WHO OWNS THE BONES?WHO OWNS THE BONES?

““Patchwork Quilt” of Women’s HealthPatchwork Quilt” of Women’s HealthWho screens?Who screens?Who treats?Who treats?Who teaches/ to whom?Who teaches/ to whom?

Whose job it it?Whose job it it?RheumatologyRheumatologyEndocrinologyEndocrinologyPrimary CarePrimary CareGynecologyGynecologyGerontologyGerontologyOrthopedicsOrthopedics

OrganizationsOrganizationsNOFNOFNAMSNAMSISCDISCD

OverviewOverview

Prevention and Treatment of OsteoporosisPrevention and Treatment of OsteoporosisDemographicsDemographicsScreeningScreeningPrevention/LifestylePrevention/LifestyleRisk FactorsRisk FactorsPharmaceuticalsPharmaceuticalsNutriceuticalsNutriceuticals

DefinitionDefinition

Osteoporosis is a skeletal disorder Osteoporosis is a skeletal disorder characterized by compromised bone characterized by compromised bone strength predisposing to an increased strength predisposing to an increased fracture risk.fracture risk.

BONE DENSITY=BONE DENSITY (70%) + BONE STRENGTH (30%)BONE DENSITY=BONE DENSITY (70%) + BONE STRENGTH (30%)

BONE DENSITY: grams of mineral per area BONE DENSITY: grams of mineral per area

BONE QUALITY: architecture, turnover, damage accumulation, BONE QUALITY: architecture, turnover, damage accumulation, and mineralization and mineralization

NIH Consensus Development NIH Consensus Development Conference on Osteoporosis, 2000Conference on Osteoporosis, 2000

DemographicsDemographics

10 Million People have Osteoporosis10 Million People have Osteoporosis

34 Million People have Osteopenia34 Million People have Osteopenia

1:2 Women will have an osteoporotic 1:2 Women will have an osteoporotic fracture in their lifetimefracture in their lifetime

1.5 Million Fractures Annually1.5 Million Fractures Annually– 20% die within one year20% die within one year

$18B Annually$18B Annually

www.nof.orgwww.nof.org

ScreeningScreening

DEXA is most cost-effective screen todayDEXA is most cost-effective screen today– All women at least 65 yoAll women at least 65 yo– Perimenopausal, if risk factorsPerimenopausal, if risk factors– Any adult > 50 yo with a fractureAny adult > 50 yo with a fracture– Adults with a condition or on a medication associated Adults with a condition or on a medication associated

with bone losswith bone loss– Patients considering or currently on a medication for Patients considering or currently on a medication for

osteoporosisosteoporosis– Postmenopausal women considering discontinuation Postmenopausal women considering discontinuation

of HRTof HRT

NOF Clinicians Guide to Prevention and NOF Clinicians Guide to Prevention and Treatment of OsteoporosisTreatment of Osteoporosis

Unrecognized Vertebral Fractures Unrecognized Vertebral Fractures in Hospitalized Patientsin Hospitalized Patients

0

5

10

15

20

25

30

35

40

45

50

FxPresent

In Report InDCSum

InRecord

On Rx

Undertreatment of Hip Fracture in Undertreatment of Hip Fracture in Hospitalized PatientsHospitalized Patients

0

5

10

15

20

25

30

35

40

DXA Ca + Vit D Rx BP Rx

Hosp A

Hosp B

Hosp C

Hosp D

DensitometryDensitometry

How often? How often? – Not more than every 2 yearsNot more than every 2 years

Which bones?Which bones?– Spine, Hip, Femoral NeckSpine, Hip, Femoral Neck

When to treat?When to treat?– OsteoporosisOsteoporosis– Osteopenia with another risk factorOsteopenia with another risk factor

Lifestyle Lifestyle – Exercise, Calcium, Vitamin D, Smoking, AlcoholExercise, Calcium, Vitamin D, Smoking, Alcohol

Risk FactorsRisk Factors– Age, activity, diet, meds (steroids>3 months), stability, previous Age, activity, diet, meds (steroids>3 months), stability, previous

fracture, BMI<21,hip fx in a parent, current smokingfracture, BMI<21,hip fx in a parent, current smoking

Bone Densitometry ValuesBone Densitometry Values

T Score: Standard Deviation comparison of a patient’s T Score: Standard Deviation comparison of a patient’s bone density to a normal 25 yo. bone density to a normal 25 yo.

We now have comparison tables by sex and ethnic group.We now have comparison tables by sex and ethnic group.

NormalNormal– T score >-1.0T score >-1.0

OsteoporosisOsteoporosis– T score < -2.5T score < -2.5

““Osteopenia”Osteopenia”– T score -1.0 to -2.5T score -1.0 to -2.5

National Osteoporosis Risk National Osteoporosis Risk Assessment (NORA)Assessment (NORA)

Bone Density RR 95% CI

Normal BMD 1

Osteopenia 1.8 1.49-2.18

Osteoporosis 4.03 3.59-4.53

FRAX SCOREFRAX SCOREWHO Fracture Risk Assessment ToolWHO Fracture Risk Assessment Tool

Uses calculations based on patient data to Uses calculations based on patient data to determine a 10-year risk of hip and major determine a 10-year risk of hip and major osteoporosis-related fractureosteoporosis-related fracture

http://www.shef.ac.uk/FRAX/index.htmhttp://www.shef.ac.uk/FRAX/index.htm

NAMS RecommendationsNAMS Recommendations

Use lowest T-score to define diagnosisUse lowest T-score to define diagnosisPrevention and nutritional measures firstPrevention and nutritional measures firstDrug Treatment:Drug Treatment:

Any Vertebral FractureAny Vertebral FractureAll T-scores < -2.5All T-scores < -2.5Anyone on steroids >3 monthsAnyone on steroids >3 monthsT-scores of -2 to -2.5 if one risk factorT-scores of -2 to -2.5 if one risk factor

BMI<21BMI<21Fragility Fracture HistoryFragility Fracture HistoryHip Fracture History in a ParentHip Fracture History in a Parent

Medical WorkupMedical Workup

25-OH Vitamin D Levels25-OH Vitamin D LevelsFSHFSHTSHTSHParathyroid HormoneParathyroid HormoneCreatinine ClearanceCreatinine ClearanceAlkaline PhosphataseAlkaline PhosphataseLiver EnzymesLiver EnzymesCeliac AntibodiesCeliac AntibodiesProtein ElectrophoresisProtein Electrophoresis24-hr. Urine24-hr. Urine– Calcium, Creatine, Sodium, Free CortisolCalcium, Creatine, Sodium, Free Cortisol

Risk Factors used in FRAXRisk Factors used in FRAX

Geographic RegionGeographic Region

RaceRace

SexSex

Height/WeightHeight/Weight

Previous Fragility Previous Fragility FractureFracture

Family History of Family History of OsteoporosisOsteoporosis

Current SmokingCurrent Smoking

Steroid Use (5 mg/da Steroid Use (5 mg/da for over 3 months)for over 3 months)

Rheumatoid ArthritisRheumatoid Arthritis

Secondary Secondary OsteoporosisOsteoporosis

Alcohol (3 or more Alcohol (3 or more units daily)units daily)

BMD (T score at BMD (T score at femoral neck)femoral neck)

So Whom Do We Treat?So Whom Do We Treat?

Patients with previous hip or vertebral Patients with previous hip or vertebral fracturefracture

T score of -2.5 or less at femoral neck, total T score of -2.5 or less at femoral neck, total hip, or spinehip, or spine

T score of -1.0 to -2.5 (Osteopenia) AND:T score of -1.0 to -2.5 (Osteopenia) AND:– Other prior fractureOther prior fracture

– Secondary cause associated with high fracture riskSecondary cause associated with high fracture risk

– FRAX risk of 3% or more at hipFRAX risk of 3% or more at hip

– FRAX risk of 20% or more for major osteoporosis FRAX risk of 20% or more for major osteoporosis related fracture at any siterelated fracture at any site

Trends in Treatment Trends in Treatment RecommendationsRecommendations

20032003Patients with previous hip Patients with previous hip or vertebral fractureor vertebral fracture

T-score of -2 at hipT-score of -2 at hip

T-score of -1.5 to -2 at hip T-score of -1.5 to -2 at hip PLUS additional risk PLUS additional risk factor. factor.

20082008Patients with previous hip Patients with previous hip or vertebral fractureor vertebral fracture

T-score of -2.5 at femoral T-score of -2.5 at femoral neck, total hip, or spineneck, total hip, or spine

T-score of -1 to -2.5 at T-score of -1 to -2.5 at femoral neck, total hip, or femoral neck, total hip, or spine AND:spine AND:– Other fractureOther fracture

– Other risk factorsOther risk factors

– FRAX of 3% or more at hipFRAX of 3% or more at hip

– FRAX of 20% for other siteFRAX of 20% for other site

Treatment OptionsTreatment Options

Nutrition and SupplementsNutrition and SupplementsExerciseExerciseFall PreventionFall PreventionAlcohol and Nicotine AvoidanceAlcohol and Nicotine AvoidancePharmaceuticalsPharmaceuticals– BisphosphanatesBisphosphanates– SERMsSERMs– PTHPTH– HRTHRT– CalcitoninCalcitonin

BisphosphanatesBisphosphanates

GenericGeneric

AlendronateAlendronate

RisendronateRisendronate

IbandronateIbandronate

Zoledronic AcidZoledronic Acid

PamidronatePamidronate

EtidronateEtidronate

TiludronateTiludronate

Brand NameBrand Name

FosamaxFosamax

ActonelActonel

BonivaBoniva

Reclast Reclast

ArediaAredia

DidronelDidronel

SkelidSkelid

BisphosphanatesBisphosphanatesPrevention Treatment Comments

Alendronate(Fosamax)

5 mg/da35 mg/wk

10 mg/da70 mg/wk

Must take on empty stomach, early am, with 8 oz. water, no food for 30 min.

Risendronate(Actonel)

5 mg/da35 mg/wk75 mg 2 days/wk150 mg/mo

5 mg/da35 mg/wk75 mg 2 days/wk150 mg/mo

Same directions as for Alendronate

Ibandronate(Boniva)

2.5 mg/da150 mg/mo3mg/3mo IVPCheck creatinine before injection.

Same directions as for Alendronate, but no food for 1hr.

Zoledronic Acid(Reclast)

5 mg. annually IVP Acute phase reaction – muscle achesSome concern for atrial fibrillation

BisphosphanatesBisphosphanates

All are indicated for prevention and/or All are indicated for prevention and/or treatment of postmenopausal osteoporosistreatment of postmenopausal osteoporosis

Bind permanently to bone to decrease Bind permanently to bone to decrease osteoclastic activity and increase bone osteoclastic activity and increase bone massmass

Concerns about bone quality (“frozen” Concerns about bone quality (“frozen” bone)bone)

Implications for fertility – contraindicated in Implications for fertility – contraindicated in women planning pregnancywomen planning pregnancy

BisphosphanatesBisphosphanates

Similar efficacySimilar efficacy

Adverse effects: Esophageal erosion, Adverse effects: Esophageal erosion, hypocalcemia, bone painhypocalcemia, bone pain

Contraindications: esophageal dysmotility, Contraindications: esophageal dysmotility, significant renal dysfunction, hypocalcemiasignificant renal dysfunction, hypocalcemia

Osteonecrosis of Jaw (ONJ): Osteonecrosis of Jaw (ONJ):

<1 case/100,000 years of exposure. Usually <1 case/100,000 years of exposure. Usually with high IV doses for cancer Rx.with high IV doses for cancer Rx.

Khann. Khann. J.Rheumatol. J.Rheumatol. 2009;Mar;36(3):478-90.2009;Mar;36(3):478-90.

Estrogen Agonist/AntagonistEstrogen Agonist/Antagonist(Formerly called SERMS)(Formerly called SERMS)

Raloxifene (Evista)Raloxifene (Evista)• Bind to ER, activating some/ blocking Bind to ER, activating some/ blocking

othersothers• Decrease vertebral fractures, but no Decrease vertebral fractures, but no

significant effect on hip fracturessignificant effect on hip fractures• One 60 mg tab dailyOne 60 mg tab daily• Adverse Effects: hot flashes, VTE, leg Adverse Effects: hot flashes, VTE, leg

crampscramps

Ettinger et al.Ettinger et al. JAMA JAMA 1999;282:637-645.1999;282:637-645.

Pharmacologic Treatment OptionsPharmacologic Treatment Options

AnabolicsAnabolics– Teriparatide (Forteo)Teriparatide (Forteo)

AntiresorptivesAntiresorptives– CalcitoninCalcitonin– EstrogensEstrogens– SERMS (Raloxifene/Evista)SERMS (Raloxifene/Evista)– BisphosphanatesBisphosphanates

AlendronateAlendronate

RisendronateRisendronate

IbandronateIbandronate

Zoledronic AcidZoledronic Acid

Recombinant Parathyroid Hormone Recombinant Parathyroid Hormone (r-PTH:Teriparatide (Forteo)(r-PTH:Teriparatide (Forteo)

Stimulates new bone formationStimulates new bone formation

New fractures are significantly decreasedNew fractures are significantly decreased– Vertebral decreased by 65%Vertebral decreased by 65%– Non vertebral decreased by 55%Non vertebral decreased by 55%

Concern about malignancies in miceConcern about malignancies in mice

DosageDosage– 20 mcg SQ daily for 2 years20 mcg SQ daily for 2 years

Cost - $20. per dayCost - $20. per dayNeer, RM, et al. Neer, RM, et al. NEJMNEJM 2001;344:1434- 2001;344:1434-

4141

Calcitonin (Miacalcin, Fortical)Calcitonin (Miacalcin, Fortical)

Naturally occuring hormone which Naturally occuring hormone which antagonizes the effects of PTHantagonizes the effects of PTH

Reduces osteoclastic bone resorptionReduces osteoclastic bone resorption

200 IU intranasal spray achieves 33% 200 IU intranasal spray achieves 33% reduction in vertebral fractures in reduction in vertebral fractures in postmenopausal women with prior postmenopausal women with prior vertebral fractures (PROOF study)vertebral fractures (PROOF study)

Chestnut et al. Chestnut et al. Am J. Med. Am J. Med. 2000;109:267-276.2000;109:267-276.

Compliance FACTCompliance FACT

After being prescribed a pharmaceutical for After being prescribed a pharmaceutical for osteoporosis or osteopenia, less than 50% osteoporosis or osteopenia, less than 50% of patients have continued therapy at 6 moof patients have continued therapy at 6 mo

Cost issuesCost issues

Side effect issuesSide effect issues

““Silent Disease” issuesSilent Disease” issues

How can we affect this statistic???How can we affect this statistic???

Lifestyle IssuesLifestyle Issues

ExerciseExercise

CalciumCalcium

Vitamin DVitamin D

MedicationsMedications

Poor Consumption of Vitamin DPoor Consumption of Vitamin DNHANES III DATANHANES III DATA

National Health and Nutrition Evaluation National Health and Nutrition Evaluation Survey Survey

J.Amer Diet AssnJ.Amer Diet Assn. 2004:104:980-983. 2004:104:980-983

Bone HealthBone Health

Calcium:Calcium:35 RCTs document that calcium prevents or 35 RCTs document that calcium prevents or reduces bone loss in adultsreduces bone loss in adultsDoseDose– Premenopausal (or on HRT): 1000 mg dailyPremenopausal (or on HRT): 1000 mg daily– Postmenopausal: 1500 mg dailyPostmenopausal: 1500 mg daily

Vitamin D:Vitamin D:Oral Vitamin D between 700-800 IU/d Oral Vitamin D between 700-800 IU/d significantly reduces the risk of fracturessignificantly reduces the risk of fractures400 IU/d is not sufficient for prevention 400 IU/d is not sufficient for prevention

Working Smarter, not HarderWorking Smarter, not Harder

Shared Medical Shared Medical Appointments (SMA)Appointments (SMA)BasicsBasics– Number servedNumber served– Confidentiality statementConfidentiality statement– Charges (99214)Charges (99214)

25-40’. 50% Counseling25-40’. 50% Counseling

Dexa SMADexa SMA– Data reviewed and Data reviewed and

distributeddistributed– Diagnoses establishedDiagnoses established– Lifestyle measuresLifestyle measures– Therapies discussedTherapies discussed

FINISHFINISH

Thank youThank you

Prescription NutritionalsPrescription Nutritionals

3 Primary Concerns for Women’s Health:3 Primary Concerns for Women’s Health:Bone HealthBone HealthCardiovascular HealthCardiovascular HealthMental Well-BeingMental Well-Being

Primary Nutrients with Supporting Evidence:Primary Nutrients with Supporting Evidence:CalciumCalciumVitamin DVitamin DOmega-3 Fatty AcidsOmega-3 Fatty AcidsFolic AcidFolic AcidVitamin B 6Vitamin B 6

Cardiovascular HealthCardiovascular HealthOmega-3 Fatty Acids:Omega-3 Fatty Acids:

Eskimo observational studiesEskimo observational studiesNurses Health StudyNurses Health StudyPhysician’s Health StudyPhysician’s Health Study

– RR 0.77 decreased mortalityRR 0.77 decreased mortality– 850 mg can be expected to save 20 lives per 1000 patients with CHD over 3.5 yrs.850 mg can be expected to save 20 lives per 1000 patients with CHD over 3.5 yrs.

Folic AcidFolic AcidLowers homocysteineLowers homocysteineImproves endothelial functionImproves endothelial function

B VitaminsB VitaminsNurses Health StudyNurses Health Study

– RR 0.55 of MI in groups with highest levels of Folate and B 6RR 0.55 of MI in groups with highest levels of Folate and B 6

SHEEP StudySHEEP Study– RR 0.66 of MI in women taking B vitamin supplementsRR 0.66 of MI in women taking B vitamin supplements

CalciumCalciumSignificantly increases HDL:LDL RatioSignificantly increases HDL:LDL RatioSuggests 30% reduction in CV eventsSuggests 30% reduction in CV events

Mental Well-BeingMental Well-Being

Omega-3 Fatty AcidsOmega-3 Fatty AcidsReverses inflammation from Omega-6 and Reverses inflammation from Omega-6 and dysmenorrheadysmenorrheaSignificant reduction in menstrual symptoms in Significant reduction in menstrual symptoms in adolescentsadolescents

CalciumCalcium48% fewer PMS symptoms than placebo group48% fewer PMS symptoms than placebo groupOsteoporosis risk much greater in women with history of Osteoporosis risk much greater in women with history of PMSPMS

Folic AcidFolic AcidLow folate has been linked to depressionLow folate has been linked to depressionDepressed patients have increased homocysteine levelsDepressed patients have increased homocysteine levels

Prescribing NutriceuticalsPrescribing Nutriceuticals

Write out above recommendations and send Write out above recommendations and send the patient to a pharmacy, healthfood the patient to a pharmacy, healthfood store, Nutritionist, or Sams Club, store, Nutritionist, or Sams Club,

Or . . . . Or . . . .

Prescribe NutriceuticalsPrescribe Nutriceuticals

ENCORAENCORA

METAGENICSMETAGENICS

Ideal Dosing of Nutritional Ideal Dosing of Nutritional Supplements for WomenSupplements for Women

CalciumCalcium1200 mg for women >51 (IOM)1200 mg for women >51 (IOM)Doses >500 mg should be dividedDoses >500 mg should be dividedBetter utilized if larger dose is at HSBetter utilized if larger dose is at HS

Vitamin DVitamin D400 IU (IOM) 400 IU (IOM) wrongwrongNew evidence suggests 700-800 IUNew evidence suggests 700-800 IUNeeded to absorb calcium and prevent hyperparathyroidismNeeded to absorb calcium and prevent hyperparathyroidism

Omega-3 Fatty AcidsOmega-3 Fatty Acids500/d in those at risk for CHD500/d in those at risk for CHD1000 mg/d if documented CHD (AHA)1000 mg/d if documented CHD (AHA)

Folic AcidFolic Acid400 mcg/d (IOM)400 mcg/d (IOM)0.8-5 mg being studied for CV benefit0.8-5 mg being studied for CV benefitLarger dose in AM (prime time for MI)Larger dose in AM (prime time for MI)