届大会西牙马德里至摘要.pdfVIP

th

39ESMOCongress

Madrid,Spain,26-30September2014

SUPPORTIVECARE

Poster

:1512P

Citation:AnnalsofOncology,Volume25,Supplement4,2014

SAFETYOFDENOSUMAB(DMAB)INPATIENTS(PTS)WITHSTAGE4ORSTAGE

5DCHRONICKIDNEYDISEASE(CKD)

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G.Block,O.Egbuna,S.Zeig,P.Pergola,B.Singh,A.Braun,Y.Yu,W.Sohn,D.Padhi

1

Nephrology,DenverNephrology,Denver,CO,USA

2Clinical,AmgenInc,ThousandOaks,CA,USA

3Clinical,PinesClinicalResearch,PembrokePines,FL,USA

4Nephrology,RenalAssociates,P.A.,SanAntonio,TX,USA

5Nephrology,SouthwestClincalResearchInstitute,LLC,Tempe,AZ,USA

Aim:DMABisahumanmonoclonalantibodythatbindstoRANKligandtoinhibitosteoclast-mediated

resorptionandisapprovedtopreventskeletal-relatedeventsinptswithbonemetastasesfromsolid

tumors.DMAB-inducedinhibitionofboneresorptionmayimpactcalcium(Ca)homeostasis,affecting

serumCalevels.Thisstudyevaluatedtheincidenceofhypocalcemiaandsafetyparametersofptswith

stage4or5DCKDwhowereadministeredtwosubcutaneous(SC)dosesofDMAB.

Methods:Patientsreceivedtwo120mgdosesofSCDMAB28daysapartandwerefolloweduntilday

113.Allptswererequiredtohavecontrolledsecondaryhyperparathyroidismandreceiveoral

supplementationof≥500mgCaand400IUvitaminDdaily.Theprimaryendpointwastheincidenceof

clinicallysignificant,albumin-adjusted,serumCalevels7.0mg