The Serum Sclerostin Levels in Cholesteatoma Patients

Cholesteatoma Clinical Trial

Official title:

The Serum Sclerostin Levels in Cholesteatoma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03954288
• Other study ID #: AbantIBU-Biochem-OMY-2
• Status: Recruiting
• Start date: March 29, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: May 2019
• Source: Abant Izzet Baysal University
• Contact: özgür m yis
• Phone: 05324940572
• Email: dromyis[@]mynet.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: March 15, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

cholesteatoma chronic otitis media

Exclusion Criteria:

Acute infection Malignancy

Related Conditions & MeSH terms

• Cholesteatoma
• Otitis
• Otitis Media
• Otitis Media Chronic

Intervention

Diagnostic Test:
• serum for sclerostin ELISA test
Blood sample to measure serum sclerostin level

Locations

Country	Name	City	State
Turkey	Özgür Mehmet Yis	Bolu	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of the levels of sclerostin in cholesteatoma at 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.	1 month