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Osteoporosis

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					Osteoporosis: Part 1
Pathophysiology, Treatment & Fall Prevention

ICARE Spring 2011
Michelle L. Rager, PharmD, BCPS
Definitions
   Osteoporosis
     Skeletal   disease characterized by:
       Low bone  density
       Decreased bone strength
       Deterioration of bone micro-architecture

     Results in:
       Bone  fragility
       Risk of fracture

   Osteopenia: low bone mass
Epidemiology
   Major public health threat for an estimated 44
    million Americans
     55%   of people age 50 years and older
   8 million women and 2.3 million men have the
    disease
   34 million Americans are estimated to have
    osteopenia
     22 million women
     11.8 million men
Epidemiology
   Significant risk is present in all ethnic
    backgrounds

                        Osteopenia        Osteoporosis

         Asian             50%                  10%

       Hispanic            47%                  10%

    Native American        45%                  12%

        White              40%                  7%

         Black             28%                  4%
Epidemiology
   Prevalence of disease increased with age
     4% in women 50-59 years old
     44-52% in women 80+ years old

   Prevalence of fracture
Type of fracture       White women        White men
          Hip                17.5%              6%
        Vertebra             15.6%              5%
        Forearm              16%               2.5%
    Any of the three         39.7%             13.1%
Tibia Trivia #1
How many women over the age of 50 years old will
   be affected by an osteoporosis related fracture in
   her remaining lifetime?

A.   1 in 2
B.   1 in 3
C.   1 in 4
D.   1 in 5
Tibia Trivia #2
How many men over the age of 50 years old will be
   affected by an osteoporosis related fracture in
   his remaining lifetime?

A.   1 in 2
B.   1 in 3
C.   1 in 4
D.   1 in 5
Tibia Trivia #3
A woman’s risk of hip fracture is ______ than her
   combined risk of breast, uterine, and ovarian
   cancer.

A. Less than
B. Equal to
C. Greater than
Disease Impact
   Pain
   Loss of mobility
   Decreased independence
   Depression
   Nursing home placement
   Cost
   Height loss and kyphosis
   Mortality
 Risk factors for Osteoporosis and Fracture

                Major                                    Other

Advanced age                           High bone turnover rate

Low bone mineral density (BMD)         Physical inactivity

Previous fracture as adult (>45yo)     Past cigarette smoking

Parent history of fragility fracture   Low calcium/vitamin D (minimal sun)

Low weight or BMI                      Sex hormone deficiency

Current cigarette smoking              Poor health/frailty

                                       Dementia/cognitive impairment

                                       Recurrent falls

                                       Female sex
                                       Alcohol use in amounts >3 drinks/day
 Secondary Causes for Osteoporosis
             Drugs                           Diseases
   Systemic Glucocorticoids                     RA
        Anticonvulsants                Hyperparathyroidism
         GnRH agonists                    Hyperthyroidism
         Cytotoxic drugs                    Alcoholism
Excessive thyroid supplementation   Severe renal or liver disease
            Heparin                    Organ transplantation
              TZD                      Cushing’s Syndrome
              PPIs                        Eating Disorders
   Immunosuppression agents                GI disorders
         (tacrolimus)                  (IBD, celiac disease)
Medroxyprogesterone implant/shot            Type 1 DM
             SSRIs                        Hypogonadism
Bone Break
Rosario is a 54 year old Hispanic school teacher.
Demographics: 5’2”, 145 lbs
SH: Alcohol intake (1-2 glasses/wk)
FH: Mother had a hip fracture last year
MH: last period 6 months ago, minimal hot flashes, sweating,
  insomnia
PMH: Celiac disease, Lactose intolerance
Meds: Lactaid prn, MVI with minerals QAM

What are Rosario’s risk factors for osteoporosis?
Types of Bone
   Cortical bone
       Dense and compact
       Responsible for bone strength
       80% of skeletal bone
       Found on surfaces of long and flat bones
   Trabecular bone
       Sponge-like in appearance
       Found along inner surfaces of long
        bones and throughout vertebrae, pelvis
        and ribs
       Allows for light weight nature of
        skeleton
Bone Remodeling
       Regulated by several circulating hormones
        including estrogens, androgens, vitamin D, and
        parathyroid hormone
       Osteoclasts (CHEW)
         Involved in resorption or breakdown of bone
         Continually create microscopic cavities in bone tissue
       Osteoblasts (BUILD)
         Involved in bone formation
         Continually mineralize new bone in the cavities created
          by osteoclasts
Bone Remodeling
Bone Metabolism
   Vitamin D
       Stimulates calcium absorption
           GI: increases calcium-binding protein
           Bone: Stimulates bone resorption and bone formation
   Parathyroid hormone (PTH)
       Increases extracellular calcium
           Kidney
                 Stimulates calcium resorption by renal tubules
                 Decreases phosphate resorption by renal tubules
                 Stimulates hydroxylation of vitamin D by the kidneys
           Bone
                 Stimulates osteoclast activity increases bone resorption
   Calcitonin
       Decreases plasma calcium levels
       Antagonistic to PTH
           Bone: Inhibits bone resorption
Bone Metabolism
Vitamin D activation
Peak Bone Mass
             Bone
             resorption
                                  Until peak bone mass
                                   is achieved, bone
                                   formation exceeds
                                   resorption
                                  Result  Overall
                                   increase in bone mass
 Bone
 formation

 •Peak bone mass achieved between age 25-35
 •90% of bone mass is attained by 18-20 years of age
Factors Influencing Peak Bone Mass

   Genetics
     Highly dependent!
     Accounts for 60-80% variability

   Modifiable Factors
     Nutritional Intake (calcium, vit D, protein)
     Exercise
     Adverse lifestyle practices (e.g. smoking, drinking)
     Hormonal Status
     Certain diseases
     Medications
Low Bone Mineral Density
   Can occur from a result of
     Failureto reach normal peak bone mass and/or
     Bone loss

   Major predictor of fracture risk
   Every standard deviation in BMD in women
    represents
     10-12%   decrease in bone mass
     1.5-2.6 fold increase in fracture risk
Low Bone Mineral Density
   Normal trabecular      Osteoporotic
    bone                    trabecular bone
Falls
   Most wrist fractures and 90% of hip fractures
    result from a fall from standing height or less
   1/3-1/2 of seniors fall each year
     50%   fall more than once
   Up to 5% of all falls result in a fracture
   Ability to adapt to a fall decreases with age
   Mortality after a fall increases with age
Pathogenesis of Osteoporosis-related
Fracture

    Inadequate
    peak bone
    mass             Low bone
                     density
                                Skeletal
    Increased                   fragility
    bone loss        Impaired
                     bone                   Fracture
                     quality    Excessive
    Propensity to               bone
    fall                        loading
                     Falls

    Fall mechanics
Postmenopausal Osteoporosis
   Accelerated bone loss as a result of loss of estrogen
   Estrogen deficiency
     Increases proliferation, differentiation, and activation of
      osteoclasts
     Prolongs survival of mature osteoclasts

   Compromised bone architecture:
     The number of remodeling sites increases
     Resorption pits are deeper and inadequately filled by
      normal osteoblastic function
   Trabecular bone is most susceptible leading to
    vertebral and wrist fractures
Male Osteoporosis
   Lower risk of osteoporosis and osteoporotic fracture
     Larger bone size
     Greater peak bone mass

     Fewer falls

     Do not undergo accelerated bone resorption similar to
      menopause
   Higher risk of mortality rate after fracture
   Age or secondary cause is usually the most
    contributing factors to disease
       Hypogonadism most common
Clinical Presentation
       General
         Asymptomatic unless patient has a fracture
         Fractures can occur after bending, lifting, falling or independent of
          any activity
       Symptoms
         Pain at site of fracture
         Immobility
         Depression, fear and low-self esteem
       Signs
         Shortened stature (> 1.5” loss)
         Kyphosis
         Vertebral, hip, wrist or forearm fracture
         Low bone density on radiography
PATIENT ASSESSMENT
Risk Factor Assessment
   Initial assessment to see who needs further
    evaluation
   Several tools available:
     The Osteoporosis Risk Assessment Instrument (ORAI)
     Simple Calculated Osteoporosis Risk Estimation
      (SCORE) decision tool
     WHO Fracture Risk Algorithm – FRAX®
Fracture Risk Assessment
       WHO Fracture Risk Algorithm - FRAX®
         Calculates the 10-year probability of a hip fracture and 10 year
          probability of major osteoporotic fracture
         Components:
            Age
            Gender
            Prior osteoporotic fracture
            Femoral neck BMD (gm/cm2)
            Low body mass index
            Oral glucocorticoids use at > 5mg for > 3 months (ever)
            Rheumatoid arthritis
            Other secondary causes of osteoporosis
            Parental history of hip fracture
            Current smoking
            Alcohol intake (> 3 drinks/day)
         http://www.shef.ac.uk/FRAX/
Measurement of BMD

       Heel ultrasound
         Most common way to screen patient
         Effective way to identify those at risk for fracture
         Recommended for:
              All postmenopausal women
              Perimenopausal women with > 1 major risk factor
              Men > 65 years of age
         NOT recommended for:
              Premenopausal women
              Osteopenia or osteoporosis diagnosis
            Referral T-score < -1
Measurement of BMD
           Central DXA
              GOLD standard for measurement of BMD used for diagnosis
              Measures BMD (g/cm2) at total hip, femoral neck or lumbar spine
              Recommended for:
                 Women > 65 years of age
                 Men > 70 yo
                 Adults > 50 yo who break a bone
                 Postmenopausal women under 65 yo with risk factors for
                  fracture
                 Women of menopause age with risk factors for fracture
                 Men 50-70 yo with risk factor for fracture
                 Adults with suspected secondary cause of low BMD
                 Anyone being considered for pharmacologic therapy
            Used every 1-2 years to monitor therapy
T-score
       The number of standard deviations from the mean
        bone mineral density in healthy young white
        women
       Used for the diagnosis of osteoporosis and
        osteopenia
       Use for postmenopausal women and men over
        the age of 65
          or in men between the ages of 50 and 65 if other risk
          factors are present
       Average young sex-matched reference
Z-score
   The number of standard deviations from the mean
    bone mineral density of age- and sex-matched
    controls
   Used for premenopausal women, men under age 50
    and patients who may have secondary causes for
    low bone mineral density
   Average age and sex-matched reference
Diagnosis of Osteoporosis

 Classification     Diagnostic criteria


    Normal              T-score > -1


  Osteopenia         T-score -1 to -2.4

                       T-score < -2.5
                              or
 Osteoporosis
                  Decreased T-score PLUS
                       fragility fracture
Bone Break
Rosario comes to your pharmacy health fair and
   wants to participate in your bone screening
   program. What do you tell her?

A. You are not postmenopausal, so wait a couple
   more years.
B. Have a heel ultrasound today.
C. Have a DXA examination.
Bone Break
If Rosario participated in the heel ultrasound today and the
     result was a T-score of -2.5, what would you tell her?

A. You have osteopenia and should get tested when you are
   postmenopausal.
B. You have osteoporosis and no further testing is needed.
C. You have osteopenia and need a DXA.
D. You have osteoporosis and need a DXA.
E. You might have low bone density and need a DXA.
TREATMENT GOALS
Goals for Osteoporosis
Treatment and Prevention

              Age Group                        Goal

Childhood and adolescence     Maximize peak adult bone mass

Young adult to menopause      Preserve bone mass

Early post-menopause          Prevent accelerated bone loss

Late post-menopause and men   Prevent bone loss

Senior life                   Prevent bone loss, falls, and fractures
Additional Treatment Goals
   In patient who has already suffered osteoporotic
    fracture:
     Reduce future  falls and fractures
     Improve functional capacity

     Reduce pain and deformity

     Improve quality of life

     Decrease risk of mortality
NON-PHARMACOLOGIC
THERAPY
Prevention & Treatment
Bone Healthy Lifestyle
   Adequate intake of calcium and VitD
   Exercise
     Aerobic,   strengthening, and balance
   NO smoking
   Minimal alcohol (<3 drinks per day)
    1   drink/day for women; 2 drinks/day for men
   Minimal caffeine
     Or   additional calcium intake
   Fall prevention
Dietary Calcium
       Essential for achieving peak bone mass and
        maintaining bone mineral density
       Sources of dietary calcium (75-80% from dairy
        products)
       Estimate 250mg from non-dairy sources
       Average American over 50 typically consumes 600
        -700mg of calcium
                                   Plain, fat-free yogurt (6oz) 450mg
       Label interpretation       American Cheese (1oz)        350mg
         Add zero to %                 Milk (8oz)                     300mg
         30%/serving = 300mg           Fortified Orange Juice (8oz)   300mg
                                        Pudding, made with milk        150mg
                                        Cottage Cheese, ½ cup          70mg
Recommended Daily Calcium
Age Group                             RDA of Calcium
                                      (National Institute of Medicine - 12/2010
                                      update)

Birth to 6 months                     210 mg
                                                                                  Females
6 months – 1 year                     270 mg
                                                                                  who are
1 – 3 years                           700 mg                                      pregnant or
                                                                                  nursing
4 – 8 years                           1000 mg                                     should get
9 – 18 years                          1300 mg                                     1000 mg of
                                                                                  calcium
19 – 50 years (men up to 70) 1000 mg
> 51 years (men over 71)              1200 mg*

* Recommended by National Osteoporosis Foundation for all patients over 50 years
Dietary Vitamin D
       Plays a major role in calcium absorption, bone health, muscle
        performance, balance and risk of falling
          Calcium absorption is normally about 30-40%, but is decreased to 10-
           15% in low vitamin D levels
       Sources of dietary Vitamin D      Vitamin-D fortified milk (8 oz)   100 IU
                                          Fortified cereals (1 serving)     40-50 IU
                                          Egg yolk                          20 IU
                                          Salt-water fish (~ 3oz)           200-350 IU
                                          Liver (3.5 oz)                    15 IU
       Label interpretation
                                          Fortified margarine (I Tbsp)      60 IU
         Multiply % by 4
         20%/serving = 80 IU
Recommended Daily Vitamin D

               National Osteoporosis   Institute of Medicine
    Age
                     Foundation           (12/2010 update)

 Birth to 50                                 600 IU
     years



51 -70 years   800 – 1000 IU                 600 IU

> 70 years     800 – 1000 IU                 800 IU
Regular Exercise
       Weight-bearing and muscle strengthening
         Benefits
              Helps to increase bone density before peak mass is reached
                 May also show moderate increases in BMD after peak
                 Benefits will be lost when person stops exercising!
              Reduces risk of falls and fractures by improving agility,
               strength, posture and balance
            Goals:
              Moderate-intensity weight bearing activity for at least 30
               mins most days of the weeks AND
              Resistance activity for 20-30 mins at least 2 times per week
Smoking Cessation
   Primary effects of smoking
       Smoking has toxic effects on osteoblasts
       Can indirectly effect estrogen metabolism  causing
        onset of menopause 1-2 years earlier and subsequent
        loss of estrogen’s protective effect on bone
   Secondary effects of smoking
       Respiratory illness
       Frailty
       Need for additional medications (i.e. steroids)
       Decreased exercise
       Reduced intestinal calcium absorption
Avoidance of Excessive Alcohol

   (> 3 drinks per day)
   Primary effect of alcohol
       Greatest impact on decreased bone formation
       Also increased bone loss
   Secondary effect
       Increased risk of fall
Fall prevention
   Reduces risk of fragility fractures
   Patients at higher risk of falls:
       Frailty
       Poor vision
       Hearing loss
       Taking medications affecting balance
Measures to reduce falls
   Balance training
   Muscle strengthening
   Removal of hazards from home (i.e. wires, rugs,
    clutter, uneven stairs, poor lighting)
   Installation of handrails
   Use of assistive devices (i.e. walkers, canes)
   Discontinuation of predisposing medications
   Correct foot and footwear problems
   Correct vision problems
   Provide patient education and information
Resources for Fall Prevention
   www.cdc.gov/ncipc/pub-res/toolkit/CheckListForSafety.htm

   www.cdc.gov/HomeandRecreationalSafety/Falls/fallsmaterial
    .html

   www.healthyagingprograms.com/resources/Fall%Prevention
    %20Rec%20Resources.pdf

   www.americangeriatrics.org/education/prevention_of_falls.s
    html
Bone Break
Rosario is a 54 year old Hispanic school teacher.
Demographics: 5’2”, 145 lbs
  SH: Alcohol intake (1-2 glasses/wk)
  FH: Mother had a hip fracture last year
  MH: last period 6 months ago, minimal hot flashes, sweating, insomnia
   PMH: Celiac disease, Lactose intolerance
   Meds: Lactaid prn, MVI with minerals QAM

Heel ultrasound T-score -2.5, FRAX 10-yr risk of major osteoporotic fracture
  ___%, 10 yr risk of hip fracture ___ %
  Meds: Lactaid prn, MVI with minerals QAM

After talking with Rosario you discover that she is able to drink one glass of
   vitamin D fortified skim milk a day using her Lactaid tablets.
Bone Break
   What is Rosario’s estimated daily intake of calcium
    and vitamin D?



   What is her recommended intake of calcium and
    vitamin D?
Bone Break
   Is she meeting this requirement? If not, how much
    does she need?



   What suggestions can you make to increase
    Rosario’s intake of calcium and vitamin D?
PHARMACOLOGIC
THERAPY
Prevention & Treatment
Pharmacologic Therapy

   Vitamin     Anti-resorptives     Anabolics
 Supplements   (bone retaining)   (bone forming)

                Bisphosphonates
   Calcium
                   Calcitonin
                                    Teriparatide
                  Raloxifene
   Vitamin D
                  Denosumab
Who should be considered for therapy?

   Vitamin Supplementation
       Patients unable to meet daily recommended intake
        of dietary calcium and vitamin D
       Patients with 25-OH vit D < 30 ng/mL
Who should be considered for therapy?

   Anti-resorptives or Anabolic
       Men and Postmenopausal women age 50 or older
        with:
           A hip or vertebral fracture
           T-score < -2.5 at femoral neck or spine after secondary
            causes are appropriately ruled out
           Low bone mass (T-score between -1.0 and -2.5 at
            femoral neck or spine) plus:
               10 yr probability of hip fracture > 3% or 10 yr probability of
                any major fracture > 20%
Calcium Supplementation
       Add supplement to dietary calcium intake to equal 1200
        mg/day in individuals over age 50
       Do not exceed 1200 mg/day
          No additional benefits
          Greater than 1500 mg/day increased risk of kidney stones
       Adverse effects: constipation, bloating, cramps, flatulence,
        hypercalcemia, hypercalciuria
       Selected drug interactions
          Levothyroxine
          Iron
          Some antibiotics (i.e. tetracycline, fluoroquinolones)
          Bisphosphonates
Calcium Supplementation
   Calcium carbonate
     40% elemental calcium
     Available in tablet, chewable, and liquid formulations
     Dose: 500-600mg taken with food
     Acid dependent disintegration and dissolution

   Calcium citrate
     21% elemental calcium
     Available in tablet and chewable formulations
     Dose: 200-625mg with or without food
     Acid independent absorption
Vitamin D Supplementation
   Add supplement to dietary vitamin D intake to equal 800-
    1000 IU/day in individuals over age 50
   Safe upper limit around 2,000 IU/day
   Adverse effects: nausea, constipation, hypercalcemia,
    hypercalciuria
   Meta-analysis of Vit D supplementation (JAMA 2005)
       NNT of 45 with 700-800 IU/day to prevent hip fracture
       NNT of 27 with 700-800 IU/day to prevent vertebral fracture
       No significant decrease in fracture with 400 IU/day
Vitamin D Supplementation
       OTC: Vit D3 (Cholecalciferol) dose 200-1000 IU
        daily
         Available as individual supplement (200, 400, 1000,
          2000, 5000 IU), in MVI or in combination with calcium
          supplement
         MVI generally contain 400 IU or now 800 IU in many
          Women’s vitamins 
       RX: Vit D2 (Ergocalciferol) 50,000 IU weekly or
        monthly based on 25(OH)D concentrations
         High dose to suppress parathyroid function and reduce
          bone turnover
Bisphosphonates
       Several agents in this class approved for the prevention
        and treatment of osteoporosis
       Also approved for treatment of glucocorticoid induced
        osteoporosis
       1st line treatment for postmenopausal women

       MOA: decreased bone loss due to stimulation of
        apoptosis of osteoclasts
         Act on the cholesterol biosynthesis pathway enzyme, farnesyl
          diphosphate synthase
         Inhibition of the enzyme they interferes with attachment of
          the lipid to regulatory proteins
         Causes osteoclast inactivation
         Bisphosphonates
                                     Advantages                                       Disadvantages

Safety                                                                   Risk of GI complications  oral agents
                                                                              contraindicated in patients who
                                                                              cannot remain upright or who have
                                                                              esophageal abnormalities; risk of
                                                                              osteonecrosis of the jaw; CI in CrCl <
                                                                              35 ml/min; increased risk of Afib
                                                                              with zolendronic acid
Tolerability   Once weekly administration of oral bisphosphonates        nausea, abdominal pain, dyspepsia,
                    may decrease risk of GI adverse effects                  esophageal erosion, ulceration,
               IV administration may alleviate GI upset completely           musculoskeletal pain; Zoledronic
                                                                             acid: fever, flu-like symptoms,
                                                                             myalgias
Efficacy       Overall large decrease risk of vertebral, hip, and non-   Absorption of oral bisphosphonates is
                   vertebral fractures; zolendronic acid also has            poor and may be decreased if taken
                   secondary prevention evidence for reduction of            with other medications, dietary
                   vertebral and non-vertebral fractures; BMD                supplements or food. Therefore,
                   increased by 3-8% in spine and hip                        medication should be taken after an
                                                                             overnight fast with 6-8 oz of water
                                                                             only.
        Bisphosphonates

                               Advantages                           Disadvantages

Price             Alendronate available on Wal-Mart       $116-126 / 30 day supply of oral;
                      generic list $9/ 30 day supply          $1011/ year + additional
                                                              administration costs with
                                                              zolendronic acid
Simplicity        Oral bisphosphonates available in       Zolendronic acid requires IV
                      daily, weekly or monthly tablets        administration; Oral
                  IV formulations available for 3 month       bisphosphonates require patient
                       or annual dosing                       to stay upright for 30-60
                                                              minutes after administration
                                                              and cannot be taken with other
                                                              medications or food
Alendronate (Fosamax®)
   Approved for prevention (5mg daily and 35mg weekly) and
    treatment (10mg daily, 70mg weekly – tab or liquid, and
    70mg tab + 2,800 IU or 5,600 IU vit D) of postmenopausal
    osteoporosis
   Approved for treatment to increase bone mass in men with
    osteoporosis
   Approved for treatment of osteoporosis in men and
    women taking glucocorticoids
   Available as generic
   Reduces incidence of spine and vertebral fracture by ~50%
    over 3 years in pts with prior vertebral fracture
   Reduced incidence of vertebral fractures by about 48%
    over 3 years in pts without prior history of fracture
Ibandronate (Boniva®)
   Approved for the treatment (2.5mg daily tablet,
    150mg monthly tablet, 3mg every 3 month IV
    injection) of postmenopausal osteoporosis
   Oral preparations are also approved for the
    prevention of postmenopausal osteoporosis
   Reduces the incidence of vertebral fractures by
    ~50% over 3 years
Risendronate (Actonel®)
   Approved for the prevention and treatment (5mg daily
    tab, 35mg weekly tab, 35mg weekly with 6 500mg
    calcium carbonate, 75mg tabs on 2 consecutive days
    every month, 150mg tab monthly) of postmenopausal
    osteoporosis
   Approved for the treatment to increase bone mass in
    men and women who are initiating or taking
    glucocorticoids
   Reduces incidence of vertebral fractures by ~36% over
    3 years, with sig risk reduction occurring in patients
    with a prior vertebral fracture
Zolendronic Acid (Reclast®)
   Approved for the prevention and treatment (5mg by IV
    infusion over at least 15 minutes once yearly for
    treatment and once every 2 years for prevention) of
    osteoporosis in postmenopausal women
   Approved for the prevention and treatment of
    osteoporosis in men and women expected to be on
    glucocorticoid therapy for at least 12 months
   Indicated for prevention of new clinical fractures in
    patients who recently had low-trauma hip fractures
   Reduces the incidence of vertebral fractures by ~70%,
    with sig reduction at one year, hip fractures by ~41%
    and non-vertebral fractures by ~25% over 3 years
Monitoring
   BMD
   Calcium
   Phosphorus
   SCr
   Dental exams
   GI upset
   Muscle pain
Bisphosphonates – Adverse Effects
   Upper GI symptoms
     Nausea, abd  pain
     Heartburn, esophageal irritation

     Ulcer, perforation, bleeding

   Muscle, bone and joint pain
     Canoccur at anytime in therapy
     May vary (localized, diffuse, migratory)

   IV administration
     Fever,   chills, acute-phase reaction
Osteonecrosis of the Jaw
   RARE
   Possible risk factors
     Higher dose IV formulation
     Age > 60 years old
     Concomitant corticosteroid use
     Radiation
     Chemotherapy

   Dental procedure before initiation increases risk
     Hold    therapy for 3 months – this is practice (no real
      data)
Bisphosphonates - Contraindications

   Renal Insufficiency
     Do not use if CrCl <30-35mL/min
     Expert consensus says ok if
         15-35 mL/min (CKD4) AND
         Age related
         Use 50% of dose for 3 years
                   Miller PD. Semin Nephrol 2009;29:144-55.
   Hypocalcemia
   Esophageal abnormalities
       Inability to remain upright after administration for required
        duration
Patient Counseling
   Take on empty stomach before breakfast
     With6-8 oz of plain water
     Remain upright (sitting or standing)
       30 minutes   for most, 60 minutes for ibandronate
     Do   not take other medications until later
   Report difficulty swallowing, GI pain, and/or
    musculoskeletal pain
   Adherence and missed doses
Long-Term Therapy with Bisphosphonates

   FLEX trial randomized women treated with
    alendronate for 5 years to:
     Placebofor 5 years
     Continued alendronate for additional years

   Excluded women with:
                   hip BMD <-3.5
     Baseline total

     Worsening total hip BMD




                            Black DM, et al. JAMA 2006; 296:2927-38
Long-Term Therapy with Bisphosphonates

   Most benefit seen in those with:
     Baseline BMD       T-scores of -2.5 or lower
     Prior   fracture
   There was a decreased risk for continued therapy
    in symptomatic vertebral fracture
   No difference, however, in asymptomatic vertebral
    fracture or nonvertebral fracture


                                  Black DM, et al. JAMA 2006; 296:2927-38
Duration of Treatment with Bisphosphonates

       Safety data exists for 7-10 years
       5 years may be max benefit in some cases
         if patient is still at high risk consider continuing
         May consider a drug holiday
CASE PRACTICE
Review for Part 1
Mrs. Larsen
   77 yo Caucasian woman admitted for a hip fragility
    fracture
   SH: lives alone, walks 1 mile daily
     No  alcohol
     Quit smoking 10 years ago
     Eats yogurt and a bagel with her tea every morning for
      breakfast. She says she usually has a salad and turkey
      sandwich for lunch daily. Dinner is a meat, veggie and
      starch. She tries to have salmon or tuna at least 3
      times a week. She loves broccoli and has this several
      times a week as well.
Mrs. Larsen
   Ht 5’3” (previous 5’5”) Wt 160 lbs
   FH: mother-breast CA, hip fracture; sister-
    osteoporosis
   Labs: TSH 0.8mlU/L (nl 0.4-10mlU/L)
     25(OH)vitaminD 10ng/mL (nl   > 30 ng/mL)
   DXA: T-scores – femoral neck -2.8, hip -2.2, spine -
    3.8
Mrs. Larsen
   PMH:                    Medications
     Hypothyroidism          Levothyroxine 100mcg daily
      (18 years)              Celecoxib 100mg daily
     Incontinence            ASA 81mg daily
     OA of the knee          Cimetidine OTC 200mg daily
     COPD                    Fluticasone/Salmeterol inh 2
     No previous fall         puffs BID
      history                 Tolterodine LA 2mg daily
                              Glucosamine 750mg BID
                              Omeprazole OTC 20mg prn
                              Ibuprofen 200mg 1-3 per day
Mrs. Larsen
   What are Mrs. Larsen’s risk factors for osteoporosis
    and osteoporotic fracture?
   What is her 10 year risk of fracture?
   What is her daily requirement for calcium and
    vitD?
     Is she meeting that requirement?
     If not, what recommendation would you make to help
      her reach this goal and why?
   Is Mrs. Larsen a candidate for treatment? Why or
    why not?
Latisha
   22 yo African American college student
   Ht 5’7” Wt 165lbs
   SH: alcohol intake (3-5 glasses/wk)
   PMH: asthma
   Meds:
     Fluticasone 220mcg 1 puff bid
     Albuterol 1-2 puffs every 6 hours prn

     Medroxyprogesterone acetate implant for the past year

     MVI with minerals
Latisha
   What osteoporosis risk factor(s) does Latisha have?

   Is/Are it/these reversible or not? Why?

   What assessment(s) would you do for Latisha?
    Why?

				
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