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New treatment option for Osteogenesis Imperfecta
Official title Effects of Bisphosphonates on OI-Related Hearing Loss
ClinicalTrials.gov ID: NCT04152551
What this study is testing
What is Risedronate Oral Tablet?
Risedronate Oral Tablet is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for osteogenesis imperfecta.
Also referred to as actonel.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 100. Healthy volunteers may be eligible.
You may be able to join if
- (Adult Treatment Arm):
- Diagnosis of OI type I
- Diagnosis of at least mild hearing loss (\>20dB pure tone average) by audiogram testing
- Vitamin D level \> 30 (Adult Control Arm):
- Diagnosis of OI type I (Child Observational Bisphosphonate Arm)
You likely can't join if
- (ALL ARMS):
- Family history of hearing-loss (not related to OI or occupational hearing loss)
- Pregnancy
See the full eligibility criteria
- (Adult Treatment Arm):
- Diagnosis of OI type I
- Diagnosis of at least mild hearing loss (\>20dB pure tone average) by audiogram testing
- Vitamin D level \> 30 (Adult Control Arm):
- Diagnosis of OI type I (Child Observational Bisphosphonate Arm)
- Diagnosis of OI
- Age 6-17 years
- Currently receiving bisphosphonate treatment as standard of care (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
- (ALL ARMS):
- Family history of hearing-loss (not related to OI or occupational hearing loss)
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 100 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.