Hearing Loss and Osteoporosis

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03895333
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 13.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss; Osteoporosis, Postmenopausal	Other: Audiological profiling and bone mineral densitometry measurement

Study Design

• Study Type: Observational
• Actual Enrollment: 160 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Audiological Profiling in Postmenopausal Women With Osteoporosis
• Actual Study Start Date: Mar 1, 2019
• Actual Primary Completion Date: Mar 1, 2020
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
study group women with hearing loss and osteoporosis will develop the study group.	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.
control group women who have hearing loss but have no osteoporosis will constitute the control group.	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.

Outcome Measures

Primary Outcome Measures

1. hearing test results [1 week]

   hearing test results will be examined; Hearing loss result: test passed or test will be recorded as not passed.

2. bone mineral densitometry measurements [1 week]

   bone mineral densitometry measurements of patients with hearing test. those with bone loss will be evaluated as osteoporosis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 60 Years
• Sexes Eligible for Study: Female

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kanuni Sultan Süleyman Training and Research Hospital	Istanbul		Turkey	33404

Sponsors and Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pınar Kadirogulları, Principal investigator, M.D, Department of Obstetrics and GynecologyR, Kanuni Sultan Suleyman Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT03895333
• Other Study ID Numbers: 2019.01.01
• First Posted: Mar 29, 2019
• Last Update Posted: Apr 28, 2020
• Last Verified: Apr 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pınar Kadirogulları, Principal investigator, M.D, Department of Obstetrics and GynecologyR, Kanuni Sultan Suleyman Training and Research Hospital: Bone mineral density; Postmenopause
• Additional relevant MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Hearing Loss; Deafness

Study Results

No Results Posted as of Apr 28, 2020