Osteoporosis and Aging

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                                                                                                              Characterize patients at risk of developing

                         Osteoporosis and                                                                     osteopenia or osteoporosis.

                              Aging                                                                                  y pharmacologic and non-pharmacologic
                                                                                                              Identify p         g           p         g
                                                                                                              strategies for prevention and treatment of low
                  Kristen Boykin, PharmD
                                                                                                              bone mineral density.
                  PGY-1 Pharmacy Practice Resident
                  Cleveland Clinic Florida
                                                                                                              Select appropriate pharmacotherapy based on
                                                                                                              patient-specific factors.

                Epidemiology                                                                                              Pathophysiology
United States estimates
                                                                                                              Bone is in a continual state of remodeling
  Osteoporosis (OP) = 10 million
  Low bone mineral density (BMD) = 34 million
                                                                                                              Healthy bone: osteoclasts = osteoblasts
  Patients > 50 yrs                                                                                           Osteoporosis: osteoclasts > osteoblasts
     1:2         d 1:4      ill have an OP l t d f t
     1 2 women and 1 4 men will h       OP-related fracture
Cost of OP-related fractures
     2005 = $19 billion
     2025 = predicted $25.3 billion
  Quality of life?
                                     National Osteoporosis Foundation (NOF). Fast facts on osteoporosis.
                     Available at: http://www.nof.org/osteoporosis/ diseasefacts.htm (Accessed 2010 Jan 2).

                 Risk Factors                                                                                                   Diagnosis
Genetic factors                                                                                               BMD measurement
Hypogonadal states                                                                                              Z-score: age and gender matched
                                                                                                                T-score: compared to “young, healthy person”
Endocrine disorders
Gastrointestinal disorders
                                                                                                              Defining OP by T-score
Hematologic disorders                                                                                           Normal                               > -1
Rheumatic and autoimmune diseases                                                                               Osteopenia                           -1 to -2.5
Lifestyle                                                                                                       Osteoporosis                         ≤ -2.5

Medications                                                                                                     Severe osteoporosis                  ≤ -2.5 + fractures
                         NOF. Clinician’s guide. http://www.nof.org/professionals/ (Accessed 2010, Jan 3).                       NOF. Clinician’s guide. http://www.nof.org/professionals/ (Accessed 2010, Jan 3).

                                     Who to Treat?                                                                                               FRAX® Assessment Tool
                                                                                                                                      Clarifies when to start treatment, particularly in osteopenia
      History of hip or vertebral fracture
                                                                                                                                      Factors: Age, gender, weight, history, lifestyle choices

      T-score indicates osteoporosis                                                                                                                   use), T-score, etc
                                                                                                                                      (smoking/alcohol use) T-score etc.

                                                                                                                                      Treat if results indicate:
      Patient or physician preference or both
                                                                                                                                           10-yr risk of hip fracture ≥ 3% OR

                                                                                                                                           10-yr risk of a major OP-related fracture ≥ 20%
    What about patients with osteopenia?
                                                                                                                                                                                                 Assessment tool available online at: http://www.shef.ac.uk/FRAX/

 Recommendations for All Patients                                                                                                                                               Calcium
                                                                                                                                      Daily recommendations
      Adequate calcium and vitamin D intake
                                                                                                                                           19-50 yrs = 1000mg
      Regular weight-bearing exercises                                                                                                     50+ yrs = 1200mg
                                                                                                                                      Many Americans do not ingest recommended
      Minimize alcohol intake
                                                                                                                                      amounts, especially the elderly
      Smoking cessation                                                                                                               National Center for Health Statistics survey (2004)
                                                                                                                                           Men ≥ 60 yrs = 797mg/day
      Fall prevention
                                                                                                                                           Women ≥ 60 yrs = 660mg/day

                                                                                                                                        NIH Dietary supplement fact sheet: Calcium. Available at http://dietary-supplements.info.nih.gov/ (Accessed 2010, Jan 3).
                                               NOF. Clinician’s guide. http://www.nof.org/professionals/ (Accessed 2010, Jan 3).
                                                                                                                                       Dietary intake of selected minerals for the United States population: 1999-2000. National Center for Health Statistics, 2004.

    Selecting a Calcium Supplement                                                                                                         Calcium Administration Tips
      Calcium carbonate (40%)
            Need to take with food (dependent on acid for absorption)
                                                                                                                                      Divide doses into 500mg or less
            $: TUMs, Caltrate, Rolaids, VIACTIV                                                                                            Maximizes absorption
      Calcium citrate (21%)                                                                                                                Minimizes GI side effects
            May take i d d t f      l (not dependent on acid)
            M t k independent of meals ( t d    d t       id)
            $$: Citracal, Cal-Citrate
                                                                                                                                      Keep the patient in mind when selecting form
      Calcium phosphate (30-39%)                                                                                                           Elderly? PPI?
            Less GI upset
                                                                                                                                           How much are you supplementing?
            $$$: Posture-D
      Other available forms                                                                                                                Cost?
            Calcium lactate (13%), calcium gluconate (9.3%)                                                                                Vitamin D?
NIH Dietary supplement fact sheet: Calcium. Available at http://dietary-supplements.info.nih.gov/factsheets/ (Accessed 2010 Jan 3).

                                                Vitamin D                                                                                                                                Vitamin D
        Functions                                                                                                                                Daily recommendation
              Absorption of calcium from the GI tract                                                                                                  Adults 50+ yrs: 800-1000IU/daily
              Aids in calcium reabsorption from the kidneys                                                                                      Healthy serum 25-hydroxyvitamin D3 = 30-100ng/mL
              Role in neuromuscular and immune functioning
                                                                                                                                                 Adverse effects: hypercalcemia, renal impairment, nausea,
        Sources                                                                                                                                  constipation, weight loss
                                                                                                                                                 Elderly are at risk for deficiency
              Exposure to sun
                                                                                                                                                       Home-bound, limited sun exposure
                                                                                                                                                       Chronic illnesses, malabsorption
        Active form: 1,25-dihydroxyvitamin D (aka calcitriol)
                                                                                                                                         NIH Dietary supplement fact sheet: Vitamin D. Available at http://dietary-supplements.info.nih.gov/factsheets/ (Accessed 2010 Jan 3).
NIH Dietary supplement fact sheet: Vitamin D. Available at: http://dietary-supplements.info.nih.gov/factsheets/ (Accessed 2010 Jan 3).
                                                                                                                                                                                                                     Dawson-Hughes B, et al. Osteoporosis Int. 2005;16:713-6.

               Lifestyle Recommendations                                                                                                                                   Bisphosphonates
                                                                                                                                                 Classification: Anti-resorptive agent
              Weight-bearing and strength training
                                                                                                                                                       Alendronate, risendronate, ibandronate, zoledronic acid
              Limit to 1 serving/day women, 2 servings/day men
                                                                                                                                                 MOA:              the rate of bone resorption by binding hydroxyapatite in
        Smoking cessation
                                                                                                                                                 areas of active bone resorption to inhibit osteoclast activity.
              Independent risk factor for fracture
                                                                                                                                                 Adverse events
        Fall prevention
                                                                                                                                                       Common: Abd pain, N/V, HA, constipation, diarrhea
              Avoid medications that increase risk
                                                                                                                                                       Serious: Esophageal ulcers/cancer, gastric ulcers,
              Assess safety of home                                                                                                                    osteonecrosis of the jaw, myalgias, arthralgias
                                                   NOF. Clinician’s guide. http://www.nof.org/professionals/ (Accessed 2010 Jan 3).
                                                                                                                                                                                                                 Micromedex Online Database. (Accessed January 4, 2010).

                     Bisphosphonates (cont.)                                                                                                                                             Calcitonin
        Contraindications                                                                                                                        Classification: Anti-resorptive agent
              Hypocalcemia, CrCl < 35 ml/min, esophageal abnormalities                                                                           MOA: Synthetic hormone that reduces the number of
              (PO), inability to remain upright for 30-60 min. (PO)                                                                              osteoclasts, thereby decreasing bone resorption and turnover
        Available dosage forms                                                                                                                   rate. Also temporarily increases osteoblastic activity to enhance
              O l O       d il
              Oral: Once daily, weekly, and monthly
                                   kl     d    thl                                                                                                     formation.
                                                                                                                                                 bone formation
              IV: Every 3 months, once yearly                                                                                                    Adverse events
        Strict PO administration instructions                                                                                                          Common: Flushing, N/V, backache, rhinitis, epistaxis
              Take in AM ≥ 30-60 min. before 1st meal or                                                                                               Serious: Myocardial infarction, anemias, anaphylaxis,
              Take with 6-8 oz. of water
              Don’t lie down for 30-60 min. after dose and                                                                                             Once daily; consider compliance issues.
              until 1st meal of day                                                                                                                    Only FDA approved for treatment
                                                                         Micromedex Online Database. (Accessed January 4, 2010).                                                                                 Micromedex Online Database. (Accessed January 4, 2010).

                                 Raloxifene                                                                                                              Teriparatide
   Classification: Anti-resorptive agent                                                                             Classification: Anabolic agent
   MOA: Selective estrogen receptor modulator (SERM) that mimics                                                     MOA: Not completely understood, but do know it encourages
                                                                                                                     bone formation by stimulating osteoblastic activity and increasing
   the action of estrogen on bone to decrease bone resorption
                                                                                                                     the osteoblastic lifespan.
   Adverse events                                                                                                    Adverse events
       Common: Hot flashes, leg cramps, peripheral edema                                                                   Common: Hypotension, syncope, hyperuricemia, constipation,
       Serious: Thromboembolic events                                                                                      diarrhea, N/V, arthralgia, dizziness, diaphoresis
                                                                                                                           Serious: Angina
   Comments                                                                                                                Black box warning: Osteosarcoma
       Once daily oral tablet; consider compliance issues.                                                           Comments
       Consider in patients with breast cancer risk                                                                        Daily SC injections. Extensive patient education needed about
       Contraindicated if active or history of VTE                                                                         storage and administration.
                                                Micromedex Online Database. (Accessed January 4, 2010).                                                                                Micromedex Online Database. (Accessed January 4, 2010).

                   Cost Considerations                                                                                 Selecting Prescription Therapy
                                                                                                                     In addition universal recommendations:
Medication Availability           Indication          Administration                Cost/mo.
                                   Prevention             Daily tablet                  $70-77
                   Fosamax®        Treatment           Once weekly tablet               $30-50                                   PO: 1st line
                                   Prevention         Once monthly tablet                $110
 Ibandronate        Boniva®
                                   Treatment          1 IV injection/3 mo.               $155
                                                                                                                                 IV: 2nd line
 Risedronate        Actonel®
                                   Prevention          Once daily, weekly
                                                                                                                           Calcitonin: Last line
                                                                                                                           C l it i L t li
                                   Treatment           or monthly tablets
                                                                                                                                 If intolerant of BPs
Zoledronic Acid     Reclast®                             1 IV injection/yr.               $95
                                   Treatment                                                                               Raloxifene
  Calcitonin       Miacalcin®,     Treatment
                                                         Daily intranasal
                                                                                       $75-110                                   Low fracture, but high breast cancer risk
                                                                                                                           Teriparatide: Severe osteoporosis
  Raloxifene        Evista®                                 Daily tablet                 $124
                                   Treatment                                                                                     Very low BMD (T-score < 3.5), multiple fractures, etc.
 Teriparatide       Forteo®        Treatment            Daily SC injection              ~$930
                                                                                                                  Qaseem A, et al. Pharmacologic treatment of low bone density or osteoporosis to prevent fractures: A clinical practice guidelines
                                         Prices from http://www.drugstore.com. (Accessed January 5, 2010).                                                       from the American College of Physicians. Ann Intern Med. 2008;149:197-213.

                  Role of the Pharmacist                                                                                                           Quiz Questions
                                                                                                             1.       A 70 year old female with a PMH of hypertension and peptic ulcers
                                                                                                                      comes to you looking for a recommendation on a calcium supplement.
   Non-pharm and risk reduction strategies                                                                            Her current medications include metoprolol, lisinopril, and

   Proper use of medications (ex. bisphosphonates)                                                                    True or False: The best recommendation for this patient would be
                                                                                                                      1000mg of calcium carbonate in divided doses daily.
   Recommend appropriate OTC products
                                                                                                             2.       True or False: Only elderly patients are at risk for osteoporosis.

   Teach how to read nutrition labels                                                                        3.       True or False: Each of the following are appropriate
                                                                                                                      recommendations for patients to decrease their risk of osteoporosis:
                                                                                                                         -Quit smoking
                                                                                                                         -Decrease/eliminate caffeine and alcohol intake
                                                                                                                         -Avoid medications that increase osteoporosis risk
                                                                                                                         -Take a suitable calcium and/or vitamin D supplement
                                                                                                                         -Increase exercise and mobility.


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