Investigating the Relationship Between Temporal Bone CT, Bone Density, and Hearing Loss in Otosclerosis Patients

İbrahim Emir Yeşil

Status: Enrolling

Conditions: Vitamin D Deficiency; Otosclerosis of Middle Ear; Bone Density

Study type: Observational

Funder types: Other

Identifiers

NCT06830187

HacettepeU-SBA 24/365

Details and patient eligibility

About

The goal of this observational case-control study is to evaluate the relationship between temporal bone computed tomography (CT) findings, bone mineral density (BMD), and audiological parameters in adults diagnosed with otosclerosis. The main questions it aims to answer are:

Is there a correlation between temporal bone CT density values and the severity of hearing loss in otosclerosis? Do bone mineral density and serum vitamin D levels differ between otosclerosis patients and individuals without otosclerosis? Researchers will compare patients diagnosed with otosclerosis to a control group without otosclerosis to determine if CT-based density variations are associated with disease severity and systemic bone metabolism markers.

Participants who have already had a temporal bone CT scan as part of their routine clinical evaluation will undergo:

Bone mineral density (BMD) assessment via dual-energy X-ray absorptiometry (DEXA) Serum vitamin D level measurement Audiological testing, including pure tone audiometry and speech discrimination tests This study aims to improve the diagnostic and prognostic understanding of otosclerosis by integrating imaging, metabolic, and audiological data.

Enrollment: 86 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Otosclerosis Group):

• Adults diagnosed with otosclerosis based on audiological and clinical assessment
• Patients with available high-resolution CT scans and audiological data
• Individuals who have undergone stapedectomy or stapedotomy surgery
• Availability of bone mineral density and serum vitamin D data

Inclusion Criteria (Control Group):

• Patients without otosclerosis but with temporal CT imaging for other indications
• No history of conductive or mixed hearing loss
• Availability of BMD and vitamin D data

Exclusion Criteria:

• History of primary metabolic bone diseases (osteoporosis, Paget's disease)
• Use of medications affecting bone metabolism (bisphosphonates, corticosteroids)
• History of chronic otitis media or prior ear surgeries
• Patients who received head and neck radiotherapy

Trial design

86 participants in 2 patient groups

Otosclerosis Group

Description:

Participants diagnosed with otosclerosis based on clinical and audiological criteria. These individuals have undergone or are planned for stapedectomy or stapedotomy surgery. High-resolution CT scans and bone metabolism markers will be analyzed to assess correlations with disease severity.

Control Group

Description:

Individuals without otosclerosis who have undergone temporal bone CT imaging for unrelated reasons. They have no history of conductive or mixed hearing loss. Their imaging and metabolic parameters will be compared with those of the otosclerosis patients to identify significant differences.