https://m2.mtmt.hu/ hun 2026-05-25 19:21 JournalArticle 34507786 VALIDATED true Divisions of Endocrinology and Metabolism and Geriatric Medicine, McMaster University, Hamilton, L8S 4L8, ON, Canada Northern Nevada Endocrinology, Reno, 89511, NV, United States University of Nevada, Reno, 89557, NV, United States Department of Endocrinology and Metabolism, Thomas Jefferson University Hospital, Philadelphia, 19107, PA, United States Takeda Development Center Americas Inc., Lexington, 02421, MA, United States Department of Medicine, CHU de Québec-Université Laval Research Centre, Quebec, G1V 4G2, Canada Department of Medicine, Université Laval, Quebec, G1V 0A6, Canada Takeda Pharmaceuticals USA, Inc., Lexington, 02421, MA, United States Department of Internal Medicine, University of Pécs, Pécs, 7624, Hungary Department of Clinical Medicine, Department of Endocrinology and Internal Medicine, Aarhus University, Aarhus, 8200, Denmark Department of Internal Medicine and Oncology, Semmelweis University, Budapest, 1083, Hungary Division of Endocrinology, Diabetes, and Metabolism, Ohio State University, Columbus, 43210, OH, United States Export Date: 08 April 2025; Cited By: 1; Correspondence Address: A.A. Khan; Divisions of Endocrinology and Metabolism and Geriatric Medicine, McMaster University, Hamilton, L8S 4L8, Canada; email: draliyakhan@gmail.com 0 false 2026-05-23T12:14:38.997+0000 2024-11-28T06:10:13.590+0000 2024-01-16T13:41:18.786+0000 true 10079502 Dienesné Fráter Daniella /api/admin/10079502 Admin false 2025-06-02T13:10:02.708+0000 2025-06-02T13:10:02.708+0000 2024-11-28T06:10:13.794+0000 true 10039043 Milánkovics Róbert /api/admin/10039043 Admin true 10039043 true false true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle true 10000059 Article true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle /api/subtype/10000059 Szakcikk SubType 101 true 10000059 true 1 /api/category/1 Category true 1 Khan, Aliya A Open-label extension of a randomized trial investigating safety and efficacy of rhPTH(1–84) in hypoparathyroidism true true /api/journal/10082736 REVIEWED true false 10082736 false 10082736 true 2473-4039 2473-4039 Journal FOREIGN 8 3 ziad010 ziad010 34 2024 Hypoparathyroidism 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 1–84 (rhPTH[1–84]) for treating hypoparathyroidism. The present study (NCT03364738) was a Phase 4, 1-year open-label extension of PARALLAX. Patients received only two doses of rhPTH(1–84) in PARALLAX and were thus considered treatment-naive at the start of the current study. rhPTH(1–84) was initiated at 50 μg 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 years; 81.8% were women, and 90.9% were White. By end of treatment (EOT), 95.5% of patients had albumin-corrected serum calcium values in the protocol-defined primary endpoint range of 1.88 mmol/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-hour urine calcium excretion decreased from baseline to EOT. Mean supplemental doses of calcium and active vitamin D were reduced from baseline to EOT (2402–855 mg/day and 0.8–0.2 μg/day, respectively). Mean serum bone turnover markers, bone-specific alkaline phosphatase, osteocalcin, procollagen type I N-terminal propeptide, and type I collagen C-telopeptide increased 2–5 fold from baseline to EOT. 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(1–84) once daily for 1 year 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. true 2024 true true true false true false GOLD 2026-05-23 true https://doi.org/10.1093/jbmrpl/ziad010 5 0 5 3 0 5 5 3 5 5 5 3 3 3 2 0 5 3 5 3 0 3 3 Folyóiratcikk Journal Article 24 4 Könyvrészlet Chapter in Book 25 1 Könyv Book 23 0 Egyéb konferenciaközlemény Conference paper 31 0 Egyéb konferenciakötet Conference proceedings 32 0 Oltalmi formák Protection forms 26 0 Disszertáció Thesis 28 0 Egyéb Miscellaneous 29 0 Alkotás Achievement 22 0 Kutatási adat Research data 33 0 Folyóiratcikk Journal Article 24 0 0 0 Könyvrészlet Chapter in Book 25 0 0 0 Könyv Book 23 0 0 0 Egyéb konferenciaközlemény Conference paper 31 0 0 0 Egyéb konferenciakötet Conference proceedings 32 0 0 0 Oltalmi formák Protection forms 26 0 0 0 Disszertáció Thesis 28 0 0 0 Egyéb Miscellaneous 29 0 0 0 Alkotás Achievement 22 0 0 0 Kutatási adat Research data 33 0 0 0 2024 0 2 1 2 1 2025 0 2 1 2 1 2026 0 1 1 1 1 Q1 false 10024031 false false false 2024-04-15T12:41:31.310+0000 Belgyógyászati és Onkológiai Klinika (SE / AOK / K); I. sz. Belgyógyászati Klinika (PTE / ÁOK) 2 12 2 11 0 true Language 10002 /api/language/10002 Angol English true 2 true PersonAuthorship 113902997 /api/authorship/113902997 1 0.091 true false true Khan Aliya A true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 113902998 /api/authorship/113902998 2 0.09090909 false false false Abbott Lisa G true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 113902999 /api/authorship/113902999 3 0.09090909 false false false Ahmed Intekhab true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 113903000 /api/authorship/113903000 4 0.09090909 false false false Ayodele Olulade true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 113903001 /api/authorship/113903001 5 0.09090909 false false false Gagnon Claudia true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 113903002 /api/authorship/113903002 6 0.09090909 false false false Finkelman Richard D true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 113903003 /api/authorship/113903003 7 0.09090909 false false false Author 10012397 /api/author/10012397 Mezősi Emese true 10012397 true Mezosi Emese true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 113903004 /api/authorship/113903004 8 0.09090909 false false false Rejnmark Lars true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 113903005 /api/authorship/113903005 9 0.09090909 false false false Author 10024031 /api/author/10024031 Takács István true 10024031 true Takacs Istvan true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 113903006 /api/authorship/113903006 10 0.09090909 false false false Yin Shaoming true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 113903007 /api/authorship/113903007 11 0.09090909 false true false Ing Steven W true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PublicationIdentifier 25302054 /api/publicationidentifier/25302054 PlainSource 6 /api/publicationsource/6 PublicationSourceType 10001 /api/publicationsourcetype/10001 true true true DOI DOI https://doi.org/@@@ true true 6 true GOLD true IDENTICAL 10.1093/jbmrpl/ziad010 https://doi.org/10.1093/jbmrpl/ziad010 false true PublicationIdentifier 26300904 /api/publicationidentifier/26300904 PlainSource 1 /api/publicationsource/1 PublicationSourceType 10003 /api/publicationsourcetype/10003 false true true WoS WoS https://www.webofscience.com/wos/woscc/full-record/@@@ true true 1 true IDENTICAL 001203142400008 https://www.webofscience.com/wos/woscc/full-record/001203142400008 true true PublicationIdentifier 26243592 /api/publicationidentifier/26243592 PlainSource 3 /api/publicationsource/3 PublicationSourceType 10003 /api/publicationsourcetype/10003 false true true Scopus Scopus http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-@@@ true true 3 true IDENTICAL 85193432043 http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-85193432043 false true PublicationIdentifier 26197972 /api/publicationidentifier/26197972 PlainSource 17 /api/publicationsource/17 PublicationSourceType 10003 /api/publicationsourcetype/10003 false true true PubMed PubMed http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=@@@&dopt=Abstract true true 17 true IDENTICAL 38741607 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=38741607&dopt=Abstract true true Classification 12215 /api/classification/12215 true true SjrRating 11489842 /api/sjrrating/11489842 54 0.24 journal RatingType 10002 /api/ratingtype/10002 sjr true true ClassificationExternal 2732 /api/classificationexternal/2732 true 2732 true Q1 DIRECT true true /api/publication/34507786 <div class="JournalArticle Publication long-list"> <div class="authors"> <img title="Forrásközlemény" style="float: left" src="/frontend/resources/grid/publication-core-icon.png"> <img title="Idézőközlemény" style="float: left" src="/frontend/resources/grid/publication-citation-icon.png"> <div class="autype autype0"> <span class="author-name" >Khan Aliya A ✉ </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Abbott Lisa G </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Ahmed Intekhab </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Ayodele Olulade </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Gagnon Claudia </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Finkelman Richard D </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10012397"><a href="/gui2/?type=authors&mode=browse&sel=10012397" target="_blank">Mezosi Emese (<span class="authorship-author-name">Mezősi Emese</span> <span class="authorAux-mtmt"> Endokrinológia</span>) </a> </span> <span class="author-affil"><span title="Pécsi Tudományegyetem">PTE</span>/<span title="Általános Orvostudományi Kar">ÁOK</span>/I. sz. Belgyógyászati Klinika</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Rejnmark Lars </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10024031"><a href="/gui2/?type=authors&mode=browse&sel=10024031" target="_blank">Takacs Istvan (<span class="authorship-author-name">Takács István</span> <span class="authorAux-mtmt"> Endokrinológia</span>) </a> </span> <span class="author-affil"><span title="Semmelweis Egyetem">SE</span>/<span title="Általános Orvostudományi Kar">AOK</span>/<span title="Klinikum">K</span>/Belgyógyászati és Onkológiai Klinika</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Yin Shaoming </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Ing Steven W </span> </div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;34507786" target="_blank">Open-label extension of a randomized trial investigating safety and efficacy of rhPTH(1–84) in hypoparathyroidism</a></div> <div> <span class="journal-title">JBMR PLUS</span> <span class="journal-issn">(<a target="_blank" href="https://portal.issn.org/resource/ISSN/2473-4039">2473-4039</a> <a target="_blank" href="https://portal.issn.org/resource/ISSN/2473-4039">2473-4039</a>)</span>: <span class="journal-volume">8</span> <span class="journal-issue">3</span> <span class="page"> Paper ziad010. 34 p. </span> <span class="year">(2024)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Nyelv: Angol | </span> <span class="identifiers"> <span class="id identifier oa_GOLD" title=" Gold "> <a style="color:blue" title="10.1093/jbmrpl/ziad010" target="_blank" href="https://doi.org/10.1093/jbmrpl/ziad010"> DOI </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="001203142400008" target="_blank" href="https://www.webofscience.com/wos/woscc/full-record/001203142400008"> WoS </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="85193432043" target="_blank" href="http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-85193432043"> Scopus </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="38741607" target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=38741607&dopt=Abstract"> PubMed </a> </span> </span> <OnlyViewableByAuthor><div class="ratings"> <div class="journal-subject">Folyóirat szakterülete: Scopus - Orthopedics and Sports Medicine&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;Q1</div> <div class="journal-subject">Folyóirat szakterülete: Scopus - Endocrinology, Diabetes and Metabolism&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;Q2</div> </div></OnlyViewableByAuthor> <div class="publication-citation" style="margin-left: 0.5cm;"> <span title="Nyilvános idézőközlemények összesen, említések nélkül" class="citingPub-count">Nyilvános idéző összesen: 5</span> | Független: 3 | Függő: 2 | Nem jelölt: 0 | WoS jelölt: 3 | Scopus jelölt:&nbsp;5 | WoS/Scopus jelölt:&nbsp;5 | DOI jelölt:&nbsp;5 </div> <div class="publication-citation"> <a target="_blank" href="/api/publication?cond=citations.related;eq;34507786&sort=publishedYear,desc&sort=title"> Idézett közlemények száma: 3 </a> </div> <div class="mtid"><span class="long-pub-mtid">Közlemény: 34507786</span> | <span class="status-data status-VALIDATED"> Egyeztetett </span> Forrás Idéző | <span class="type-subtype">Folyóiratcikk ( Szakcikk ) </span> | <span class="pub-category">Tudományos</span> | <span class="publication-sourceOfData">kézi felvitel</span> </div> <div class="lastModified">Utolsó módosítás: 2024.11.28. 07:10 Milánkovics Róbert (PTE ÁOK admin 4) </div> <pre class="comment" style="margin-top: 0; margin-bottom: 0;"><u>Megjegyzés</u>: Divisions of Endocrinology and Metabolism and Geriatric Medicine, McMaster University, Hamilton, L8S 4L8, ON, Canada Northern Nevada Endocrinology, Reno, 89511, NV, United States University of Nevada, Reno, 89557, NV, United States Department of Endocrinology and Metabolism, Thomas Jefferson University Hospital, Philadelphi...</pre> </div></div>