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Review

Safety and tolerability of denosumab for the treatment of postmenopausal osteoporosis

Pages 79-91 | Published online: 01 Dec 2011

References

  • NIH Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and TherapyOsteoporosis prevention, diagnosis, and therapyJAMA2001285678579511176917
  • CooperCCampionGMeltonLJIIIHip fractures in the elderly: a world-wide projectionOsteoporos Int1992262852891421796
  • European Foundation for Osteoporosis and Bone Disease, National Osteoporosis FoundationWho are candidates for prevention and treatment for osteoporosis?Osteoporos Int19977116
  • MeltonLJIIIChrischillesEACooperCLaneAWRiggsBLPerspective. How many women have osteoporosis?J Bone Miner Res199279100510101414493
  • CenterJRNguyenTVSchneiderDSambrookPNEismanJAMortality after all major types of osteoporotic fracture in men and women: an observational studyLancet1999353915687888210093980
  • CooperCThe crippling consequences of fractures and their impact on quality of lifeAm J Med19971032A12S19S9302893
  • LewieckiEMBilezikianJPKhoslaSOsteoporosis update from the 2010 Santa Fe bone symposiumJ Clin Densitom201114112121295739
  • BeaupreLAMorrishDWHanleyDAOral bisphosphonates are associated with reduced mortality after hip fractureOsteoporos Int201122398399121052642
  • CenterJRBliucDNguyenNDNguyenTVEismanJAOsteoporosis medication and reduced mortality risk in elderly women and menJ Clin Endocrinol Metab20119641006101421289270
  • Nurmi-LuthjeISundRJuntunenMLuthjePPost-hip fracture use of prescribed calcium plus vitamin D or vitamin D supplements and antiosteoporotic drugs is associated with lower mortality: A nationwide study in FinlandJ Bone Miner Res20112681845185321351147
  • BollandMJGreyABGambleGDReidIREffect of osteoporosis treatment on mortality: a meta-analysisJ Clin Endocrinol Metab20109531174118120080842
  • CurtisJRCarboneLChengHLongitudinal trends in use of bone mass measurement among older Americans, 1999–2005J Bone Miner Res20082371061106718302495
  • FoleyKAFosterSAMeadowsESBaserOLongSRAssessment of the clinical management of fragility fractures and implications for the new HEDIS osteoporosis measureMed Care200745990290617712262
  • McCombsJSThiebaudPLaughlin-MileyCShiJCompliance with drug therapies for the treatment and prevention of osteoporosisMaturitas200448327128715207894
  • CaroJJIshakKJHuybrechtsKFRaggioGNaujoksCThe impact of compliance with osteoporosis therapy on fracture rates in actual practiceOsteoporos Int200415121003100815167989
  • McHorneyCASchousboeJTClineRRWeissTWThe impact of osteoporosis medication beliefs and side-effect experiences on non-adherence to oral bisphosphonatesCurr Med Res Opin200723123137315217988435
  • LewieckiEMRisk communication and shared decision making in the care of patients with osteoporosisJ Clin Densitom201013433534520663701
  • MontoriVMShahNDPencilleLJUse of a decision aid to improve treatment decisions in osteoporosis: the osteoporosis choice randomized trialAm J Med2011124654955621605732
  • ParfittAMOsteonal and hemi-osteonal remodeling: the spatial and temporal framework for signal traffic in adult human boneJ Cell Biochem19945532732867962158
  • BurrDBTargeted and nontargeted remodelingBone20023012411792556
  • Collin-OsdobyPRegulation of vascular calcification by osteoclast regulatory factors RANKL and osteoprotegerinCirc Res200495111046105715564564
  • HsuHLaceyDLDunstanCRTumor necrosis factor receptor family member RANK mediates osteoclast differentiation and activation induced by osteoprotegerin ligandProc Natl Acad Sci U S A19999673540354510097072
  • LaceyDLTimmsETanHLOsteoprotegerin ligand is a cytokine that regulates osteoclast differentiation and activationCell19989321651769568710
  • Eghbali-FatourechiGKhoslaSSanyalABoyleWJLaceyDLRiggsBLRole of RANK ligand in mediating increased bone resorption in early postmenopausal womenJ Clin Invest200311181221123012697741
  • SimonetWSLaceyDLDunstanCROsteoprotegerin: a novel secreted protein involved in the regulation of bone densityCell19978923093199108485
  • RossABBatemanTAKostenuikPJThe effects of osteoprotegerin on the mechanical properties of rat boneJ Mater Sci Mater Med200112758358815348250
  • BekkerPJHollowayDNakanishiAArrighiMLeesePTDunstanCRThe effect of a single dose of osteoprotegerin in postmenopausal womenJ Bone Miner Res200116234836011204435
  • BekkerPJHollowayDLRasmussenASA single-dose placebo-controlled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal womenJ Bone Miner Res20041971059106615176987
  • McClungMRLewieckiEMCohenSBDenosumab in post-menopausal women with low bone mineral densityN Engl J Med2006354882183116495394
  • LewieckiEMMillerPDMcClungMRTwo-year treatment with denosumab (AMG 162) in a randomized phase 2 study of post-menopausal women with low bone mineral densityJ Bone Miner Res200722121832184117708711
  • MillerPDBologneseMALewieckiEMEffect of denosumab on bone density and turnover in postmenopausal women with low bone mass after long-term continued, discontinued, and restarting of therapy: A randomized blinded phase 2 clinical trialBone200843222222918539106
  • MillerPDWagmanRBPeacockMEffect of denosumab on bone mineral density and biochemical markers of bone turnover: six-year results of a phase 2 clinical trialJ Clin Endocrinol Metab201196239440221159841
  • McClungMLewieckiEMBologneseMAEffects of denosumab on bone mineral density and biochemical markers of bone turnover: 8-Year results of a phase 2 clinical trialJ Bone Miner Res201124Suppl 1S20
  • CummingsSRSan MartinJMcClungMRDenosumab for prevention of fractures in postmenopausal women with osteoporosisN Engl J Med2009361875676519671655
  • BoneHGBologneseMAYuenCKEffects of denosumab on bone mineral density and bone turnover in postmenopausal womenJ Clin Endocrinol Metab20089362149215718381571
  • BrownJPPrinceRLDealCComparison of the effect of denosumab and alendronate on BMD and biochemical markers of bone turnover in postmenopausal women with low bone mass: a randomized, blinded, phase 3 trialJ Bone Miner Res200924115316118767928
  • KendlerDLRouxCBenhamouCLEffects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapyJ Bone Miner Res2010251728119594293
  • AmgenAmgen medical information [web page on the Internet]Thousand Oaks, CAAmgen Inc2009, 2010 Available from: https://www.amgenmedinfo.com/HomeAccessed September 15, 2011
  • AmgenProlia® Postmarketing Active Safety Surveillance Program [website on the Internet]Thousand Oaks, CAAmgen Inc2011 Available from: https://proliasafety.secure.force.com/proliaAccessed August 26, 2011
  • US Food and Drug AdministrationMedWatch: The FDA Safety Information and Adverse Event Reporting Program [website on the Internet]Silverspring, MDFDA2011 [updated October 3]. Available from: http://www.fda.gov/Safety/MedWatch/default.htmAccessed October 4, 2011
  • AmgenProlia® (denosumab) risk evaluation and mitigation strategy [website on the Internet]Thousand Oaks, CAAmgen Inc2011 Available from: http://www.proliahcp.com/risk-evaluation-mitigation-strategy/Accessed August 26, 2011
  • AmgenProlia® prescribing informationThousand Oaks, CAAmgen Inc20102011 Available from: http://pi.amgen.com/united_states/prolia/prolia_pi.pdfAccessed August 28, 2011
  • AmgenMedication Guide: Prolia®Thousand Oaks, CAAmgen Inc2011 Available from: http://pi.amgen.com/united_states/prolia/prolia_mg.pdfAccessed August 28, 2011
  • AmgenImportant Drug Warning Regarding Prolia® (densoumab). [Dear healthcare professional letter.]Thousand Oaks, CAAmgen Incnd Available from: http://www.proliahcp.com/pdf/dear_healthcare_professional_letter.pdfAccessed August 28, 2011
  • AmgenProlia® (denosumab) Injection [homepage on the Internet]Thousand Oaks, CAAmgen Inc2011 Available from: http://www.prolia.com/Accessed September 15, 2011
  • US Food and Drug AdministrationInvestigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humansFederal Register. 21 CFR Parts 312 and 3202010751885993559963 Available from: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2010_register&docid=fr29se10-3.pdfAccessed September 2, 2011
  • US Food and Drug AdministrationAn FDA guide to drug safety terms [web page on the Internet]Silverspring, MDFDA2011 [updated September 9]. Available from: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107970.htmAccessed October 4, 2011
  • Houghton Miflin CompanyThe American Heritage Dictionary4th edBoston, MA, and New York, NYHoughton Miflin Company2000
  • US Food and Drug AdministrationCFR – Code of Federal Regulations Title 21. Medication Guides for Prescription Drug ProductsSilverspring, MDFDA2011 [updated April 1]. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=208&showFR=1Accessed October 12, 2011
  • US Food an Drug AdmistrationCFR – Code of Federal Regulations Title 21: Food and Drugs. Part 201 – Labeling. Subpart B – Labeling Requirements for Prescription Drugs and/or InsulinSilverspring, MDFDA2011 [updated April 1]. Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=201.57Accessed August 30, 2011
  • RothsteinADenosumab Safety: FDA AnalysisSilverspring, MDFDAnd Available from: http://courses.washington.edu/bonephys/denosumab/Rothstein%20FDA%20deno%20safety.pdfAccessed September 6, 2011
  • Advisory Committee for Reproductive Health Drugs of the Center for Drug Evaluation and ResearchSummary Minutes of the Advisory Committee for Reproductive Health Drugs: August 13, 2009Washington DC North, Githersburg, MD Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM249267.pdfAccessed September 6, 2011
  • DougallWCGlaccumMCharrierKRANK is essential for osteoclast and lymph node developmentGenes Dev199913182412242410500098
  • JosienRWongBRLiHLSteinmanRMChoiYTRANCE, a TNF family member, is differentially expressed on T cell subsets and induces cytokine production in dendritic cellsJ Immunol199916252562256810072496
  • AndersonDMMaraskovskyEBillingsleyWLA homologue of the TNF receptor and its ligand enhance T-cell growth and dendritic-cell functionNature199739066561751799367155
  • SeshasayeeDWangHLeeWPA novel in vivo role for osteoprotegerin ligand in activation of monocyte effector function and inflammatory responseJ Biol Chem200427929302023020915145935
  • LiYToraldoGLiAB cells and T cells are critical for the preservation of bone homeostasis and attainment of peak bone mass in vivoBlood200710993839384817202317
  • StolinaMDwyerDOminskyMSContinuous RANKL inhibition in osteoprotegerin transgenic mice and rats suppresses bone resorption without impairing lymphorganogenesis or functional immune responsesJ Immunol2007179117497750518025194
  • StolinaMDwyerDMoronySRats and mice overexpressing soluble OPG have high bone mass but no alteration in immunological parameters or lymphocyte functionArthritis Rheum200520S708
  • BarbarouxJBBeleutMBriskenCMuellerCGGrovesRWEpidermal receptor activator of NF-kappaB ligand controls Langerhans cells numbers and proliferationJ Immunol200818121103110818606662
  • LoserKMehlingALoeserSEpidermal RANKL controls regulatory T-cell numbers via activation of dendritic cellsNat Med200612121372137917143276
  • ReckerRRLewieckiEMMillerPDReiffelJSafety of bisphosphonates in the treatment of osteoporosisAm J Med20091222 SupplS22S3219187809
  • ReidIRMillerPDBrownJPEffects of denosumab on bone histomorphometry: the FREEDOM and STAND studiesJ Bone Miner Res201025102256226520533525
  • OdvinaCVZerwekhJERaoDSMaaloufNGottschalkFAPakCYSeverely suppressed bone turnover: a potential complication of alendronate therapyJ Clin Endocrinol Metab20059031294130115598694
  • VisekrunaMWilsonDMcKiernanFESeverely suppressed bone turnover and atypical skeletal fragilityJ Clin Endocrinol Metab20089382948295218522980
  • JorgensenNRSchwarzPEffects of anti-osteoporosis medications on fracture healingCurr Osteoporos Rep20119314915521698357
  • MarxRECilloJEJrUlloaJJOral bisphosphonate-induced osteonecrosis: risk factors, prediction of risk using serum CTX testing, prevention, and treatmentJ Oral Maxillofac Surg200765122397241018022461
  • RasmussenLMTarnowLHansenTKParvingHHFlyvbjergAPlasma osteoprotegerin levels are associated with glycaemic status, systolic blood pressure, kidney function and cardiovascular morbidity in type 1 diabetic patientsEur J Endocrinol20061541758116381994
  • BrownerWSLuiLYCummingsSRAssociations of serum osteoprotegerin levels with diabetes, stroke, bone density, fractures, and mortality in elderly womenJ Clin Endocrinol Metab200186263163711158021
  • KiechlSSchettGWenningGOsteoprotegerin is a risk factor for progressive atherosclerosis and cardiovascular diseaseCirculation2004109182175218015117849
  • NittaKAkibaTUchidaKSerum osteoprotegerin levels and the extent of vascular calcification in haemodialysis patientsNephrol Dial Transplant20041971886188915128884
  • MorenaMTerrierNJaussentIPlasma osteoprotegerin is associated with mortality in hemodialysis patientsJ Am Soc Nephrol200617126227016280472
  • KearnsAEKhoslaSKostenuikPJReceptor activator of nuclear factor kappaB ligand and osteoprotegerin regulation of bone remodeling in health and diseaseEndocr Rev200829215519218057140
  • BlackDMDelmasPDEastellROnce-yearly zoledronic acid for treatment of postmenopausal osteoporosisN Engl J Med2007356181809182217476007
  • US Food and Drug AdministrationUpdate of safety review follow-up to the October 1, 2007Early communication about the ongoing safety review of bisphosphonates [web page on the Internet]Silverspring, MDFDA2010 [updated March 4]. Available from: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm136201.htmAccessed August 11, 2011
  • SmithMREgerdieBHernandezTNDenosumab in men receiving androgen-deprivation therapy for prostate cancerN Engl J Med2009361874575519671656
  • Division of Reproductive and Urologic Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug AdministrationBackground Document for Meeting of Advisory Committee for Reproductive Health Drugs (August 13, 2009)Denosumab (Proposed trade name: PROLIA), Amgen, Inc.Silverspring, MDFDA2009 Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM176605.pdfAccessed September 15, 2011
  • AdamiSPalaciosSPavelkaKFREEDOM trial: denosumab is not associated with fracture healing complications in postmenopausal women with osteoporosisOsteoporos Int201122S243
  • BrownJPDempsterDWDingBBone remodeling in postmenopausal women who discontinued denosumab treatment: Off-treatment biopsy studyJ Bone Miner Res2011 Epub 2011 Oct 20
  • WattsNBRouxCModlinJFInfections in postmenopausal women with osteoporosis treated with denosumab or placebo: coincidence or causal association?Osteoporos Int2011 Epub 2011 Sep 3
  • BoneHGChapurlatRLibanatiCSafety observations from denosumab long-term extension and cross-over studies in postmenopausal women with osteoporosisJ Bone Miner Res201126S22
  • BoneHGIIIChapurlatRBrandiMLDenosumab treatment for 5 years of postmenopausal women with osteoporosis: results from the first two years of the FREEDOM trial extensionAmerican Association of Clinical Endocrinologists 20th Annual Meeting and Clinical Congress2011 Abstract 503
  • von KeyserlingkCHopkinsRAnastasilakisAClinical efficacy and safety of denosumab in postmenopausal women with low bone mineral density and osteoporosis: a meta-analysisSemin Arthritis Rheum20114117818621616520
  • EllisGKBoneHGChlebowskiRRandomized trial of denosumab in patients receiving adjuvant aromatase inhibitors for nonmetastatic breast cancerJ Clin Oncol200826304875488218725648
  • FizaziKCarducciMSmithMDenosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind studyLancet2011377976881382221353695
  • HenryDHCostaLGoldwasserFRandomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myelomaJ Clin Oncol20112991125113221343556
  • StopeckATLiptonABodyJJDenosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind studyJ Clin Oncol201028355132513921060033
  • KendlerDLMcClungMRFreemantleNAdherence, preference, and satisfaction of postmenopausal women taking denosumab or alendronateOsteoporos Int20112261725173520827547
  • McClungMFreemantleNKaurPThe denosumab adherence, preference, satisfaction (DAPS) study: bone mineral density results at 24 monthsJ Clin Densitom201114159
  • National Osteoporosis FoundationClinician’s Guide to Prevention and Treatment of OsteoporosisWashington DCNational Osteoporosis Foundation2010 Available at: http://www.nof.org/sites/default/files/pdfs/NOF_ClinicianGuide2009_v7.pdfAccessed October 10, 2011
  • WattsNBBilezikianJPCamachoPMAmerican Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the diagnosis and treatment of postmenopausal osteoporosisEndocr Pract201016Suppl 313721224201
  • LewieckiEMThe role of risk communication in the care of osteoporosisCurr Osteoporos Rep20119314114821505788