Clinical trial NCT05322538: Menier's Disease - Bone Density Study
Official title: Menier's Disease - Bone Density Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Meniere Disease
Osteoporosis
Osteopenia
Vitamin D Deficiency
Vestibular Disorder
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Vitamin D plasma levels
timeFrame: baseline
measure: Vitamin D plasma levels
timeFrame: one year follow up
measure: Vitamin D plasma levels
timeFrame: two years follow-up
measure: Z-score and T-score of femur and lumbur spine
timeFrame: baseline
measure: Z-score and T-score of femur and lumbur spine
timeFrame: one year follow up
measure: Z-score and T-score of femur and lumbur spine
timeFrame: two years follow-up
Secondary outcomes:
measure: positive ortostatic hypotension
timeFrame: baseline
measure: positive ortostatic hypotension
timeFrame: one year follow up
measure: positive ortostatic hypotension
timeFrame: Two years follow-up
measure: cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete
timeFrame: baseline
measure: cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete
timeFrame: one year follow up
measure: cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete
timeFrame: two years follow-up
measure: ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test
timeFrame: baseline
measure: ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test
timeFrame: one year follow up
measure: ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test
timeFrame: two years follow-up
measure: Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam
timeFrame: baseline
measure: Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam
timeFrame: one year follow up
measure: Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam
timeFrame: two years follow-up
Other outcomes:
Locations:
Study officials:
References: