Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
NCT ID:
NCT01617057
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01617057
Study Brief:
Protocol Section:
NCT01617057