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Review

Long-term treatment of osteoporosis: safety and efficacy appraisal of denosumab

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Pages 295-306 | Published online: 19 Jun 2012

References

  • AhlborgHGRosengrenBEJärvinenTLPrevalence of osteoporosis and incidence of hip fracture in women – secular trends over 30 yearsBMC Musculoskelet Disord2010114820222965
  • WattsNBDiabDLLong-term use of bisphosphonates in osteoporosisJ Clin Endocrinol Metab20109541555156520173017
  • KongYYYoshidaHSarosiIOPGL is a key regulator of osteoclastogenesis, lymphocyte development and lymph-node organogenesisNature199939767173153239950424
  • SimonetWSLaceyDLDunstanCROsteoprotegerin: a novel secreted protein involved in the regulation of bone densityCell19978923093199108485
  • AnastasilakisADToulisKAPolyzosSATerposERANKL inhibition for the management of patients with benign metabolic bone disordersExpert Opin Investig Drugs200918810851102
  • KostenuikPJOsteoprotegerin and RANKL regulate bone resorption, density, geometry and strengthCurr Opin Pharmacol2005561862516188502
  • BekkerPJHollowayDNakanishiAArrighiMLeesePTDunstanCRThe effect of a single dose of osteoprotegerin in postmenopausal womenJ Bone Miner Res200116234836011204435
  • BodyJJGreippPColemanREA Phase I study of AMGN-0007, a recombinant osteoprotegerin construct, in patients with multiple myeloma or breast carcinoma related bone metastasesCancer200397Suppl 388789212548591
  • MoronySLuJCapparelliCDunstanCRLaceyDLKostenuikPJOsteoprotegerin (OPG) prevents bone loss in a rat model of glucocorticoid- induced osteopeniaJ Bone Miner Res200116S148
  • BoyleWJSimonetWSLaceyDLOsteoclast differentiation and activationNature2003423693733734212748652
  • BekkerPHollowayDRasmussenAA single-dose placebo-controlled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal womenJ Bone Miner Res20041971059106615176987
  • KearnsAEKhoslaSKostenuikPJReceptor activator of nuclear factor kappaB ligand and osteoprotegerin regulation of bone remodeling in health and diseaseEndocr Rev200829215519218057140
  • 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
  • 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
  • BoneHGBologneseMAYuenCKEffects of denosumab treatment and discontinuation on bone mineral density and bone turnover markers in postmenopausal women with low bone massJ Clin Endocrinol Metab20119697298021289258
  • BoonenSFerrariSMillerPDPostmenopausal osteoporosis treatment with antiresorptives: effects of discontinuation or long-term continuation on bone turnover and fracture risk-a perspectiveJ Bone Miner Res201227596397422467094
  • SutjandraLRodriguezRDDoshiSPopulation pharmacokinetic meta-analysis of denosumab in healthy subjects and postmenopausal women with osteopenia or osteoporosisClin Pharmacokinet2011501279380722087866
  • Amgen IncProlia (denosumab) package insertThousand Oaks, CAAmgen Inc2010
  • BridgemanMBPathakRDenosumab for the reduction of bone loss in postmenopausal osteoporosis: a reviewClin Ther201133111547155922108301
  • BodyJJFaconTColemanREA study of the biological receptor activator of nuclear factor K-B ligand inhibitor, denosumab, in patients with multiple myeloma or bone metastasis from breast cancerClin Cancer Res2006121221122816489077
  • RodriguezRDSutjandraLPetersonMCJangGRPerez RuixoJPopulation pharmacokinetic meta-analysis of denosumab in healthy and cancer subjects and postmenopausal women with osteopenia or osteoporosisAAPS J200911S1
  • LoboEDHansenRJBalthasarJPAntibody pharmacokinetics and pharmacodynamicsJ Pharm Sci200493112645266815389672
  • LewieckiEMDenosumab – an emerging treatment for postmenopausal osteoporosisExpert Opin Biol Ther201010346747620095877
  • WangJLeeJBurnsDFit-for-purpose method validation and application of a biomarker (C-terminal telopeptides of type 1 collagen) in denosumab clinical studiesAAPS J200911238539419462251
  • KostenuikPJNguyenHQMcCabeJDenosumab, a fully human monoclonal antibody to RANKL, inhibits bone resorption and increases BMD in knock-in mice that express chimeric (murine/human) RANKLJ Bone Miner Res20092418219519016581
  • OminskyMSSchroederJSmithSYFarrellDJAtkinsonJEKostenuikPJDenosumab (AMG 162), a fully human RANKL antibody, improves cortical and cancellous bone mass and bone strength in ovariectomized cynomolgus monkeysJ Bone Miner Res200722S23
  • OminskyMSSchroederJSmithSYFarrellJPKostenuikPJAtkinsonJEDenosumab (AMG 162, a fully human RANKL antibody) increases cortical and cancellous bone mass in aged ovariectomized cynomolgus monkeysJ Bone Miner Res200621S72
  • AnastasilakisADToulisKAGoulisDGEfficacy and safety of denosumab in postmenopausal women with osteopenia or osteoporosis: a systematic review and a meta-analysisHorm Metab Res2009411072172919536731
  • EastellRChristiansenCGrauerAEffects of denosumab on bone turnover markers in postmenopausal osteoporosisJ Bone Miner Res201126353053720839290
  • PapapoulosSChapurlatRLibanatiCFive years of denosumab exposure in women with postmenopausal osteoporosis: results from the first two years of the FREEDOM extensionJ Bone Miner Res201227369470122113951
  • CummingsSRSan MartinJMcClungMRDenosumab for prevention of fractures in postmenopausal women with osteoporosisN Engl J Med2009361875676519671655
  • McClungMLewieckiECohenSDenosumab in postmenopausal women with low bone mineral densityN Engl J Med2006354882183116495394
  • BoneHBologneseMYuenCEffects of denosumab on bone mineral density and bone turnover in postmenopausal womenJ Clin Endocrinol Metab20089362149215718381571
  • MuradMHDrakeMTMullanRJComparative effectiveness of drug treatments to prevent fragility fractures: a systematic review and network meta-analysisJ Clin Endocrinol MetabMarch 302012 [Epub ahead of print.]
  • McCloskeyEVJohanssonHOdenADenosumab reduces the risk of osteoporotic fractures in postmenopausal women, particularly in those with moderate to high fracture risk as assessed with FRAX®J Bone Miner ResMarch 102012 [Epub ahead of print.]
  • McClungMBoonenSTörringOEffect of denosumab treatment on the risk of fractures in subgroups of women with postmenopausal osteoporosisJ Bone Miner ResOctober 42011 [Epub ahead of print.]
  • BoonenSAdachiJDManZTreatment with denosumab reduces the incidence of new vertebral and hip fractures in postmenopausal women at high riskJ Clin Endocrinol Metab20119661727173621411557
  • JamalSALjunggrenOStehman-BreenCEffects of denosumab on fracture and bone mineral density by level of kidney functionJ Bone Miner Res20112681829183521491487
  • BeckTJLewieckiEMMillerPDEffects of denosumab on the geometry of the proximal femur in postmenopausal women in comparison with alendronateJ Clin Densitom200811335135918495508
  • ToulisKAAnastasilakisADPolyzosSAMakrasPTargeting the osteoblast: approved and experimental anabolic agents for the treatment of osteoporosisHormones (Athens)20111017419522001129
  • AndersonDMMaraskovskyEBillingsleyWLA homologue of the TNF receptor and its ligand enhance T-cell growth and dendritic-cell functionNature199739066561751799367155
  • BachmannMFWongBRJosienRSteinmanRMOxeniusAChoiYTRANCE, a tumor necrosis factor family member critical for CD40 ligand-independent T helper cell activationJ Exp Med199918971025103110190893
  • WongBJosienRLeeSYTRANCE (tumor necrosis factor [TNF]-related activation induced cytokine), a new TNF family member predominantly expressed in T cells, is a dendritic cell-specific survival factorJ Exp Med199718612207520809396779
  • SchwartzmanJYaziciYDenosumab in postmenopausal women with low bone mineral densityN Engl J Med2006354222390239116738280
  • Ferrari-LacrazSFerrariSDo RANKL inhibitors (denosumab) affect inflammation and immunity?Osteoporos Int20102243544620571772
  • WattsNBRouxCModlinJFInfections in postmenopausal women with osteoporosis treated with denosumab or placebo: coincidence or causal association?Osteoporos Int201223132733721892677
  • SobacchiCFrattiniAGuerriniMMOsteoclast-poor human osteopetrosis due to mutations in the gene encoding RANKLNat Genet200739896096217632511
  • ToulisKAAnastasilakisADIncreased risk of serious infections in women with osteopenia or osteoporosis treated with denosumabOsteoporos Int201021111963196420012939
  • von KeyserlingkCHopkinsRAnastasilakisAClinical efficacy and safety of denosumab in postmenopausal women with low bone mineral density and osteoporosis: a meta-analysisSemin Arthritis Rheum201141217818621616520
  • EmeryJGMcDonnellPBurkeMBOsteoprotegerin is a receptor for the cytotoxic ligand TRAILJ Biol Chem199827314363143679603945
  • WileySRSchooleyKSmolakPJIdentification and characterization of a new member of the TNF family that induces apoptosisImmunity1995366736828777713
  • Gonzalez-SuarezEJacobAPJonesJRANK ligand mediates progestin-induced mammary epithelial proliferation and carcinogenesisNature2010468732010310720881963
  • LoserKMehlingALoeserSEpidermal RANKL controls regulatory T-cell numbers via activation of dendritic cellsNat Med200612121372137917143276
  • SchousboeJTTaylorBCKielDPEnsrudKEWilsonKEMcCloskeyEVAbdominal aortic calcification detected on lateral spine images from a bone densitometer predicts incident myocardial infarction or stroke in older womenJ Bone Miner Res20082340941617956153
  • PricePAJuneHHBuckleyJRWilliamsonMKOsteoprotegerin inhibits artery calcification induced by warfarin and by vitamin DArterioscler Thromb Vasc Biol200121101610161611597934
  • HelasSGoettschCSchoppetMInhibition of receptor activator of NF-kappaB ligand by denosumab attenuates vascular calcium deposition in miceAm J Pathol2009175247347819590040
  • JonoSIkariYShioiASerum osteoprotegerin levels are associated with the presence and severity of coronary artery diseaseCirculation2002106101192119412208791
  • SchoppetMSattlerAMSchaeferJRHerzumMMaischBHofbauerLCIncreased osteoprotegerin serum levels in men with coronary artery diseaseJ Clin Endocrinol Metab20038831024102812629080
  • 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
  • PennisiPSignorelliSSRiccobeneSLow bone density and abnormal bone turnover in patients with atherosclerosis of peripheral vesselsOsteoporos Int200415538939514661073
  • VisekrunaMWilsonDMcKiernanFSeverely suppressed bone turnover and atypical skeletal fragilityJ Clin Endocrinol Metab20089382948295218522980
  • KyrgidisATriaridisSVahtsevanosKAntoniadesKOsteonecrosis of the jaw and bisphosphonate use in breast cancer patientsExpert Rev Anticancer Ther200991125113419671032
  • RizzoliRReginsterJYBoonenSAdverse reactions and drug-drug interactions in the management of women with postmenopausal osteoporosisCalcif Tissue Int20118929110421637997
  • KyrgidisATzellosTGToulisKAntoniadesKThe facial skeleton in patients with osteoporosis: a field for disease signs and treatment complicationsJ Osteoporos20111614768921403823
  • KyrgidisAToulisKADenosumab-related osteonecrosis of the jawsOsteoporos Int201122136937020306021
  • PazianasMOsteonecrosis of the jaw and the role of macrophagesJ Natl Cancer Inst2011103323224021189409
  • FlickLMWeaverJMUlrich-VintherMEffects of receptor activator of NFkappaB (RANK) signaling blockade on fracture healingJ Orthop Res200321467668412798068
  • DelosDYangXRicciardiBFMyersERBostromMPCamachoNPThe effects of RANKL inhibition on fracture healing and bone strength in a mouse model of osteogenesis imperfectaJ Orthop Res200826215316417729310
  • OtaNTakaishiHKosakiNAccelerated cartilage resorption by chondroclasts during bone fracture healing in osteoprotegerin-deficient miceEndocrinology 2009003B1501148234834
  • GerstenfeldLCSacksDJPelisMComparison of effects of the bisphosphonate alendronate versus the RANKL inhibitor denosumab on murine fracture healingJ Bone Miner Res200924219620819016594
  • AdamiSAdachiJBoonenSDenosumab administration is not associated with fracture healing complications in postmenopausal women with osteoporosis: results from the FREEDOM trialJ Bone Miner Res201025Suppl 1MO0405
  • RizzoliRYasothanUKirkpatrickPDenosumabNat Rev Drug Discov20109859159220671758
  • RittmasterRBologneseMEttingerMEnhancement of bone mass in osteoporotic women with parathyroid hormone followed by alendronateJ Clin Endocrinol Metab20008562129213410852440
  • HiligsmannMReginsterJYPotential cost-effectiveness of denosumab for the treatment of postmenopausal osteoporotic womenBone2010471344020303422
  • HiligsmannMReginsterJYCost effectiveness of denosumab compared with oral bisphosphonates in the treatment of post-menopausal osteoporotic women in BelgiumPharmacoeconomics2011291089591121692551
  • JönssonBStrömOEismanJACost-effectiveness of denosumab for the treatment of postmenopausal osteoporosisOsteoporos Int201122396798220936401
  • BlackDMSchwartzAVEnsrudKEEffects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX): a randomized trialJAMA2006296242927293817190893
  • MakrasPVaiopoulosGLyritisGP2011 guidelines for the diagnosis and treatment of osteoporosis in GreeceJ Musculoskelet Neuronal Interact2012121384222373950
  • StolinaMKostenuikPJDougallWCFitzpatrickLAZackDJRANKL inhibition: from mice to men (and women)Adv Exp Med Biol200760214315017966399
  • RachnerTDKhoslaSHofbauerLCOsteoporosis: now and the futureLancet201137797731276128721450337
  • SilvermanSChristiansenCIndividualizing osteoporosis therapyOsteoporos Int201223379780922218417
  • PalaciosSBazedoxifene acetate for the management of postmenopausal osteoporosisDrugs Today (Barc)201147318719521494696
  • LewieckiEMMillerPDMcClungMRTwo-year treatment with denosumab (AMG 162) in a randomized phase 2 study of postmenopausal women with low BMDJ 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