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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT04146935
Eligibility Criteria:
Inclusion Criteria:
1. 18-65 years of age
2. Diagnosis of XLH
3. eGFR ≥ 50 (estimated glomerular filtration rate)
4. Normal serum calcium
5. Phosphate ≤ 2.5 mg/dl
6. Deemed clinically appropriate for starting therapy with Burosumab/Crysvita® (based on the treating physician's evaluation)
7. Deemed appropriate for MR Spectroscopy
Exclusion Criteria:
1. Patients with fixed skeletal abnormalities which would prevent them from successfully completing study-related functional assessments
2. Patients unwilling to stop therapy with supplemental phosphate and calcitriol 2 weeks prior to enrollment.
3. Patients who have undergone an orthopaedic procedure within the previous 6 months involving implantation of metal hardware
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04146935
Study Brief:
Protocol Section:
NCT04146935