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

NCT01617057 | Terminated Phase 3

• 1 other identifier: P081235
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Otosclerosis

Keywords

otosclerosis; inner ear; tiludronic acid

Outcome Measures

Primary Outcomes (1)

• Hearing preservation on pure-tone audiometry at 2 years

  Effect on hearing preservation as assessed by air conduction pure-tone average at 2 years. Hearing deterioration is defined by a deterioration of pure-tone average by air conduction \>20 dB at 500, 1000, 2000 and 4000 Hz between inclusion and the end of the observation period.

  year 2

Secondary Outcomes (7)

• hearing preservation at one year

  year 1

• cochlear function

  years 1 and 2

• Stapedial reflex preservation

  years 1 and 2

• Speech reception threshold and speech discrimination score

  years 1 and 2

• Tinnitus and balance disorders

  years 1 and 2

Study Arms (2)

Skelid

EXPERIMENTAL

tiludronic acid

Drug: tiludronic acid

Control

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

tiludronic acid DRUG

400 mg / day for 3 months

Skelid

Placebo DRUG

400 mg / day for 3 month

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Beaujon Hospital

Paris, 92118, France

Location

MeSH Terms

Conditions

Otosclerosis

Interventions

tiludronic acid

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Alexis BOZORG-GRAYELI, Pr

  Hôpital Général, CHU de Dijon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2012
• First Posted: June 12, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)