Effects of Bisphosphonates on OI-Related Hearing Loss
Recruiting
Phase 4
Interventional Study
Osteogenesis Imperfecta
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 6 – 100
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 100 (estimated)
- Sponsor
- Hospital for Special Surgery, New York · Other
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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 …
Trial Locations
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Eligibility Criteria
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 Bisp…