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Osteoporosis UnAd

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O steoporosis is often asymptomatic until a fracture occurs; these can occur with minimal or no trauma. 1 Risk factors for osteoporosis include female gender, older age, low calcium intake, vitamin D deficiency,BMI < 21 kg/m 2 , steroid use, excessive alcohol intake, smoking, and inadequate exercise. 2-4 Keeping bones from breaking Osteoporosis is common in elderly patients. It can cause preventable fractures leading to hospitalization, loss of mobility, nursing home admission, and increased mortality. A few simple interventions can make a big difference. Balanced data about medications The Alosa Foundation
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Page 1: Osteoporosis UnAd

Osteoporosis is often asymptomatic until a

fracture occurs; these can occur with minimal or

no trauma.1 Risk factors for osteoporosis include

female gender,older age, low calcium intake,

vitamin D deficiency,BMI < 21 kg/m2, steroid use,

excessive alcohol intake, smoking,and inadequate

exercise.2-4

Keeping bones from breaking

Osteoporosis is common in elderly patients. It can cause preventable

fractures leading to hospitalization, loss of mobility, nursing home admission,

and increased mortality.

A few simple interventions can make a big difference.

Balanced data about medications

The Alosa Foundation

References: 1. Sweet MG, Sweet JM, Jeremiah MP, Galazka SS. Diagnosis and treatment of osteoporosis. Am Fam Physician. Feb 1 2009;79(3):193-200.2. National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis 2010.Available at: http://www.nof.org/professionals/pdfs/NOF_ClinicianGuide2009_v7.pdf. 3. Poole KE, Compston JE. Osteoporosis and its management. BMJ. Dec 16 2006;333(7581):1251-1256. 4. Managementof osteoporosis in postmenopausal women: 2010 position statement of The North American Menopause Society. Menopause. Jan-Feb;17(1):25-54; quiz 55-26.5. US Department of Health and Human Services.Agency for Healthcare Research and Quality. Clinician's Guide: Fracture Prevention Treatments forPostmenopausal Women with Osteoporosis 2008.Available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=95. 6. Holick MF.Vitamin D deficiency. N Engl J Med. Jul 19 2007;357(3):266-281. 7. Reichrath J. Skin cancer prevention and UV-protection: how to avoid vitamin D-deficiency? Br J Dermatol. Nov 2009;161 Suppl 3:54-60. 8. Bonaiuti D, Shea B, Iovine R, et al. Exercise for preventing andtreating osteoporosis in postmenopausal women. Cochrane Database Syst Rev. 2002(3):CD000333. 9. Tannirandorn P, Epstein S. Drug-induced bone loss.Osteoporos Int. 2000;11(8):637-659. 10. Farquhar C, Marjoribanks J, Lethaby A, Suckling JA, Lamberts Q. Long term hormone therapy for perimenopausal andpostmenopausal women. Cochrane Database Syst Rev. 2009(2):CD004143. 11. US Department of Health and Human Services.Agency for HealthcareResearch and Quality. Comparative Effectiveness of Treatments To Prevent Fractures in Men and Women With Low Bone Density or Osteoporosis 2007.Available at: http://effectivehealthcare.ahrq.gov/ehc/products/8/73/LowBoneDensityExecSummary.pdf. 12. MacLean C, Newberry S, Maglione M, et al.Systematic review: comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis. Ann Intern Med.Feb 5 2008;148(3):197-213. 13. Cadarette SM, Katz JN, Brookhart MA, Sturmer T, Stedman MR, Solomon DH. Relative effectiveness of osteoporosis drugs forpreventing nonvertebral fracture. Ann Intern Med. May 6 2008;148(9):637-646. 14. Papaioannou A, Kennedy CC, Dolovich L, Lau E,Adachi JD. Patientadherence to osteoporosis medications: problems, consequences and management strategies. Drugs Aging. 2007;24(1):37-55. 15. Caro JJ, Ishak KJ, HuybrechtsKF, Raggio G, Naujoks C.The impact of compliance with osteoporosis therapy on fracture rates in actual practice. Osteoporos Int. Dec 2004;15(12):1003-1008.16. Ruggiero SL, Dodson TB,Assael LA, Landesberg R, Marx RE, Mehrotra B.American Association of Oral and Maxillofacial Surgeons position paper onbisphosphonate-related osteonecrosis of the jaw - 2009 update.Available at http://www.aaoms.org/docs/position_papers/bronj_update.pdf.

Additional references documenting these recommendations are provided in the evidence document accompanying this material.

visit our website: www.RxFacts.orgThis material was produced by Leslie Jackowski,B.Sc.,M.B.B.S., Senior Clinical Consultant,Division of Pharmacoepidemiologyand Pharmacoeconomics, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital; NiteeshK. Choudhry, M.D., Ph.D.,Assistant Professor of Medicine, Harvard Medical School; Michael A. Fischer, M.D., M.S.,AssistantProfessor of Medicine, Harvard Medical School; Danielle Scheurer, M.D., M.Sc., F.H.M.,Assistant Professor of Medicine,Harvard Medical School; and William H. Shrank, M.D., M.S.H.S.,Assistant Professor of Medicine, Harvard Medical School.Series editor: Jerry Avorn, M.D., Professor of Medicine, Harvard Medical School. Drs Avorn, Choudhry, Fischer, Scheurer, andShrank are all physicians at the Brigham and Women’s Hospital in Boston. None of the authors accepts any personalcompensation from any drug company.

The Independent Drug Information Service (iDiS) is supported by the PACE Program of the Department of Aging of theCommonwealth of Pennsylvania, the Massachusetts Department of Public Health, and the Washington D.C. Departmentof Health.

This material is provided by the The Alosa Foundation, a nonprofit organization that is not affiliated in any way with anypharmaceutical company.

These are general recommendations only; specific clinical decisions should be made by the treatingphysician based on an individual patient’s clinical condition.

©2010 by The Alosa Foundation.All rights reserved. June 2010Balanced data about medications

The Alosa Foundation

Page 2: Osteoporosis UnAd

Several simple dietary and lifestyle interventions can help maintain BMD and/or reduce therisk of falls and fractures, even for patients with normal bone mass.

Test bone mineral densityTest bone mineral density (BMD) with dual-energy x-ray absorptiometry (DXA,DEXA) in

the following groups:2, 4

• women ≥ 65 and men ≥ 70 • younger peri- and post-menopausal women and men with risk factors such as low body

weight (BMI < 21 kg/m2) or prior low-trauma fracture• anyone with other risk factors for low bone mass such as rheumatoid arthritis or systemic

steroid use for ≥ 3 months• anyone with prior fracture after age 50 • postmenopausal women discontinuing estrogen

2 3

Make a few simple assessments

BMD measurements are reported as T-scores. Use the lowest (most negative) of the hip,femoral neck, and lumbar spine scores for diagnosis.4 A patient who has had a low/no traumafracture should be considered to have osteoporosis regardless of BMD.5

T-score

≤ -2.5

Between -1.0 and -2.5

≥ -1.0

Osteoporosis

Osteopenia (“low bone mass”)

Normal bone mineral density

Diagnosis

Table 1. T-scores and diagnosis

Estimate fracture risk A WHO fracture risk algorithm (FRAX) can be used to calculate the 10-year risk of hip and

other major osteoporotic fractures.2 The US-adapted algorithm is available at http://www.shef.ac.uk/FRAX/ for Hispanic, Black, Caucasian, and Asian men and women. The score isbased upon age, gender, weight, height, BMD, and clinical risk factors including priorfracture, family history of hip fracture, use of oral glucocorticoids (at a daily dose ≥ 5 mg ofprednisone or equivalent for ≥ 3 months), smoking, excessive alcohol use (3 or more drinksper day), and rheumatoid arthritis. The risk calculator can help determine whether or not tostart drug therapy (see Figure 1). Hardcopy charts of fracture risk are available at the abovewebsite and examples of these charts are provided as an appendix to the accompanyingevidence document.

Test

Vitamin D

Calcium

Other

• Vitamin D deficiency is common.2, 6, 7 Consider checking serum 25-OH vitamin D, especially in older patients and those with low bone density.4

• Measure serum calcium, and work up if abnormal; a 24-hour urine calcium ≤ 50 mg suggests either insufficient calcium intake or poor absorption.4

• If a specific cause of osteoporosis is suspected, other relevant studies may include thyroid function tests, testosterone levels in men, antibody testing for celiac disease, and a serum parathyroid hormone level.

Comments

Table 2. A few lab tests

A few easy interventions for all patients

Intervention

Calcium

Vitamin D

Exercise*

Smoking* and alcohol control

Falls prevention*

• Daily intake of at least 1,200 mg of elemental calcium per day for people 50 years and older, including supplements if dietary intake is inadequate.2

• An easy-to-use dietary calcium calculator is available at http://www.myoptum health.com/portal/ManageMyHealth/Calcium+Calculator• For optimal absorption, a single dose of calcium supplement should contain no more than 500 mg of elemental calcium, so divided doses may be needed.1,4

• Calcium carbonate should be taken with meals. Calcium citrate is more expensive, but does not need to be taken with meals; it is preferred in patients on acid-suppressive therapies.1,4

• Daily intake of 800 - 1,000 international units (IU) per day for people ≥ 50.2

• Some older patients may need at least 2,000 IU per day to maintain adequate 25(OH)D levels.2

• One strategy for correcting vitamin D deficiency is 50,000 IU weekly of oral vitamin D2 for 8 weeks, followed by a maintenance dosage of 50,000 IU every 2-4 weeks or 1,000 IU of oral vitamin D3 once daily.1

• Re-test serum 25(OH)D levels after at least 12 weeks of supplementation, because steady state of 25(OH)D is not achieved until that time.4

• Weight-bearing and muscle-strengthening exercises reduce the risk of falls and increase bone density.8

• Review prescriptions that may cause impaired balance/mobility, sedation, or confusion; check and correct vision and hearing problems; improve home safety.

• Smoking and excessive alcohol consumption (over 3 drinks per day) increase the risk of osteoporosis.10 Yet another reason to quit smoking.

Recommendations and comments

Table 3. Interventions for all patients

*Comprehensive discussions on exercise for elderly people, falls prevention, and smoking cessation, can be found in previous iDiS modules: (i) Preventing Falls and Enhancing Mobility, and (ii) Chronic Obstructive Pulmonary Disease, available at www.RxFacts.org.

Page 3: Osteoporosis UnAd

Several simple dietary and lifestyle interventions can help maintain BMD and/or reduce therisk of falls and fractures, even for patients with normal bone mass.

Test bone mineral densityTest bone mineral density (BMD) with dual-energy x-ray absorptiometry (DXA,DEXA) in

the following groups:2, 4

• women ≥ 65 and men ≥ 70 • younger peri- and post-menopausal women and men with risk factors such as low body

weight (BMI < 21 kg/m2) or prior low-trauma fracture• anyone with other risk factors for low bone mass such as rheumatoid arthritis or systemic

steroid use for ≥ 3 months• anyone with prior fracture after age 50 • postmenopausal women discontinuing estrogen

2 3

Make a few simple assessments

BMD measurements are reported as T-scores. Use the lowest (most negative) of the hip,femoral neck, and lumbar spine scores for diagnosis.4 A patient who has had a low/no traumafracture should be considered to have osteoporosis regardless of BMD.5

T-score

≤ -2.5

Between -1.0 and -2.5

≥ -1.0

Osteoporosis

Osteopenia (“low bone mass”)

Normal bone mineral density

Diagnosis

Table 1. T-scores and diagnosis

Estimate fracture risk A WHO fracture risk algorithm (FRAX) can be used to calculate the 10-year risk of hip and

other major osteoporotic fractures.2 The US-adapted algorithm is available at http://www.shef.ac.uk/FRAX/ for Hispanic, Black, Caucasian, and Asian men and women. The score isbased upon age, gender, weight, height, BMD, and clinical risk factors including priorfracture, family history of hip fracture, use of oral glucocorticoids (at a daily dose ≥ 5 mg ofprednisone or equivalent for ≥ 3 months), smoking, excessive alcohol use (3 or more drinksper day), and rheumatoid arthritis. The risk calculator can help determine whether or not tostart drug therapy (see Figure 1). Hardcopy charts of fracture risk are available at the abovewebsite and examples of these charts are provided as an appendix to the accompanyingevidence document.

Test

Vitamin D

Calcium

Other

• Vitamin D deficiency is common.2, 6, 7 Consider checking serum 25-OH vitamin D, especially in older patients and those with low bone density.4

• Measure serum calcium, and work up if abnormal; a 24-hour urine calcium ≤ 50 mg suggests either insufficient calcium intake or poor absorption.4

• If a specific cause of osteoporosis is suspected, other relevant studies may include thyroid function tests, testosterone levels in men, antibody testing for celiac disease, and a serum parathyroid hormone level.

Comments

Table 2. A few lab tests

A few easy interventions for all patients

Intervention

Calcium

Vitamin D

Exercise*

Smoking* and alcohol control

Falls prevention*

• Daily intake of at least 1,200 mg of elemental calcium per day for people 50 years and older, including supplements if dietary intake is inadequate.2

• An easy-to-use dietary calcium calculator is available at http://www.myoptum health.com/portal/ManageMyHealth/Calcium+Calculator• For optimal absorption, a single dose of calcium supplement should contain no more than 500 mg of elemental calcium, so divided doses may be needed.1,4

• Calcium carbonate should be taken with meals. Calcium citrate is more expensive, but does not need to be taken with meals; it is preferred in patients on acid-suppressive therapies.1,4

• Daily intake of 800 - 1,000 international units (IU) per day for people ≥ 50.2

• Some older patients may need at least 2,000 IU per day to maintain adequate 25(OH)D levels.2

• One strategy for correcting vitamin D deficiency is 50,000 IU weekly of oral vitamin D2 for 8 weeks, followed by a maintenance dosage of 50,000 IU every 2-4 weeks or 1,000 IU of oral vitamin D3 once daily.1

• Re-test serum 25(OH)D levels after at least 12 weeks of supplementation, because steady state of 25(OH)D is not achieved until that time.4

• Weight-bearing and muscle-strengthening exercises reduce the risk of falls and increase bone density.8

• Review prescriptions that may cause impaired balance/mobility, sedation, or confusion; check and correct vision and hearing problems; improve home safety.

• Smoking and excessive alcohol consumption (over 3 drinks per day) increase the risk of osteoporosis.10 Yet another reason to quit smoking.

Recommendations and comments

Table 3. Interventions for all patients

*Comprehensive discussions on exercise for elderly people, falls prevention, and smoking cessation, can be found in previous iDiS modules: (i) Preventing Falls and Enhancing Mobility, and (ii) Chronic Obstructive Pulmonary Disease, available at www.RxFacts.org.

Page 4: Osteoporosis UnAd

4 5

Comparative effectivenessNo head-to-head clinical trials have studied bisphosphonates in relation to each other

or to other drug classes for anti-fracture efficacy,4 making comparisons difficult.11, 12 A largeobservational study, controlling for patient characteristics, found that patient takingbisphosphonates had lower fracture risks than those taking raloxifene or calcitonin.13 The most affordable and tolerable bisphosphonate should be the first-line treatment for fractureprevention.

When a prescription is needed

Bisphosphonates include alendronate (generics, Fosamax, Fosamax plus D), ibandronate(Boniva), risedronate (Actonel, Actonel with calcium), and zoledronate (Reclast).

Consider an osteoporosis drug for postmenopausal women and men ≥ 50 who have:

• an osteoporotic hip or vertebral fracture; or• a T-score equal to or more negative than -2.5 at any site ; or • low BMD (T-score between -1.0 and -2.5) as well as: – a 10-year risk of a hip fracture ≥ 3%, based on FRAX, or – a 10-year risk of any major osteoporosis-related fracture (spine, hip, shoulder, or wrist) ≥ 20%, based on FRAX

Postmenopausal women

• a bisphosphonate

• 2nd line therapies: raloxifene, teriparatide, calcitonin, denosumab

Figure 1. Algorithm for use of osteoporosis medications2, 4

Steroid-induced osteoporosis

• a bisphosphonate

• 2nd line therapy: teriparatide

Men

• a bisphosphonate

• 2nd line therapy: teriparatide

Medication

Bisphosphonates(alendronate, ibandronate, risedronate, zoledronate)

Teriparatide (Forteo)

Raloxifene (Evista)

Denosumab (Prolia)

Estrogen-based Hormone therapy (HT)

Calcitonin (generics, Miacalcin, Fortical)

• Reduce the risk of vertebral, non-vertebral, and hip fractures in postmenopausal women. Treatment beyond 5 years may not provide additional benefit in many women. • Also reduce the risk of vertebral fractures in men, as well as steroid-induced osteoporosis.

• Reduces the risk of vertebral and non-vertebral fractures in postmenopausal women with a prior vertebral fracture. • Duration of therapy (up to 2 years only) and high cost may limit its usefulness. • Also reduces the risk of vertebral fractures in men, as well as steroid-induced osteoporosis.

• Reduces the risk of vertebral fractures in postmenopausal women with osteoporosis..

• Reduces the risk of vertebral fractures in postmenopausal women with osteoporosis.

• Reduces the risk of risk of vertebral, non-vertebral, and hip fractures in postmenopausal women with osteoporosis.

• Although HT (estrogens with or without progestogens) is FDA-approved for the prevention of osteoporosis in postmenopausal women, if this is the sole aim of treatment, other drugs should be used because of the cancer and cardiovascular side effects of HT.2 • Long term HT use is not indicated for the treatment of osteoporosis,10 and its BMD benefits are lost soon after discontinuation.4

Efficacy

Table 4. The evidence for efficacy

Page 5: Osteoporosis UnAd

4 5

Comparative effectivenessNo head-to-head clinical trials have studied bisphosphonates in relation to each other

or to other drug classes for anti-fracture efficacy,4 making comparisons difficult.11, 12 A largeobservational study, controlling for patient characteristics, found that patient takingbisphosphonates had lower fracture risks than those taking raloxifene or calcitonin.13 The most affordable and tolerable bisphosphonate should be the first-line treatment for fractureprevention.

When a prescription is needed

Bisphosphonates include alendronate (generics, Fosamax, Fosamax plus D), ibandronate(Boniva), risedronate (Actonel, Actonel with calcium), and zoledronate (Reclast).

Consider an osteoporosis drug for postmenopausal women and men ≥ 50 who have:

• an osteoporotic hip or vertebral fracture; or• a T-score equal to or more negative than -2.5 at any site ; or • low BMD (T-score between -1.0 and -2.5) as well as: – a 10-year risk of a hip fracture ≥ 3%, based on FRAX, or – a 10-year risk of any major osteoporosis-related fracture (spine, hip, shoulder, or wrist) ≥ 20%, based on FRAX

Postmenopausal women

• a bisphosphonate

• 2nd line therapies: raloxifene, teriparatide, calcitonin, denosumab

Figure 1. Algorithm for use of osteoporosis medications2, 4

Steroid-induced osteoporosis

• a bisphosphonate

• 2nd line therapy: teriparatide

Men

• a bisphosphonate

• 2nd line therapy: teriparatide

Medication

Bisphosphonates(alendronate, ibandronate, risedronate, zoledronate)

Teriparatide (Forteo)

Raloxifene (Evista)

Denosumab (Prolia)

Estrogen-based Hormone therapy (HT)

Calcitonin (generics, Miacalcin, Fortical)

• Reduce the risk of vertebral, non-vertebral, and hip fractures in postmenopausal women. Treatment beyond 5 years may not provide additional benefit in many women. • Also reduce the risk of vertebral fractures in men, as well as steroid-induced osteoporosis.

• Reduces the risk of vertebral and non-vertebral fractures in postmenopausal women with a prior vertebral fracture. • Duration of therapy (up to 2 years only) and high cost may limit its usefulness. • Also reduces the risk of vertebral fractures in men, as well as steroid-induced osteoporosis.

• Reduces the risk of vertebral fractures in postmenopausal women with osteoporosis..

• Reduces the risk of vertebral fractures in postmenopausal women with osteoporosis.

• Reduces the risk of risk of vertebral, non-vertebral, and hip fractures in postmenopausal women with osteoporosis.

• Although HT (estrogens with or without progestogens) is FDA-approved for the prevention of osteoporosis in postmenopausal women, if this is the sole aim of treatment, other drugs should be used because of the cancer and cardiovascular side effects of HT.2 • Long term HT use is not indicated for the treatment of osteoporosis,10 and its BMD benefits are lost soon after discontinuation.4

Efficacy

Table 4. The evidence for efficacy

Page 6: Osteoporosis UnAd

ONJ is a condition of localized “bone death” that has been reported rarely in patients takingoral bisphosphonates, and can be difficult to treat. After widely publicized reports of ONJ, manypatients stopped taking their bisphosphonates, and many physicians became concerned aboutwhether to continue prescribing them. However, the risk of bisphosphonate-related ONJ is verylow with oral bisphosphonates used to treat osteoporosis; dental surgery increases the risk. Thecondition is more commonly seen in cancer patients given intravenous bisphosphonates.16

Consider discontinuing an oral bisphosphonate for at least 3 months prior to oral surgery inpatients who have taken the drug for >3 years, or in those who have taken it for <3 years and areon corticosteroids. The drug should not be restarted until bone has fully healed.16

76

When should I worry about osteonecrosis of the jaw (ONJ)?

Figure 2. Cost of medications used for osteoporosis

$0 $200 $400 $600 $800 $1,000Costs of 30-day supply of defined daily dose

Alendronate 10mg oral

Ibandronate (Boniva) 5mg oral

Risedronate (Actonel) 5mg oral

Zoledronate (Reclast) 5mg IV

Raloxifene (Evista) 60mg oral

Teriparatide (Forteo) 20 micrograms SC

Calcitonin

Denosumab (Prolia), 60mg SC

Fosamax, $95

generics, $71

$111

$119

$93

$123

$948

Miacalcin 100 units SC/IM, $477

Fortical 200 units, nasal $75

Miacalcin 200 units nasal, $131

generics 200 units nasal, $110

$135

SC/IM: subcutaneous/intramuscular injection; SC: subcutaneous injection; IV: intravenous. Prices from www.epocrates.com, May 2010.

• Assess adverse effects and compliance (which is often poor).• Encourage adequate calcium and vitamin D intake, exercise, falls prevention, smoking

cessation, and avoidance of excessive alcohol use.• Re-check bone mineral density 2 years after starting a drug, and every 2 years thereafter.

More frequent testing may be warranted for some patients, such as those taking high-dosesteroids.

• Reassess the need for continuing use of a bisphosphonate after 5 years unless the T-scoreremains lower than – 2.5.

Adherence to regimens of medications for osteoporosis (including calcium and vitamin D)is often quite low.5, 11, 14 One study found that women with high prescription drug compliancehad a 16% lower fracture rate than those with low compliance.15

Strategies to improve adherence include:5, 11

• educate patients about the importance of the medication and the need to take itconsistently;

• consider a weekly-dosed oral bisphosphonate – it may improve adherence compared withdaily dosing in some patients;

• choose the most affordable and effective option;• provide written instructions on dosing and duration of therapy;• encourage a reminder system or use of an adherence aid such as a pill box; and• ask about adverse effects (such as gastrointestinal side effects with bisphosphonates, or

hot flashes with raloxifene) and consider an alternative if indicated.

Monitor response to therapy

Cost may be a barrier to adherence. Generic alendronate is now available, makingbisphosphonate therapy more affordable. Injectable drugs may incur an additional up-frontexpense.5 The costs of a 30-day supply of typical doses of these medications are listed below. Theprice of calcium and vitamin D varies, but these medications are widely available and inexpensive(under $10 per month).5

Cost

Page 7: Osteoporosis UnAd

ONJ is a condition of localized “bone death” that has been reported rarely in patients takingoral bisphosphonates, and can be difficult to treat. After widely publicized reports of ONJ, manypatients stopped taking their bisphosphonates, and many physicians became concerned aboutwhether to continue prescribing them. However, the risk of bisphosphonate-related ONJ is verylow with oral bisphosphonates used to treat osteoporosis; dental surgery increases the risk. Thecondition is more commonly seen in cancer patients given intravenous bisphosphonates.16

Consider discontinuing an oral bisphosphonate for at least 3 months prior to oral surgery inpatients who have taken the drug for >3 years, or in those who have taken it for <3 years and areon corticosteroids. The drug should not be restarted until bone has fully healed.16

76

When should I worry about osteonecrosis of the jaw (ONJ)?

Figure 2. Cost of medications used for osteoporosis

$0 $200 $400 $600 $800 $1,000Costs of 30-day supply of defined daily dose

Alendronate 10mg oral

Ibandronate (Boniva) 5mg oral

Risedronate (Actonel) 5mg oral

Zoledronate (Reclast) 5mg IV

Raloxifene (Evista) 60mg oral

Teriparatide (Forteo) 20 micrograms SC

Calcitonin

Denosumab (Prolia), 60mg SC

Fosamax, $95

generics, $71

$111

$119

$93

$123

$948

Miacalcin 100 units SC/IM, $477

Fortical 200 units, nasal $75

Miacalcin 200 units nasal, $131

generics 200 units nasal, $110

$135

SC/IM: subcutaneous/intramuscular injection; SC: subcutaneous injection; IV: intravenous. Prices from www.epocrates.com, May 2010.

• Assess adverse effects and compliance (which is often poor).• Encourage adequate calcium and vitamin D intake, exercise, falls prevention, smoking

cessation, and avoidance of excessive alcohol use.• Re-check bone mineral density 2 years after starting a drug, and every 2 years thereafter.

More frequent testing may be warranted for some patients, such as those taking high-dosesteroids.

• Reassess the need for continuing use of a bisphosphonate after 5 years unless the T-scoreremains lower than – 2.5.

Adherence to regimens of medications for osteoporosis (including calcium and vitamin D)is often quite low.5, 11, 14 One study found that women with high prescription drug compliancehad a 16% lower fracture rate than those with low compliance.15

Strategies to improve adherence include:5, 11

• educate patients about the importance of the medication and the need to take itconsistently;

• consider a weekly-dosed oral bisphosphonate – it may improve adherence compared withdaily dosing in some patients;

• choose the most affordable and effective option;• provide written instructions on dosing and duration of therapy;• encourage a reminder system or use of an adherence aid such as a pill box; and• ask about adverse effects (such as gastrointestinal side effects with bisphosphonates, or

hot flashes with raloxifene) and consider an alternative if indicated.

Monitor response to therapy

Cost may be a barrier to adherence. Generic alendronate is now available, makingbisphosphonate therapy more affordable. Injectable drugs may incur an additional up-frontexpense.5 The costs of a 30-day supply of typical doses of these medications are listed below. Theprice of calcium and vitamin D varies, but these medications are widely available and inexpensive(under $10 per month).5

Cost

Page 8: Osteoporosis UnAd

Osteoporosis is often asymptomatic until a

fracture occurs; these can occur with minimal or

no trauma.1 Risk factors for osteoporosis include

female gender,older age, low calcium intake,

vitamin D deficiency,BMI < 21 kg/m2, steroid use,

excessive alcohol intake, smoking,and inadequate

exercise.2-4

Keeping bones from breaking

Osteoporosis is common in elderly patients. It can cause preventable

fractures leading to hospitalization, loss of mobility, nursing home admission,

and increased mortality.

A few simple interventions can make a big difference.

Balanced data about medications

The Alosa Foundation

References: 1. Sweet MG, Sweet JM, Jeremiah MP, Galazka SS. Diagnosis and treatment of osteoporosis. Am Fam Physician. Feb 1 2009;79(3):193-200.2. National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis 2010.Available at: http://www.nof.org/professionals/pdfs/NOF_ClinicianGuide2009_v7.pdf. 3. Poole KE, Compston JE. Osteoporosis and its management. BMJ. Dec 16 2006;333(7581):1251-1256. 4. Managementof osteoporosis in postmenopausal women: 2010 position statement of The North American Menopause Society. Menopause. Jan-Feb;17(1):25-54; quiz 55-26.5. US Department of Health and Human Services.Agency for Healthcare Research and Quality. Clinician's Guide: Fracture Prevention Treatments forPostmenopausal Women with Osteoporosis 2008.Available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=95. 6. Holick MF.Vitamin D deficiency. N Engl J Med. Jul 19 2007;357(3):266-281. 7. Reichrath J. Skin cancer prevention and UV-protection: how to avoid vitamin D-deficiency? Br J Dermatol. Nov 2009;161 Suppl 3:54-60. 8. Bonaiuti D, Shea B, Iovine R, et al. Exercise for preventing andtreating osteoporosis in postmenopausal women. Cochrane Database Syst Rev. 2002(3):CD000333. 9. Tannirandorn P, Epstein S. Drug-induced bone loss.Osteoporos Int. 2000;11(8):637-659. 10. Farquhar C, Marjoribanks J, Lethaby A, Suckling JA, Lamberts Q. Long term hormone therapy for perimenopausal andpostmenopausal women. Cochrane Database Syst Rev. 2009(2):CD004143. 11. US Department of Health and Human Services.Agency for HealthcareResearch and Quality. Comparative Effectiveness of Treatments To Prevent Fractures in Men and Women With Low Bone Density or Osteoporosis 2007.Available at: http://effectivehealthcare.ahrq.gov/ehc/products/8/73/LowBoneDensityExecSummary.pdf. 12. MacLean C, Newberry S, Maglione M, et al.Systematic review: comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis. Ann Intern Med.Feb 5 2008;148(3):197-213. 13. Cadarette SM, Katz JN, Brookhart MA, Sturmer T, Stedman MR, Solomon DH. Relative effectiveness of osteoporosis drugs forpreventing nonvertebral fracture. Ann Intern Med. May 6 2008;148(9):637-646. 14. Papaioannou A, Kennedy CC, Dolovich L, Lau E,Adachi JD. Patientadherence to osteoporosis medications: problems, consequences and management strategies. Drugs Aging. 2007;24(1):37-55. 15. Caro JJ, Ishak KJ, HuybrechtsKF, Raggio G, Naujoks C.The impact of compliance with osteoporosis therapy on fracture rates in actual practice. Osteoporos Int. Dec 2004;15(12):1003-1008.16. Ruggiero SL, Dodson TB,Assael LA, Landesberg R, Marx RE, Mehrotra B.American Association of Oral and Maxillofacial Surgeons position paper onbisphosphonate-related osteonecrosis of the jaw - 2009 update.Available at http://www.aaoms.org/docs/position_papers/bronj_update.pdf.

Additional references documenting these recommendations are provided in the evidence document accompanying this material.

visit our website: www.RxFacts.orgThis material was produced by Leslie Jackowski,B.Sc.,M.B.B.S., Senior Clinical Consultant,Division of Pharmacoepidemiologyand Pharmacoeconomics, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital; NiteeshK. Choudhry, M.D., Ph.D.,Assistant Professor of Medicine, Harvard Medical School; Michael A. Fischer, M.D., M.S.,AssistantProfessor of Medicine, Harvard Medical School; Danielle Scheurer, M.D., M.Sc., F.H.M.,Assistant Professor of Medicine,Harvard Medical School; and William H. Shrank, M.D., M.S.H.S.,Assistant Professor of Medicine, Harvard Medical School.Series editor: Jerry Avorn, M.D., Professor of Medicine, Harvard Medical School. Drs Avorn, Choudhry, Fischer, Scheurer, andShrank are all physicians at the Brigham and Women’s Hospital in Boston. None of the authors accepts any personalcompensation from any drug company.

The Independent Drug Information Service (iDiS) is supported by the PACE Program of the Department of Aging of theCommonwealth of Pennsylvania, the Massachusetts Department of Public Health, and the Washington D.C. Departmentof Health.

This material is provided by the The Alosa Foundation, a nonprofit organization that is not affiliated in any way with anypharmaceutical company.

These are general recommendations only; specific clinical decisions should be made by the treatingphysician based on an individual patient’s clinical condition.

©2010 by The Alosa Foundation.All rights reserved. June 2010Balanced data about medications

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