI changes. If this hypothesis proves to be correct, early diagnosis and research of the possible pathogenetic mechanisms at this early stage might be very rewarding in investigations of the early aberrations of the entheses homeostasis and eventually early, more targeted therapeutic interventions. The study will examine MRI changes in patients, in their 5th decade of life, with high risk for the development of DISH (ie diabetes mellitus, metabolic syndrome) compared with patients who don't have this risk.

Conditions

Hyperostosis, Diffuse Idiopathic Skeletal; Metabolic Syndrome; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Inflammatory changes in the spine and/or sacroiliac joints

  inflammatory bone marrow edema lesions and fatty lesions and the anterior and posterior corners of the spine (Berlin score) as well as for the presence of enthesitis on the posterior elements. The sacroiliac joints will also be scored according to the Berlin scoring method for the presence of acute and structural inflammatory lesion, including BME, fat metaplasia, erosions, sclerosis, ankylosis. Anterior and posterior extraarticular enthesitis will also be registered

  6 months

Study Arms (2)

study group

EXPERIMENTAL

Thoracic spine x-rays+whole spine MRI blood tests constitutional and demographic data collection

Diagnostic Test: Thoracic spine x-rays+whole spine MRI; Diagnostic Test: blood tests; Other: constitutional and demographic data collection

control group

ACTIVE COMPARATOR

Thoracic spine x-rays+whole spine MRI blood tests constitutional and demographic data collection

Diagnostic Test: Thoracic spine x-rays+whole spine MRI; Diagnostic Test: blood tests; Other: constitutional and demographic data collection

Interventions

Thoracic spine x-rays+whole spine MRI DIAGNOSTIC_TEST

PA radiographs of the thoracic spine and MRI of the whole spine and sacroiliac joints

Also known as: imaging

control group; study group

blood tests DIAGNOSTIC_TEST

blood chemistry including total cholesterol, LDL HDL, CBC, HbA1C, fasting glucose, TG, and insulin levels, HLA-B27, 2 vials of frozen serum for future studies.

Also known as: laboratory

control group; study group

constitutional and demographic data collection OTHER

demographics, concomitant diseases (in particular type 2 DM, hypertension, hyperlipidemia) concomitant medications, height and weight (BMI), waist circumference

Also known as: data

control group; study group

Eligibility Criteria

• Age: 40 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Meet the NCEP 3 criteria for metabolic syndrome and/or have type 2 diabetes mellitus (9).
• Age 40-49 years

You may not qualify if:

• ESR and CRP levels above common levels adjusted for age, gender, and weight.(I have ref for the determination of common CRP levels).
• Positive HLA B-27 Personal or family history of Spondyloarthritis, psoriasis or inflammatory arthritis (past or present) Inflammatory back pain as defined by the ASAS definition (age at onset \<40y, insidious onset, improvement with exercise, no improvement with rest, pain at night with improvement upon getting up = IBP if 4/5 items are present) (Ref) History of uveitis Plain radiographs with evidence for DISH

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead
• The Chaim Sheba Medical Center: collaborator

Study Sites (1)

HaEmek MC and Chaim Sheba MC

Afula, 18101, Israel

RECRUITING

Related Publications (10)

• Mader R, Verlaan JJ, Buskila D. Diffuse idiopathic skeletal hyperostosis: clinical features and pathogenic mechanisms. Nat Rev Rheumatol. 2013 Dec;9(12):741-50. doi: 10.1038/nrrheum.2013.165. Epub 2013 Nov 5.

  PMID: 24189840 BACKGROUND

• Mader R, Novofestovski I, Adawi M, Lavi I. Metabolic syndrome and cardiovascular risk in patients with diffuse idiopathic skeletal hyperostosis. Semin Arthritis Rheum. 2009 Apr;38(5):361-5. doi: 10.1016/j.semarthrit.2008.01.010. Epub 2008 Mar 4.

  PMID: 18304611 BACKGROUND

• Mader R, Buskila D, Verlaan JJ, Atzeni F, Olivieri I, Pappone N, Di Girolamo C, Sarzi-Puttini P. Developing new classification criteria for diffuse idiopathic skeletal hyperostosis: back to square one. Rheumatology (Oxford). 2013 Feb;52(2):326-30. doi: 10.1093/rheumatology/kes257. Epub 2012 Sep 29.

  PMID: 23024057 BACKGROUND

• Weiss BG, Bachmann LM, Pfirrmann CW, Kissling RO, Zubler V. Whole Body Magnetic Resonance Imaging Features in Diffuse Idiopathic Skeletal Hyperostosis in Conjunction with Clinical Variables to Whole Body MRI and Clinical Variables in Ankylosing Spondylitis. J Rheumatol. 2016 Feb;43(2):335-42. doi: 10.3899/jrheum.150162. Epub 2015 Dec 15.

  PMID: 26669910 BACKGROUND

• Mader R, Novofastovski I, Iervolino S, Pavlov A, Chervinsky L, Schwartz N, Pappone N. Ultrasonography of peripheral entheses in the diagnosis and understanding of diffuse idiopathic skeletal hyperostosis (DISH). Rheumatol Int. 2015 Mar;35(3):493-7. doi: 10.1007/s00296-014-3190-0. Epub 2014 Dec 13.

  PMID: 25503650 BACKGROUND

• Arad U, Elkayam O, Eshed I. Magnetic resonance imaging in diffuse idiopathic skeletal hyperostosis: similarities to axial spondyloarthritis. Clin Rheumatol. 2017 Jul;36(7):1545-1549. doi: 10.1007/s10067-017-3617-6. Epub 2017 Mar 31.

  PMID: 28364275 BACKGROUND

• Julkunen H, Heinonen OP, Pyorala K. Hyperostosis of the spine in an adult population. Its relation to hyperglycaemia and obesity. Ann Rheum Dis. 1971 Nov;30(6):605-12. doi: 10.1136/ard.30.6.605. No abstract available.

  PMID: 5130140 BACKGROUND

• 8. Mader R, Fawaz A, Bieber A, Novofastovski I. Diffuse idiopathic skeletal hyperostosis (DISH) of young adults: lessons to be learnt. Austin J Orthopade & Rheumatol. 2016; 3(4): 1043.

  BACKGROUND

• Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001 May 16;285(19):2486-97. doi: 10.1001/jama.285.19.2486. No abstract available.

  PMID: 11368702 BACKGROUND

• Landewe RB, Hermann KG, van der Heijde DM, Baraliakos X, Jurik AG, Lambert RG, Ostergaard M, Rudwaleit M, Salonen DC, Braun J. Scoring sacroiliac joints by magnetic resonance imaging. A multiple-reader reliability experiment. J Rheumatol. 2005 Oct;32(10):2050-5.

  PMID: 16206369 BACKGROUND

MeSH Terms

Conditions

Hyperostosis, Diffuse Idiopathic Skeletal; Metabolic Syndrome; Diabetes Mellitus

Interventions

Diagnostic Imaging; Hematologic Tests

Condition Hierarchy (Ancestors)

Hyperostosis; Bone Diseases; Musculoskeletal Diseases; Spinal Osteophytosis; Spinal Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Reuven Mader, MD

  HaEmek MC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reuven Mader, MD

CONTACT

972-4-6494354; mader_r@clalit.org.il

Irina Novofastovski, MD

CONTACT

972-4-6494354; irina_no@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Reader of the MRI studies will be blinded to the patients diagnoses
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate clinical professor

Model Details: case control study

Study Record Dates

• First Submitted: July 30, 2017
• First Posted: August 2, 2017
• Study Start: August 1, 2018
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)