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Surgery versus observation in patients 65 years or older with primary hyperparathyroidism: randomized clinical trial
Door Bergenfelz AOJ, Thier M, Almquist M en 2 anderen.
Inhoud in het Engels
Abstract
Background
A substantial portion of surgically treated patients with primary hyperparathyroidism (pHPT) are older than 65 years. The indication for parathyroidectomy in older patients with pHPT and mild hypercalcaemia is unclear. Specifically, it is not known whether parathyroid surgery improves bone mineral density (BMD) in this age group.
Method
Patients 65 years or older with pHPT, ionized calcium not exceeding 1.50 mmol/l, and a BMD Z-score above -2.5 standard deviations who were referred to the Department of Surgery, Lund University Hospital, were included in the study. Follow-up was performed over 2 years. The random allocation sequence to surgery or observation was computer generated. There was no blinding. Primary outcome was BMD of the hip, with the primary endpoint being the change in total hip BMD from baseline to the end of follow-up. Secondary outcome was BMD of the lumbar spine. Continuous variables were analysed using Satterthwaite's t-test. Intention-to-treat analysis of change from baseline was performed using a mixed-model repeated-measures ANOVA (MMRM ANOVA).