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:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT02824718
Eligibility Criteria:
Inclusion criteria :
* Patients aged from 18 to 80 years, of both sexes
* Patient with primary hypoparathyroidism related to a genetically proven ADH OR primary hypoparathyroidism related to other cause but complicated by hypercalciuria under treatment
* Affiliated to a French health insurance system, and who have consented to the study.
Exclusion criteria :
* Pregnant and breastfeeding women;
* Women of childbearing age without contraception;
* For men aged from 18 to 20 years, presence of cartilage of growth on X-ray of left knee;
* Anuria;
* Kidney failure with plasmatic creatinine \>125 mmol/l and urea \>10 mmol/l;
* Long QT interval : QTc \> 450 ms (men) or 470 ms (women);
* Hepatic failure;
* Metabolic bone diseases (Paget's disease of bone) other than primary osteoporosis or glucocorticoid-induced osteoporosis;
* Association to other potassium sparing diuretics;
* Hypokalemia (\<3.5 mmol/l) without diuretic therapy;
* Hyperkalemia (\>5.5 mmol/l);
* Hyponatremia (\<135 mmol/l) without diuretic therapy;
* Hypercalcemia (\>2.6 mmol/l);
* Severe hypomagnesemia (≤ 0.5 mmol/l);
* Vitamin D deficiency (25OH vit D \< 20 ng/mL);
* Unexplained increase in alkaline phosphatase (\>2N);
* Intolerance to sulfamide;
* Intolerance to amiloride or other component of the drug;
* Hypersensitivity to any active substance or excipient of one of the experimental drugs;
* Gluten intolerance;
* Bone break history within the three previous months;
* History of radiotherapy of the skeleton;
* History of bone cancer or metastasis.
* Personnal or familial (first degree relatives) of skin cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02824718
Study Brief:
Protocol Section:
NCT02824718