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This version published online on May 29, 2007
Journal of Clinical Endocrinology & Metabolism, doi:10.1210/jc.2007-0219
A more recent version of this article appeared on August 1, 2007
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Submitted on January 30, 2007
Accepted on May 17, 2007

Surgery or Surveillance for Mild Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Clinical Trial

Elena Ambrogini, Filomena Cetani, Luisella Cianferotti, Edda Vignali, Chiara Banti, Giuseppe Viccica, Annalisa Oppo, Paolo Miccoli, Piero Berti, John P. Bilezikian, Aldo Pinchera, and Claudio Marcocci*

Departments of Endocrinology (E.A., F.C., L.C., E.V., C.B., G.V., A.P., C.M.), Psychiatry, Neurobiology, Pharmacology and Biotechnology (A.O.), Surgery (P.M., P.B.), University of Pisa, Pisa, Italy and Department of Medicine and Pharmacology (J.P.B), Columbia University, College of Physicians & Surgeons, New York, NY 10032, USA

* To whom correspondence should be addressed. E-mail: c.marcocci{at}endoc.med.unipi.it.

Context. It is unclear whether patients with asymptomatic primary hyperparathyroidism (PHPT) do better with parathyroidectomy (PTx) as compared to conservative medical management.

Objective. To evaluate the beneficial effect of PTx vs. conservative management in patients with mild asymptomatic PHPT.

Design. A prospective, randomized study.

Setting. Referral Center.

Patients. Fifty patients who did not meet any guidelines for parathyroid surgery as recommended by the NIH Consensus Development Conference on Asymptomatic PHPT.

Intervention. Patients were randomly assigned to PTx or no PTx and evaluated at 6 months and at 1 year.

Main outcome measure. Comparison of changes (percentage of basal) of lumbar spine BMD between the 2 groups at 1 year.

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 year between both groups at the one-third radius site. In comparison to those who did not have surgery, the PTx subjects, after 1 year, showed significant differences in 4 quality of life measures as determined by the SF-36 scale: bodily pain (P=0.001), general health (P =0.008), vitality (P =0.003), and mental health (P =0.017).

Conclusion. In patients with mild asymptomatic PHPT successful PTx is followed by an improvement in BMD and in quality of life. Most patients followed without surgery did not show evidence of progression.




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