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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03895333
Other study ID # 2019.01.01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date March 1, 2020

Study information

Verified date April 2020
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To compare the audiological profiles in postmenopausal women with and without osteoporosis and to examine the pattern of hearing loss in osteoporotic patients. postmenopausal women will be separated as normal, osteopenic and osteoporotic according to bone mineral densitometry results. The evaluation of hearing test will be done in these groups and the results will be compared between the groups.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers
Gender Female
Age group 45 Years to 60 Years
Eligibility Inclusion Criteria:

- Between 45-60 years

- postmenopausal women

Exclusion Criteria:

- Women over 60 years old,

- acute or chronic otitis media,

- ear surgery,

- use of ototoxic drugs,

- congenital hearing loss,

- previous long-term steroid use,

- malignant or benign neoplasm of the brain,

- Patients with a history of exposure to noise were excluded from the study.

Study Design


Intervention

Other:
Audiological profiling and bone mineral densitometry measurement
bone mineral densitometry measurements and hearing test patients, osteoporosis according to whether the hearing test will be analyzed.

Locations

Country Name City State
Turkey Kanuni Sultan Süleyman Training and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary hearing test results hearing test results will be examined; Hearing loss result: test passed or test will be recorded as not passed. 1 week
Primary bone mineral densitometry measurements bone mineral densitometry measurements of patients with hearing test. those with bone loss will be evaluated as osteoporosis. 1 week
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