Download - Osteoporosis Update
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Osteoporosis Review
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#ailure $o %ianose and $reat
• Studies show failure to dianosis and treatosteoporosis in older patients who ha&esuffered a fracture
• !n study of ' Midwestern health systems:
– ()* – ()' of hip fracture pts recei&ed +M%
testin – , - were i&en calcium)% supplements
– , ()(. treated with antiresorpti&e medications
US Department of Health and Human Services: Bone Health andOsteoporosis: A Report of the Surgeon General, Oce of theSurgeon General, 2004
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/is" #actors
Ma0or • 1istory of fracture as an
adult
• #raility fracture in firstderee relati&e
• Caucasian)2sianpostmenopausal woman
• Low body weiht 3, (45 lb6
• Current smo"in
• 7se of oral corticosteroids 8
9 mo
2dditional• !mpaired &ision
• ;stroen deficiency at earlyae 3, '< =O6
• %ementia
• >oor health)frailty• /ecent falls
• Low calcium inta"e 3lifelon6
• Low physical acti&ity
• 8 4 alcoholic drin"s per day
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#actors 2ssociated with +one Loss in Men
• ?enetics
• Smo"in)alcohol
• Calcium inta"e
• >hysicalacti&ity)strenth
• $estosteroneproduction
• ;stroen production
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Medical Conditions 2ssociated with!ncreased /is" of Osteoporosis
• CO>%
• Cushin@s syndrome
• ;atin disorders
• 1yperparathyroidism
• 1ypophosphatasia
• !+S
• /2A other autoimmuneconnecti&e tissuedisorders
• !nsulin dependentdiabetes
• Multiple sclerosis
• Multiple myeloma
• Stro"e 3CB26
• $hyrotoicosis
•Bitamin % deficiency• Li&er diseases
Dot an inclusi&e list
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%rus 2ssociated with/educed +one Mass
• 2luminum
• 2nticon&ulsants
• Cytotoic drus
• ?lucocorticosteroids3oral)hih dose inhaled6
• !mmunosuppresants
•?onadotropinEreleasinhormone 3e Lupron6
• Lithium
• 1eparin 3chronic use6
• Supraphysioloic
thyroine doses
• 2romatase inhibitors
• %epoE>ro&era
Dot an inclusi&e list
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/is" 2ssessment)%ianosis
• 2fter menopauseA all women should be e&aluated clinicallyfor osteoporosis ris" to determine need for +M% testin
• <.EF.G of men with osteoporosis ha&e disorders "nown toreduce bone lossA such as hyperparathyroidismA intestinal
disordersA malinanciesA conditions resultin inimmobilization
• +M% recommended in men with "nown ris" factors andwho ha&e lost 8 (< inches in heiht
• %ianosis can be established in patients who ha&e ne&erhad a fraility fracture by +M% measurement
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Horld 1ealth Oranization%ianostic Criteria
%!2?DOS!S +M% C/!$;/!2I• Normal within ( S% of a “youn normal”
adult 3$Escore at E(. and abo&e6
• Osteopenia between ( and 4< S% below
that of a “youn normal” adult3$Escore between E( and E4<6
• Osteoporosis 4< S% or more below that of a “younnormal” adult 3$Escore at or below E4<6
• Severe Osteoporosis 4< S% or more below that of a “youn normal”adult and fracture3s6
• $Escore is the number of S%s abo&e or below the a&erae +M% &alue for younAnormal adults of the same se
+M% J +one mineral density S% J Standard de&iation
IMeasured at the hipA spineA or wrist
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Hho Should be $estedK
• %ecision to test based on indi&idual ris" profileAne&er indicated unless results influencetreatment decision
• +M% testin should be performed on:( 2ll women F< =O2 and older reardless of ris"factorsI
4 =ouner postmenopausal women with one or moreris" factors 3other than bein whiteA postmenopausal
and female69 >ostmenopausal women who present with fractures
3confirm dianosisA determine disease se&erity6
IMedicare permits repeat +M% testin e&ery 4 years
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DO# – Clinician’s Guide to Prevention
and Treatment of Osteoporosiswww.nof.org
• /eleased 4)4().* 3pre&ious update in 4..96
• ?uidelines epanded to include 2fricanE2mericanA 2sianA
Latina and other postmenopausal womenA also addressesmen <. years and older
• %ramatically alters approach to assessin fracture ris" andtreatment
• Hill help identify people at hih ris" for de&elopinosteoporosis)fractures and ensure appropriate treatment
• 7ses absolute fracture ris" methodoloy to enhance treatment
decisions to indi&idualize plan for each patient
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DO#@s Clinician’s Guide
• 2pplies the recently released alorithm on absolutefracture ris" call #/2M by the H1O
• 2lso called (.Eyear fracture ris" model and (.Eyearfracture probability
• ;stimates the li"elihood of a person to brea" a bone dueto low bone mass o&er a period of (. years
• Most useful to determine if treatment needed for thosewith low bone mass or osteopenia
• http:))wwwshefacu")#/2)tool0spKlocationBalueJ4
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7ni&ersal /ecommendations
• 2deNuate inta"e of calciumA &itamin %
• HeihtEbearin and muscleEstrenthenin eercises toreduce ris" of falls)fracture
• >ro&ide strateies for fall pre&ention
• 2&oidance of tobacco use)ecessi&e alcohol use
• $al" to your pro&ider about bone health
• 1a&e a bone density test and ta"e medication whenappropriate
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Calcium)% >roduct Selection
>roduct 3G elementalCa6 ;lementalCalcium3m6
Bitamin% 3units6 Comments
Calcium carbonate 3'.6
E$ums 7ltra
ECaltrate F.. >lusEOscal >lus %
EBiacti& Chews
'..
F..<..
<..
4..(4<
(..
/eNuires acidic en&ironment for dissolution anddisinteration +est to ta"e with meals
?reater ris" for constipation with carbonate
form
Calcium citrate 34'6
ECitracal >lus %
E Citracal >etites withBit%
9(<
4..
4..
4..
$a"e without reard to meals Ser&in sizeusually eNuals 4 capsules so label can be
misleadin to patients
Bitamin %
EMulti&itamin 3%96
EBitamin %
(4.E'<. '..
(..E'..
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Bitamin % and #all /is"
• !n addition to its effect on +M%A may contribute to reduction in fractureris" – !mpro&ed muscle function – /eduction in ris" for falls
• MetaEanalyses of < clinical trials 38 F. =O26 showed sinificantreduction in ris" for fallin in those ta"in &itamin % plus calcium &ersusthose ta"in placebo
• Bitamin % deficiency pre&alent in older adult population – !nadeNuate sun eposureA use of sunscreen –
1omeboundA institutionalized – Dorthern latitudes
– Maintain 4<Ehydroy&itamin %9 at least 8 '. n)mL – $reatment: <.A... !7 &it% wee"ly FE* wee"sA then assess need for
chronic monthly therapy
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/eular HeihtE+earin ;ercise
• %efined as those in which bones and muscleswor" aainst ra&ity as feet and les bear thebody@s weiht
• !nclude wal"inA 0oinA $aiEChiA stair climbinAdancinA tennisA yoa
• !mpro&e ailityA strenthA balance
• May increase bone density modestlyA reduce fallris"A enhance muscle strenthA impro&e balance
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2&oidance of $obacco and 2lcohol
• $obacco products detrimental to s"eletonAo&erall health
• DO# stronly encouraes tobaccocessation prorams as osteoporosisinter&ention
• ;cessi&e alcohol inta"e also detrimental tobone health and reNuires treatment
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Hho Should +e $reatedKNOF Recommendations – !!"
• !nitiate therapy to reduce fractures inpostmenopausal women)men 8 <. with:
( +M% $Escores , E4< at hip or spine
4 >rior &ertebral or hip fracture
9 Low bone mass 3$Escores E(. to E4< at hip orspine6 when:
– (.Eyear probability of hip fracture is 8 9G – (.Eyear probability of ma0or osteoporosisErelated
fracture is 8 4.G
– +ased on 7SEadapted H1O alorithm
wwwnofor
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#%2E2ppro&ed %rus for Osteoporosis
• +isphosphonates – 2lendronateA 2lendronate
plus % 3#osamaA#osama >lus %6
– /isedronateA/isedronate withCalcium 32ctonel6
– !bandronate 3+oni&a6
• Selecti&e ;stroen/eceptor Modulators 3S;/Ms6 – /aloifene 3;&ista6
• Calcitonin 3MiacalcinMA#orticalMA Calcimar M6
• >arathyroid 1ormone >$1 3(E9'6AteriparatideP – #orteo
• ;stroen)1ormone$herapy 3;$)1$6 – >remarinA ;straceA
>rempro
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+isphosphonates – 2ntiresorpti&e 2ents
• 2ents #%2Eappro&ed for: – >re&ention and treatment of osteoporosis in postmenopausal
women
– $reatment to increase bone mass in men with osteoporosis
– $reatment of lucocorticoidEinduced osteoporosis in men and
women recei&in lucocorticoids – $reatment of >aet@s disease of bone in men and women
• Mechanism: inhibits bone resorption by attachin to bonysurfaces underoin acti&e resorption and inhibitin actionof osteoclasts – Leads to increases in bone density and reduced fracture ris"
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+isphosphonates – Clinical ;fficacy
• Controlled clinical trials indicate o&er 9E' year periodA alendronate Qbone mass and R incidence of &ertebralA hipA and all nonE&ertebralfractures by <.G
• Controlled clinical trials indicate risedronate Q bone mass and R ris" of&ertebral fractures by '.G and nonE&ertebral fractures by 9.G o&er9Eyear period
• !bandronate has been shown in controlled clinical trials to Q +M% andreduce the ris" of verte#ral fracture by <.G o&er 9Eyear period
• 2lendronate appears to be well tolerated and effecti&e for at least ten
years
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+isphosphonates – %osin
• 2lendronateI – >re&ention
• < m >O daily• 9< m >O wee"ly
– $reatment• (. m >O daily• 5. m >O wee"ly• 5. m)4A*.. !7 &itamin
% >O wee"ly
• /isedronate
– >re&ention)$reatment• < m >O daily• 9< m >O wee"ly
• !bandronate – >re&ention)$reatment
• 4< m >O daily• (<. m >O monthly
– $reatment• 9 m !B e&ery 9 months
!"lendronate also availa#le in oral
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+isphosphonates – 2dministration
• Must be ta"en at least oneEhalf hour before the first foodAbe&eraeA or medication of the day with plain water only3( hour prior for monthly ibandronate6
• Should only be ta"en upon arisin for the day
• $ablet should be swallowed with a full lass of water 3* oz6and patients should remain uprihtA wal"inA standinA orsittin for at least 9. minutes 3F. minutes for monthlyibandronate6
• Should supplement with calcium)&itamin % if dietary inta"einadeNuate
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+isphosphonates – 2d&erse ;ffects
• 1ypocalcemia 3(*G6
• 1ypophosphatemia
3(.G6
• Musculos"eletal painAcramps – recent #%2
warnin
• ?astrointestinal – 2bdominal pain
– 2cid reflu
– %ypepsia – ;sophaeal ulcer
– ?astritis
• Osteonecrosis of the 0aw3!B bisphosphonates6
• Bisual disturbances 3rare6
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+isphosphonates
Contraindications)>recautions• 2bnormalities of the esophaus which delay
esophaeal emptyinA such as stricture or achalasia
• !nability to stand or sit upriht for at least 9. minutes
• >atients at increased ris" of aspiration
• 1ypocalcemia – Should be corrected prior to initiatin therapy
• /enal insufficiency 3Dot recommended if CrCl , 9.E9< ml)min6
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+isphosphonates – Missed %ose
• Once wee"ly alendronateA risedronate – $a"e on mornin after rememberinA then resume
once wee"ly on reularly chosen day
• Once monthly ibandronate – !f net dose 8 5 days awayA ta"e dose the mornin
followin the date remembered
• $hen return to oriinal schedule – !f net dose , 5 days awayA wait until net scheduled
dose• Must not ta"e two (<. m tablets within the same wee"
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olendronic 2cid 3/eclast6
• 2ppro&ed for treatment of osteoporosis inpostmenopausal women in 2uust 4..5
• Sinle < m infusion i&en !B o&er 8 (< minutesAonce yearly
• Should still supplement with calcium)&itamin %
• May be ideal for those with ?! contraindications tothe oral formulations
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>rice Comparison
%ru >rice
2lendronate 3#osama6
(. m once daily
5. m once wee"ly
5. m)4*.. !7 wee"ly
9. day supply: T54UU
9. day supply: T94UU3eneric6
9. day supply: T5U5.
/isedronate 32ctonel6
< m once daily
9< m once wee"ly
9. day supply: TF<UU
9. day supply: TF9UU
!bandronate 3+oni&a6
4< m once daily
(<. m once monthly
9. day supply: TF<UU
9. day supply: T5<UU
$$$drugstorecom
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+isphosphonates
• Bery well tolerated in patients who adhere toproper administration techniNues
• >roper patient counselin for correctadministration is V;= to reduce ris" of ad&erseeffects and increase tolerability
• >lace in $herapy: should be considered firstElinefor pre&ention)treatment of osteoporosis inpatients with no contraindications
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S;/Ms – /aloifene
• #%2Eappro&ed for: – >re&ention and treatment of osteoporosis in
postmenopausal women
• Mechanism: tissueEselecti&e acti&ityA actsas an estroen aonist on bone
– ;stroen antaonist on breastA uterus
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/aloifene – Clinical ;fficacy
• /educes ris" of &ertebral fracture by 9.G inpatients with pre&ious spinal fractureA <<G inpatients without prior spinal fracture o&er 9 years
• !ncreases +M% at all s"eletal sites and reducestotal and L%L cholesterol
• Less potent antiresorpti&e aent thanbisphosphonatesA althouh direct comparisonstudies lac"in
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/aloifene – %osin)2dministration
• #or pre&ention and treatment
– F. m >O once daily
• Can be ta"en any time of day withoutreard to meals
• Should supplement with calcium)&itamin %if dietary inta"e inadeNuate
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/aloifene – 2d&erse ;ffects
• #reNuency 8 (.G – 1ot flashes
– 2rthralias
– Sinusitis
• #reNuency (E(.G – Chest pain
– !nsomnia
– Miraines
– >eripheral edema
– %iaphoresis
II1as been associated with increased ris" of thromboembolism3%B$A >;6 and superficial thrombophlebitisW ris" is similar to reportedris" of 1/$
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/aloifene
Contraindications)>recautions• 1istory of %B$)>; or at hih ris"
• Cardio&ascular disease
• 1istory of uterine)cer&ical carcinoma• %iscontinue at least 54 hours prior to anddurin proloned immobilization
• >rice – 9.Eday supply J T*FUU
• Do eneric a&ailable
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/aloifene
• >lace in $herapy: considered firstEline in womenwho cannot tolerate bisphosphonates and ha&eno contraindications to therapy
• Combination therapy 3usually a bisphosphonatewith a nonEbisphosphonate6 can pro&ideadditional small increases in +M% whencompared to monotherapy
• !mpact of combination therapy on fracture rateun"nown
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;stroen)1ormone $herapy 3;$)1$6
• #%2 appro&ed for: – >re&ent osteoporosis
– $reatment of moderate)se&ere &asomotor
symptoms of menopause – $reatment of moderate)se&ere symptoms of
&ul&ar and &ainal atrophy associated withmenopause
– Consider topical preparations to treat &ainalsymptoms rather than oral ;$)1$
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#%2 /ecommendations – ;$)1$
• Hhen prescribin medications for osteoporosisAphysicians should consider all nonEestroentherapies first
• Hhen prescribin ;$)1$A use smallest dose forshortest amount of time to achie&e treatmentoals
• >rescribe ;$)1$ products only when benefitsbelie&ed to outweih ris"s for a specific patient
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Calcitonin
• #%2Eappro&ed for: – $reatment of osteoporosis in women who are 8 < years
postmenopausal – $reatment of >aet@s disease of bone
– 2d0uncti&e therapy for hypercalcemia
• Mechanism: – >eptide composed of 94 amino acids which binds to
osteoclasts and inhibits bone resorption – >romotes the renal ecretion of calciumA phosphateA
sodiumA manesium and potassium by decreasintubular reabsorption
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Calcitonin – Clinical ;fficacy
• 1as been shown to increase spinal bone massand may decrease ris" of &ertebral fracture
• Conflictin data on efficacy of calcitonin at sitesother than the spine
• Less effecti&e than bisphosphonates in treatmentof osteoporosis
• +eneficialA shortEterm effect on acute bone painafter osteoporotic fracture 3&ertebral6
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Calcitonin – %osin)2dministration
• !ntranasal – 4.. units 3( spray6 alternatin nares daily – Store unopened bottles in refrieratorA protect from freezin – Can store open bottles at room temperature for up to 9< days – 2cti&ate pump of new bottles until full spray produced 3allow to reach
room temperature before primin6
– ;ach bottle contains at least 9. doses
• !M)SX – (.. units)e&ery other day 3minimum effecti&e dose not wellEdefined6 – Should perform s"in test prior to initiatin therapy
• Should supplement with calcium)&itamin % if dietary inta"einadeNuate
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Calcitonin – 2d&erse ;ffects
• Most common: – Dasal spray: rhinitis 3(4G6A irritation of nasal
mucosa 3UG6A epistais 39<G6A sinusitis
349G6A bac" painA arthraliaA headache – !n0ection: nausea 3(.G6A flushin 34E<G6
• $emporarily withdraw use of nasal spray if
ulceration of nasal mucosa occurs• >eriodic nasal eaminations recommended
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Calcitonin
• Contraindications – Clinical allery to calcitoninEsalmon
• >recautions
– Dasal ulcerations – $achyphylais 3parenteral dosae forms6
• %ru interactions – Do formal studies desined to e&aluate %!
• >rice per month – 4.. units)mL 346: T'4.*
– 4.. units)2C$ 3956: T*(<U
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Calcitonin
• Balid option for treatment of establishedosteoporosisA especially when accompanied byfracture pain
• >lace in therapy: because of costA ad&erseeffectsA incon&enience of nasal administrationA
recommend usin calcitonin until pain is no lonera problem and then switchin to abisphosphonate for lonEterm therapy
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>arathyroid 1ormone >$1 3(E9'6P $na#olic agent
• #%2Eappro&ed for: – $reatment of osteoporosis in postmenopausal women at hih ris"
for fracture• pre&ious osteoporotic fractureA multiple ris" factors for fractureA
etremely low +M% 3, E4<6A or failed)intolerant to pre&ious treatment
– $reatment of primary or hypoonadal osteoporosis in men at hihris" of fracture
• Mechanism: recombinant formulation of endoenous
parathyroid hormone 3>$16 – stimulates osteoblast functionA increases astrointestinal calciumabsorptionA increases renal tubular reabsorption of calcium
– ;nhances bone turno&er by initiatin reater bone formation
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>$1 3(E9'6 – Clinical ;fficacy
• Shown to decrease the ris" of new &ertebralfractures by F<G and non&ertebral fractures by<9G &ersus placebo after median eposure of (Umonths
• !ncreases lumbar spine +M% as well as at thefemoral nec"A total hipA and total body
• SafetyA efficacy of >$1 3(E9'6 has not beendemonstrated beyond 4 years of treatment
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>$1 3(E9'6 – %osin)2dministration
• 4. Y SX once daily for treatment of osteoporosis – $hih or abdominal wall
• #orteoM
prefilled pen contains 4* daily doses
• !mportant to read Medication ?uide and 7ser Manualbefore startin and each time medication refilled
• Should be administered initially under circumstanceswhere the patient can immediately sit or lie downA in thee&ent of orthostasis 3dizzinessA palpitations are transient6
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>$1 3(E9'6 – 2d&erse ;ffects
• Most common – %izzinessA rashA nauseaA headacheA le crampsA arthraliaA rhinitisA
transient hypercalcemia
• S)s of hypercalcemia: nauseaA &omitinA constipationA loweneryA or muscle wea"ness
• Most ad&erse effects in the clinical trials were mild andenerally did not lead to the discontinuation of the dru
• Osteosarcoma ris" in animals – Lead to blac" bo warnin by #%2
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>$1 3(E9'6 – Harnins)>recautions
• !ncreased ris" of osteosarcoma 3rats6 – clinicalrele&ance un"nown 3no ecess reports inhumans6
• 2&oid in: – >aet@s disease of bone
– >rior radiation therapy to s"eleton
– +one metastases – 1ypercalcemia
– 1istory of s"eletal malinancy
– >renant)nursin
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>$1 3(E9'6 – >rice
• OneEmonth supply T<9UUU
• Lilly offers #orteo >atient 2ssistance >roram for MedicareEeliible3LillyMedicare2nswers6 and nonEMedicare eliible patients
• LillyMedicare2nswers intended for patients who are enrolled in anyMedicare >art % prescription dru plan and who meet certaineliibility reNuirements – ;pected to start early 4..5
• #or nonEMedicare patientsA application process includes paper
application and income restrictions
• Call (E*55E5U<E'<<U or &isit wwwlillycom for more details
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>$1 3(E9'6
• %ue to safety concernsA >$1 treatment should belimited to those most se&erely affected and for amaimum of two years
• Combination therapy with a bisphosphonate notrecommended as effects do not appear additi&e
• CostA daily SX in0ection may be prohibiti&e forsome patients
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>$1 3(E9'6
>lace in $herapy:
• /ecommend >$1 for women or men with se&ere osteoporosis 3lowbone mineral density $Escore , E4<P and at least one frailityfracture6 who are refractory to or unable to tolerate bisphosphonatetherapy
• !n patients considered to be bisphosphonate ZfailuresAZ >$1 may bestarted approimately 9 months after bisphosphonates arediscontinued
• 2ntiresorpti&e therapy may be considered after discontinuation of>$1 to maintain ains in +M% acNuired with >$1 alone in those athih ris" for subseNuent fracture
8/9/2019 Osteoporosis Update
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2pproaches to Monitorin $herapy
• 2lways important to as" patients about adherenceAencourae continuation of therapies to reduce fracture ris"
• Monitorin of therapy should be consideredA as up to ()Fof women ta"in effecti&e therapies continue to lose boneAespecially if they smo"e
• May measure bone mineral density at a sinle site afterone year of therapyA but results may be misleadinW
usually done e&ery 4 years
• %rus may decrease a patient@s ris" for fracture e&enwhen there is no apparent increase in +M%
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• 2C/ recommends the followin inter&entions inpatients ta"in prednisone doses of < m)day orhiher for more than 9 months
– Calcium)&itamin % 3(<..m)dayA *.. !7)day6 – Hee"ly formulations of bisphosphonate therapy
– /eplacement of onadal steroids in menA if deficient
– Calcitonin therapyA if bisphosphonates contraindicatedor not tolerated
– #ollow +M% to assess if bone loss continues
?lucocorticoidE!nduced Osteoporosis –/ecommendations
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1ow Can 1ealth >rofessionals !mpro&e+one 1ealthK
To help patients maintain strong, healthy bones, health care professionals should:
• !ndentify and assist in recommendin appropriate treatment forindi&iduals at hih ris" for osteoporosis and other bone disorders
• /econize ris" factors that warrant osteoporosis screenin
• 2ssess diet)lifestyle for effect on bone health
• 2d&ise patients to ta"e acti&e steps to ensure bone health
• +e familiar with treatment of osteoporosis)low bone mass
• 2cti&ely loo" for other bone disease that can lead to bone loss)fractures
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/eferences
• 2ctonelM >rescribin !nformation 3wwwactonelcom6• 2nn !ntern Med (UU.W((4:9<4
• 2nn !ntern Med 4..FW('':5<9
• +oni&aM >rescribin !nformation 3wwwboni&acom6
• Clinical /e&iews in +one and Mineral Metabolism4..'W43'6:4U(
• ;&istaM >rescribin !nformation 3wwwe&istacom6
• #orteoM >rescribin !nformation 3wwwforteocom6
• #orticalM >rescribin !nformation 3wwwforticalcom6
• #osamaM >rescribin !nformation 3wwwfosamacom6
8/9/2019 Osteoporosis Update
http://slidepdf.com/reader/full/osteoporosis-update 57/57
/eferences
• [2M2 4..'W4U(3(F6:(UUU• [ Clin %ensitom 4..'W53(6:(EF
• [ 2m 2cad Orthop Sur 4..FW(':9'5
• MiacalcinM >rescribin !nformation 3wwwmiacalcincom6
• /eclastM >rescribin !nformation 3wwwreclastcom6• Dational Osteoporosis #oundation 3http:))wwwnofor6
• D;[M 4..9W9'*:((*5
• D;[M 4..'W9<.3(46:((*UEUU
• Osteoporosis !nt (UU*W*:(