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

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ClinicalTrials.gov Identifier: NCT03237455
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
The Chaim Sheba Medical Center
Information provided by (Responsible Party):
Reuven Mader, HaEmek Medical Center, Israel

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.

Condition or disease Intervention/treatment Phase
Hyperostosis, Diffuse Idiopathic Skeletal Metabolic Syndrome Diabetes Mellitus Diagnostic Test: Thoracic spine x-rays+whole spine MRI Diagnostic Test: blood tests Other: constitutional and demographic data collection Not Applicable

Detailed Description:

Patient's selection- Patients will be recruited from obesity/metabolic/diabetes clinics and from bariatric surgeries clinics. All patients will have the diagnosis of metabolic syndrome National Cholesterol Education Panel III (NCEP). Patients in their 5th decade of life will be recruited for the study. This study group will have to meet the NCEP 3 criteria for metabolic syndrome and/or have type 2 diabetes mellitus (9). An age and sex matched individuals who do not meet these pre-requisits will serve as a control group.

All asymptomatic patients will undergo postero-anterior and lateral x-rays of the thoracic spine, unless they have postero-anterior or lateral thoracic spine or chest x-rays in the year preceding the recruitment. For patients with back pain, addition of cervical or lumbar spine radiographs will be permitted based on the physician judgement. Patients recruited for the study will have a total spine and sacroiliac MRI (see below) read by radiologists and rheumatologists, expert in musculoskeletal imaging, who will be blinded for the patient's data. The readings of the radiographs and the MRI will be performed in a random order.

All patients and controls will undergo postero anterior and lateral thoracic spine X-rays and MRI of the entire spine and their sacroiliac joints (Spine: sagittal T1-weighted and T2 with fat suppression sequences, SIJ semicoronal T1-weighted and T2 with fat suppression sequences) at study entry.

An accepted scoring system for the interpretation of the MRI studies will be employed for both the spine and the sacroiliac joints.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: case control study
Masking: Single (Outcomes Assessor)
Masking Description: Reader of the MRI studies will be blinded to the patients diagnoses
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Imaging in High Risk Patients for the Development of Diffuse Idiopathic Skeletal Hyperostosis (DISH)
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Experimental: study group
Thoracic spine x-rays+whole spine MRI blood tests constitutional and demographic data collection
Diagnostic Test: Thoracic spine x-rays+whole spine MRI
PA radiographs of the thoracic spine and MRI of the whole spine and sacroiliac joints
Other Name: imaging

Diagnostic Test: blood tests
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.
Other Name: laboratory

Other: constitutional and demographic data collection
demographics, concomitant diseases (in particular type 2 DM, hypertension, hyperlipidemia) concomitant medications, height and weight (BMI), waist circumference
Other Name: data

Active Comparator: control group
Thoracic spine x-rays+whole spine MRI blood tests constitutional and demographic data collection
Diagnostic Test: Thoracic spine x-rays+whole spine MRI
PA radiographs of the thoracic spine and MRI of the whole spine and sacroiliac joints
Other Name: imaging

Diagnostic Test: blood tests
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.
Other Name: laboratory

Other: constitutional and demographic data collection
demographics, concomitant diseases (in particular type 2 DM, hypertension, hyperlipidemia) concomitant medications, height and weight (BMI), waist circumference
Other Name: data




Primary Outcome Measures :
  1. Inflammatory changes in the spine and/or sacroiliac joints [ Time Frame: 6 months ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Age 40-49 years

Exclusion Criteria:

  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237455


Contacts
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Contact: Reuven Mader, MD 972-4-6494354 mader_r@clalit.org.il
Contact: Irina Novofastovski, MD 972-4-6494354 irina_no@clalit.org.il

Locations
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Israel
HaEmek MC and Chaim Sheba MC Recruiting
Afula, Israel, 18101
Contact: Reuven Mader, MD    972-4-6494354    mader_r@clalit.org.il   
Contact: Irina Novofastovski, MD    972-4-6494354    Irina_no@clalit.org.il   
Sub-Investigator: Irina Novofastovski, MD         
Sub-Investigator: Abdallah Fawaz, MD         
Sub-Investigator: Amir Bieber, MD         
Sub-Investigator: Iris Eshed, MD         
Principal Investigator: Reuven Mader, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
The Chaim Sheba Medical Center
Investigators
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Principal Investigator: Reuven Mader, MD HaEmek MC
Publications:
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.

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Responsible Party: Reuven Mader, Associate clinical professor, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT03237455    
Other Study ID Numbers: 0102-17-EMC
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Other researchers are expected to perform the study in their own countries. If they perform the study, unidentified data from the present study will be processed with the other parties data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperostosis
Hyperostosis, Diffuse Idiopathic Skeletal
Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Bone Diseases
Musculoskeletal Diseases
Spinal Osteophytosis
Spinal Diseases