{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T02:47:24Z","timestamp":1787021244252,"version":"build-2736575974"},"reference-count":29,"publisher":"The Endocrine Society","issue":"11","license":[{"start":{"date-parts":[[2019,8,1]],"date-time":"2019-08-01T00:00:00Z","timestamp":1564617600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Shire Human Genetic Therapies, Inc., a member of the Takeda group of companies."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,11,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Context<\/jats:title>\n                    <jats:p>Conventional hypoparathyroidism treatment with oral calcium and active vitamin D is aimed at correcting hypocalcemia but does not address other physiologic defects caused by PTH deficiency.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate long-term safety and tolerability of recombinant human PTH (1-84) [rhPTH(1-84)].<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Open-label extension study; 5-year interim analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>12 US centers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients<\/jats:title>\n                    <jats:p>Adults (N = 49) with chronic hypoparathyroidism.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention(s)<\/jats:title>\n                    <jats:p>rhPTH(1-84) 25 or 50 \u00b5g\/d initially, with 25-\u00b5g adjustments permitted to a 100 \u00b5g\/d maximum.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main Outcome Measure(s)<\/jats:title>\n                    <jats:p>Safety parameters; composite efficacy outcome was the proportion of patients with \u226550% reduction in oral calcium (or \u2264500 mg\/d) and calcitriol (or \u22640.25 \u00b5g\/d) doses, and albumin-corrected serum calcium normalized or maintained compared with baseline, not exceeding upper limit of normal.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Forty patients completed 60 months of treatment. Mean albumin-corrected serum calcium levels remained between 8.2 and 8.7 mg\/dL. Between baseline and month 60, levels \u00b1 SD of urinary calcium, serum phosphorus, and calcium-phosphorus product decreased by 101.2 \u00b1 236.24 mg\/24 hours, 1.0 \u00b1 0.78 mg\/dL, and 8.5 \u00b1 8.29 mg2\/dL2, respectively. Serum creatinine level and estimated glomerular filtration rate were unchanged. Treatment-emergent adverse events (AEs) were reported in 48 patients (98.0%; hypocalcemia, 36.7%; muscle spasms, 32.7%; paresthesia, 30.6%; sinusitis, 30.6%; nausea, 30.6%) and serious AEs in 13 (26.5%). At month 60, 28 patients (70.0%) achieved the composite efficacy outcome. Bone turnover markers increased, peaked at \u223c12 months, and then declined to values that remained above baseline.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Treatment with rhPTH(1-84) for 5 years demonstrated a safety profile consistent with previous studies and improved key biochemical parameters.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1210\/jc.2019-01010","type":"journal-article","created":{"date-parts":[[2019,8,7]],"date-time":"2019-08-07T14:47:38Z","timestamp":1565189258000},"page":"5136-5147","source":"Crossref","is-referenced-by-count":63,"title":["Safety and Efficacy of 5 Years of Treatment With Recombinant Human Parathyroid Hormone in Adults With 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