Effects of Bisphosphonates on OI-Related Hearing Loss

Recruiting now · Phase 4

Conditions studied: Osteogenesis Imperfecta

In brief

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.

Key facts

Study ID
NCT04152551
Run by
Hospital for Special Surgery, New York
People needed
100
Starts
2019-11-02
Expected to finish
2027-01-01
Last updated by the study team
2026-04-28

Who can join

Age: 6 and older, up to 100. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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