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Recruiting NCT06830187

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

— Observational Otosclerosis of Middle Ear Bone Density Vitamin D Deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Otosclerosis of Middle Ear, Bone Density, Vitamin D Deficiency. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Radiological and Audiological Correlation in Otosclerosis: a Prospective Case-Control Study Evaluating Temporal Bone CT, Bone Mineral Density, and Hearing Loss

Overview

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.

Primary outcome measures

  • Temporal Bone CT Density Measurements [Time frame: Baseline (Preoperative assessment)]
  • Pure Tone Audiometry (PTA) Thresholds [Time frame: Baseline (Preoperative assessment)]
  • Air-Bone Gap (ABG) Measurement [Time frame: Baseline (Preoperative assessment)]
  • Bone Mineral Density (BMD) Scores [Time frame: Baseline (Preoperative assessment)]
  • Serum Vitamin D Levels [Time frame: Baseline (Preoperative assessment)]
Secondary outcome measures (2)
  • Correlation Between CT Density and Audiological Parameters [Time frame: Baseline (Preoperative assessment)]
  • Association Between Otosclerosis Severity and BMD/Vitamin D Levels [Time frame: Baseline (Preoperative assessment)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Hacettepe University Hospitals — Ankara

Identifiers

NCT: NCT06830187 · HacettepeU-SBA 24/365

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗