Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT04152551
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
100 Years
Study:
NCT04152551
Study Brief:
Protocol Section:
NCT04152551