Journal
JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
Volume 98, Issue 1, Pages 137-144Publisher
ENDOCRINE SOC
DOI: 10.1210/jc.2012-2984
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Funding
- National Institutes of Health [DK069350, DK095944]
- Food and Drug Administration Grant [002525]
- NPS Pharmaceuticals
- Amgen
- Roche Diagnostics
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Context: PTH may be an effective treatment option for hypoparathyroidism, but long-term data are not available. Objective: We studied the effect of 4 yr of PTH(1-84) treatment in hypoparathyroidism. Design: Twenty-seven subjects were treated with PTH(1-84) for 4 yr, with prospective monitoring of calcium and vitamin D requirements, serum and urinary calcium, serum phosphorus, bone turnover markers, and bone mineral density (BMD). Results: Treatment with PTH(1-84) reduced supplemental calcium requirements by 37% (P = 0.006) and 1,25-dihydroxyvitamin Drequirements by 45% (P = 0.008). Seven subjects (26%) were able to stop 1,25-dihydroxyvitamin D completely. Serum calcium concentration remained stable, and urinary calcium and phosphorus excretion fell. Lumbar spine BMD increased by 5.5 +/- 9% at 4 yr (P < 0.0001). Femoral neck and total hip BMD remained stable. At 4 yr, distal radius BMD was not different from baseline. Bone turnover markers increased significantly, reaching a 3-fold peak from baseline values at 6-12 months (P < 0.05 for all), subsequently declining to steady-state levels at 30 months. Hypercalcemia was uncommon (11 episodes in eight subjects over 4 yr; 1.9% of all values), with most episodes occurring within the first 6 months and resolving with adjustment of supplemental calcium and vitamin D. Conclusions: PTH(1-84) treatment of hypoparathyroidism for up to 4 yr maintains the serum calcium concentration, while significantly reducing supplemental calcium and 1,25-dihydroxyvitamin D requirements. Lumbar spine BMD increases without significant changes at other sites. These data provide support for the safety and efficacy of PTH(1-84) therapy in hypoparathyroidism for up to 4 yr. (J Clin Endocrinol Metab 98: 137-144, 2013)
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