{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T19:59:25Z","timestamp":1774641565420,"version":"3.50.1"},"reference-count":53,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2024,1,5]],"date-time":"2024-01-05T00:00:00Z","timestamp":1704412800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100007723","name":"Takeda Pharmaceuticals U.S.A.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007723","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Takeda Development Center Americas Inc."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,3,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>\u00a0<\/jats:title>\n                  <jats:p>Hypoparathyroidism (HypoPT) is a rare disease, often inadequately controlled by conventional treatment. PARALLAX was a mandatory post-marketing trial assessing pharmacokinetics and pharmacodynamics of different dosing regimens of recombinant human parathyroid hormone 1\u201384 (rhPTH[1\u201384]) for treating HypoPT. The present study (NCT03364738) was a phase 4, 1-yr open-label extension of PARALLAX. Patients received only 2 doses of rhPTH(1\u201384) in PARALLAX and were considered treatment-naive at the start of the current study. rhPTH(1\u201384) was initiated at 50\u00a0\u03bcg once daily, with doses adjusted based on albumin-corrected serum calcium levels. Albumin-corrected serum calcium (primary outcome measure), health-related quality of life (HRQoL), adverse events, and healthcare resource utilization (HCRU) were assessed. The mean age of the 22 patients included was 50.0\u00a0yr; 81.8% were women, and 90.9% were White. By the end of treatment (EOT), 95.5% of patients had albumin-corrected serum calcium values in the protocol-defined range of 1.88\u00a0mmol\/L to the upper limit of normal. Serum phosphorus was within the healthy range, and albumin-corrected serum calcium-phosphorus product was below the upper healthy limit throughout, while mean 24-h urine calcium excretion decreased from baseline to EOT. Mean supplemental doses of calcium and active vitamin D were reduced from baseline to EOT (2402\u2013855\u00a0mg\/d and 0.8\u20130.2\u00a0\u03bcg\/d, respectively). Mean serum bone turnover markers, bone-specific alkaline phosphatase, osteocalcin, procollagen type I N-terminal propeptide, and type I collagen C-telopeptide increased 2\u20135 fold from baseline to EOT. The HCRU, disease-related symptoms and impact on HRQoL improved numerically between baseline and EOT. Nine patients (40.9%) experienced treatment-related adverse events; no deaths were reported. Treatment with rhPTH(1\u201384) once daily for 1\u00a0yr improved HRQoL, maintained eucalcemia in 95% of patients, normalized serum phosphorus, and decreased urine calcium excretion. The effects observed on urine calcium and the safety profile are consistent with previous findings.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical trial identifier<\/jats:title>\n                  <jats:p>NCT03364738.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jbmrpl\/ziad010","type":"journal-article","created":{"date-parts":[[2024,1,5]],"date-time":"2024-01-05T21:36:28Z","timestamp":1704490588000},"source":"Crossref","is-referenced-by-count":4,"title":["Open-label extension of a randomized trial investigating safety and efficacy of rhPTH(1\u201384) in hypoparathyroidism"],"prefix":"10.1093","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3733-8956","authenticated-orcid":false,"given":"Aliya A","family":"Khan","sequence":"first","affiliation":[{"name":"Divisions of Endocrinology and Metabolism and Geriatric Medicine, McMaster University , Hamilton, Ontario L8S 4L8, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lisa G","family":"Abbott","sequence":"additional","affiliation":[{"name":"Northern Nevada Endocrinology , Reno, NV 89511, United States"},{"name":"University of Nevada , Reno, NV 89557, United States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Intekhab","family":"Ahmed","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Metabolism, Thomas Jefferson University Hospital , Philadelphia, PA 19107, United States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Olulade","family":"Ayodele","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas Inc. , Lexington, MA, 02421, United States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9623-962X","authenticated-orcid":false,"given":"Claudia","family":"Gagnon","sequence":"additional","affiliation":[{"name":"Department of Medicine, CHU de Qu\u00e9bec-Universit\u00e9 Laval Research Centre , Quebec G1V 4G2, Canada"},{"name":"Universit\u00e9 Laval Department of Medicine, , Quebec G1V 0A6, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard D","family":"Finkelman","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals USA, Inc. , Lexington, MA 02421, United States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emese","family":"Mezosi","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, University of P\u00e9cs , 7624 P\u00e9cs, Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lars","family":"Rejnmark","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine \u2013 Department of Endocrinology and Internal Medicine, Aarhus University , 8200, Aarhus, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Istvan","family":"Takacs","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Oncology, Semmelweis University , 1083 Budapest, Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shaoming","family":"Yin","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas Inc. , Lexington, MA, 02421, United States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4343-6723","authenticated-orcid":false,"given":"Steven W","family":"Ing","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Diabetes, and Metabolism, Ohio State University , Columbus, OH 43210, United States"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2024,1,5]]},"reference":[{"issue":"4","key":"2024050707484761500_ref1","doi-asserted-by":"crossref","first-page":"391","DOI":"10.1056\/NEJMcp0803050","article-title":"Clinical practice. 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