Effects of Bisphosphonates on OI-Related Hearing Loss
Key facts
- Who runs it
- Hospital for Special Surgery, New York
- Where
- New York, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 100 people, planned
- Started
- 2 Nov 2019
- Expected to end
- Jan 2027
- Type of study
- Interventional, 4 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Risedronate Oral Tablet
- Record updated
- 28 April 2026
Who can take part
- Age
- 6 years to 100 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- Diagnosis of OI type I
- Diagnosis of at least mild hearing loss (>20dB pure tone average) by audiogram testing
- 18+
- Vitamin D level > 30
- Diagnosis of OI type I
- Diagnosis of OI
- Age 6-17 years
- Currently receiving bisphosphonate treatment as standard of care
- Diagnosis of OI
- Age 6-17 years
- NOT receiving bisphosphonate treatment and will not receive bisphosphonate treatment for the duration of the study
Who cannot take part
- Family history of hearing-loss (not related to OI or occupational hearing loss)
- Pregnancy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 100 years old?
Where in United States
- Hospital for Special SurgeryNew York, United StatesContact: Su HtweTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 4 groups in the trial
- Adult Treatment ArmTreatment being tested
Intervention treatment arm. Adults (18+ years) with type 1 OI. Must have at least mild hearing loss. Will receive Risedronate (35mg, 0-2x/week as clinically indicated) for duration of study. Changes in hearing, quality of life, and bone density will be monitored.
Treatment: Risedronate Oral Tablet
- Child (Bisphosphonate Arm)No study treatment, for comparison
Observational (no investigational intervention) arm. Children (6-17 years) with any type of OI who are already receiving bisphosphonate treatment as standard of care treatment for orthopedic symptoms. Changes in hearing, quality of life, and bone density will be observed for the duration of the study.
- Child (Control Arm)No study treatment, for comparison
Observational arm. Children (6-17 years) with any type of OI who are not receiving bisphosphonate treatment. Changes in hearing, quality of life, and bone density will be observed for the duration of the study.
- Adult Control ArmNo study treatment, for comparison
Observational arm. Adults (18+ years) with type 1 OI. Changes in hearing, quality of life, and bone density will be monitored.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effects of Bisphosphonates on OI-Related Hearing Loss: A Pilot Study
- Fit questions
- Built from NCT04152551, who can take part
- Record updated
- 28 April 2026