Clinical trial: Therapeutic Efficacy of Tiludronic Acid on Inner Ear Involvement in Advanced Otosclerosis (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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? 0