NCT04152551 Effects of Bisphosphonates on OI-Related Hearing Loss
| NCT ID | NCT04152551 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hospital for Special Surgery, New York |
| Condition | Osteogenesis Imperfecta |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2019-11-02 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2019-11-02 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 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
Contact & Investigator
Cathleen Raggio, MD
PRINCIPAL INVESTIGATOR
Hospital for Special Surgery, New York
Frequently Asked Questions
Who can join the NCT04152551 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 100 Years, studying Osteogenesis Imperfecta. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04152551 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04152551 currently recruiting?
Yes, NCT04152551 is actively recruiting participants. Contact the research team at htwes@hss.edu for enrollment information.
Where is the NCT04152551 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT04152551 clinical trial?
NCT04152551 is sponsored by Hospital for Special Surgery, New York. The principal investigator is Cathleen Raggio, MD at Hospital for Special Surgery, New York. The trial plans to enroll 100 participants.