Menier's Disease - Bone Density Study

HaEmek Medical Center, Israel

Status: Not yet enrolling

Conditions: Osteopenia; Osteoporosis; Meniere Disease; Vitamin D Deficiency; Vestibular Disorder

Treatments: Diagnostic Test: Measuring Orthostatic Blood Pressure two years after recruitment; Diagnostic Test: cervical Vestibular evoked myogenic potentials one year after recruitment; Diagnostic Test: cold pressor test at baseline; Diagnostic Test: Audiogram two years after recruitment; Diagnostic Test: vitamin D plasma levels one year after recruitment; Diagnostic Test: cold pressor test one year after recruitment; Diagnostic Test: vitamin D plasma levels two years after recruitment; Diagnostic Test: cervical Vestibular evoked myogenic potentials two years after recruitment; Diagnostic Test: Measuring Orthostatic Blood Pressure at baseline; Diagnostic Test: Dual-energy X-ray absorptiometry at baseline; Diagnostic Test: Audiogram one year after recruitment; Diagnostic Test: Dual-energy X-ray absorptiometry one year after recruitment; Diagnostic Test: Measuring Orthostatic Blood Pressure one year after recruitment; Diagnostic Test: Audiogram at baseline; Diagnostic Test: cervical Vestibular evoked myogenic potentials at baseline; Diagnostic Test: Dual-energy X-ray absorptiometry two years after recruitment; Diagnostic Test: cold pressor test two years after recruitment; Diagnostic Test: vitamin D plasma levels baseline

Study type: Interventional

Funder types: Other

Identifiers

NCT05322538

EMC-22-0031

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Controls

Other group

Description:

Healthy controls with no known vestibular disease

Treatment:

Diagnostic Test: Dual-energy X-ray absorptiometry at baseline

Diagnostic Test: Measuring Orthostatic Blood Pressure at baseline

Diagnostic Test: cold pressor test at baseline

Diagnostic Test: vitamin D plasma levels baseline

Definite Meniere's disease

Experimental group

Description:

Patients with Definite Meniere's disease

Treatment:

Diagnostic Test: vitamin D plasma levels one year after recruitment

Diagnostic Test: Audiogram at baseline

Diagnostic Test: cervical Vestibular evoked myogenic potentials at baseline

Diagnostic Test: Measuring Orthostatic Blood Pressure one year after recruitment

Diagnostic Test: Audiogram one year after recruitment

Diagnostic Test: Dual-energy X-ray absorptiometry one year after recruitment

Diagnostic Test: Dual-energy X-ray absorptiometry at baseline

Diagnostic Test: Dual-energy X-ray absorptiometry two years after recruitment

Diagnostic Test: Measuring Orthostatic Blood Pressure at baseline

Diagnostic Test: cold pressor test at baseline

Diagnostic Test: cold pressor test one year after recruitment

Diagnostic Test: cervical Vestibular evoked myogenic potentials two years after recruitment

Diagnostic Test: cold pressor test two years after recruitment

Diagnostic Test: vitamin D plasma levels baseline

Diagnostic Test: Audiogram two years after recruitment

Diagnostic Test: cervical Vestibular evoked myogenic potentials one year after recruitment

Diagnostic Test: Measuring Orthostatic Blood Pressure two years after recruitment

Diagnostic Test: vitamin D plasma levels two years after recruitment