- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03895333
Hearing Loss and Osteoporosis
April 25, 2020 updated by: Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
Audiological Profiling in Postmenopausal Women With Osteoporosis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
160
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey, 33404
- Kanuni Sultan Suleyman Training and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 60 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Postmenopausal women who had hearing test between the ages of 45-60 formed the study group
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
study group
women with hearing loss and osteoporosis will develop the study group.
|
bone mineral densitometry measurements and hearing test patients, osteoporosis according to whether the hearing test will be analyzed.
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control group
women who have hearing loss but have no osteoporosis will constitute the control group.
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bone mineral densitometry measurements and hearing test patients, osteoporosis according to whether the hearing test will be analyzed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hearing test results
Time Frame: 1 week
|
hearing test results will be examined; Hearing loss result: test passed or test will be recorded as not passed.
|
1 week
|
bone mineral densitometry measurements
Time Frame: 1 week
|
bone mineral densitometry measurements of patients with hearing test.
those with bone loss will be evaluated as osteoporosis.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2019
Primary Completion (Actual)
March 1, 2020
Study Completion (Actual)
March 1, 2020
Study Registration Dates
First Submitted
March 26, 2019
First Submitted That Met QC Criteria
March 27, 2019
First Posted (Actual)
March 29, 2019
Study Record Updates
Last Update Posted (Actual)
April 28, 2020
Last Update Submitted That Met QC Criteria
April 25, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019.01.01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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