15-Hydroxyprostaglandin Dehydrogenase in Osteoarthritis and Ankylosing Spondylitis: Associations With Clinical and Musculoskeletal Ultrasound Features.
| Registry | NCT07751263, acronym HPGD-OA-AS-US |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 51 (Estimated) |
| Sponsor | Assiut University (Other) |
| Conditions | Osteoarthritis, Ankylosing Spondylitis |
| Dates | start 2026-08-02 (estimated), primary completion 2027-08-02 (estimated), completion 2028-08-02 (estimated), first posted 2026-08-07, last updated 2026-08-07 |
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All trials for Osteoarthritis All trials for Ankylosing Spondylitis
To evaluate serum and synovial fluid 15-PGDH levels in patients with osteoarthritis and ankylosing spondylitis and determine their associations with clinical and musculoskeletal ultrasound features.
To compare 15-PGDH concentrations among patients with knee osteoarthritis, and ankylosing spondylitis with knee effusion
To evaluate whether serum 15-PGDH reflects intra-articular 15-PGDH concentrations.
Analysis the level of 15-PGDH in relation to disease activity and severity of both diseases.
Osteoarthritis (OA) and Ankylosing Spondylitis (AS) are chronic musculoskeletal disorders with different pathophysiology, clinical manifestations, and management strategies. OA is a degenerative joint disease in which inflammation also contributes to symptom severity and structural progression, while AS is a chronic inflammatory spondyloarthropathy characterized by axial inflammation and, in some patients, peripheral arthritis.
Prostaglandin E2 (PGE2) is a key mediator involved in pain, inflammation, and tissue remodeling in musculoskeletal disease. 15-hydroxyprostaglandin dehydrogenase (15-PGDH) is the major enzyme responsible for degradation of prostaglandins, especially PGE2, and therefore acts as an important regulator of prostaglandin activity in the joint microenvironment. In inflammatory arthritis, synovial studies have shown that 15-PGDH is present in healthy and inflamed synovial tissue, mainly in lining macrophages, fibroblasts, and vessels, supporting a possible role in local inflammatory regulation.
In osteoarthritis, experimental evidence indicates that 15-PGDH is biologically relevant to cartilage degeneration and repair, and inhibition of 15-PGDH may promote cartilage regeneration and reduce OA-associated pain. These findings support the rationale for investigating 15-PGDH as a biomarker in OA and AS.
Musculoskeletal ultrasound is a valuable non-invasive imaging tool in rheumatology and can detect synovial hypertrophy, effusion, and power Doppler activity. EULAR has published recommendations for standardized ultrasound procedures and reporting in rheumatic and musculoskeletal diseases, supporting its use in this study.
Accordingly, this study will assess serum and synovial fluid 15-PGDH levels in patients with OA and AS and examine their correlation with clinical and musculoskeletal ultrasound features.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| • Arm 1: Osteoarthritis • Arm 2: Ankylosing spondylitis • Arm 3: Healthy controls | Three analytical study arms: OA, AS, and control groups. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria:
* Inclusion criteria
* Adults aged 18 years or older. AxSpA group Patients diagnosed as ankylosing spondylitis according to ASAS criteria . R OA group
* Adults with osteoarthritis Diagnosed according to the American College of Rheumatology classification criteria.\[8\]R ACR Clinical classification criteria for Osteoarthritis of the hip ACR Clinical classification criteria for Osteoarthritis of the knee ACR Clinical classification criteria for Osteoarthritis of the hand Control group Age- and sex-matched healthy controls.
Exclusion Criteria:
* • Other inflammatory arthritides such as psoriatic arthritis, gout, or SLE-related arthritis.
* Septic arthritis or suspected joint infection.
* Recent intra-articular steroid injection if it may influence biomarker results.
* Any major systemic illness likely to affect biomarker measurement or ultrasound interpretation.
* Patients received certain drugs as non-steroidal anti-inflammatory drugs (NSAIDs)