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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT00131469
Eligibility Criteria:
Inclusion Criteria:
* Previous established diagnosis of Osteogenesis Imperfecta AND
* \> 2 previous adult fractures, AND/OR
* BMD at lumbar spine, femoral neck or total hip T score \< -2.0
Exclusion Criteria:
* Open epiphyses.
* History of external beam radiation to the skeleton.
* Pagets disease.
* Bone metastases or skeletal malignancies.
* Total lifetime exposure to any antiresorptive medication \< 90 days (Primary Inclusion).
* Treatment with any antiresorptive medication 12 months proceeding enrollment - (Secondary Inclusion).
* Women with OI who are pregnant or unwilling to use 1 form of contraception.
* Vitamin D insufficiency (25-hydroxyvitamin D \<15ng/ml)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00131469
Study Brief:
Protocol Section:
NCT00131469