Menier's Disease - Bone Density Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Meniere Disease
- Sponsor
- HaEmek Medical Center, Israel
- Enrollment
- 60
- Primary Endpoint
- Z-score and T-score of femur and lumbur spine
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Paker Miki
Attending physician, Otolaryngology head and neck surgery department
HaEmek Medical Center, Israel
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
Outcomes
Primary Outcomes
Z-score and T-score of femur and lumbur spine
Time Frame: two years follow-up
DEXA exam - bone density. higher score means better resuls. osteopenia is defined as \<-1 score , osteoporosis is defined as \<-2.5 score
Vitamin D plasma levels
Time Frame: two years follow-up
Vitamin D plasma levels
Secondary Outcomes
- Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam(two years follow-up)
- ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test(two years follow-up)
- positive ortostatic hypotension(Two years follow-up)
- cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete(two years follow-up)