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Long-Term Treatment of Hypoparathyroidism: A Randomized Controlled Study Comparing Parathyroid Hormone-(1–34) Versus Calcitriol and Calcium

Pediatric and Reproductive Endocrinology Branch, National Institute of Child Health and Human Development, National Institute of Deafness and other Communication Disorders, National Institutes of Health, Bethesda, Maryland 20892

Address all correspondence and requests for reprints to: Dr. Karen K. Winer, National Institute of Child Health and Human Development, National Institutes of Health, 6100 Executive Boulevard, Room 4B11, Bethesda, Maryland 20892-7510. E-mail: winerk{at}mail.nih.gov.

Hypoparathyroidism is one of the few remaining hormonal insufficiency states for which replacement therapy is unavailable. Previous short-term controlled trials have shown PTH to be a safe and effective treatment of hypoparathyroidism. In this randomized, parallel group, open-label trial, we compared synthetic human PTH-(1–34) (PTH) with conventional therapy, calcitriol and calcium, over a 3-yr period. Twenty-seven patients with confirmed hypoparathyroidism, aged 18–70 yr, were randomized to either twice daily sc PTH or oral calcitriol and calcium. The primary end points were calcium levels in serum and urine. Secondary end points were creatinine clearance, markers of bone turnover, and bone mineral density. Throughout the 3-yr study period, serum calcium levels were similar in both treatment groups within or just below the normal range. Mean urinary calcium excretion was within the normal range from 1–3 yr in PTH-treated patients, but remained above normal in the calcitriol group. Bone mineral content and bone mineral density showed no significant between-group differences over the 3-yr study period. We conclude that treatment with twice daily sc PTH provides a safe and effective alternative to calcitriol therapy and is able to maintain normal serum calcium levels without hypercalciuria for at least 3 yr in patients with hypoparathyroidism.

Current address for G.B.C.: Eli Lilly & Co., Indianapolis, Indiana 46285.

C.W.K. is affiliated with the Clinical Trial, Epidemiology, and Biostatistics Branch, National Institute of Deafness and Other Communication Disorders, NIH.

Abbreviations: BMC, Bone mineral content; BMD, bone mineral density; CaR, calcium-sensing receptor.

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