About 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.
Eligibility criteria
Qualifiers
Diagnosis of OI type I
Diagnosis of at least mild hearing loss (>20dB pure tone average) by audiogram testing
18+
Vitamin D level > 30
Disqualifiers
Family history of hearing-loss (not related to OI or occupational hearing loss)
Pregnancy
Trial design
Treatments tested in this trial
- Risedronate Oral Tablet
Treatment groups
Sponsors and collaborators
Hospital for Special Surgery, New York
Lead sponsor
The New York Community Trust
Collaborator
East River Medical Imaging
Collaborator
Northwell Health
Collaborator