General consensus and contemporary guidelines, recommend surgery for primary hyperparathyroidism (pHPT)for all patients below the age of 50, for patients with pronounced hypercalcemia and for patients with organ complications to the disease (osteoporosis and decreased renal function). The purpose of this study is to determine if surgery for pHPT, is appropriate for patients with moderate to mild hypercalcemia older than 65 years of age. The hypothesis of the study is that surgery for pHPT in patients older than 65 years of age, and with mild hypercalcemia, will increase bone density and hence decrease future risk for fragility fractures compared to patients with follow-up only.
The majority of patients diagnosed and operated due to primary HPT in Scandinavia are older than 65 years of age. The vast majority of the patients have mild aberrations of serum calcium (\< 1.50 mmol/l ionized calcium), and some patients may even be asymptomatic. The present trial is designed to clarify the indications for surgical treatment in this large subgroup of patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Parathyroid Surgery (regardless of surgical strategy; i.e., focused operation, unilateral- or bilateral neck exploration)
Skåne University Hospital, Department of Surgery, Lund
Lund, Sweden
Bone density at the hip
Bone density is assessed with DEXA (dual energy x-ray absorptiometry), at the hip.
Time frame: At two years
Bone density at the lumbar spine
Bone density is assessed with DEXA (dual energy x-ray absorptiometry) at the lumber spine
Time frame: At two years
Blood lipids
Triglyceride and cholesterol concentrations of whole serum and of the lipoprotein classes; low-density-lipoprotein (LDL), very-low-density-lipoprotein (VLDL) and high-density-lipoprotein (HDL).
Time frame: At two years
Cardiac function
Cardiac function assessed with echocardiography; Left ventricular ejection fraction (EF), Left ventricular end-diastolic diameter (LVDD), Left ventricular mass index (LVMI), Ratio between mitral peak velocity flow of the early filling wave and the atrial filling wave (E/A ratio).
Time frame: At two years
Cognitive function
Mini Mental State Examination test (MMSE), for cognitive function. A Quich Test (AQT), for cognitive speed
Time frame: At two years
Atherosclerosis
Carotid ultrasound/duplex scans with evaluation of intimal-medial thickness and plaques.
Time frame: At one two years
Oral glucose tolerance
Oral glucose tolerance test (75 Gram), with measurement of blood glucose and insulin after 60, 120 and 180 min.
Time frame: At two years
Blood pressure (systolic and diastolic)
24 hours blood pressure measurement
Time frame: At two years
Renal function
GFR measured by the clearance of iohexol and urinary albumin excretion
Time frame: At two years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.