Primary Hyperparathyroidism
Conditions
Keywords
Hyperparathyroidism, primary, Aged 66 years or older, Mild hypercalcaemia, Surgical Procedures, Elective, Indication, Osteoporosis, Cognitive function, Atherosclerosis, Follow-up, Randomized trial
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREParathyroid surgery
Parathyroid Surgery (regardless of surgical strategy; i.e., focused operation, unilateral- or bilateral neck exploration)
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
66 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary Hyperparathyroidism * No previous parathyroid surgery * Sporadic disease
Exclusion criteria
* Z-score of Bone density \< -2.5 SD (regardless of site) * Serum level of ionized calcium \> 1.50 mmol/L * Inability to understand given information or to comply with scheduled follow-up * Symptoms of hypercalcaemia for which specific medical treatment has been prescribed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone density at the hip | At two years | Bone density is assessed with DEXA (dual energy x-ray absorptiometry), at the hip. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood lipids | At two years | 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). |
| Cardiac function | At two years | 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). |
| Cognitive function | At two years | Mini Mental State Examination test (MMSE), for cognitive function. A Quich Test (AQT), for cognitive speed |
| Bone density at the lumbar spine | At two years | Bone density is assessed with DEXA (dual energy x-ray absorptiometry) at the lumber spine |
| Oral glucose tolerance | At two years | Oral glucose tolerance test (75 Gram), with measurement of blood glucose and insulin after 60, 120 and 180 min. |
| Blood pressure (systolic and diastolic) | At two years | 24 hours blood pressure measurement |
| Renal function | At two years | GFR measured by the clearance of iohexol and urinary albumin excretion |
| Atherosclerosis | At one two years | Carotid ultrasound/duplex scans with evaluation of intimal-medial thickness and plaques. |
Countries
Sweden
Outcome results
None listed