Pharmacotherapy of Osteoporosis - ABCForYourHealth



Pharmacotherapy of Osteoporosis

Marie Meyer, PharmD Candidate 2007

|Epidemiology |Osteoporosis is the most common disease of the bones |

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| |Prevalence: ~55% of the US population over age 50 are at risk (~44 million Americans) |

| |~12% of the US population already have osteoporosis (~10 million Americans) |

| |~43% have low bone mass… may develop into osteoporosis in their lifetime (~34 million Americans) |

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| |Incidence: ~ 1.5 million fractures per year |

| |Location of fractures: vertebrae ~700,000, hip ~300,000, wrist ~250,000, other sites ~300,000 |

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| |Distribution: 80% of cases are in females, 20% in males |

| |People of all ethnic backgrounds are at risk |

| |Females: White and Asian > Hispanic > Black |

| |Males: White and Asian > Black and Hispanic |

|Disease State |Osteoporosis = “porous bone” |

|Definition | |

| |Characteristics: |

| |low bone mass |

| |structural deterioration of bone tissue micro-architecture |

| |decreased bone strength ( bone fragility |

| |increased risk of fractures, especially of the hip, spine, or wrist |

| | |

| |Clinically defined by low bone mineral density (BMD) |

| |Significant clinical outcome fractures of the vertebrae, hips, wrists, and other bones |

|Patho-physiology |Bone remodeling: the constant process of bone formation and resorption. |

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| |Bone development: in children and adolescents bone formation exceeds bone resorption |

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| |Peak bone mass: bone is at maximum density and strength, occurs around age 25-30 |

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| |Bone loss occurs when bone resorption exceeds bone formation, typically after age 30 |

| |Post-menopausal estrogen deficiency accelerates the age-related bone formation/resorption imbalance |

| |Other risk factors (below) also accelerate bone loss or cause a low peak bone mass |

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| |Adult bone mass = peak bone mass – subsequent bone loss |

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| |Increased bone loss or low peak bone mass ( low bone density |

| |Low bone density ( increased risk of fractures |

|Clinical Presentation |“silent disease”… often undiagnosed until fragility fracture occurs |

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| |fragility fracture = bone fracture occurring in the absence of trauma or from very mild trauma |

| |( disability |

| |pain |

| |deformity |

| | |

| |vertebral compression fractures ( internal organ crowding, disability, pain, increased mortality |

| |( changes in body appearance… height loss |

| |curved shoulders and back |

| |thickened waistline |

|Risk Factors |Age |

| |risk increases with age beyond 30 |

| |Gender |

| |menopause causes women to lose bone mass faster than men |

| |PMH |

| |history of fracture as an adult (fragility or traumatic fractures) |

| |history of recent falls |

| |early onset estrogen deficit (< 45 years old) |

| |visual impairment |

| |dementia |

| |general poor health |

| |FH |

| |1st degree relative with history of fragility fracture |

| |Race |

| |Caucasian and Asian women are at the greatest risk |

| |Black and Hispanic women also have a significant risk |

| |Bone structure |

| |small body frame increases risk |

| |osteopenia = low bone mass |

| |Body weight |

| |< 127 lbs (< 57.7 kg) increases risk |

| |Medications |

| |*steroids* (glucocorticoids, andrenocorticotropin) |

| |anticonvulsants (phenobarbital, phenytoin) |

| |aluminum antacids |

| |cholestyramine |

| |cytotoxic drugs (methotrexate) |

| |estrogen antagonist (tamoxifen – before menopause) |

| |gonadotropin releasing hormone (GnRH) |

| |heparin (long-term use) |

| |immunosuppresants (cyclosporine A) |

| |lithium |

| |thyroid hormones (thyroxine in excessive doses) |

| |Lifestyle factors |

| |current smoking |

| |excessive EtOH intake (>2 drinks daily) |

| |lifelong inadequate calcium intake |

| |physical inactivity |

|Diagnosis |Bone mineral density (BMD) measurement |

| |lower BMD correlates with higher fracture risk |

| |Hip BMD = best predictor of hip fractures, also predicts fractures at other sites |

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| |Z-score = expected BMD for age and sex of the patient |

| |T-score = expected BMD for young normal adults of the same sex as the patient |

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| |Normal = T-score ≥ –1 = BMD within 1 standard deviation (SD) of “young normal” |

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| |Osteopenia = T-score between –1 and –2.5 = BMD between 1 and 2.5 SD less than “young normal” |

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| |Osteoporosis = T-score ≤ –2.5 = BMD 2.5 or more less than “young normal” |

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| |Established osteoporosis = T-score ≤ –2.5 plus history of fragility fracture |

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|Diagnosis | |

|Continued |BMD Measurement Techniques |

| |Dual x-ray absorptiometry (DXA) |

| |Central DXA – spine, hip, or wrist (diagnosis & monitoring) |

| |**** Spine or hip central DXA is the standard diagnostic technique **** |

| |Peripheral DXA – forearm, finger, heel (screening) |

| |Single-energy x-ray absorptiometry (SXA) – forearm, finger, heel (screening) |

| |Quantitative computed tomography (QCT) – central or peripheral (diagnosis & monitoring) |

| |Ultrasound densitometry – heel, tibia, patella, or other peripheral sites. |

| |Not as precise as DXA or SXA, but good prediction of fracture risk (screening)  |

| |BMD testing should be performed on: |

| |All women ≥ 65 |

| |Postmenopausal women < 65 with one or more risk factors (other than race, gender, postmenopausal) |

| |Postmenopausal women with fractures (confirm diagnosis, determine disease severity) |

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| |Treatment to reduce fracture risk is recommended for women with |

| |T-scores < –2.0 by hip DXA without risk factors |

| |T-scores < –1.5 by hip DXA plus ≥ 1 risk factors |

| |prior vertebral or hip fracture |

|Desired Therapeutic |Osteoporosis prevention goals* |

|Outcomes* |Optimize skeletal development and maximize peak bone mass at skeletal maturity |

| |Prevent age-related and secondary causes of bone loss |

| |Preserve the structural integrity of the skeleton |

| |Prevent fractures |

| |Osteoporosis treatment goals* |

| |Prevent fractures |

| |Stabilize or achieve an increase in bone mass |

| |Relieve symptoms of fractures and skeletal deformity |

| |Maximize physical function |

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| |*American Association of Clinical Endocrinologists Medical Guidelines For Clinical Practice For the Prevention and Treatment of |

| |Postmenopausal Osteoporosis: 2001 Edition, with selected updates for 2003 |

|Treatment Options** |Non-pharmacologic |

| |adequate calcium/vitamin D intake and good nutrition in general |

| |calcium ~1000-1200mg daily |

| |vitamin D ~400-800 IU daily |

| |regular weight bearing exercise |

| |fall prevention – vision, hearing, neurological defects, medication side effects, home safety, walking aids |

| |fall protection – hip protective garments |

| |alcohol moderation and tobacco abstinence |

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|**See Treatment Options|Pharmacologic |

|Table |therapeutic class generic drug (Brand) |

| |bisphosphonates alendronate (Fosamax), ibandronate (Boniva), risedronate (Actonel) |

| |calcitonin (Miacalcin, Fortical) |

| |estrogen therapy (Climara, Estrace, Estraderm, Ogen, Ortho-Est, Premarin, Vivelle) |

| |hormone therapy (Activella, Femhrt, Premphase, Prempro) |

| |parathyroid hormone teriparatide (Forteo) |

| |selective estrogen raloxifene (Evista) |

| |receptor modulator |

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|Monitoring |Efficacy |

| |DXA every 1-2 years (note that fracture risk may decrease without noted increase in BMD) |

| |Height yearly |

| |Patient reported fall, fracture, bone pain monthly or weekly |

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| |Toxicity |

| |Bisphospinates |

| |Alendronate – serum calcium and phosphorus |

| |patient reported dyspepsia, heartburn, acid reflux, dysphagia |

| |physical exam for GERD, esophagitis, esophageal ulcer, gastritis, gastric ulcer |

| |Ibandronate – serum creatinine before each IV dose, serum calcium, phosphorus, and magnesium, |

| |patient reported dyspepsia |

| |physical exam for esophagitis, gastritis, ulcer |

| |Risedronate – alkaline phosphates, serum calcium, phosphorus, and potassium |

| |patient reported dyspepsia, heartburn, acid reflux, dysphagia |

| |physical exam for esophagitis, gastritis, ulcer |

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| |Calcitonin |

| |serum calcium |

| |patient reported rhinitis, nosebleeds, sinusitis |

| |physical exam for nasal ulceration |

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| |Estrogen |

| |patient reported chest pain, SOB, hemoptysis, cardiac awareness, one-sided weakness, sudden visual or speech problems, sudden confusion or |

| |dizziness, sudden severe headache, claudication, leg warmth/ redness/ swelling |

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| |Hormone therapy |

| |mammogram yearly |

| |patient reported chest pain, SOB, hemoptysis, cardiac awareness, one-sided weakness, sudden visual or speech problems, sudden confusion or |

| |dizziness, sudden severe headache, claudication, leg warmth/ redness/ swelling |

| |patient reported unusual vaginal bleeding |

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| |Teriparatide |

| |calcium, BP, uric acid |

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| |Raloxifene |

| |CBC, lipid profile |

| |patient reported claudication, leg cramps, leg warmth/ redness/ swelling of the leg, hot flashes, leg cramps |

References

American Association of Clinical Endocrinologists Medical Guidelines For Clinical Practice For the Prevention and Treatment of Postmenopausal Osteoporosis: 2001 Edition, with selected updates for 2003

Physician’s Guide to Prevention and Treatment of Osteoporosis, National Osteoporosis Foundation, 2003

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