Effects of bisphosphonates on hearing loss in osteogenesis imperfecta
Effects of Bisphosphonates on OI-Related Hearing Loss: A Pilot Study
PHASE4 · Hospital for Special Surgery, New York · NCT04152551
This study is testing if a medication called bisphosphonates can help adults with Osteogenesis Imperfecta type I who have hearing loss.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 6 Years to 100 Years |
| Sex | All |
| Sponsor | Hospital for Special Surgery, New York (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04152551 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-100 with a diagnosis of OI type I and at least mild hearing loss.
Not a fit: Patients with a family history of hearing loss unrelated to OI or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve hearing outcomes for patients with Osteogenesis Imperfecta-related hearing loss.
How similar studies have performed: Previous studies have shown bisphosphonates to be effective in treating otosclerosis, suggesting potential success for this approach in OI-related hearing loss.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteogenesis Imperfecta, hearing loss, bisphosphonate, skeletal dysplasia, brittle bone disorder, osteogenesis imperfecta, OI