Effects of bisphosphonates on hearing loss in osteogenesis imperfecta

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of bisphosphonate treatment on hearing loss associated with Osteogenesis Imperfecta (OI) type I. It aims to enroll 50 adults, with half receiving bisphosphonates and the other half serving as a control group. Participants must have a diagnosis of OI type I and at least mild hearing loss. The study will assess the effectiveness of bisphosphonates, which have shown promise in treating similar hearing loss conditions.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital for Special Surgery
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Cathleen Raggio, MD — Hospital for Special Surgery, New York
• Study coordinator: Su Htwe
• Email: htwes@hss.edu
• Phone: (212)774-2355

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.