Therapeutic Efficacy of Tiludronic Acid on Inner Ear Involvement in Advanced Otosclerosis

• Status: Terminated
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to assess the efficacy of a biphosphonate (tiludronic acid, Skelid®, Sanofi-Aventis) in the treatment of inner ear involvement in advanced otosclerosis

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Diphosphonates; Tiludronic acid

Criteria

Inclusion Criteria:

• Age between 18 and 75 years

• French citizen

• Signed consent for participation

• No dental infection

• No programmed dental surgery during the treatment

• Effective contraception for women of childbearing potential

• Patient with advanced otosclerosis defined by:

• Slowly progressive uni or bilateral hearing loss

• No past medical history of chronic otitis media

• No past medical history of other causes of cochlear damage (significant surgical trauma with a 30 dB deterioration of bone conduction at 4000 Hz in postoperative period, sound trauma, barotrauma, ototoxic drugs)

• Normal tympanic membranes

• A conductive or mixed hearing loss

• A moderate to severe hearing loss on at least one ear (average of thresholds at 500, 1000, 2000 and 4000 Hz) on air conduction between 30 and 90 dB.

• Normal tympanometry or with a decreased peak

• Absent ipsilateral stapedial reflex

• As possible, intraoperative confirmation of stapediovestibular ankylosis

• radiological confirmation if CT-scan before inclusion available

Exclusion Criteria:

• Individuals not covered by the french public health insurance

• Pure-tone average < 30 dB ou > 90 dB

• Programmed stapes surgery during the observation period

• Previous treatment by biphosphonate

• Known intolerance to tiludronate

• Other contraindications to tiludronate treatment:

• allergy to biphosphonates

• hypersensitivity to one of the excipients

• severe renal failure (creatinine clearance < 30 mL/min)

• juvenile Paget's disease

• pregnancy and breastfeeding

• galactose intolerance, lactase insufficiency, glucose-galactose malabsorption

• Ongoing chemotherapy or radiotherapy or patient achieves of a cancer

• Long-term systemic steroid treatment