Effects of Bisphosphonates on OI-Related Hearing Loss: a Pilot Study

Who is this study for? Patients with Osteogenesis Imperfecta
What treatments are being studied? Risedronate Oral Tablet
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 100
Healthy Volunteers: t
View:

• 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

Locations
United States
New York
Hospital for Special Surgery
RECRUITING
New York
Contact Information
Primary
Su Htwe
htwes@hss.edu
(212)774-2355
Backup
Erin Carter, MS, CGC
(212) 774-7332
Time Frame
Start Date: 2019-11-02
Estimated Completion Date: 2025-11
Participants
Target number of participants: 100
Treatments
Experimental: Adult Treatment Arm
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.
No_intervention: Child (Bisphosphonate Arm)
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.
No_intervention: Child (Control Arm)
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.
No_intervention: Adult Control Arm
Observational arm. Adults (18+ years) with type 1 OI. Changes in hearing, quality of life, and bone density will be monitored.
Sponsors
Collaborators: East River Medical Imaging, Northwell Health, The New York Community Trust
Leads: Hospital for Special Surgery, New York

This content was sourced from clinicaltrials.gov

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