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 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT04569604
Eligibility Criteria:
Inclusion Criteria:
* Patients:
* Male or female with age between 18 and 70 years.
* A low endogenous PTH production as verified by low plasma levels of intact PTH, necessitating treatment with 1-αhydroxylated vitamin D analogs.
* HypoPT for 3 years with continuous alphacalcidol or calcitriol treatment prior to study entry (except for the patients with PHP).
* Stable P-calcium levels 1 month prior to inclusion.
* In case of thyroid disease, TSH within reference range within the last year
* Speaks and reads Danish
Controls:
* Male or female with age between 18 and 80 years.
* No known diseases in the calcium homeostasis
* Speaks and reads Danish
Exclusion Criteria:
* Reduced kidney function (eGFR \< 30 mL/min/1.73m2).
* Diabetes type 1 or 2
* History of hypertension for more than two years (treated or untreated)
* Clinical suspicion of major depression (also if treated)
* Clinical suspicion of alcohol-related dementia
* Other organic or psychiatric cause the patients symptoms
* Contraindications to contrast-enhanced MRI.
* Metal implants close to the head, which will interfere with the MRI or pacemaker. The patients will complete a metal scheme.
* Claustrophobia
* Unwillingness to participate
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04569604
Study Brief:
Protocol Section:
NCT04569604