Last reviewed · How we verify
NCT03237455
Magnetic Resonance Imaging in High Risk Patients for the Development of Diffuse Idiopathic Skeletal Hyperostosis (DISH)
NA trial testing Thoracic spine x-rays+whole spine MRI in Hyperostosis, Diffuse Idiopathic Skeletal in 30 participants. Status unknown.
30 December 2022
Quick facts
| Lead sponsor | HaEmek Medical Center, Israel |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | diagnostic |
| Enrollment | 30 |
| Start date | 1 August 2018 |
| Primary completion | 30 December 2022 |
| Estimated completion | 30 December 2022 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- Thoracic spine x-rays+whole spine MRI
- blood tests — full drug profile →
- constitutional and demographic data collection
Conditions studied
- Hyperostosis, Diffuse Idiopathic Skeletal — all drugs for Hyperostosis, Diffuse Idiopathic Skeletal →
- Metabolic Syndrome — all drugs for Metabolic Syndrome →
- Diabetes Mellitus — all drugs for Diabetes Mellitus →
Sponsor
HaEmek Medical Center, Israel
Who can join
Adults 40 to 49, any sex, with Hyperostosis, Diffuse Idiopathic Skeletal or Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03237455
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other HaEmek Medical Center, Israel trials
Trials by the same sponsor.
- NCT06656286 — Hysteroscopic Intrauterine Suturing · NA · not yet recruiting
- NCT06803992 — Induction of Labor - Comparison Propess With Prostaglandin E2 Vaginal Gel and Balloon Catheter · Phase 4 · recruiting
- NCT06542367 — Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and "TachoSil" · NA · not yet recruiting
- NCT05732155 — Preliminary Effectiveness of Individual and Group MDMA-assisted Therapy for Israeli Veterans With PTSD and Moral Injury. · Phase 2 · unknown
- NCT05933018 — Night Hyperglycemia and Fatty Liver in Type 1 Diabetes · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03237455 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by HaEmek Medical Center, Israel
- Last refreshed: 9 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03237455.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing