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Results of a Short-term Randomized Crossover Trial

Karen K. Winer, MD; Jack A. Yanovski, MD, PhD; Gordon B. Cutler, Jr, MD

JAMA. 1996;276(8):631-636.

Abstract
Objective.
—To test the hypothesis that treatment with human parathyroid hormone 1-34 (PTH 1-34) can maintain normal serum calcium without hypercalciuria in patients with hypoparathyroidism.

Design.
—Randomized crossover trial lasting 20 weeks. Each 10-week arm consisted of a 2-week inpatient dose-adjustment phase followed by an 8-week outpatient phase.

Setting.
—Tertiary care center.

Patients.
—A total of 10 patients with hypoparathyroidism were enrolled consecutively over a 15-month period. Half of the patients were prior National Institutes of Health patients, and the other 5 patients were referred from outside physicians.

Interventions.
—A dose of PTH 1-34 was administered each morning by subcutaneous injection. Calcitriol was given orally twice daily with supplemental calcium carbonate.

Main Outcome Measures.
—Serum and urine calcium and phosphorus levels.

Results.
—Once-daily treatment with PTH 1-34 maintained serum calcium in the normal range with decreased urine calcium excretion (P<.05 at 2 weeks and P<.01 at 10 weeks) compared with calcitriol treatment. Biochemical markers of bone turnover increased significantly (P<.01 at 10 weeks) during PTH 1-34 treatment.

Conclusions.
—Treatment of hypoparathyroidism with PTH 1-34 reduces urine calcium excretion compared with treatment with calcitriol and calcium.

Author Affiliations
From the Developmental Endocrinology Branch of the National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Md.

Footnotes
Reprints: Karen K. Winer, MD, NICHD/DEB/SDE, Bldg 10, Room 10N262, 10 Center Dr, MSC 1862, National Institutes of Health, Bethesda, MD 20892-1862.

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