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August 28, 1996

Synthetic Human Parathyroid Hormone 1-34 vs Calcitriol and Calcium in the Treatment of HypoparathyroidismResults of a Short-term Randomized Crossover Trial

Author Affiliations

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

JAMA. 1996;276(8):631-636. doi:10.1001/jama.1996.03540080053029

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.