Alfacalcidol for Secondary hyperparathyroidism

Inclusion criteria

• {"criterion_text":"- Men and both pre- and postmenopausal women who have had Roux-en-Y-gastric bypass surgery, aged 18 years or above, and present with secondary hyperparathyroidism after surgery, with a vitamin D sufficient state (>50 nmol/l), and only on standard supplementation, are included\n- Provide informed consent prior to any specific study procedure"}

Exclusion criteria

• {"criterion_text":"- Patients who are already on active treatment for osteoporosis before inclusion\n- Patients with chronic kidney disease defined as eGFR < 60 ml/min\n- Patients who had a bariatric intervention before and are re-operated\n- Patients that are on chronic steroid use, for example for inflammatory conditions\n- Patients that appear to have hypercalcemia on screening\n- Patients with known inflammatory conditions (i.e. rheumatoid arthritis)\n- Patients that have an active pregnancy wish"}

Primary endpoints

• {"endpoint_text":"- Normalization of PTH (and thus recovery of secondary hyperparathyroidism) at 2 years after diagnosis and start of treatment in one of the study groups. Secondary hyperparathyroidism will be defined as PTH at the upper limit or above the labs reference value combined with a normal or decreased serum calcium level (in patients with 25(OH)D >50 nmol/L","definition_or_measurement_approach":"Normalization of PTH measured at 2 years after diagnosis/start of treatment. Secondary hyperparathyroidism defined as PTH at the upper limit or above the laboratory reference value combined with a normal or decreased serum calcium level in patients with 25(OH)D >50 nmol/L."}

Secondary endpoints

• {"endpoint_text":"- Decrease in BMD (defined as 3% decrease in T-score at the lumbar spine and 5% decrease in T-score at the hip / forearm), measured at 1 and 2 years after inclusion","definition_or_measurement_approach":"Bone mineral density (BMD) measured at lumbar spine, hip and forearm; decrease defined as 3% decrease in T-score at lumbar spine and 5% decrease in T-score at hip/forearm, measured at 1 and 2 years after inclusion."}
• {"endpoint_text":"- Quality of life is measured after inclusion and thereafter every 6 months with the OBESI-Q questionnaire","definition_or_measurement_approach":"Quality of life assessed using the OBESI-Q questionnaire at baseline and every 6 months thereafter."}

Netherlands

Earliest CTIS Part Ii Submission Date

01-11-2024

Latest Decision Or Authorization Date

04-11-2024

Processing Time Days

3

Number Of Sites

5

Number Of Participants

130

Primary sponsor

Full Name

Academisch Ziekenhuis Leiden

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands