Surgery for Primary Hyperparathyroidism (pHPT) in Patients Older Than 65 Years Compared With Follow-up

Study Overview
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Brief Summary
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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
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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.

Official Title
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Primary Hyperparathyroidism in Patients Older Than 65 Years: A Prospective Randomized Trial of Surgical Treatment Compared With Follow-up

Conditions
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Primary Hyperparathyroidism

Intervention / Treatment
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* Procedure: Parathyroid surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Follow-up<br>Patients diagnosed biochemically and clinically with primary hyperparathyroidism who are followed only | |
| Experimental: Surgery<br>Patients diagnosed biochemically and clinically with primary hyperparathyroidism who are treated with parathyroid surgery | Procedure: Parathyroid surgery<br>* Parathyroid Surgery (regardless of surgical strategy; i.e., focused operation, unilateral- or bilateral neck exploration)<br>* Other names: BA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone density at the hip | Bone density is assessed with DEXA (dual energy x-ray absorptiometry), at the hip. | At two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone density at the lumbar spine | Bone density is assessed with DEXA (dual energy x-ray absorptiometry) at the lumber spine | 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). | 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). | At two years | 
| Cognitive function | Mini Mental State Examination test (MMSE), for cognitive function. A Quich Test (AQT), for cognitive speed | At two years | 
| Atherosclerosis | Carotid ultrasound/duplex scans with evaluation of intimal-medial thickness and plaques. | 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. | At two years | 
| Blood pressure (systolic and diastolic) | 24 hours blood pressure measurement | At two years | 
| Renal function | GFR measured by the clearance of iohexol and urinary albumin excretion | At two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperparathyroidism, primary, Aged 66 years or older, Mild hypercalcaemia, Surgical Procedures, Elective, Indication, Osteoporosis, Cognitive function, Atherosclerosis, Follow-up, Randomized trial