Effects of Bisphosphonates on OI-Related Hearing Loss
Osteogenesis Imperfecta
About this trial
This is an interventional prevention trial for Osteogenesis Imperfecta focused on measuring hearing loss, bisphosphonate, skeletal dysplasia, brittle bone disorder, osteogenesis imperfecta, OI
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
Sites / Locations
- Hospital for Special SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
No Intervention
No Intervention
No Intervention
Adult Treatment Arm
Child (Bisphosphonate Arm)
Child (Control Arm)
Adult Control 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.
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.
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.
Observational arm. Adults (18+ years) with type 1 OI. Changes in hearing, quality of life, and bone density will be monitored.