Have you or your loved ones been diagnosed with primary hyperparathyroidism?

You may be eligible to participate in a primary hyperparathyroidism clinical trial.

Have you or your loved ones been diagnosed with primary hyperparathyroidism? You may be eligible to participate in a primary hyperparathyroidism clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Primary Hyperparathyroidism Clinical Trial in Lund

NCT01087619 | Interventional

Have you or your loved ones been diagnosed with primary hyperparathyroidism?

You may be eligible to participate in a primary hyperparathyroidism clinical trial.

Have you or your loved ones been diagnosed with primary hyperparathyroidism? You may be eligible to participate in a primary hyperparathyroidism clinical trial.

Recruiting

Male & Female

66 Years +

This study is looking to recruit 115 Participants

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.

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Details for the study

Brief Title

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

Official Title

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

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.

Treatments and/or Procedures

Parathyroid surgery

Parathyroid Surgery (regardless of surgical strategy; i.e., focused operation, unilateral- or bilateral neck exploration)

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Bone density at the hip

Bone density is assessed with DEXA (dual energy x-ray absorptiometry), at the hip.

At two years

Secondary

Bone density at the lumbar spine

Bone density is assessed with DEXA (dual energy x-ray absorptiometry) at the lumber spine

At two years

Secondary

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

Secondary

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

Secondary

Cognitive function

Mini Mental State Examination test (MMSE), for cognitive function. A Quich Test (AQT), for cognitive speed

At two years

Secondary

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

Secondary

Blood pressure (systolic and diastolic)

24 hours blood pressure measurement

At two years

Secondary

Renal function

GFR measured by the clearance of iohexol and urinary albumin excretion

At two years

Secondary

Atherosclerosis

Carotid ultrasound/duplex scans with evaluation of intimal-medial thickness and plaques.

At one two years

Study Criteria

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