PTH(1–34) for the Primary Prevention of Postthyroidectomy Hypocalcemia: The THYPOS Trial

Context: There are no studies evaluating teriparatide for prevention of post-thyroidectomy hypocalcemia. Objective: Our objective was to evaluate whether teriparatide can prevent postsurgical hypocalcemia and shorten the hospitalization in subjects at high risk of hypocalcemia following thyroid surg...

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Veröffentlicht in:The journal of clinical endocrinology and metabolism 2016-11, Vol.101 (11), p.4039-4045
Hauptverfasser: Palermo, Andrea, Mangiameli, Giuseppe, Tabacco, Gaia, Longo, Filippo, Pedone, Claudio, Briganti, Silvia Irina, Maggi, Daria, Vescini, Fabio, Naciu, Anda, Lauria Pantano, Angelo, Napoli, Nicola, Angeletti, Silvia, Pozzilli, Paolo, Crucitti, Pierfilippo, Manfrini, Silvia
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container_end_page 4045
container_issue 11
container_start_page 4039
container_title The journal of clinical endocrinology and metabolism
container_volume 101
creator Palermo, Andrea
Mangiameli, Giuseppe
Tabacco, Gaia
Longo, Filippo
Pedone, Claudio
Briganti, Silvia Irina
Maggi, Daria
Vescini, Fabio
Naciu, Anda
Lauria Pantano, Angelo
Napoli, Nicola
Angeletti, Silvia
Pozzilli, Paolo
Crucitti, Pierfilippo
Manfrini, Silvia
description Context: There are no studies evaluating teriparatide for prevention of post-thyroidectomy hypocalcemia. Objective: Our objective was to evaluate whether teriparatide can prevent postsurgical hypocalcemia and shorten the hospitalization in subjects at high risk of hypocalcemia following thyroid surgery. Design: This was a prospective phase II randomized open-label trial. Setting: This trial was set on a surgical ward. Patients: Twenty-six subjects (six males, 20 females) with intact PTH lower than10 pg/ml 4 hours after thyroidectomy were included. Intervention: Subjects were randomized (1:1) to receive SC administration of 20 mcg of teriparatide every 12 hours until the discharge (treatment group) or to follow standard clinical care (control group). Main Outcome Measure: Adjusted serum calcium, duration of hospitalization, and calcium/calcitriol supplementation were measured. Results: Overall, the incidence of hypocalcemia was 3/13 in treatment group and 11/13 in the control group (P = .006). Treated patients had a lower risk of hypocalcemia than controls (relative risk, 0.26 [95% confidence interval, 0.09–0.723)]). The median duration of hospitalization was 3 days (interquartile range, 1) in control subjects and 2 days (interquartile range, 0) in treated subjects (P = .012). One month after discharge, 10/13 subjects in the treatment group had stopped calcium carbonate supplements, while only 5/13 in the control group had discontinued calcium. The ANOVA for repeated measures showed a significant difference in calcium supplements between groups at 1-month visit (P = .04) as well as a significant difference between discharge and 1-month visit in the treatment group (P for interaction time group = .04) Conclusions: Teriparatide may prevent postsurgical hypocalcemia, shorten the duration of hospitalization, and reduce the need for calcium and vitamin D supplementation after discharge in high risk subjects after thyroid surgery. Teriparatide may prevent post-thyroidectomy hypocalcemia, shorten the duration of hospitalization and reduce the need for calcium and vitamin D supplementation after discharge.
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Objective: Our objective was to evaluate whether teriparatide can prevent postsurgical hypocalcemia and shorten the hospitalization in subjects at high risk of hypocalcemia following thyroid surgery. Design: This was a prospective phase II randomized open-label trial. Setting: This trial was set on a surgical ward. Patients: Twenty-six subjects (six males, 20 females) with intact PTH lower than10 pg/ml 4 hours after thyroidectomy were included. Intervention: Subjects were randomized (1:1) to receive SC administration of 20 mcg of teriparatide every 12 hours until the discharge (treatment group) or to follow standard clinical care (control group). Main Outcome Measure: Adjusted serum calcium, duration of hospitalization, and calcium/calcitriol supplementation were measured. Results: Overall, the incidence of hypocalcemia was 3/13 in treatment group and 11/13 in the control group (P = .006). Treated patients had a lower risk of hypocalcemia than controls (relative risk, 0.26 [95% confidence interval, 0.09–0.723)]). The median duration of hospitalization was 3 days (interquartile range, 1) in control subjects and 2 days (interquartile range, 0) in treated subjects (P = .012). One month after discharge, 10/13 subjects in the treatment group had stopped calcium carbonate supplements, while only 5/13 in the control group had discontinued calcium. The ANOVA for repeated measures showed a significant difference in calcium supplements between groups at 1-month visit (P = .04) as well as a significant difference between discharge and 1-month visit in the treatment group (P for interaction time group = .04) Conclusions: Teriparatide may prevent postsurgical hypocalcemia, shorten the duration of hospitalization, and reduce the need for calcium and vitamin D supplementation after discharge in high risk subjects after thyroid surgery. Teriparatide may prevent post-thyroidectomy hypocalcemia, shorten the duration of hospitalization and reduce the need for calcium and vitamin D supplementation after discharge.</description><identifier>ISSN: 0021-972X</identifier><identifier>EISSN: 1945-7197</identifier><identifier>DOI: 10.1210/jc.2016-2530</identifier><identifier>PMID: 27525532</identifier><language>eng</language><publisher>United States: Endocrine Society</publisher><subject>Calcitriol ; Calcitriol - therapeutic use ; Calcium (blood) ; Calcium carbonate ; Calcium, Dietary - therapeutic use ; Dietary Supplements ; Drug Administration Schedule ; Female ; Goiter, Nodular - surgery ; Graves Disease - surgery ; Hormone Replacement Therapy - adverse effects ; Hospitalization ; Hospitals, University ; Humans ; Hypocalcemia ; Hypocalcemia - blood ; Hypocalcemia - epidemiology ; Hypocalcemia - etiology ; Hypocalcemia - prevention &amp; control ; Incidence ; Injections, Subcutaneous ; Italy - epidemiology ; Length of Stay ; Male ; Middle Aged ; Parathyroid hormone ; Parathyroid Hormone - blood ; Patients ; Postoperative Complications - blood ; Postoperative Complications - epidemiology ; Postoperative Complications - etiology ; Postoperative Complications - prevention &amp; control ; Prevention ; Risk ; Surgery ; Teriparatide - administration &amp; dosage ; Teriparatide - adverse effects ; Teriparatide - therapeutic use ; Thyroid ; Thyroid gland ; Thyroid Neoplasms - surgery ; Thyroidectomy ; Thyroidectomy - adverse effects ; Vitamin D</subject><ispartof>The journal of clinical endocrinology and metabolism, 2016-11, Vol.101 (11), p.4039-4045</ispartof><rights>Copyright © 2016 by the Endocrine Society</rights><rights>Copyright © 2016 by the Endocrine Society 2016</rights><rights>Copyright © 2016 by The Endocrine Society</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4789-6ff09d81f3ef0901a8092bfb280ea2408c44621d59e3b875adfc245411ea6ed63</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27525532$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Palermo, Andrea</creatorcontrib><creatorcontrib>Mangiameli, Giuseppe</creatorcontrib><creatorcontrib>Tabacco, Gaia</creatorcontrib><creatorcontrib>Longo, Filippo</creatorcontrib><creatorcontrib>Pedone, Claudio</creatorcontrib><creatorcontrib>Briganti, Silvia Irina</creatorcontrib><creatorcontrib>Maggi, Daria</creatorcontrib><creatorcontrib>Vescini, Fabio</creatorcontrib><creatorcontrib>Naciu, Anda</creatorcontrib><creatorcontrib>Lauria Pantano, Angelo</creatorcontrib><creatorcontrib>Napoli, Nicola</creatorcontrib><creatorcontrib>Angeletti, Silvia</creatorcontrib><creatorcontrib>Pozzilli, Paolo</creatorcontrib><creatorcontrib>Crucitti, Pierfilippo</creatorcontrib><creatorcontrib>Manfrini, Silvia</creatorcontrib><title>PTH(1–34) for the Primary Prevention of Postthyroidectomy Hypocalcemia: The THYPOS Trial</title><title>The journal of clinical endocrinology and metabolism</title><addtitle>J Clin Endocrinol Metab</addtitle><description>Context: There are no studies evaluating teriparatide for prevention of post-thyroidectomy hypocalcemia. Objective: Our objective was to evaluate whether teriparatide can prevent postsurgical hypocalcemia and shorten the hospitalization in subjects at high risk of hypocalcemia following thyroid surgery. Design: This was a prospective phase II randomized open-label trial. Setting: This trial was set on a surgical ward. Patients: Twenty-six subjects (six males, 20 females) with intact PTH lower than10 pg/ml 4 hours after thyroidectomy were included. Intervention: Subjects were randomized (1:1) to receive SC administration of 20 mcg of teriparatide every 12 hours until the discharge (treatment group) or to follow standard clinical care (control group). Main Outcome Measure: Adjusted serum calcium, duration of hospitalization, and calcium/calcitriol supplementation were measured. Results: Overall, the incidence of hypocalcemia was 3/13 in treatment group and 11/13 in the control group (P = .006). Treated patients had a lower risk of hypocalcemia than controls (relative risk, 0.26 [95% confidence interval, 0.09–0.723)]). The median duration of hospitalization was 3 days (interquartile range, 1) in control subjects and 2 days (interquartile range, 0) in treated subjects (P = .012). One month after discharge, 10/13 subjects in the treatment group had stopped calcium carbonate supplements, while only 5/13 in the control group had discontinued calcium. The ANOVA for repeated measures showed a significant difference in calcium supplements between groups at 1-month visit (P = .04) as well as a significant difference between discharge and 1-month visit in the treatment group (P for interaction time group = .04) Conclusions: Teriparatide may prevent postsurgical hypocalcemia, shorten the duration of hospitalization, and reduce the need for calcium and vitamin D supplementation after discharge in high risk subjects after thyroid surgery. Teriparatide may prevent post-thyroidectomy hypocalcemia, shorten the duration of hospitalization and reduce the need for calcium and vitamin D supplementation after discharge.</description><subject>Calcitriol</subject><subject>Calcitriol - therapeutic use</subject><subject>Calcium (blood)</subject><subject>Calcium carbonate</subject><subject>Calcium, Dietary - therapeutic use</subject><subject>Dietary Supplements</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Goiter, Nodular - surgery</subject><subject>Graves Disease - surgery</subject><subject>Hormone Replacement Therapy - adverse effects</subject><subject>Hospitalization</subject><subject>Hospitals, University</subject><subject>Humans</subject><subject>Hypocalcemia</subject><subject>Hypocalcemia - blood</subject><subject>Hypocalcemia - epidemiology</subject><subject>Hypocalcemia - etiology</subject><subject>Hypocalcemia - prevention &amp; control</subject><subject>Incidence</subject><subject>Injections, Subcutaneous</subject><subject>Italy - epidemiology</subject><subject>Length of Stay</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Parathyroid hormone</subject><subject>Parathyroid Hormone - blood</subject><subject>Patients</subject><subject>Postoperative Complications - blood</subject><subject>Postoperative Complications - epidemiology</subject><subject>Postoperative Complications - etiology</subject><subject>Postoperative Complications - prevention &amp; control</subject><subject>Prevention</subject><subject>Risk</subject><subject>Surgery</subject><subject>Teriparatide - administration &amp; dosage</subject><subject>Teriparatide - adverse effects</subject><subject>Teriparatide - therapeutic use</subject><subject>Thyroid</subject><subject>Thyroid gland</subject><subject>Thyroid Neoplasms - surgery</subject><subject>Thyroidectomy</subject><subject>Thyroidectomy - adverse effects</subject><subject>Vitamin D</subject><issn>0021-972X</issn><issn>1945-7197</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kM-K1EAQxhtxccfVm2cJeHCFzdrVf5KON1nUERZ2wAjqpenpVJiMSTp2Jy5z8x18Q5_EDhkVRAuKqoZffXz9EfII6CUwoM_39pJRyFImOb1DVlAImeZQ5HfJilIGaZGzD6fkfgh7SkEIye-RU5ZLJiVnK_JpU67P4ce371w8S2rnk3GHycY3nfGHOPEr9mPj-sTVycaFcdwdvGsqtKPrDsn6MDhrWotdY14kZbws1x83N--S0jemfUBOatMGfHicZ-T961fl1Tq9vnnz9urldWpFroo0q2taVApqjnGhYBQt2LbeMkXRMEGVFSJjUMkC-Vbl0lS1ZUIKADQZVhk_I-eL7uDdlwnDqLsmWGxb06ObggbFpWC5kkVEn_yF7t3k--hOc8gEz3kmVKQuFsp6F4LHWg9LIBqonjPXe6vnzPWcecQfH0WnbYfVb_hXyBEQC3Dr2hF9-NxOt-j1Dk077jSNJbJcpbMiQHylsWE2-3Q5c9PwPwfp0QFfSOwrZ33T4-AxhD-f-6fvn9_4pzI</recordid><startdate>201611</startdate><enddate>201611</enddate><creator>Palermo, Andrea</creator><creator>Mangiameli, Giuseppe</creator><creator>Tabacco, Gaia</creator><creator>Longo, Filippo</creator><creator>Pedone, Claudio</creator><creator>Briganti, Silvia Irina</creator><creator>Maggi, Daria</creator><creator>Vescini, Fabio</creator><creator>Naciu, Anda</creator><creator>Lauria Pantano, Angelo</creator><creator>Napoli, Nicola</creator><creator>Angeletti, Silvia</creator><creator>Pozzilli, Paolo</creator><creator>Crucitti, Pierfilippo</creator><creator>Manfrini, Silvia</creator><general>Endocrine Society</general><general>Oxford University Press</general><general>Copyright by The Endocrine Society</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>7T5</scope><scope>7TM</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>201611</creationdate><title>PTH(1–34) for the Primary Prevention of Postthyroidectomy Hypocalcemia: The THYPOS Trial</title><author>Palermo, Andrea ; Mangiameli, Giuseppe ; Tabacco, Gaia ; Longo, Filippo ; Pedone, Claudio ; Briganti, Silvia Irina ; Maggi, Daria ; Vescini, Fabio ; Naciu, Anda ; Lauria Pantano, Angelo ; Napoli, Nicola ; Angeletti, Silvia ; Pozzilli, Paolo ; Crucitti, Pierfilippo ; Manfrini, Silvia</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4789-6ff09d81f3ef0901a8092bfb280ea2408c44621d59e3b875adfc245411ea6ed63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Calcitriol</topic><topic>Calcitriol - therapeutic use</topic><topic>Calcium (blood)</topic><topic>Calcium carbonate</topic><topic>Calcium, Dietary - therapeutic use</topic><topic>Dietary Supplements</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Goiter, Nodular - surgery</topic><topic>Graves Disease - surgery</topic><topic>Hormone Replacement Therapy - adverse effects</topic><topic>Hospitalization</topic><topic>Hospitals, University</topic><topic>Humans</topic><topic>Hypocalcemia</topic><topic>Hypocalcemia - blood</topic><topic>Hypocalcemia - epidemiology</topic><topic>Hypocalcemia - etiology</topic><topic>Hypocalcemia - prevention &amp; control</topic><topic>Incidence</topic><topic>Injections, Subcutaneous</topic><topic>Italy - epidemiology</topic><topic>Length of Stay</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Parathyroid hormone</topic><topic>Parathyroid Hormone - blood</topic><topic>Patients</topic><topic>Postoperative Complications - blood</topic><topic>Postoperative Complications - epidemiology</topic><topic>Postoperative Complications - etiology</topic><topic>Postoperative Complications - prevention &amp; control</topic><topic>Prevention</topic><topic>Risk</topic><topic>Surgery</topic><topic>Teriparatide - administration &amp; dosage</topic><topic>Teriparatide - adverse effects</topic><topic>Teriparatide - therapeutic use</topic><topic>Thyroid</topic><topic>Thyroid gland</topic><topic>Thyroid Neoplasms - surgery</topic><topic>Thyroidectomy</topic><topic>Thyroidectomy - adverse effects</topic><topic>Vitamin D</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Palermo, Andrea</creatorcontrib><creatorcontrib>Mangiameli, Giuseppe</creatorcontrib><creatorcontrib>Tabacco, Gaia</creatorcontrib><creatorcontrib>Longo, Filippo</creatorcontrib><creatorcontrib>Pedone, Claudio</creatorcontrib><creatorcontrib>Briganti, Silvia Irina</creatorcontrib><creatorcontrib>Maggi, Daria</creatorcontrib><creatorcontrib>Vescini, Fabio</creatorcontrib><creatorcontrib>Naciu, Anda</creatorcontrib><creatorcontrib>Lauria Pantano, Angelo</creatorcontrib><creatorcontrib>Napoli, Nicola</creatorcontrib><creatorcontrib>Angeletti, Silvia</creatorcontrib><creatorcontrib>Pozzilli, Paolo</creatorcontrib><creatorcontrib>Crucitti, Pierfilippo</creatorcontrib><creatorcontrib>Manfrini, Silvia</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium &amp; Calcified Tissue Abstracts</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>The journal of clinical endocrinology and metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Palermo, Andrea</au><au>Mangiameli, Giuseppe</au><au>Tabacco, Gaia</au><au>Longo, Filippo</au><au>Pedone, Claudio</au><au>Briganti, Silvia Irina</au><au>Maggi, Daria</au><au>Vescini, Fabio</au><au>Naciu, Anda</au><au>Lauria Pantano, Angelo</au><au>Napoli, Nicola</au><au>Angeletti, Silvia</au><au>Pozzilli, Paolo</au><au>Crucitti, Pierfilippo</au><au>Manfrini, Silvia</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>PTH(1–34) for the Primary Prevention of Postthyroidectomy Hypocalcemia: The THYPOS Trial</atitle><jtitle>The journal of clinical endocrinology and metabolism</jtitle><addtitle>J Clin Endocrinol Metab</addtitle><date>2016-11</date><risdate>2016</risdate><volume>101</volume><issue>11</issue><spage>4039</spage><epage>4045</epage><pages>4039-4045</pages><issn>0021-972X</issn><eissn>1945-7197</eissn><abstract>Context: There are no studies evaluating teriparatide for prevention of post-thyroidectomy hypocalcemia. Objective: Our objective was to evaluate whether teriparatide can prevent postsurgical hypocalcemia and shorten the hospitalization in subjects at high risk of hypocalcemia following thyroid surgery. Design: This was a prospective phase II randomized open-label trial. Setting: This trial was set on a surgical ward. Patients: Twenty-six subjects (six males, 20 females) with intact PTH lower than10 pg/ml 4 hours after thyroidectomy were included. Intervention: Subjects were randomized (1:1) to receive SC administration of 20 mcg of teriparatide every 12 hours until the discharge (treatment group) or to follow standard clinical care (control group). Main Outcome Measure: Adjusted serum calcium, duration of hospitalization, and calcium/calcitriol supplementation were measured. Results: Overall, the incidence of hypocalcemia was 3/13 in treatment group and 11/13 in the control group (P = .006). Treated patients had a lower risk of hypocalcemia than controls (relative risk, 0.26 [95% confidence interval, 0.09–0.723)]). The median duration of hospitalization was 3 days (interquartile range, 1) in control subjects and 2 days (interquartile range, 0) in treated subjects (P = .012). One month after discharge, 10/13 subjects in the treatment group had stopped calcium carbonate supplements, while only 5/13 in the control group had discontinued calcium. The ANOVA for repeated measures showed a significant difference in calcium supplements between groups at 1-month visit (P = .04) as well as a significant difference between discharge and 1-month visit in the treatment group (P for interaction time group = .04) Conclusions: Teriparatide may prevent postsurgical hypocalcemia, shorten the duration of hospitalization, and reduce the need for calcium and vitamin D supplementation after discharge in high risk subjects after thyroid surgery. Teriparatide may prevent post-thyroidectomy hypocalcemia, shorten the duration of hospitalization and reduce the need for calcium and vitamin D supplementation after discharge.</abstract><cop>United States</cop><pub>Endocrine Society</pub><pmid>27525532</pmid><doi>10.1210/jc.2016-2530</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record>
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subjects Calcitriol
Calcitriol - therapeutic use
Calcium (blood)
Calcium carbonate
Calcium, Dietary - therapeutic use
Dietary Supplements
Drug Administration Schedule
Female
Goiter, Nodular - surgery
Graves Disease - surgery
Hormone Replacement Therapy - adverse effects
Hospitalization
Hospitals, University
Humans
Hypocalcemia
Hypocalcemia - blood
Hypocalcemia - epidemiology
Hypocalcemia - etiology
Hypocalcemia - prevention & control
Incidence
Injections, Subcutaneous
Italy - epidemiology
Length of Stay
Male
Middle Aged
Parathyroid hormone
Parathyroid Hormone - blood
Patients
Postoperative Complications - blood
Postoperative Complications - epidemiology
Postoperative Complications - etiology
Postoperative Complications - prevention & control
Prevention
Risk
Surgery
Teriparatide - administration & dosage
Teriparatide - adverse effects
Teriparatide - therapeutic use
Thyroid
Thyroid gland
Thyroid Neoplasms - surgery
Thyroidectomy
Thyroidectomy - adverse effects
Vitamin D
title PTH(1–34) for the Primary Prevention of Postthyroidectomy Hypocalcemia: The THYPOS Trial
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