The Serum Sclerostin Levels in Cholesteatoma Patients

• Conditions: Cholesteatoma; Otitis Media Chronic
• Interventions: Diagnostic Test: serum for sclerostin ELISA test

• Registration Number: NCT03954288
• Lead Sponsor: Abant Izzet Baysal University

Brief Summary

The aim of this study is to investigate the levels of sclerostin in patients with cholesteatoma. So far, there is no study showing the levels of sclerostin in cholesteatoma. The investigators hope that the results of our study will start new processes that can be used in the clinic.

Detailed Description

Chronic otitis media (COM) is the perforation of the eardrum and mucosal inflammation of the space in the middle ear and the air cavities of the temporal bone over a period of three months. Although COM is defined as a multifactorial disease, its etiopathogenesis has not been fully elucidated. Cholesteatoma is a condition that disrupts the balance between bone formation and resorption in COM. The cholesteatoma is a destructive squamous epithelial lesion of temporal bone, it gradually expands and leads to serious complications by the destruction of near bone structures, ossicular chain and otic capsule. A growing debate examines the role of bone formation and destruction with osteoblasts, osteocytes and osteoclast cells in cholesteatoma formation. Sclerostin is a glycoprotein that plays a role in the regulation of bone metabolism secreted by osteocytes. Antibodies directed against sclerostin stimulate bone formation and represent a new therapeutic option for the treatment of increased bone resorption diseases, such as osteoporosis and generalized bone loss, inflammatory diseases with cartilage damage. The aim of this study is to investigate the levels of sclerostin in patients with cholesteatoma. So far, there is no study showing the levels of sclerostin in cholesteatoma. The investigators hope that the results of our study will start new processes that can be used in the clinic.

Study Timeline

• Study Start: 2019-03-29
• Study First Submitted: 2019-04-30
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-17
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-21
• Primary Completion: 2020-02-15
• Study Completion: 2020-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

cholesteatoma chronic otitis media

Exclusion Criteria

Acute infection Malignancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chronic otitis media	serum for sclerostin ELISA test	patients with chronic otitis media without cholesteatoma
control	serum for sclerostin ELISA test	patients scheduled to operation with diagnosis of other causes
cholesteatoma	serum for sclerostin ELISA test	patients with chronic otitis media whose cholesteatoma

Primary Outcome Measures

Name	Time	Method
change of the levels of sclerostin in cholesteatoma at 1 month	1 month	So far, there is no study showing the levels of sclerostin in cholesteatoma. The investigators hope that the results of our study will initiate new processes that can be used in clinical applications.

Trial Locations

Locations (1)

Özgür Mehmet Yis; 🇹🇷 Bolu, Merkez, Turkey