Bisphosphonates for Hearing Loss
Trial Summary
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.
What data supports the effectiveness of the drug Risedronate Oral Tablet for hearing loss?
How is the drug Risedronate unique for treating hearing loss?
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.
Research Team
Cathleen Raggio, MD
Principal Investigator
Hospital for Special Surgery, New York
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Adults with type 1 OI receive Risedronate treatment; children observed for changes in hearing, quality of life, and bone density
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Risedronate Oral Tablet
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hospital for Special Surgery, New York
Lead Sponsor
Northwell Health
Collaborator
East River Medical Imaging
Collaborator
The New York Community Trust
Collaborator