100 Participants Needed

Bisphosphonates for Hearing Loss

EC
HL
SH
Overseen BySu Htwe
Age: Any Age
Sex: Any
Trial Phase: Phase 4
Sponsor: Hospital for Special Surgery, New York
Must be taking: Bisphosphonates
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Osteogenesis Imperfecta-related hearing loss usually occurs in individuals with mild (type I) OI and is much earlier in onset than age-related hearing loss, with the majority of individuals experiencing some minor hearing loss in their 20s. Bisphosphonates have been successfully used to treat otosclerosis, a common cause of hearing loss similar to OI-related hearing loss. As many individuals with OI-related hearing loss also present with otosclerosis and because of their mechanistic similarities, the investigators propose studying the effects of bisphosphonate treatment on individuals diagnosed with both OI type I and hearing loss, thereby determining its effectiveness as a potential treatment for hearing loss.The investigators will enroll 50 individuals diagnosed with type I OI and age 18-100. 25 adults will be enrolled into the treatment arm and receive bisphosphonate treatment (must have at least mild hearing loss), while 25 adults will be enrolled into the control arm. The investigators will enroll 25 children (6-17 years of age) diagnosed with OI who are currently receiving bisphosphonate treatment as part of their care for orthopedic symptoms. The investigators will also observe 25 children (6-17 years of age) diagnosed with OI who are NOT currently receiving bisphosphonate treatment. The study duration is 63 months (approximately 5 years). Enrollment is anticipated to begin in November 2019.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are a child currently receiving bisphosphonate treatment, you will continue with it as part of the study.

How is the drug Risedronate unique for treating hearing loss?

Risedronate is unique for treating hearing loss because it is a bisphosphonate, typically used for bone conditions like osteoporosis, and works by inhibiting bone resorption (breakdown). This is different from other hearing loss treatments, which usually do not involve bone-targeting drugs.12345

What data supports the effectiveness of the drug Risedronate Oral Tablet for hearing loss?

Research suggests that bisphosphonates, like Risedronate, may help with hearing loss related to otosclerosis (a bone condition in the ear) by improving hearing outcomes without causing harm to the ear.678910

Who Is on the Research Team?

CR

Cathleen Raggio, MD

Principal Investigator

Hospital for Special Surgery, New York

Are You a Good Fit for This Trial?

This trial is for individuals with type I Osteogenesis Imperfecta (OI) and hearing loss. Adults aged 18+ with mild hearing loss and children aged 6-17, whether currently on bisphosphonates or not, can join. Participants must have a Vitamin D level >30. Those with family history of non-OI related hearing loss or pregnant individuals cannot participate.

Inclusion Criteria

My child is between 6 and 17 years old.
I am between 6 and 17 years old.
I have been diagnosed with mild hearing loss.
See 7 more

Exclusion Criteria

My family has a history of hearing loss not due to OI or work.
ALL ARMS: Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Adults with type 1 OI receive Risedronate treatment; children observed for changes in hearing, quality of life, and bone density

63 months
Yearly visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Risedronate Oral Tablet
Trial Overview The study tests the effects of Risedronate Oral Tablet, a bisphosphonate, on OI-related hearing loss in adults and observes its use in children already receiving it for orthopedic symptoms. It's a comparison between treated adults/children and untreated controls over approximately 5 years.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: Adult Treatment ArmExperimental Treatment1 Intervention
Intervention treatment arm. Adults (18+ years) with type 1 OI. Must have at least mild hearing loss. Will receive Risedronate (35mg, 0-2x/week as clinically indicated) for duration of study. Changes in hearing, quality of life, and bone density will be monitored.
Group II: Adult Control ArmActive Control1 Intervention
Observational arm. Adults (18+ years) with type 1 OI. Changes in hearing, quality of life, and bone density will be monitored.
Group III: Child (Control Arm)Active Control1 Intervention
Observational arm. Children (6-17 years) with any type of OI who are not receiving bisphosphonate treatment. Changes in hearing, quality of life, and bone density will be observed for the duration of the study.
Group IV: Child (Bisphosphonate Arm)Active Control1 Intervention
Observational (no investigational intervention) arm. Children (6-17 years) with any type of OI who are already receiving bisphosphonate treatment as standard of care treatment for orthopedic symptoms. Changes in hearing, quality of life, and bone density will be observed for the duration of the study.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials
257
Recruited
61,800+

Northwell Health

Collaborator

Trials
481
Recruited
470,000+

East River Medical Imaging

Collaborator

Trials
1
Recruited
100+

The New York Community Trust

Collaborator

Trials
7
Recruited
1,200+

Published Research Related to This Trial

The study confirms that osteonecrosis of the auditory canal, a rare condition, can occur in patients taking bisphosphonates, a class of drugs commonly used to treat osteoporosis and other bone diseases.
This finding is supported by reports found in databases of adverse drug reactions, highlighting the need for awareness among healthcare providers regarding this potential side effect.
Bisphosphonate-associated osteonecrosis of the auditory canal.Kharazmi, M., Hallberg, P., Persson, U., et al.[2013]
In a retrospective study of 10 patients with otosclerosis-related sensorineural hearing loss, treatment with third-generation bisphosphonates (risedronate or zoledronate) resulted in stabilization of hearing loss over an average follow-up of 13 months, with no major complications reported.
Out of the 19 ears treated, 2 patients showed actual improvement in hearing, indicating that these bisphosphonates may not only halt progression but could also enhance hearing outcomes in some cases.
Third-generation bisphosphonates for treatment of sensorineural hearing loss in otosclerosis.Quesnel, AM., Seton, M., Merchant, SN., et al.[2021]
Long-term use of bisphosphonates for osteoporosis treatment is linked to a small but significant increase in the risk of cholesteatoma in the external auditory canal, particularly with higher doses and longer treatment durations, based on a study of 131,794 patients in Denmark.
Despite the increased risk of cholesteatoma, the overall incidence remains low, with no cases of bone destruction observed during the 7-year study period, indicating that while there are risks, they are relatively rare.
External auditory canal and middle ear cholesteatoma and osteonecrosis in bisphosphonate-treated osteoporosis patients: a Danish national register-based cohort study and literature review.Thorsteinsson, AL., Vestergaard, P., Eiken, P.[2021]

Citations

Bisphosphonate-associated osteonecrosis of the auditory canal. [2013]
Third-generation bisphosphonates for treatment of sensorineural hearing loss in otosclerosis. [2021]
External auditory canal and middle ear cholesteatoma and osteonecrosis in bisphosphonate-treated osteoporosis patients: a Danish national register-based cohort study and literature review. [2021]
Two Cases of External Auditory Canal Osteonecrosis in Patients on Antiresorptive Therapy for Osteoporosis. [2023]
Non-Ototoxic Local Delivery of Bisphosphonate to the Mammalian Cochlea. [2018]
Oesophageal transit, disintegration and gastric emptying of a film-coated risedronate placebo tablet in gastro-oesophageal reflux disease and normal control subjects. [2019]
Placebo-controlled, randomized, evaluator-blinded endoscopy study of risedronate vs. aspirin in healthy postmenopausal women. [2019]
Esophageal transit of risedronate cellulose-coated tablet and gelatin capsule formulations. [2019]
Risedronate. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Bisphosphonate-induced exposed bone (osteonecrosis/osteopetrosis) of the jaws: risk factors, recognition, prevention, and treatment. [2022]
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