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Effects of Bisphosphonates on OI-Related Hearing Loss: A Pilot Study
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.
Age
6 - 100 years
Sex
ALL
Healthy Volunteers
Yes
Hospital for Special Surgery
New York, New York, United States
Start Date
November 2, 2019
Primary Completion Date
January 1, 2026
Completion Date
January 1, 2026
Last Updated
December 15, 2025
100
ESTIMATED participants
Risedronate Oral Tablet
DRUG
Lead Sponsor
Hospital for Special Surgery, New York
Collaborators
NCT05317637
NCT03706482
NCT00001594
Data Source & Attribution
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