Zoledronic acid for Primary hyperparathyroidism

Inclusion criteria

• {"criterion_text":"- Females or males > 40 years\n- A diagnosis of hyperparathyroid hypercalcemia due to sporadic PHPT referred to PTX\n- aBMD T-score or Z-score ≤ -1 at total hip, femoral neck, distal forearm, or lumbar spine\n- 25-hydroxyvitamin D ≥ 50 nmol/l prior to randomization\n- Willingness to undergo PTX"}

Exclusion criteria

• {"criterion_text":"- Known or suspected familial ethology (e.g., MEN1 or 2)\n- Estimated glomerular filtration rate < 35 ml/min\n- Known allergy to bisphosphonates\n- Planned or recent (within the last 3 months) major dental procedures (e.g., jaw surgery or tooth extraction)\n- Chronic or acute disorders (e.g., rheumatoid arthritis, inflammatory bowel disease, cancer) or prior medications (e.g., lithium, glucocorticoids within the last year, antiresorptive or bone anabolic treatment within the last 3 years) known to affect bone metabolism\n- Current or planned pregnancy in females"}

Primary endpoints

• {"endpoint_text":"- Effects of ZOL vs. placebo at time of parathyroidectomy on aBMD at lumbar spine, one year after PTX.","definition_or_measurement_approach":"Effects of ZOL vs. placebo at time of parathyroidectomy on aBMD at lumbar spine, one year after PTX."}

Secondary endpoints

• {"endpoint_text":"- Effects on aBMD at distal forearm, femoral neck, and total hip","definition_or_measurement_approach":"Effects on aBMD at distal forearm, femoral neck, and total hip"}
• {"endpoint_text":"- Effects on microarchitecture measured by high-resolution peripheral computed tomography (HRpQCT)","definition_or_measurement_approach":"Effects on microarchitecture measured by high-resolution peripheral computed tomography (HRpQCT)"}
• {"endpoint_text":"- Effects on biochemical bone turnover markers (BTM).","definition_or_measurement_approach":"Effects on biochemical bone turnover markers (BTM)."}
• {"endpoint_text":"- Effects on vBMD at the hip and lumbar spine.","definition_or_measurement_approach":"Effects on vBMD at the hip and lumbar spine."}
• {"endpoint_text":"- Effects on CACS.","definition_or_measurement_approach":"Effects on CACS."}
• {"endpoint_text":"- Effects on PWV.","definition_or_measurement_approach":"Effects on PWV."}
• {"endpoint_text":"- Effects on renal calcifications and urinary analytes.","definition_or_measurement_approach":"Effects on renal calcifications and urinary analytes."}

Denmark

Earliest CTIS Part Ii Submission Date

14-12-2024

Latest Decision Or Authorization Date

02-02-2026

Processing Time Days

415

Number Of Sites

1

Number Of Participants

140

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":"Aarhus Universitet","duties_or_roles":"1","organisation_type":"Educational Institution"}