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Surgery or surveillance for mild asymptomatic primary hyperparathyroidism: a prospective, randomized clinical trial
Authors:Ambrogini Elena  Cetani Filomena  Cianferotti Luisella  Vignali Edda  Banti Chiara  Viccica Giuseppe  Oppo Annalisa  Miccoli Paolo  Berti Piero  Bilezikian John P  Pinchera Aldo  Marcocci Claudio
Affiliation:Department of Endocrinology, University of Pisa, Via Paradisa 2, 56124 Pisa, Italy.
Abstract:
CONTEXT: It is unclear whether patients with asymptomatic primary hyperparathyroidism (PHPT) do better with parathyroidectomy (PTx) as compared with conservative medical management. OBJECTIVE: The aim of the study was to evaluate the beneficial effect of PTx vs. conservative management in patients with mild asymptomatic PHPT. DESIGN: We conducted a prospective, randomized study. SETTING: The study took place at a referral center. PATIENTS: We studied 50 patients who did not meet any guidelines for parathyroid surgery as recommended by the National Institutes of Health Consensus Development Conference on Asymptomatic PHPT. INTERVENTION: Patients were randomly assigned to PTx or no PTx and were evaluated at 6 months and at 1 yr. MAIN OUTCOME MEASURES: We compared changes (percentage of basal) of lumbar spine bone mineral density (BMD) between the two groups at 1 yr. RESULTS: The change in BMD at lumbar spine was greater after PTx (+4.16 +/- 1.13 for PTx vs. -1.12 +/- 0.71 for no PTx; P = 0.0002). The change in BMD at the total hip was also significantly greater in the PTx group (+2.61 +/- 0.71 for PTx vs. -1.88 +/- 0.60 for no PTx; P = 0.0001). There was no difference in BMD after 1 yr between both groups at the one-third radius site. In comparison with those who did not undergo surgery, the PTx subjects, after 1 yr, showed significant differences in four quality of life measures as determined by the 36-item short form health survey scale: bodily pain (P = 0.001), general health (P = 0.008), vitality (P = 0.003), and mental health (P = 0.017). CONCLUSIONS: In patients with mild asymptomatic PHPT, successful PTx is followed by an improvement in BMD and quality of life. Most patients followed without surgery did not show evidence of progression.
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