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Generic Name: Risedronate Sodium
Class: Bone Resorption Inhibitors
VA Class: HS900
Chemical Name: [1-hydroxy-2-(3-pyridinyl)ethylidene]bis-phosphonic acid monosodium salt
Molecular Formula: C7H10NNaO7P2
CAS Number: 115436-72-1

Introduction

Synthetic bisphosphonate; bone resorption inhibitor.1 2 4 5 6 8 9 12 13 14

Uses for Actonel

Osteoporosis in Postmenopausal Women

Used alone or with calcium carbonate for prevention of osteoporosis in postmenopausal women.1 17 33 Risk factors for osteoporosis include premature ovarian failure; family history of osteoporosis; a small, slim body frame; cigarette smoking; excessive alcohol use; low dietary calcium intake; sedentary lifestyle; and Caucasian or Asian race.1 17

Used alone or with calcium carbonate for treatment of osteoporosis in postmenopausal women.1 5 6 7 33

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

Osteoporosis in Men

Treatment of osteoporosis in men.1 60

Corticosteroid-induced Osteoporosis

Prevention of corticosteroid-induced osteoporosis in men and women initiating therapy with corticosteroids (daily dosage ≥7.5 mg of prednisone or equivalent).1 8 10

Treatment of corticosteroid-induced osteoporosis in men and women receiving corticosteroids (daily dosage ≥7.5 mg of prednisone or equivalent).1 4 9 10 11

American College of Rheumatology (ACR) currently recommends use of one of several bisphosphonates (i.e., alendronate, risedronate, or zoledronic acid) in conjunction with lifestyle modification and calcium and vitamin D supplementation for the prevention and treatment of corticosteroid-induced osteoporosis in select postmenopausal women and men ≥50 years of age who are initiating or currently receiving corticosteroid therapy.57

ACR recommendations based on a risk-stratification approach in which an individual’s clinical risk for developing a fracture is determined based on variables such as gender, age, race/ethnicity, and femoral neck density57 and the individual’s preexisting or anticipated corticosteroid dosage.57

ACR states that because of limited data, use of bisphosphonates for prevention or treatment of corticosteroid-induced osteoporosis in premenopausal women and men <50 years of age can be recommended only in those who have a history of fragility fracture.57

Paget’s Disease of Bone

Treatment of Paget’s disease of bone (osteitis deformans).1 2 13 1

Actonel Dosage and Administration

General

  • Use adjunctively with other measures (e.g., weight-bearing exercise, reduction in smoking and alcohol use) to retard further bone loss.1 4

  • Supplemental calcium and vitamin D recommended if daily dietary intake is inadequate, particularly in patients with Paget’s disease of bone or receiving corticosteroids.1

Administration

Oral Administration

Administer risedronate sodium or risedronate sodium copackaged with calcium carbonate orally1 5 6 7 8 9 10 33 34 with a full glass (180–240 mL) of plain water ≥30 minutes before the first food or beverage of the day.1

Administer in an upright position (sitting or standing).1 Avoid lying down for ≥30 minutes following administration.1 (See Upper GI Effects under Cautions.)

Do not suck or chew tablets; potential for oropharyngeal irritation.1 (See Upper GI Effects under Cautions.)

Do not administer at the same time as other beverages, foods, antacids, or mineral supplements containing calcium, aluminum, or magnesium.1 5 33 34 (See Antacids or Mineral Supplements Containing Divalent Cations under Interactions.)

Missed dose in patients taking weekly 35-mg dose of risedronate sodium: take the missed dose the morning after it is remembered, then resume the regular weekly schedule.1 Do not take two 35-mg tablets on the same day.1

Missed dose of risedronate sodium (orange tablet) in patients taking weekly 35-mg dose copackaged with calcium carbonate (blue tablet): take missed dose the next morning, followed by resumption of the regular weekly schedule on the originally chosen day;34 do not take missed dose later on the same day.34 Take usual dose of calcium carbonate (blue tablet) with food later in the same day that the missed risedronate sodium tablet is taken.34 Do not take risedronate sodium and calcium carbonate at the same time.34 If a calcium carbonate tablet (days 2–7) is missed and it is remembered later the same day, take that tablet with food.34 If 1 day of calcium carbonate therapy is missed, take 2 tablets of calcium carbonate the next day at separate times of the day with food.34 Do not take more than 2 tablets of calcium carbonate on the same day unless directed by clinician.34

Missed dose in patients taking monthly 150-mg dose: If next scheduled dose is >7 days away, take the missed dose the morning after it is remembered and resume the regular schedule.1 If the next scheduled dose is 1–7 days away, maintain the regular schedule;1 do not take more than one 150-mg tablet within the same week.1

Missed dose(s) in patients taking 2 consecutive daily 75-mg doses each month and next scheduled dose is >7 days away: If one dose is missed, take the missed dose the morning after it is remembered, then resume the regular schedule.1 If both doses are missed, take one missed dose the morning after it is remembered and the next missed dose on the next consecutive morning, then resume the regular schedule.1 Do not take more than two 75-mg tablets within the same week.1

Missed dose(s) in patients taking 2 consecutive daily 75-mg doses each month and next scheduled dose is 1–7 days away: Maintain the regular schedule (i.e., wait until time of next month’s scheduled dose).1 Do not take more than two 75-mg tablets within the same week.1

Dosage

Available as risedronate sodium; dosage expressed in terms of the salt.18

Adults

Osteoporosis
Prevention of Postmenopausal Osteoporosis
Oral

Risedronate sodium: 5 mg once daily, 35 mg once weekly, or 150 mg monthly (given as a 150-mg tablet once monthly or a 75-mg tablet on 2 consecutive days each month).1

Risedronate sodium copackaged with calcium carbonate: 35 mg of risedronate sodium (orange tablet) once weekly (day 1), followed by 1.25 g of calcium carbonate (blue tablet containing 500 mg of elemental calcium) daily on days 2–7; treatment cycle repeated weekly.33 34 Each blister package contains enough tablets of each drug for four 7-day treatment cycles.33 34

Treatment in Postmenopausal Women
Oral

Risedronate sodium: 5 mg once daily, 35 mg once weekly, or 150 mg monthly (given as a 150-mg tablet once monthly or a 75-mg tablet on 2 consecutive days each month).1

Risedronate sodium copackaged with calcium carbonate: 35 mg of risedronate sodium (orange tablet) once weekly (day 1), followed by 1.25 g of calcium carbonate (blue tablet containing 500 mg of elemental calcium) daily on days 2–7; treatment cycle repeated weekly.33 34 Each blister package contains enough tablets of each drug for four 7-day treatment cycles.33 34

Optimal duration of treatment not established.1 33 Safety and efficacy based on data supporting fracture reduction over 3 years of treatment.1 33 Reevaluate need for continued therapy periodically in all patients receiving bisphosphonates.1 33

Treatment in Men
Oral

Men: 35 mg once weekly.1

Corticosteroid-induced Osteoporosis
Prevention of Corticosteroid-induced Osteoporosis
Oral

5 mg once daily.1

Continue risedronate as long as patient continues to receive corticosteroid therapy.21 57

Treatment of Corticosteroid-induced Osteoporosis
Oral

5 mg once daily.1

Continue risedronate as long as patient continues to receive corticosteroid therapy.21 57

Paget’s Disease of Bone
Oral

30 mg once daily for 2 months.1 2

Consider retreatment (same dosage and duration) after a 2-month posttreatment evaluation period if relapse occurs or if initial treatment failed to normalize serum alkaline phosphatase concentrations.1

Prescribing Limits

Adults

Paget’s Disease of Bone
Oral

Safety and efficacy not established for >1 course of retreatment.1

Special Populations

Hepatic Impairment

Dosage adjustments not necessary.1

Renal Impairment

Dosage adjustments not necessary in patients with mild to moderate impairment (Clcr ≥30 mL/minute).1 Use not recommended in patients with severe impairment (Clcr <30 mL/minute).1

Geriatric Patients

Dosage adjustments not necessary in geriatric patients based solely on age.1

Cautions for Actonel

Contraindications

  • Abnormalities of the esophagus that delay esophageal emptying (e.g., stricture, achalasia).1

  • Inability to stand or sit upright for ≥30 minutes.1

  • Hypocalcemia.1

  • Known hypersensitivity to risedronate or any ingredient in the formulation.1

Warnings/Precautions

Upper GI Effects

Possible severe adverse esophageal effects (e.g., esophagitis, esophageal ulcers, erosions, strictures, perforation).1 (See Oral Administration under Dosage and Administration.) Monitor for any manifestations and discontinue if dysphagia, odynophagia, new or worsening heartburn, or retrosternal pain occurs.1

Risk of severe adverse esophageal effects greater in patients who do not drink 180–240 mL of water with risedronate, do not avoid lying down for ≥30 minutes following oral administration, and/or continue to take drug after developing symptoms suggesting esophageal irritation.1 Instruct patients carefully about proper administration and give copy of patient instructions provided by manufacturer.1

Use with caution in patients with history of upper GI disease (e.g., Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, ulcers).1 Gastric and duodenal ulcers (some severe and with complications) reported during postmarketing experience.1

Osteonecrosis of the Jaw

Osteonecrosis and osteomyelitis of the jaw reported, principally in cancer patients receiving bisphosphonates,28 29 30 31 32 33 usually when given IV.1 33 Known risk factors include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), cancer, concomitant therapies (e.g., chemotherapy, radiation therapy, corticosteroids), poor oral hygiene, and comorbid disorders (e.g., periodontal and/or other preexisting dental disease, anemia, coagulopathy, infection, ill-fitting dentures).1

If osteonecrosis of the jaw develops, consult an oral surgeon for treatment.1 Dental surgery may exacerbate condition.1

In patients requiring dental procedures, no data are available to suggest whether discontinuance of therapy prior to procedure reduces the risk of osteonecrosis of the jaw.1 Base management of patients requiring dental treatment on an individual assessment of risks and benefits.1

Musculoskeletal Pain

Severe and occasionally incapacitating bone, joint, and/or muscle pain reported infrequently with bisphosphonate therapy.1 28 33 35 36 Time to onset varied from 1 day to years (mean onset about 3 months) after treatment initiation.1 28 33 35 36

If severe symptoms occur, discontinue drug.35 Such pain generally improves following discontinuance of the drug, but may recur upon subsequent rechallenge with the same drug or another bisphosphonate.1 28 33 36

Atypical Fracture of the Femur

Atypical (subtrochanteric or diaphyseal), low-energy or low-trauma femur fractures reported rarely with long-term use (>3 years) of bisphosphonates, mostly in patients receiving these drugs for osteoporosis.43 44 45 Often occurs with minimal or no trauma, and may be bilateral.41 42 43 45 Causality not established; atypical fractures also occur in osteoporotic patients not receiving bisphosphonates. 43 44 45 46 Risk may be increased with concomitant use of glucocorticoid, estrogen, and proton-pump inhibitor therapy.45 47 48 50

Evaluate patients who present with new thigh or groin pain for possibility of an atypical femoral fracture; include assessment of the contralateral limb.41 42 43 45 Consider interruption of bisphosphonate therapy in patients with manifestations of possible femoral fracture; weigh risks versus benefits of continued treatment.41 42 Discontinue if a femoral shaft fracture is confirmed.43 44 45

Potential Risk of Esophageal Cancer

Some evidence (from postmarketing experience and observational studies) suggests a possible association between use of oral bisphosphonates and an increased risk of esophageal cancer.40 51 52 However, because of conflicting data,52 53 54 additional study needed to confirm such findings.51

FDA states that benefits of oral bisphosphonates continue to outweigh their potential risks in patients with osteoporosis; it is important to consider that esophageal cancer is rare, especially in women.51 52

Avoidance of oral bisphosphonates in patients with Barrett’s esophagus, a known precursor to esophageal adenocarcinoma, has been recommended.40

Use of Combination Preparations

When risedronate is given concurrently with calcium carbonate, consider the cautions, precautions, and contraindications associated with calcium carbonate in addition to those associated with risedronate.1

Metabolic Effects

Possible asymptomatic decreases in serum calcium and phosphorus concentrations.1

Correct hypocalcemia and other disturbances of bone and mineral metabolism before initiating therapy.1 If daily dietary intake is inadequate, administer supplemental calcium and vitamin D.1

Endocrine Effects

Before initiating therapy in patients receiving long-term corticosteroid therapy, measure sex hormones and consider replacement therapy, if appropriate.1 4 11

Atrial Fibrillation

Although data are conflicting, possible increased risk of atrial fibrillation with use of bisphosphonates.37 38 39 FDA analysis of data from long-term (6 months to 3 years) controlled trials identified a higher rate of atrial fibrillation in patients receiving bisphosphonates (alendronate, ibandronate, risedronate, or zoledronic acid) versus placebo; however, only a few events reported in each study.39 FDA is continuing to monitor this safety concern.39

Specific Populations

Pregnancy

Category C.1

Lactation

Distributed into milk in rats.1 Discontinue nursing or the drug.1

Pediatric Use

Safety and efficacy not established.1 Not indicated in pediatric patients.1

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1

Gender

Safety and efficacy of risedronate sodium copackaged with calcium carbonate not established in men for the treatment of primary osteoporosis.33

Hepatic Impairment

Safety and efficacy not established.1

Renal Impairment

Decreased clearance; use not recommended in patients with severe renal impairment (Clcr <30 mL/minute).1 (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Postmenopausal osteoporosis: Infection (unspecified),1 33 back pain,1 8 10 arthralgia,1 8 10 33 accidental injury,1 pain (unspecified), 1 33 constipation,1 33 abdominal pain,1 5 6 8 10 urinary tract infection,1 33 nausea,1 33 diarrhea,1 33 dyspepsia,1 33 flu syndrome,1 hypertension,1 bronchitis,1 33 headache,1 arthritis,1 33 traumatic bone fracture,1 33 sinusitis,1 33 rash,1 33 dizziness,1 joint disorder,1 depression,1 33 myalgia,1 33 cataract,1 rhinitis,1 pharyngitis,1 increased cough.1

Paget’s disease: Arthralgia,1 diarrhea,1 headache,1 abdominal pain,1 rash,1 flu syndrome,1 nausea,1 peripheral edema,1 chest pain,1 constipation,1 dizziness.1

Interactions for Actonel

Does not induce or inhibit CYP isoenzymes and is not metabolized.1

Antacids or Mineral Supplements Containing Divalent Cations

Potential decreased risedronate absorption when administered with divalent cations (e.g., aluminum, calcium, magnesium).1

Drugs Affecting Hepatic Microsomal Enzymes

Pharmacokinetic interaction unlikely.1

Specific Drugs

Drug

Interaction

Comments

Histamine H2-receptor antagonists

No evidence of increased adverse upper GI effects1

Hormone replacement therapy

Potential additive effects on bone mineral density1 18 20

NSAIAs

No evidence of increased adverse upper GI effects1

Proton pump inhibitors

No evidence of increased adverse upper GI effects1

Actonel Pharmacokinetics

Absorption

Bioavailability

The mean absolute oral bioavailability is 0.63%.1

Onset

Reduction of bone turnover evident within 14 days of beginning therapy; maximal effects observed in about 6 months.1

Food

When administered 30 minutes or 1 hour prior to breakfast, the extent of absorption is reduced by 55 or 30%, respectively, compared to the fasting state.1 However, drug is effective when administered ≥30 minutes before breakfast.1

Distribution

Extent

Mean steady-state volume of distribution is 6.3 L/kg.1 In animal studies, 60% of a dose distributed into bone.1

Animal data indicate that the drug crosses placenta and is distributed into fetal bones.1

Distributed into milk in animals.1 Not known whether the drug is distributed into human milk.1

Plasma Protein Binding

About 24%.1

Elimination

Metabolism

There is no evidence of systemic metabolism.1

Elimination Route

Eliminated mainly in urine; only unabsorbed drug is excreted in feces.1

Half-life

Initial half-life is about 1.5 hours and terminal exponential half-life is 480 hours.1 The terminal half-life is thought to represent the dissociation of the drug from the surface of bone.1

Special Populations

Renal clearance is decreased by 70% in patients with severe renal impairment (i.e., Clcr <30 mL/minute).1

Stability

Storage

Oral

Tablets

20–25 °C.1

Actions and Spectrum

  • Inhibits osteoclast-mediated bone resorption.1 2 4 5 6 8 9 12 13 14

  • Maintains or increases bone mineral density.1 5 6 7 8 10 18 19 20

Advice to Patients

  • Importance of providing a copy of the manufacturer’s patient information.1

  • Importance of proper administration (e.g., avoiding foods and beverages other than plain water, not lying down for 30 minutes following administration).1

  • Importance of swallowing tablets whole, without crushing, chewing, or sucking.1

  • Importance of discontinuing and informing clinician if symptoms of esophageal disease (e.g., difficulty or pain on swallowing; retrosternal, abdominal, or esophageal pain; severe or persistent heartburn) develop.1

  • Importance of adhering to recommended life-style modifications (e.g., weight-bearing exercise, calcium and vitamin D consumption, avoidance of excessive cigarette smoking and/or alcohol consumption).1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing clinicians of severe kidney disease.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

  • Importance of advising patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Risedronate Sodium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

5 mg

Actonel

Warner Chilcott

30 mg

Actonel

Warner Chilcott

35 mg

Actonel

Warner Chilcott

75 mg

Actonel

Warner Chilcott

150 mg

Actonel

Warner Chilcott

Risedronate Sodium Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

35 mg (4 tablets) with Calcium Carbonate 1.25 g (24 tablets)

Actonel with Calcium

Warner Chilcott

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Actonel 150MG Tablets (WARNER CHILCOTT PROF PROD DIV): 1/$139.99 or 3/$405.95

Actonel 150MG Tablets (WARNER CHILCOTT PROF PROD DIV): 3/$415.99 or 9/$1,195.97

Actonel 30MG Tablets (WARNER CHILCOTT PHARMA): 10/$297.83 or 30/$867.40

Actonel 5MG Tablets (WARNER CHILCOTT PHARMA): 30/$140.99 or 90/$395.99

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions March 21, 2012. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Warner Chilcott. Actonel (risedronate sodium) tablets prescribing information. Rockaway, NJ; 2011 Feb.

2. Miller PD, Brown JP, Siris ES et al. A randomized, double-blind comparison of risedronate and etidronate in the treatment of Paget’s disease of bone. Am J Med. 1999; 106:513-20. [IDIS 428270] [PubMed 10335722]

4. American College of Rheumatology Task Force on Osteoporosis Guidelines. Recommendations for the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Rheum. 1996; 39:1791-801. [IDIS 375200] [PubMed 8912500]

5. Fogelman I, Ribot C, Smith R et al. Risedronate reverses bone loss in postmenopausal women with low bone mass: results from a multinational, double-blind, placebo-controlled trial. J Clin Endocrinol Metab. 2000; 85:1895-900. [IDIS 446998] [PubMed 10843171]

6. Harris ST, Watts NB, Genant HK et al. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. JAMA. 1999; 282:1344-52. [IDIS 433492] [PubMed 10527181]

7. Reginster J, Minne HW, Sorensen OH et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral efficacy with risedronate therapy (VERT) study group. Osteoporos Int. 2000; 11:83-91. [PubMed 10663363]

8. Cohen S, Levy RM, Keller M et al. Risedronate therapy prevents corticosteroid-induced bone loss: a twelve-month, randomized, double-blind, placebo-controlled, parallel group study. Arthritis Rheum. 1999; 42:2309-18. [IDIS 438381] [PubMed 10555025]

9. Reid DM, Hughes RA, Laan RF et al. Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: a randomized trial. European Corticosteroid-induced osteoporosis treatment study. J Bone Miner Res. 2000; 15:1006-13. [PubMed 10841169]

10. Wallach S, Cohen S, Reid DM et al. Effects of risedronate treatment on bone density and vertebral fracture in patients on corticosteroid therapy. Calcif Tissue Int. 2000; 67:277-85. [PubMed 11000340]

11. Eastell R, Reid DM, Compston J et al. A UK Consensus Group on management of glucocorticoid-induced osteoporosis: an update. J Int Med. 1998; 244:271-92.

12. Lourwood DL. The pharmacology and therapeutic utility of bisphosphonates. Pharmacotherapy. 1998; 18:779-89. [IDIS 415603] [PubMed 9692651]

13. Anon. Risedronate for Paget’s disease of bone. Med Lett Drugs Ther. 1998; 40:87-8. [PubMed 9731243]

14. Goa KL, Balfour JA. Risedronate. Drugs Aging. 1998; 13:83-91. [PubMed 9679211]

15. Patel S. Risedronate: a viewpoint. Drugs Aging. 1998; 13:92.

16. Johnston CC. Risedronate: a viewpoint. Drugs Aging. 1998; 13:92.

17. National Osteoporosis Foundation. Physician’s guide to prevention and treatment of osteoporosis. Washington, DC; 2000. From National Osteoporosis Foundation web site ().

18. Procter & Gamble Pharmaceuticals, Cincinnati, OH: Personal communication.

19. Hooper M, Ebeling P, Roberts A et al. Risedronate prevents bone loss in early postmenopausal women. Calcif Tissue Int. 1999; 64(Suppl 1):S69.

20. Harris ST, Wasnich R, Ettinger M et al. The effects of risedronate plus estrogen compared with estrogen alone in postmenopausal women. J Bone Miner Res. 1999; 14(Suppl 1):S410.

21. American College of Rheumatology Ad Hoc Committee on Glucocorticoid-induced Osteoporosis. Recommendations for the prevention and treatment of glucocorticoid-induced osteoporosis: 2001 update. Arthritis Rheum. 2001; 44:1496-503. [IDIS 466759] [PubMed 11465699]

22. Sambrook PN. Corticosteroid osteoporosis: practical implications of recent trials. J Bone Miner Res. 2000; 15:1645-9. [PubMed 10976984]

23. Plotkin LI, Weinstein RS, Parfitt AM et al. Prevention of osteocyte and osteoblast apoptosis by biphosphonates and calcitonin. J Clin Invest. 1999; 104:1363-74. [PubMed 10562298]

24. Adachi JD, Bensen WG, Brown J et al. Intermittent etidronate therapy to prevent corticosteroid-induced osteoporosis. N Engl J Med. 1997; 337:382-7. [IDIS 389180] [PubMed 9241127]

25. Roux C, Oriente P, Laan R et al. Randomized trial of effect of cyclical etidronate in the prevention of corticosteroid-induced bone loss. J Clin Endocrinol Metab. 1998; 83:1128-33. [IDIS 404610] [PubMed 9543129]

26. Adachi JD, Saag KG, Delmas PD et al. Two-year effects of alendronate on bone mineral density and vertebral fracture in patients receiving glucocorticoids: a randomized, double-blind, placebo-controlled extension trial. Arthritis Rheum. 2001; 44:202-11. [PubMed 11212161]

27. Brown JP, Kendler DL, McClung MR et al. The efficacy and tolerability of risedronate once a week for the treatment of postmenopausal osteoporosis. Calcif Tissue Int. 2002; 71:103-11. [PubMed 12085156]

28. Novartis. Zometa (zoledronic acid) injection prescribing information. East Hanover, NJ; 2008 Mar.

29. Ruggiero SL, Mehrotra B, Rosenberg TJ et al. Osteonecrosis of the jaws associated with the use of bisphosphonates: a review of 63 cases. J Oral Maxillofac Surg. 2004; 62:527-34. [IDIS 518769] [PubMed 15122554]

30. Hohneker JA. Dear doctor letter regarding osteonecrosis of the jaw in patients with cancer receiving bisphophonates. East Hanover, NJ: Novartis; 2004 September 24.

31. Ruggiero SL, Mehrotra B. Ten years of alendronate treatment for osteoporosis in postmenopausal women. N Engl J Med. 2004; 351:191.

32. Bone HG, Santora AC. Ten years of alendronate treatment for osteoporosis in postmenopausal women. N Engl J Med. 2004; 351:191-2.

33. Warner Chilcott. Actonel with Calcium (risedronate sodium with calcium carbonate) tablets prescribing information. Cincinnati, OH; 2011 Jan.

34. Warner Chilcott. Actonel with Calcium (risedronate sodium with calcium carbonate) tablets MedGuide. Cincinnati, OH; 2011 Jan.

35. Center for Drug Evaluation and Research, Food and Drug Administration. FDA Alert: Information on bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa. 2008 Jan 7. Available from FDA website. Accessed 2008 Oct 28.

36. Wysowski DK, Chang JT. Alendronate and risedronate: reports of severe bone, joint, and muscle pain. Arch Intern Med. 2005; 165:346-7. [PubMed 15710802]

37. Black DM, Delmas PD, Eastell R et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007; 356:1809-22. [PubMed 17476007]

38. Cummings SR, Schwartz AV, Black DM. Alendronate and atrial fibrillation. N Engl J Med. 2007; 356:1895-6. [PubMed 17476024]

39. Center for Drug Evaluation and Research, Food and Drug Administration. Update of safety review follow-up to the October 1, 2007 early communication about the ongoing safety review of bisphosphonates. Bisphosphonates: alendronate (Fosamax, Fosamax plus D) etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel, Actonel w/calcium), tiludronate (Skelid), and zoledronic acid (Reclast, Zometa). 2008 Nov 12. Available from FDA website. Accessed 2008 Nov 21.

40. Wysowski DK. Reports of esophageal cancer with oral bisphosphonate use. N Engl J Med. 2009; 360:89-90. Letter. [PubMed 19118315]

41. Food and Drug Administration. Actonel (risedronate sodium) tablets [2010 Oct 13: Warner Chilcott]. Safety labeling change and REMS notification. Silver Spring, MD; 2010 Oct 13. Available from FDA website.

42. Food and Drug Administration. Actonel with Calcium (risedronate and calcium carbonate) tablets [2010 Oct 13: Warner Chilcott]. Safety labeling change and REMS notification. Silver Spring, MD; 2010 (2010 Oct 13). Available from FDA website.

43. Food and Drug Administration. FDA drug safety communication: Safety update for osteoporosis drugs, bisphosphonates, and atypical fractures. Silver Spring, MD; 2010 Oct 13. Available from FDA website. Accessed 2010 Nov 4.

44. Food and Drug Administration. FDA MedWatch label change: Atypical fracture update for bisphosphonates (osteoporosis drugs) including alendronate (marketed as Fosamax), alendronate with cholecalciferol (marketed as Fosamax plus D), risedronate (marketed as Actonel and Atelvia), risedronate with calcium carbonate (marketed as Actonel with Calcium), ibandronate (marketed as Boniva), and zoledronic acid (marketed as Reclast). Silver Spring, MD; 2010 Oct 13. Available from FDA website. Accessed 2010 Nov 4.

45. Shane E, Burr D, Ebeling PR et al. Atypical subtrochanteric and diaphyseal femoral fractures: Report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res. 2010; 25:2267-94. [PubMed 20842676]

46. Food and Drug Administration. FDA News Release: Possible increased risk of thigh bone fracture with bisphosphonates. Silver Spring, MD; 2010 Oct 13. Available from FDA website. Accessed 2010 Nov 4.

47. Giusti A, Hamdy NA, Papapoulos SE. Atypical fractures of the femur and bisphosphonate therapy: A systematic review of case/case series studies. Bone. 2010; 47:169-80. [PubMed 20493982]

48. Girgis CM, Sher D, Seibel MJ. Atypical femoral fractures and bisphosphonate use. N Engl J Med. 2010; 362:1848-9. [PubMed 20463351]

49. Sellmeyer DE. Atypical fractures as a potential complication of long-term bisphosphonate therapy. JAMA. 2010; 304:1480-4. [PubMed 20924014]

50. Schmidt GA, Horner KE, McDanel DL et al. Risks and benefits of long-term bisphosphonate therapy. Am J Health Syst Pharm. 2010; 67:994-1001. [PubMed 20516469]

51. Food and Drug Administration. FDA drug safety communication: Ongoing safety review of oral osteoporosis drugs (bisphosphonates) and potential increased risk of esophageal cancer. Rockville, MD; 2011 July 21. Available from FDA website. Accessed 2011 Sept 12.

52. Green J, Czanner G, Reeves G et al. Oral bisphosphonates and risk of cancer of oesophagus, stomach, and colorectum: case-control analysis within a UK primary care cohort. BMJ. 2010; 341:c4444. [PubMed 20813820]

53. Cardwell CR, Abnet CC, Cantwell MM et al. Exposure to oral bisphosphonates and risk of esophageal cancer. JAMA. 2010; 304:657-63. [PubMed 20699457]

54. Abrahamsen B, Eiken P, Eastell R. More on reports of esophageal cancer with oral bisphosphonate use. N Engl J Med. 2009; 360:1789; author reply 1791-2.

55. Abrahamsen B, et al. The risk of oesophageal and cancer incidence and mortality in alendronate users: a national cohort study. Presented at the 3rd Joint Meeting of the European Calcified Tissue Society and the International Bone and Mineral Society. Athens, Greece: May 10, 2011. Abstract No. 0C29.

56. Solomon DH, Patrick A, Brookhart MA. More on reports of esophageal cancer with oral bisphosphonate use. N Engl J Med. 2009; 360:1789-90; author reply 1791-2. [PubMed 19391255]

57. Grossman JM, Gordon R, Ranganath VK et al. American College of Rheumatology 2010 recommendations for the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Care Res (Hoboken). 2010; 62:1515-26. [PubMed 20662044]

58. Kanis JA, Oden A, Johansson H et al. FRAX and its applications to clinical practice. Bone. 2009; 44:734-43. [PubMed 19195497]

60. Boonen S, Orwoll ES, Wenderoth D et al. Once-weekly risedronate in men with osteoporosis: results of a 2-year, placebo-controlled, double-blind, multicenter study. J Bone Miner Res. 2009; 24:719-25. [PubMed 19049326]

61. Delmas PD, Benhamou CL, Man Z et al. Monthly dosing of 75 mg risedronate on 2 consecutive days a month: efficacy and safety results. Osteoporos Int. 2008; 19:1039-45. [PubMed 18087660]

62. Delmas PD, McClung MR, Zanchetta JR et al. Efficacy and safety of risedronate 150 mg once a month in the treatment of postmenopausal osteoporosis. Bone. 2008; 42:36-42. [PubMed 17920005]

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