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Hypocalcaemia in patients with metastatic bone disease treated with denosumab.

Identifieur interne : 002962 ( PubMed/Corpus ); précédent : 002961; suivant : 002963

Hypocalcaemia in patients with metastatic bone disease treated with denosumab.

Auteurs : Jean-Jacques Body ; Henry G. Bone ; Richard H. De Boer ; Alison Stopeck ; Catherine Van Poznak ; Ronaldo Damião ; Karim Fizazi ; David H. Henry ; Toni Ibrahim ; Allan Lipton ; Fred Saad ; Neal Shore ; Toshimi Takano ; Adam J. Shaywitz ; Huei Wang ; Oswaldo L. Bracco ; Ada Braun ; Paul J. Kostenuik

Source :

RBID : pubmed:26093811

English descriptors

Abstract

This analysis was performed to further characterise treatment-emergent hypocalcaemia in patients with bone metastases receiving denosumab.

DOI: 10.1016/j.ejca.2015.05.016
PubMed: 26093811

Links to Exploration step

pubmed:26093811

Le document en format XML

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<name sortKey="Body, Jean Jacques" sort="Body, Jean Jacques" uniqKey="Body J" first="Jean-Jacques" last="Body">Jean-Jacques Body</name>
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<nlm:affiliation>Department of Medicine, CHU Brugmann, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: jean-jacques.body@chu-brugmann.be.</nlm:affiliation>
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<name sortKey="Bone, Henry G" sort="Bone, Henry G" uniqKey="Bone H" first="Henry G" last="Bone">Henry G. Bone</name>
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<name sortKey="De Boer, Richard H" sort="De Boer, Richard H" uniqKey="De Boer R" first="Richard H" last="De Boer">Richard H. De Boer</name>
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<name sortKey="Stopeck, Alison" sort="Stopeck, Alison" uniqKey="Stopeck A" first="Alison" last="Stopeck">Alison Stopeck</name>
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<name sortKey="Van Poznak, Catherine" sort="Van Poznak, Catherine" uniqKey="Van Poznak C" first="Catherine" last="Van Poznak">Catherine Van Poznak</name>
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<name sortKey="Damiao, Ronaldo" sort="Damiao, Ronaldo" uniqKey="Damiao R" first="Ronaldo" last="Damião">Ronaldo Damião</name>
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<name sortKey="Lipton, Allan" sort="Lipton, Allan" uniqKey="Lipton A" first="Allan" last="Lipton">Allan Lipton</name>
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<name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name>
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<name sortKey="Shore, Neal" sort="Shore, Neal" uniqKey="Shore N" first="Neal" last="Shore">Neal Shore</name>
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<name sortKey="Takano, Toshimi" sort="Takano, Toshimi" uniqKey="Takano T" first="Toshimi" last="Takano">Toshimi Takano</name>
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<name sortKey="Shaywitz, Adam J" sort="Shaywitz, Adam J" uniqKey="Shaywitz A" first="Adam J" last="Shaywitz">Adam J. Shaywitz</name>
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<name sortKey="Wang, Huei" sort="Wang, Huei" uniqKey="Wang H" first="Huei" last="Wang">Huei Wang</name>
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<name sortKey="Bracco, Oswaldo L" sort="Bracco, Oswaldo L" uniqKey="Bracco O" first="Oswaldo L" last="Bracco">Oswaldo L. Bracco</name>
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<name sortKey="Braun, Ada" sort="Braun, Ada" uniqKey="Braun A" first="Ada" last="Braun">Ada Braun</name>
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<nlm:affiliation>Department of Hematology/Oncology, Amgen Inc., Thousand Oaks, CA, USA. Electronic address: PKost@roadrunner.com.</nlm:affiliation>
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<name sortKey="Damiao, Ronaldo" sort="Damiao, Ronaldo" uniqKey="Damiao R" first="Ronaldo" last="Damião">Ronaldo Damião</name>
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<nlm:affiliation>Department of Urology, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil. Electronic address: damiao@email.com.</nlm:affiliation>
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<name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name>
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<nlm:affiliation>Department of Medical Oncology, Institut Gustave Roussy, University of Paris Sud, Villejuif, France. Electronic address: Karim.FIZAZI@igr.fr.</nlm:affiliation>
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<name sortKey="Henry, David H" sort="Henry, David H" uniqKey="Henry D" first="David H" last="Henry">David H. Henry</name>
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<nlm:affiliation>Department of Medicine, Joan Karnell Cancer Center at Pennsylvania Hospital, Philadelphia, PA, USA. Electronic address: dhhenry@juno.com.</nlm:affiliation>
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<name sortKey="Ibrahim, Toni" sort="Ibrahim, Toni" uniqKey="Ibrahim T" first="Toni" last="Ibrahim">Toni Ibrahim</name>
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<nlm:affiliation>Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS-Osteoncology and Rare Tumors Center, Meldola, Italy. Electronic address: toni.ibrahim@irst.emr.it.</nlm:affiliation>
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<name sortKey="Lipton, Allan" sort="Lipton, Allan" uniqKey="Lipton A" first="Allan" last="Lipton">Allan Lipton</name>
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<name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name>
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<nlm:affiliation>Department of Surgery, University of Montreal Hospital Center, Montreal, QC, Canada. Electronic address: fredsaad@videotron.ca.</nlm:affiliation>
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<name sortKey="Shore, Neal" sort="Shore, Neal" uniqKey="Shore N" first="Neal" last="Shore">Neal Shore</name>
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<nlm:affiliation>Department of Urology, Carolina Urologic Research Center, Myrtle Beach, SC, USA. Electronic address: nshore@gsuro.com.</nlm:affiliation>
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<name sortKey="Takano, Toshimi" sort="Takano, Toshimi" uniqKey="Takano T" first="Toshimi" last="Takano">Toshimi Takano</name>
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<nlm:affiliation>Department of Medical Oncology, Toranomon Hospital, Tokyo, Japan. Electronic address: takano@toranomon.gr.jp.</nlm:affiliation>
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<name sortKey="Shaywitz, Adam J" sort="Shaywitz, Adam J" uniqKey="Shaywitz A" first="Adam J" last="Shaywitz">Adam J. Shaywitz</name>
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<name sortKey="Wang, Huei" sort="Wang, Huei" uniqKey="Wang H" first="Huei" last="Wang">Huei Wang</name>
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<nlm:affiliation>Department of Hematology/Oncology, Amgen Inc., Thousand Oaks, CA, USA. Electronic address: hueiw@amgen.com.</nlm:affiliation>
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<name sortKey="Bracco, Oswaldo L" sort="Bracco, Oswaldo L" uniqKey="Bracco O" first="Oswaldo L" last="Bracco">Oswaldo L. Bracco</name>
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<nlm:affiliation>Department of Hematology/Oncology, Amgen Inc., Thousand Oaks, CA, USA. Electronic address: ozzie.bracco@gmail.com.</nlm:affiliation>
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<name sortKey="Braun, Ada" sort="Braun, Ada" uniqKey="Braun A" first="Ada" last="Braun">Ada Braun</name>
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<nlm:affiliation>Department of Hematology/Oncology, Amgen Inc., Thousand Oaks, CA, USA. Electronic address: adahbraun@yahoo.de.</nlm:affiliation>
</affiliation>
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<name sortKey="Kostenuik, Paul J" sort="Kostenuik, Paul J" uniqKey="Kostenuik P" first="Paul J" last="Kostenuik">Paul J. Kostenuik</name>
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<nlm:affiliation>Department of Hematology/Oncology, Amgen Inc., Thousand Oaks, CA, USA. Electronic address: PKost@roadrunner.com.</nlm:affiliation>
</affiliation>
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<term>Antineoplastic Agents (adverse effects)</term>
<term>Biomarkers (blood)</term>
<term>Bone Density Conservation Agents (adverse effects)</term>
<term>Bone Neoplasms (drug therapy)</term>
<term>Bone Neoplasms (secondary)</term>
<term>Calcium (blood)</term>
<term>Clinical Trials, Phase III as Topic</term>
<term>Denosumab (adverse effects)</term>
<term>Diphosphonates (adverse effects)</term>
<term>Humans</term>
<term>Hypocalcemia (blood)</term>
<term>Hypocalcemia (chemically induced)</term>
<term>Hypocalcemia (diagnosis)</term>
<term>Hypocalcemia (epidemiology)</term>
<term>Hypocalcemia (prevention & control)</term>
<term>Imidazoles (adverse effects)</term>
<term>Incidence</term>
<term>Retrospective Studies</term>
<term>Risk Assessment</term>
<term>Risk Factors</term>
<term>Severity of Illness Index</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
<term>Vitamin D Deficiency (complications)</term>
<term>Vitamin D Deficiency (diagnosis)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en">
<term>Antineoplastic Agents</term>
<term>Bone Density Conservation Agents</term>
<term>Denosumab</term>
<term>Diphosphonates</term>
<term>Imidazoles</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en">
<term>Biomarkers</term>
<term>Calcium</term>
</keywords>
<keywords scheme="MESH" qualifier="blood" xml:lang="en">
<term>Hypocalcemia</term>
</keywords>
<keywords scheme="MESH" qualifier="chemically induced" xml:lang="en">
<term>Hypocalcemia</term>
</keywords>
<keywords scheme="MESH" qualifier="complications" xml:lang="en">
<term>Vitamin D Deficiency</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en">
<term>Hypocalcemia</term>
<term>Vitamin D Deficiency</term>
</keywords>
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<term>Bone Neoplasms</term>
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<term>Hypocalcemia</term>
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<term>Hypocalcemia</term>
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<term>Bone Neoplasms</term>
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<keywords scheme="MESH" xml:lang="en">
<term>Clinical Trials, Phase III as Topic</term>
<term>Humans</term>
<term>Incidence</term>
<term>Retrospective Studies</term>
<term>Risk Assessment</term>
<term>Risk Factors</term>
<term>Severity of Illness Index</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
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<front>
<div type="abstract" xml:lang="en">This analysis was performed to further characterise treatment-emergent hypocalcaemia in patients with bone metastases receiving denosumab.</div>
</front>
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<PMID Version="1">26093811</PMID>
<DateCreated>
<Year>2015</Year>
<Month>08</Month>
<Day>10</Day>
</DateCreated>
<DateCompleted>
<Year>2016</Year>
<Month>04</Month>
<Day>28</Day>
</DateCompleted>
<DateRevised>
<Year>2015</Year>
<Month>08</Month>
<Day>10</Day>
</DateRevised>
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<Journal>
<ISSN IssnType="Electronic">1879-0852</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>51</Volume>
<Issue>13</Issue>
<PubDate>
<Year>2015</Year>
<Month>Sep</Month>
</PubDate>
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<Title>European journal of cancer (Oxford, England : 1990)</Title>
<ISOAbbreviation>Eur. J. Cancer</ISOAbbreviation>
</Journal>
<ArticleTitle>Hypocalcaemia in patients with metastatic bone disease treated with denosumab.</ArticleTitle>
<Pagination>
<MedlinePgn>1812-21</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ejca.2015.05.016</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S0959-8049(15)00447-5</ELocationID>
<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">This analysis was performed to further characterise treatment-emergent hypocalcaemia in patients with bone metastases receiving denosumab.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Laboratory abnormalities and adverse events of hypocalcaemia in patients with metastatic bone disease were analysed using data from three identically designed phase 3 trials of subcutaneous denosumab 120 mg (n = 2841) versus intravenous zoledronic acid 4 mg (n = 2836).</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">The overall incidence of laboratory events of hypocalcaemia grade ⩾ 2 was higher with denosumab (12.4%) than with zoledronic acid (5.3%). Hypocalcaemia events were primarily grade 2 in severity and usually occurred within the first 6 months of treatment. Patients who reported taking calcium and/or vitamin D supplements had a lower incidence of hypocalcaemia. Prostate cancer or small-cell lung cancer, reduced creatinine clearance and higher baseline bone turnover markers of urinary N-telopeptide of type I collagen (uNTx; > 50 versus ⩽ 50 nmol/mmol) and bone-specific alkaline phosphatase (BSAP; > 20.77 μg/L [median] versus ⩽ 20.77 μg/L) values were important risk factors for developing hypocalcaemia. The risk associated with increased baseline BSAP levels was greater among patients who had > 2 bone metastases at baseline versus those with ⩽ 2 bone metastases at baseline.</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">Hypocalcaemia was more frequent with denosumab versus zoledronic acid, consistent with denosumab's greater antiresorptive effect. Low serum calcium levels and potential vitamin D deficiency should be corrected before initiating treatment with a potent osteoclast inhibitor, and corrected serum calcium levels should be monitored during treatment. Adequate calcium and vitamin D intake appears to substantially reduce the risk of hypocalcaemia.</AbstractText>
<CopyrightInformation>Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.</CopyrightInformation>
</Abstract>
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<LastName>Body</LastName>
<ForeName>Jean-Jacques</ForeName>
<Initials>JJ</Initials>
<AffiliationInfo>
<Affiliation>Department of Medicine, CHU Brugmann, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: jean-jacques.body@chu-brugmann.be.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Bone</LastName>
<ForeName>Henry G</ForeName>
<Initials>HG</Initials>
<AffiliationInfo>
<Affiliation>Michigan Bone and Mineral Clinic, Detroit, MI, USA. Electronic address: hgbone.md@att.net.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>de Boer</LastName>
<ForeName>Richard H</ForeName>
<Initials>RH</Initials>
<AffiliationInfo>
<Affiliation>Department of Medical Oncology, Royal Melbourne Hospital, Melbourne, VIC, Australia. Electronic address: richard.deboer@wh.org.au.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Stopeck</LastName>
<ForeName>Alison</ForeName>
<Initials>A</Initials>
<AffiliationInfo>
<Affiliation>Stony Brook Cancer Center, Stony Brook, NY, USA. Electronic address: Alison.Stopeck@stonybrookmedicine.edu.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Van Poznak</LastName>
<ForeName>Catherine</ForeName>
<Initials>C</Initials>
<AffiliationInfo>
<Affiliation>Department of Medical Oncology, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA. Electronic address: cvanpoz@med.umich.edu.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Damião</LastName>
<ForeName>Ronaldo</ForeName>
<Initials>R</Initials>
<AffiliationInfo>
<Affiliation>Department of Urology, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil. Electronic address: damiao@email.com.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Fizazi</LastName>
<ForeName>Karim</ForeName>
<Initials>K</Initials>
<AffiliationInfo>
<Affiliation>Department of Medical Oncology, Institut Gustave Roussy, University of Paris Sud, Villejuif, France. Electronic address: Karim.FIZAZI@igr.fr.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Henry</LastName>
<ForeName>David H</ForeName>
<Initials>DH</Initials>
<AffiliationInfo>
<Affiliation>Department of Medicine, Joan Karnell Cancer Center at Pennsylvania Hospital, Philadelphia, PA, USA. Electronic address: dhhenry@juno.com.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Ibrahim</LastName>
<ForeName>Toni</ForeName>
<Initials>T</Initials>
<AffiliationInfo>
<Affiliation>Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS-Osteoncology and Rare Tumors Center, Meldola, Italy. Electronic address: toni.ibrahim@irst.emr.it.</Affiliation>
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<Initials>A</Initials>
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<Affiliation>Division of Oncology, Pennsylvania State University, Milton S. Hershey Medical Center, Hershey, PA, USA. Electronic address: alipton@hmc.psu.edu.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Saad</LastName>
<ForeName>Fred</ForeName>
<Initials>F</Initials>
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