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 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
NCT ID:
NCT03748966
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of XLH with family history excluding male-to-male transmission, or positive genotype for PHEX mutation
* Serum PTH levels less than 1.5x the upper limit of normal
* Serum calcium levels less than 10.0 mg/dl
* eGFR \>= 60 mL/min/1.73m2
* 25(OH) vitamin D level \>= 20 ng/dL
Exclusion Criteria:
* Known allergy to calcitriol
* Pregnancy or breast feeding
* Use of skeletally active agents such as bisphosphonates, teriparatide, SERMS, hormone replacement therapy and progesterone-only contraceptive agents (combination oral contraceptive use in premenopausal women is not an exclusion criterion).
* Unwilling or unable to stop therapy with calcitriol and phosphate therapy for two weeks prior to study
* Therapy with cinacalcet within the past two weeks
* Current use of growth hormone therapy
* Use of diuretics or medications that alter renal handling of mineral ions.
* Use of glucocorticoids for more than 14 days in the past 12 months with the exception of inhaled agents.
* History of malignancy except basal and squamous cell carcinoma of the skin.
* Significant history of psychiatric disease per DSM-5.
* Substance use disorder per DSM-5.
* Significant cardiopulmonary disease (unstable CAD or stage D ACC/AHA heart failure).
* Absence of laboratory values for serum calcium, phosphate and creatinine in the 24 months prior to enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
70 Years
Study:
NCT03748966
Study Brief:
Protocol Section:
NCT03748966