Practice Guidelines

ACOG Releases Practice Bulletin on Osteoporosis

 


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Am Fam Physician. 2013 Aug 15;88(4):269-275.

Guideline source: American College of Obstetricians and Gynecologists

Evidence rating system used? Yes

Literature search described? Yes

Guideline developed by participants without relevant financial ties to industry? Not stated

Published source: Obstetrics & Gynecology, September 2012

Available at: http://journals.lww.com/greenjournal/Citation/2012/09000/Practice_Bulletin_No__129___Osteoporosis.41.aspx (subscription required)

This practice bulletin from the American College of Obstetricians and Gynecologists (ACOG) reviews diagnosis, evaluation, and treatment options for women with osteoporosis.

Recommendations

Women should be counseled on the recommended daily dietary allowances for calcium and vitamin D from the Institute of Medicine, which are as follows:

  • Persons nine to 18 years of age: 1,300 mg of calcium, 600 IU of vitamin D

  • Persons 19 to 50 years of age: 1,000 mg of calcium, 600 IU of vitamin D

  • Persons 51 to 70 years of age: 1,200 mg of calcium, 600 IU of vitamin D

  • Persons 71 years and older: 1,200 mg of calcium, 800 IU of vitamin D

A serum vitamin D level of 20 ng per mL (50 nmol per L) is recommended for good bone health.

Dual energy x-ray absorptiometry (DEXA) should be performed in all women 65 years and older. It can also be performed in postmenopausal women younger than 65 years who are at risk of fracture, including those with a history of fragility fracture, who weigh less than 127 lb (58 kg), who take medications or have diseases that cause bone loss, who have a parental history of hip fracture, who smoke, who have alcoholism, or who have rheumatoid arthritis. DEXA every one or two years can be used to determine the effectiveness of treatment; however, it should not be performed more often than every two years if the patient has no new risk factors, or if bone mineral density has improved or has not changed significantly.

In women older than 65 years with low bone mass, as indicated by bone mineral density reports, the World Health Organization's Fracture Risk Assessment Tool (FRAX; available at http://www.shef.ac.uk/FRAX/index.aspx) should be used to establish if a woman is at increased risk of fracture. Treatment is recommended if she is at increased risk. Among those not at increased risk, screening should be performed every 15 years for women older than 65 years with a normal bone mineral density or a T-score of −1.5 or greater, every five years for women with a T-score of −1.5 to −1.99, and every year for women with a T-score of −2.0 to −2.49.

Treatment is recommended in women with a T-score of −2.5 or less. For women with a T-score between −1.0 and −2.5, FRAX can assist in making an informed decision about treatment. Pharmacologic treatment should be considered in women with a 10-year risk of major osteoporotic fracture of at least 20% or a risk of hip fracture of at least 3%. Treatment should also be considered in women who have had a low-trauma fracture, even if DEXA does not indicate osteoporosis.

Because nutrition and lifestyle (e.g., inactivity, smoking) affect bone health, these factors should be discussed with females of all ages. To reduce the risk of bone loss and osteoporotic fractures, women with osteoporosis or who are at risk of osteoporosis should be counseled about lifestyle changes (e.g., weight-bearing exercise, smoking cessation, reducing alcohol intake).

First-line therapy usually consists of bisphosphonates; selection should be based on patient preference. Raloxifene (Evista) can be a good initial treatment in younger postmenopausal women, and denosumab is an option for women with a high risk of fracture. Teriparatide (Forteo) is typically only used in women with severe osteoporosis or who have had fractures. Calcitonin has weaker data compared with other options; therefore, it should be used only in women with less serious osteoporosis who cannot tolerate other treatments. Typically, combination therapy is not recommended. Whether there should be a limit to the duration of bisphosphonate therapy is unknown; however, there appears to be a trend toward interrupting therapy after five to 10 years. Hormone therapy (i.e., estrogen or combined estrogen/progestogen) positively affects bone health; it is approved for use in women with an increased risk of osteoporosis and fracture. Medications for preventing and treating postmenopausal osteoporosis are listed in Tables 1 and 2.

View/Print Table

Table 1.

Government-Approved Drugs for Prevention and Treatment of Postmenopausal Osteoporosis

Generic (brand)DosageIndicationContraindications

Bisphosphonates (oral unless otherwise specified)

Alendronate (Fosamax)

5 mg per day or 35 mg per week, tablet or solution

Prevention

Abnormalities of the esophagus

Inability to stand or sit upright for at least 30 minutes

Hypersensitivity to any component of this product

Hypocalcemia

Patients at increased risk of aspiration should not receive alendronate solution

10 mg per day or 70 mg per week, tablet or solution

Treatment

Alendronate/cholecalciferol (Fosamax Plus D)

70 mg plus 2,800 IU per week; 70 mg plus 5,600 IU per week

Treatment

Risedronate (Actonel)

5 mg per day; 35 mg per week; 75 mg in two consecutive days per month; 150 mg per month

Prevention and treatment

Risedronate (Atelvia)

35 mg per week (delayed release)

Treatment

Risedronate/calcium carbonate (Actonel with calcium)

35 mg per week (day 1) plus 1,250 mg calcium for no-risedronate days (days 2 through 7 of seven-day treatment cycle)

Prevention and treatment

Ibandronate (Boniva)

150 mg per month; 2.5 mg per day

Prevention and treatment

3 mg IV every three months

Treatment

Zoledronic acid (Reclast)

5 mg IV every two years

Prevention

Hypocalcemia

Creatinine clearance < 35 mL per minute per 1.73 m2 (0.58 mL per second per m2) and acute renal impairment

Hypersensitivity to zoledronic acid or any components of this product

5 mg IV every year

Treatment

Estrogen agonist/antagonist

Raloxifene (Evista)

60 mg per day

Prevention and treatment

Venous thromboembolism

Pregnancy, women who may become pregnant, and breastfeeding mothers

Calcitonin

Calcitonin-salmon (Fortical)

200 IU per day, nasal spray

Treatment*

Allergy to calcitonin-salmon or synthetic calcitonin-salmon

Calcitonin-salmon (Miacalcin)

200 IU per day, nasal spray

Treatment*

100 IU SC or IM every other day

Treatment*

Parathyroid hormone

Teriparatide (recombinant human parathyroid hormone1-34; Forteo)

20 mcg SC per day

Treatment (high fracture risk)

Hypersensitivity to teriparatide or to any of its excipients

Reactions have included angioedema and anaphylaxis

RANK ligand inhibitor

Denosumab (Prolia)

60 mg SC every six months

Treatment

Hypocalcemia


IM = intramuscularly; IV = intravenously; SC = subcutaneously.

*—In women more than five years past menopause.

Adapted with permission from North American Menopause Society. Government-approved drugs for postmenopausal osteoporosis in the United States and Canada. November 2012. http://www.menopause.org/otcharts.pdf. Accessed December 6, 2012

Table 1.

Government-Approved Drugs for Prevention and Treatment of Postmenopausal Osteoporosis

Generic (brand)DosageIndicationContraindications

Bisphosphonates (oral unless otherwise specified)

Alendronate (Fosamax)

5 mg per day or 35 mg per week, tablet or solution

Prevention

Abnormalities of the esophagus

Inability to stand or sit upright for at least 30 minutes

Hypersensitivity to any component of this product

Hypocalcemia

Patients at increased risk of aspiration should not receive alendronate solution

10 mg per day or 70 mg per week, tablet or solution

Treatment

Alendronate/cholecalciferol (Fosamax Plus D)

70 mg plus 2,800 IU per week; 70 mg plus 5,600 IU per week

Treatment

Risedronate (Actonel)

5 mg per day; 35 mg per week; 75 mg in two consecutive days per month; 150 mg per month

Prevention and treatment

Risedronate (Atelvia)

35 mg per week (delayed release)

Treatment

Risedronate/calcium carbonate (Actonel with calcium)

35 mg per week (day 1) plus 1,250 mg calcium for no-risedronate days (days 2 through 7 of seven-day treatment cycle)

Prevention and treatment

Ibandronate (Boniva)

150 mg per month; 2.5 mg per day

Prevention and treatment

3 mg IV every three months

Treatment

Zoledronic acid (Reclast)

5 mg IV every two years

Prevention

Hypocalcemia

Creatinine clearance < 35 mL per minute per 1.73 m2 (0.58 mL per second per m2) and acute renal impairment

Hypersensitivity to zoledronic acid or any components of this product

5 mg IV every year

Treatment

Estrogen agonist/antagonist

Raloxifene (Evista)

60 mg per day

Prevention and treatment

Venous thromboembolism

Pregnancy, women who may become pregnant, and breastfeeding mothers

Calcitonin

Calcitonin-salmon (Fortical)

200 IU per day, nasal spray

Treatment*

Allergy to calcitonin-salmon or synthetic calcitonin-salmon

Calcitonin-salmon (Miacalcin)

200 IU per day, nasal spray

Treatment*

100 IU SC or IM every other day

Treatment*

Parathyroid hormone

Teriparatide (recombinant human parathyroid hormone1-34; Forteo)

20 mcg SC per day

Treatment (high fracture risk)

Hypersensitivity to teriparatide or to any of its excipients

Reactions have included angioedema and anaphylaxis

RANK ligand inhibitor

Denosumab (Prolia)

60 mg SC every six months

Treatment

Hypocalcemia


IM = intramuscularly; IV = intravenously; SC = subcutaneously.

*—In women more than five years past menopause.

Adapted with permission from North American Menopause Society. Government-approved drugs for postmenopausal osteoporosis in the United States and Canada. November 2012. http://www.menopause.org/otcharts.pdf. Accessed December 6, 2012

View/Print Table

Table 2.

Government-Approved Estrogen and Estrogen/Progestin Drugs for Prevention of Postmenopausal Osteoporosis

Generic (brand)Contraindications

Estrogen

Undiagnosed abnormal genital bleeding

Known, suspected, or history of breast cancer except in appropriately selected patients being treated for metastatic disease

Known or suspected estrogen-dependent neoplasia

Active deep venous thrombosis, pulmonary embolism, or a history of these conditions

Active or recent (within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction)

Liver dysfunction or disease

Known thrombophilic disorders (e.g., protein C, protein S, antithrombin deficiency)

Known hypersensitivity to any of the ingredients in this product

Known or suspected pregnancy

Conjugated estrogens (Premarin)

Estropipate

Estradiol oral tablet (Estrace)

Estradiol weekly transdermal patch (Climara, Menostar)

Estradiol biweekly transdermal patch (Alora, Vivelle Dot)

Estrogen/progestin

Conjugated estrogens/medroxyprogesterone acetate (continuous-cyclic; Premphase)

Conjugated estrogens/medroxyprogesterone acetate (continuous-combined; Prempro)

Ethinyl estradiol/norethindrone acetate (Femhrt)

Estradiol/norethindrone acetate (Activella)

Estradiol/norgestimate (intermittent-combined; Prefest)

Estradiol/levonorgestrel (continuous-combined; Climara Pro)


*—Doses and formulations vary for estrogen and estrogen/progestin prescriptions. For a complete list, see http://journals.lww.com/greenjournal/Citation/2012/09000/Practice_Bulletin_No__129___Osteoporosis.41.aspx (subscription required).

Adapted with permission from North American Menopause Society. Government-approved drugs for postmenopausal osteoporosis in the United States and Canada. November 2012. http://www.menopause.org/otcharts.pdf. Accessed December 6, 2012.

Table 2.

Government-Approved Estrogen and Estrogen/Progestin Drugs for Prevention of Postmenopausal Osteoporosis

Generic (brand)Contraindications

Estrogen

Undiagnosed abnormal genital bleeding

Known, suspected, or history of breast cancer except in appropriately selected patients being treated for metastatic disease

Known or suspected estrogen-dependent neoplasia

Active deep venous thrombosis, pulmonary embolism, or a history of these conditions

Active or recent (within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction)

Liver dysfunction or disease

Known thrombophilic disorders (e.g., protein C, protein S, antithrombin deficiency)

Known hypersensitivity to any of the ingredients in this product

Known or suspected pregnancy

Conjugated estrogens (Premarin)

Estropipate

Estradiol oral tablet (Estrace)

Estradiol weekly transdermal patch (Climara, Menostar)

Estradiol biweekly transdermal patch (Alora, Vivelle Dot)

Estrogen/progestin

Conjugated estrogens/medroxyprogesterone acetate (continuous-cyclic; Premphase)

Conjugated estrogens/medroxyprogesterone acetate (continuous-combined; Prempro)

Ethinyl estradiol/norethindrone acetate (Femhrt)

Estradiol/norethindrone acetate (Activella)

Estradiol/norgestimate (intermittent-combined; Prefest)

Estradiol/levonorgestrel (continuous-combined; Climara Pro)


*—Doses and formulations vary for estrogen and estrogen/progestin prescriptions. For a complete list, see http://journals.lww.com/greenjournal/Citation/2012/09000/Practice_Bulletin_No__129___Osteoporosis.41.aspx (subscription required).

Adapted with permission from North American Menopause Society. Government-approved drugs for postmenopausal osteoporosis in the United States and Canada. November 2012. http://www.menopause.org/otcharts.pdf. Accessed December 6, 2012.

If a patient loses bone mineral density during treatment, the physician should first determine if the patient is taking the medication correctly. The next appropriate step would be to assess the patient for secondary causes of osteoporosis, or to refer the patient to a specialist. The evaluation for secondary causes of osteoporosis includes two tiers of testing, with a complete blood count, metabolic profile, and 24-hour urine calcium, 25-hydroxyvitamin D, and thyroid-stimulating hormone measurement performed first, and a celiac panel and serum protein electrophoresis performed second.

LISA HAUK, Senior Associate Editor, AFP Online

Coverage of guidelines from other organizations does not imply endorsement by AFP or the AAFP.

A collection of Practice Guidelines published in AFP is available at http://www.aafp.org/afp/practguide.



 

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