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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 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 Summary: 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.
Sponsor: Region Skane

Current Primary Outcome: Bone density [ Time Frame: At one and two years ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Blood lipids [ Time Frame: At one and 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 [ Time Frame: At one and 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 [ Time Frame: At one and two years ]

    Mini Mental State Examination test (MMSE), for cognitive function.

    A Quich Test (AQT), for cognitive speed

  • Atherosclerosis [ Time Frame: At one and two years ]
    Carotid ultrasound/duplex scans with evaluation of intimal-medial thickness and plaques.
  • Oral glucose tolerance [ Time Frame: At one and two years ]
    Oral glucose tolerance test (75 Gram), with measurement of blood glucose and insulin after 60, 120 and 180 min.


Original Secondary Outcome: Same as current

Information By: Region Skane

Dates:
Date Received: March 15, 2010
Date Started: August 2010
Date Completion: December 2018
Last Updated: April 11, 2017
Last Verified: April 2017