Effects of Bisphosphonates on OI-Related Hearing Loss
Status:
Recruiting
Trial end date:
2024-11-01
Target enrollment:
Participant gender:
Summary
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, ages 18-100, who have
documented hearing loss. 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.
Phase:
Phase 4
Details
Lead Sponsor:
Hospital for Special Surgery, New York
Collaborators:
Northwell Health The New York Community Trust Weill Cornell Medicine Weill Medical College of Cornell University