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Effects of Bisphosphonates on OI-Related Hearing Loss

RecruitingPhase 4Ages 6 Years - 100 YearsAllHospital for Special Surgery, New York
NCT04152551 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria (Adult Treatment Arm): * Diagnosis of OI type I * Diagnosis of at least mild hearing loss (\>20dB pure tone average) by audiogram testing * 18+ * Vitamin D level \> 30 Inclusion Criteria (Adult Control Arm): * Diagnosis of OI type I Inclusion Criteria (Child Observational Bisphosphonate Arm) * Diagnosis of OI * Age 6-17 years * Currently receiving bisphosphonate treatment as standard of care Inclusion Criteria (Child Observational No Treatment Arm) * Diagnosis of OI * Age 6-17 years * NOT receiving bisphosphonate treatment and will not receive bisphosphonate treatment for the duration of the study Exclusion Criteria (ALL ARMS): * Family history of hearing-loss (not related to OI or occupational hearing loss) * Pregnancy
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What it tests

  • Risedronate Oral Tablet
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Where

1 site
Hospital for Special Surgery
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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