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 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT00459732
Eligibility Criteria:
Inclusion Criteria:
* 6 to 30 years of age
* thalassemia
* bone mineral density Z-score \< -1.0 (by DXA)
Exclusion Criteria:
* Bone marrow transplant recipient
* Currently prescribed treatment for low bone mass other than calcium or vitamin D (e.g. calcitonin, bisphosphonates)
* Currently prescribed zinc supplementation who are unable or unwilling to stop during this trial
* Currently participating in another trial with a medication known to affect bone mineral density.
* Chronic use of systemic corticosteroids
* Untreated hypogonadism or growth hormone deficiency
* Baseline serum copper \< 70 µg/dL
* Baseline vitamin D-25OH \< 11 ng/mL
* Pregnant or lactating at study entry
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
30 Years
Study:
NCT00459732
Study Brief:
Protocol Section:
NCT00459732