PALOPEGTERIPARATIDE for Hypoparathyroidism

Inclusion criteria

• {"criterion_text":"- Male or female with age between 18 and 80 years.\n- A low endogenous PTH production is verified by low plasma levels of intact PTH, necessitating treatment with 1-αhydroxylated vitamin D analogs.\n- Stable P-calcium levels 1 month prior to inclusion\n- Stable thyroid function as measured by thyroid stimulating hormone (TSH)\n- Speaks and reads Danish"}

Exclusion criteria

• {"criterion_text":"- Reduced kidney function (eGFR < 30 mL/min/1.73m2).\n- Unwillingness to participate\n- Uncontrolled diabetes type 1 or 2\n- Uncontrolled hypertension\n- Clinical suspicion of major depression (also if treated)\n- Clinical suspicion of ongoing alcohol abuse (or alcohol-related dementia)\n- Other organic or psychiatric cause the patients’ symptoms\n- Contraindications to contrast-enhanced MRI.\n- Metal implants close to the head, which will interfere with the MRI or pacemaker. The patients will complete a metal scheme\n- Claustrophobia\n- Pregnancy"}

Primary endpoints

• {"endpoint_text":"- Difference in microvascular hemodynamic between PTH- and conventionally treated patients with chronic HypoPT","definition_or_measurement_approach":"Measured using microvascular hemodynamic assessment with a contrast-enhanced MRI based method to examine cerebral capillary bloodflow and capillary dysfunction."}

Secondary endpoints

• {"endpoint_text":"- Correlation between cognitive impairment measured by neuropsychological assessment and capillary transit time heterogeneity, cortical blood volume and hemodynamic parameters.","definition_or_measurement_approach":"Neuropsychological assessments correlated with MRI-derived measures including capillary transit time heterogeneity, cortical blood volume and hemodynamic parameters."}
• {"endpoint_text":"- Status of cognitive function in PTH treated compared to conventional treated controls","definition_or_measurement_approach":"Assessment of cognitive function using neuropsychological tests."}
• {"endpoint_text":"- Difference in groups in size of structures in the brain.","definition_or_measurement_approach":"Brain structural size differences assessed by MRI."}

Denmark

Earliest CTIS Part Ii Submission Date

30-03-2026

Latest Decision Or Authorization Date

20-04-2026

Processing Time Days

21

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Region Midtjylland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"GCP enhederne","duties_or_roles":"Sponsor duties (code 1); contact gcp@clin.au.dk","organisation_type":"Regulatory Authority"}