Menier's Disease - Bone Density Study

Not Applicable

Not yet recruiting

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

• Registration Number: NCT05322538
• Lead Sponsor: HaEmek Medical Center, Israel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-04-03
• Study First Posted: 2022-04-12
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03
• Study Start: 2022-10-01
• Primary Completion: 2028-06-30
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Z-score and T-score of femur and lumbur spine	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	two years follow-up	Vitamin D plasma levels

Secondary Outcome Measures

Name	Time	Method
Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam	two years follow-up	audiology exam
ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test	two years follow-up	cervical vestibular evoked myogenic potential exam
positive ortostatic hypotension	Two years follow-up	drop of 20mmHg systolic blood pressure or drop of 10mmHG diastolic blood pressure after 3 minutes of standing up. all other results - negetive
cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete	two years follow-up	a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function