Menier's Disease - Bone Density Study

Osteoporosis Clinical Trial

Official title:

Menier's Disease - Bone Density Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05322538
• Other study ID #: EMC-22-0031
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: August 2022
• Source: HaEmek Medical Center, Israel
• Contact: Yoni Evgeni Gutkovich, M.D\Ph.D
• Phone: +972-526894497
• Email: gutkovichj[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Meniere's disease is a progressive and debilitating inner ear disease characterised by vertigo and hearing loss. Several studies have linked Menierws disease with lower bone density and lower vitamin D levels. In the current prospective study definite Meniere's patients will be followed over a period of 2 year, during which repetitive measurements of bone density, vitamin D plasma levels, blood pressure as well as hearing and vestibular tests will be made. Results will be compared to healthy controls.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Definite Meniere's disease

Exclusion Criteria:

• hyperthyroidism

• hyperparathyroidism

• acromegaly

• hypogonadism

• diabetes melitus

• chronic renal failure

• alcoholism

• cushing syndrome

• rheumatoid arthritis

• systemic lupus erythematosus

• ankylosing spondylitis

• inflammatory bowel disease

• obstructive lung disease

• sarcoidosis

• amyloidosis

• celiac disease.

• chronic treatment with bisphosphonates

• chronic treatment with glucocorticoids

• chronic treatment with androgen deprivation therapy

• chronic treatment with gonadotropin releasing hormone agonist chronic treatment with aromatase inhibitor chronic treatment with loop diuretics chronic treatment with proton pump inhibitors chronic treatment with anti-seizure drugs chronic treatment with warfarin chronic treatment with SSRI chronic treatment with alpha or beta-blockers

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Meniere Disease
• Osteopenia
• Osteoporosis
• Vestibular Diseases
• Vestibular Disorder
• Vitamin D Deficiency

Intervention

Diagnostic Test:
• vitamin D plasma levels baseline
Measuring vitamin D plasma levels at baseline
• Dual-energy X-ray absorptiometry at baseline
Measuring T-score and Z-score of the femur and lumbar spine at baseline
• cervical Vestibular evoked myogenic potentials at baseline
cVEMP is a vestibular test for saccular function, an otolith organ in the inner ear. the electrical response of the stermocledomastoid muscle to saccular stimulation is measured via two distinct waves - P13 and N23. the latency, amplitude and peak to peak amplitude will be measured.
• Audiogram at baseline
hearing measurement will be performed. Hearing level in dB will be performed in the 250-8,000 Hz frequency. The test includes Speech reception threshold and word recognition score.
• Measuring Orthostatic Blood Pressure at baseline
blood pressure will be measure two minutes after lying supine and repeated 3 minutes after standing. A drop of at least 20mmHg systolic pressure or at least 10mmHg diastolic blood pressure is considered a positive test
• cold pressor test at baseline
The cold pressor test is an indicator for sympathetic system function. A rise of at least 15mmHg of systolic pressure after putting the subject's hand in cold water (4 deg Celsius) is indicative of normal sympathetic function.
• vitamin D plasma levels one year after recruitment
Measuring vitamin D plasma levels one year after recruitment
• vitamin D plasma levels two years after recruitment
Measuring vitamin D plasma levels two years after recruitment
• Dual-energy X-ray absorptiometry one year after recruitment
Measuring T-score and Z-score of the femur and lumbar spine one year after recruitment
• Dual-energy X-ray absorptiometry two years after recruitment
Measuring T-score and Z-score of the femur and lumbar spine two years after recruitment
• cervical Vestibular evoked myogenic potentials one year after recruitment
cVEMP is a vestibular test for saccular function, an otolith organ in the inner ear. the electrical response of the stermocledomastoid muscle to saccular stimulation is measured via two distinct waves - P13 and N23. the latency, amplitude and peak to peak amplitude will be measured one year after recruitment
• cervical Vestibular evoked myogenic potentials two years after recruitment
cVEMP is a vestibular test for saccular function, an otolith organ in the inner ear. the electrical response of the stermocledomastoid muscle to saccular stimulation is measured via two distinct waves - P13 and N23. the latency, amplitude and peak to peak amplitude will be measured two years after recruitment
• Audiogram one year after recruitment
hearing measurement will be performed. Hearing level in dB will be performed in the 250-8,000 Hz frequency. The test includes Speech reception threshold and word recognition score performed one year after recruitment
• Audiogram two years after recruitment
hearing measurement will be performed. Hearing level in dB will be performed in the 250-8,000 Hz frequency. The test includes Speech reception threshold and word recognition score performed two years after recruitment
• Measuring Orthostatic Blood Pressure one year after recruitment
blood pressure will be measure two minutes after lying supine and repeated 3 minutes after standing. A drop of at least 20mmHg systolic pressure or at least 10mmHg diastolic blood pressure is considered a positive test. The test will be performed one year after recruitment
• Measuring Orthostatic Blood Pressure two years after recruitment
blood pressure will be measure two minutes after lying supine and repeated 3 minutes after standing. A drop of at least 20mmHg systolic pressure or at least 10mmHg diastolic blood pressure is considered a positive test. The test will be performed two year after recruitment.
• cold pressor test one year after recruitment
The cold pressor test is an indicator for sympathetic system function. A rise of at least 15mmHg of systolic pressure after putting the subject's hand in cold water (4 deg Celsius) is indicative of normal sympathetic function. The test will be performed one year after recruitment.
• cold pressor test two years after recruitment
The cold pressor test is an indicator for sympathetic system function. A rise of at least 15mmHg of systolic pressure after putting the subject's hand in cold water (4 deg Celsius) is indicative of normal sympathetic function. The test will be performed two years after recruitment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D plasma levels	Vitamin D plasma levels	baseline
Primary	Vitamin D plasma levels	Vitamin D plasma levels	one year follow up
Primary	Vitamin D plasma levels	Vitamin D plasma levels	two years follow-up
Primary	Z-score and T-score of femur and lumbur spine	DEXA exam - bone density. higher score means better resuls. osteopenia is defined as <-1 score , osteoporosis is defined as <-2.5 score	baseline
Primary	Z-score and T-score of femur and lumbur spine	DEXA exam - bone density. higher score means better resuls. osteopenia is defined as <-1 score , osteoporosis is defined as <-2.5 score	one year follow up
Primary	Z-score and T-score of femur and lumbur spine	DEXA exam - bone density. higher score means better resuls. osteopenia is defined as <-1 score , osteoporosis is defined as <-2.5 score	two years follow-up
Secondary	positive ortostatic hypotension	drop of 20mmHg systolic blood pressure or drop of 10mmHG diastolic blood pressure after 3 minutes of standing up. all other results - negetive	baseline
Secondary	positive ortostatic hypotension	drop of 20mmHg systolic blood pressure or drop of 10mmHG diastolic blood pressure after 3 minutes of standing up. all other results - negetive	one year follow up
Secondary	positive ortostatic hypotension	drop of 20mmHg systolic blood pressure or drop of 10mmHG diastolic blood pressure after 3 minutes of standing up. all other results - negetive	Two years follow-up
Secondary	cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete	a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function	baseline
Secondary	cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete	a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function	one year follow up
Secondary	cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete	a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function	two years follow-up
Secondary	ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test	cervical vestibular evoked myogenic potential exam	baseline
Secondary	ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test	cervical vestibular evoked myogenic potential exam	one year follow up
Secondary	ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test	cervical vestibular evoked myogenic potential exam	two years follow-up
Secondary	Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam	audiology exam	baseline
Secondary	Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam	audiology exam	one year follow up
Secondary	Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam	audiology exam	two years follow-up