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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follow-up | No Intervention | Patients diagnosed biochemically and clinically with primary hyperparathyroidism who are followed only | |
| Surgery | Experimental | Patients diagnosed biochemically and clinically with primary hyperparathyroidism who are treated with parathyroid surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parathyroid surgery | Procedure | Parathyroid Surgery (regardless of surgical strategy; i.e., focused operation, unilateral- or bilateral neck exploration) |
|
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders OJ Bergenfelz, MD, PhD | Skåne University Hospital, Department of Surgery, Lund | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skåne University Hospital, Department of Surgery, Lund | Lund | 22185 | Sweden |
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| ID | Term |
|---|---|
| D049950 | Hyperparathyroidism, Primary |
| D010024 | Osteoporosis |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D001851 | Bone Diseases, Metabolic |
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| 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 |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |