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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT03027557
Eligibility Criteria:
Inclusion Criteria:
* Men and women of 18 years of age or older.
* T-score by Dual X-ray Absorptiometry (DXA) between -1,0 og -3,5
* Patients from The North Jutland Region diagnosed with primary hyperparathyroidism at the Department of Endocrinology, Aalborg University Hospital. (Hypercalcaemia measured at two different time-points and simultaneous elevated/inappropriately high PTH, and exclusion of differential diagnosis.)
Exclusion Criteria:
* Medical history of diseases leading to hypercalcaemia other than Primary Hyperparathyroidism.
* Patients being treated with Denosumab or Cinacalcet prior to inclusion or previously treated with Denosumab or Cinacalcet.
* Moderately - Severely decreased liver function (alanine aminotransferase \>250u/l, gamma-glutamyl transferase\>150u/l, Bilirubin \>30)
* Acute myocardial infarction or apoplexia in the 3 months before inclusion.
* Medical record of heart failure
* Risk factors of prolonged corrected QT interval (QTc).
* Open lesions from oral surgery.
* Primary diseases of the bone other than osteoporosis.
* Patients suffering from kidney disease or renal failure.
* Patients under treatment with thiazide or lithium.
* Medical record of generalized seizures or epilepsy.
* Active malignant disease.
* Known allergies towards the specified medicinal products (IMPs).
* Pregnancy or breastfeeding.
* Fertile women who do not agree to the usage of effective contraception.
* Other circumstances, evaluated by the responsible investigator, making the subject unsuitable for participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03027557
Study Brief:
Protocol Section:
NCT03027557