Effects of Bisphosphonates on OI-Related Hearing Loss (NCT04152551)
Effects of Bisphosphonates on OI-Related Hearing Loss: A Pilot Study
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Hospital for Special Surgery — New York, New York
Age range: 6 Years to 100 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Hospital for Special Surgery — New York, New York
📞 Contact the Study Coordinator
Phone: (212) 774-2355
Email: htwes@hss.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Osteogenesis Imperfecta
- Dental Malocclusion and Craniofacial Development in OI — Los Angeles, California
- Setrusumab vs Placebo for Osteogenesis Imperfecta — Little Rock, Arkansas
- Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708 — Los Angeles, California
- Clear Aligners for the Treatment of Dental Malocclusion in OI — Los Angeles, California
- Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta — Birmingham, Alabama
- Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta — Phoenix, Arizona
Explore by condition: All Osteogenesis Imperfecta clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.