NCT03895333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

March 26, 2019

Last Update Submit

April 25, 2020

Conditions

Keywords

Bone mineral densityPostmenopause

Outcome Measures

Primary Outcomes (2)

  • hearing test results

    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

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

    1 week

Study Arms (2)

study group

women with hearing loss and osteoporosis will develop the study group.

Other: Audiological profiling and bone mineral densitometry measurement

control group

women who have hearing loss but have no osteoporosis will constitute the control group.

Other: Audiological profiling and bone mineral densitometry measurement

Interventions

bone mineral densitometry measurements and hearing test patients, osteoporosis according to whether the hearing test will be analyzed.

control groupstudy group

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Postmenopausal women who had hearing test between the ages of 45-60 formed the study group

You may qualify if:

  • Between 45-60 years
  • postmenopausal women

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hearing LossOsteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, M.D, Department of Obstetrics and GynecologyR

Study Record Dates

First Submitted

March 26, 2019

First Posted

March 29, 2019

Study Start

March 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

April 28, 2020

Record last verified: 2020-04

Locations