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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT03029312
Eligibility Criteria:
Inclusion Criteria:
Patients with mild OI (type 1 and 4; \>5y of age) who need to be at least partly ambulant and have a CHAQ score of greater than 0.13, constituting at least mild disability. Minimum requirement is the ability to rise from a chair.
Informed consent is required from the participant and/or parent/guardian.
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Exclusion Criteria:
* On bisphosphonate treatment for less than 2years (since mobility usually improves during the initial phase treatment).
* Finished bisphosphonate therapy less than 6 months ago
* Recent lower limb fracture \<3months ago, or upper limb fracture which is still in plaster.
* Heart or lung disease, use of steroids (oral, systemic, topical or inhaled, for more than 3 weeks in the last 12 months) or any other bone-active treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
16 Years
Study:
NCT03029312
Study Brief:
Protocol Section:
NCT03029312