Hearing LossNCT03895333
Hearing Loss and Osteoporosis
An observational study of Hearing Loss and Osteoporosis, Postmenopausal, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Hearing Loss, Osteoporosis, Postmenopausal
- What is being tested?
- Audiological profiling and bone mineral densitometry measurement
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Adult
Study population: Postmenopausal women who had hearing test between the ages of 45-60 formed the study group
Who may be able to join
- Between 45-60 years
- postmenopausal women
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 33404
About this study
Official title: 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.
- Conditions
- Hearing Loss, Osteoporosis, Postmenopausal
- Being tested
- Audiological profiling and bone mineral densitometry measurement
- Keywords
- Bone mineral density, Postmenopause
- Medical subject headings
- Hearing Loss, Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiological profiling and bone mineral densitometry measurementOther
bone mineral densitometry measurements and hearing test patients, osteoporosis according to whether the hearing test will be analyzed.
| Study group | Role | What they receive |
|---|---|---|
| study group | women with hearing loss and osteoporosis will develop the study group. Receives: Other: Audiological profiling and bone mineral densitometry measurement | |
| control group | women who have hearing loss but have no osteoporosis will constitute the control group. Receives: Other: Audiological profiling and bone mineral densitometry measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
hearing test results
hearing test results will be examined; Hearing loss result: test passed or test will be recorded as not passed.
Measured: 1 week
bone mineral densitometry measurements
bone mineral densitometry measurements of patients with hearing test. those with bone loss will be evaluated as osteoporosis.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Mar 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895333
- Sponsor's protocol ID
- 2019.01.01
- Status last verified
- Apr 2020
- First submitted
- 26 Mar 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audiological Profiling in Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT03895333
- Acronym / sponsor ID
- 2019.01.01
- Conditions
- Hearing Loss, Osteoporosis, Postmenopausal
- Keywords
- Bone mineral density, Postmenopause
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Other: Audiological profiling and bone mineral densitometry measurementwomen with hearing loss and osteoporosis will develop the study group. |
| control group | – | Other: Audiological profiling and bone mineral densitometry measurementwomen who have hearing loss but have no osteoporosis will constitute the control group. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Postmenopausal women who had hearing test between the ages of 45-60 formed the study group
Key inclusion criteria (2 listed)
- Between 45-60 years
- postmenopausal women
Key exclusion criteria (8 listed)
- Women over 60 years old,
- acute or chronic otitis media,
- ear surgery,
- use of ototoxic drugs,
- congenital hearing loss,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiological profiling and bone mineral densitometry measurementbone mineral densitometry measurements and hearing test patients, osteoporosis according to whether the hearing test will be analyzed. | Other | control group, study group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss and Osteoporosis, Postmenopausal, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hearing test results (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.