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Menier's Disease - Bone Density Study

H

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)

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

Trial contacts and locations

0

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Central trial contact

Yoni Evgeni Gutkovich, M.D\Ph.D; Miki Peker, M/D

Data sourced from clinicaltrials.gov

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