Safety of Bisphosphonates in the Treatment of Osteoporosis

American Journal of Medicine

Volumn 122, Issue 2 SUPPL., 2009, Pages

  Recker, Robert R ^a   Lewiecki, E Michael ^b   Miller, Paul D ^c   Reiffel, James ^d  

^a CREIGHTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b NEW MEXICO CLINICAL RESEARCH AND OSTEOPOROSIS CENTER   (United States)

^c University of Colorado Health Sciences Center   (United States)

^d Och Spine at New York Presbyterian Hospitals   (United States)

Author keywords

Atrial fibrillation; Bisphosphonate safety; Fractures; Healing; Oversuppression; Renal safety

Indexed keywords

ALENDRONIC ACID; BISPHOSPHONIC ACID DERIVATIVE; CLODRONIC ACID; ETIDRONIC ACID; IBANDRONIC ACID; PAMIDRONIC ACID; PLACEBO; RISEDRONIC ACID; TILUDRONIC ACID; ZOLEDRONIC ACID;

ARTHRALGIA; ARTICLE; BONE; BONE PAIN; BONE REMODELING; CARDIOVASCULAR SYSTEM; CLINICAL TRIAL; DIGESTIVE SYSTEM INJURY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; ESOPHAGITIS; ESOPHAGUS DISEASE; ESOPHAGUS IRRITATION; FEVER; FLU LIKE SYNDROME; FRACTURE; FRACTURE HEALING; GASTROINTESTINAL SYMPTOM; HEADACHE; HEART ATRIUM FIBRILLATION; HUMAN; HYPOCALCEMIA; JAW OSTEONECROSIS; KIDNEY; KIDNEY DISEASE; KIDNEY FAILURE; MALABSORPTION; MUSCULOSKELETAL PAIN; MYALGIA; NAUSEA; NONHUMAN; OSTEOPOROSIS; PRIORITY JOURNAL; SKELETON; SYSTEMATIC REVIEW;

BONE DENSITY CONSERVATION AGENTS; CHRONIC DISEASE; DIPHOSPHONATES; FEMALE; GASTROINTESTINAL DISEASES; HUMANS; HYPOCALCEMIA; MUSCULOSKELETAL DISEASES; OSTEOPOROSIS; PAIN;

EID: 58949086108     PISSN: 00029343     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.amjmed.2008.12.004     Document Type: Article

References (85)

1. Silverman S.L., and Landesberg R. Osteonecrosis of the jaw and the role of bisphosphonates: a critical review. Am J Med 122 (2009) S33-S45
2. IMS HEALTH, National Prescription Audit Plus™, 2008.
3. Russell R. Bisphosphonates: from bench to bedside. Ann N Y Acad Sci 1068 (2006) 367-401
4. Nancollas G.H., Tang R., Phipps R.J., et al. Novel insights into actions of bisphosphonates on bone: differences in interactions with hydroxyapatite. Bone 38 (2006) 617-627
5. Luckman S.P., Hughes D.E., Coxon F.P., Graham R., Russell G., and Rogers M.J. Nitrogen-containing bisphosphonates inhibit the mevalonate pathway and prevent post-translational prenylation of GTP-binding proteins, including Ras. J Bone Miner Res 13 (1998) 581-589
6. Lerner U.H. Bone remodeling in post-menopausal osteoporosis. J Dent Res 85 (2006) 584-595
7. Recker R.R., Kimmel D.B., Parfitt A.M., Davies K.M., Keshawarz N., and Hinders S. Static and tetracycline-based bone histomorphometric data from 34 normal postmenopausal females. J Bone Miner Res 3 (1988) 133-144
8. Recker R.R., Delmas P.D., Halse J., et al. Effects of intravenous zoledronic acid once yearly on bone remodeling and bone structure. J Bone Miner Res 23 (2008) 6-16
9. Frost H.M. Some ABCs of skeletal pathophysiology. IV. The transient/steady state distinction. Calcif Tissue Int 45 (1989) 134-136
10. Heaney R.P. Is the paradigm shifting?. Bone 33 (2003) 457-465
11. Hirano T., Turner C.H., Forwood M.R., Johnston C.C., and Burr D.B. Does suppression of bone turnover impair mechanical properties by allowing microdamage accumulation?. Bone 27 (2000) 13-20
12. Liberman U.A., Weiss S.R., Bröll J., et al. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. N Engl J Med 333 (1995) 1437-1443
13. Harris S.T., Watts N.B., Genant H.K., et al. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. JAMA 282 (1999) 1344-1352
14. Bone H.G., Hosking D., Devogelaer J.-P., et al. Ten years' experience with alendronate for osteoporosis in postmenopausal women. N Engl J Med 350 (2004) 1189-1199
15. Recker R., Lappe J., Davies K.M., and Heaney R. Bone remodeling increases substantially in the years after menopause and remains increased in older osteoporosis patients. J Bone Miner Res 19 (2004) 1628-1633
16. Recker R.R., Weinstein R., Chesnut III C.H., et al. Histomorphometric evaluation of daily and intermittent oral ibandronate in women with postmenopausal osteoporosis: results from the BONE study. Osteoporos Int 15 (2004) 231-237
17. Recker R.R., Miller P.D., Ste-Marie L., Phipps R.J., Zhou X., and Seeman E. Comparison of risedronate and alendronate on bone remodeling and on trabecular and cortical bone architecture: a cross-sectional study in women with postmenopausal osteoporosis on long-term bisphosphonate therapy. Bone 40 suppl 2 (2007) S260
18. Goh S., Yang K., Koh J., Wong M.K., Chua S.Y., Chua D.T., and Howe T.S. Subtrochanteric insufficiency fractures in patients on alendronate therapy. J Bone Joint Surg Br 89 (2007) 349-353
19. Odvina C.V., Zerwekh J.E., Rao D.S., Maalouf N., Gottschalk F.A., and Pak C.Y.C. Severely suppressed bone turnover: a potential complication of alendronate therapy. J Clin Endocrinol Metab 90 (2005) 1294-1301
20. Armamento-Villareal R., Napoli N., Pinwar V., and Novacek D. Suppressed bone turnover during alendronate therapy for high-turnover osteoporosis. N Engl J Med 355 (2006) 2048-2049
21. Mashiba T., Hirano T., Turner C.H., Forwood M.R., Johnston C.C., and Burr D.B. Suppressed bone turnover by bisphosphonates increases microdamage accumulation and reduces some biomechanical properties in dog rib. J Bone Miner Res 15 (2000) 613-620
22. Kimmel D.B., Recker R.R., Gallagher J.C., Vaswani A.S., and Aloia J.F. A comparison of iliac bone histomorphometric data in post-menopausal osteoporotic and normal subjects. Bone Miner 11 (1990) 217-235
23. Lenart B.A., Lorich D.G., and Lane J.M. Atypical fractures of the femoral diaphysis in postmenopausal women taking alendronate. N Engl J Med 358 (2008) 1304-1306
24. Munns C.F., Rauch F., Zeitlin L., Fassier F., and Glorieux F.H. Delayed osteotomy but not fracture healing in pediatric osteogenesis imperfecta patients receiving pamidronate. J Bone Miner Res 19 (2004) 1779-1786
25. Little D., Ramachandran M., and Schindeler A. The anabolic and catabolic responses in bone repair. J Bone Joint Surg Br 89 (2007) 425-433
26. Goodship AE, Walker P, McNally DS, Chambers TJ, Green J, inventors. Use of methanebisphosphonic acid derivatives for the manufacture of a medicament for fracture healing. European patent application 93810808. 1994.
27. Peter C.P., Handt L.K., and Smith S.M. Esophageal irritation due to alendronate sodium tablets: possible mechanisms. Dig Dis Sci 43 (1998) 1998-2002
28. Blank M.A., Gibson G.W., Myers W.R., Dierckman T.A., Phipps R.J., and Smith P.N. Gastric damage in the rat with nitrogen-containing bisphosphonates depends on pH. Aliment Pharmacol Ther 14 (2000) 1215-1223
29. Cryer B., and Bauer D.C. Oral bisphosphonates and upper gastrointestinal tract problems: what is the evidence?. Mayo Clin Proc 77 (2002) 1031-1043
30. Miller P.D., Woodson G., Licata A.A., et al. Rechallenge of patients who had discontinued alendronate therapy because of upper gastrointestinal symptoms. Clin Ther 22 (2000) 1433-1442
31. Adachi J.D., Adami S., Miller P.D., et al. Tolerability of risedronate in postmenopausal women intolerant of alendronate. Aging (Milano) 13 (2001) 347-354
32. de Groen P.C., Lubbe D.F., Hirsch L.J., et al. Esophagitis associated with the use of alendronate. N Engl J Med 335 (1996) 1016-1021
33. Hamilton B., McCoy K., and Taggart H. Tolerability and compliance with risedronate in clinical practice. Osteoporos Int 14 (2003) 259-262
34. Schnitzer T.J., Bone H.G., Crepaldi G., et al. Therapeutic equivalence of alendronate 70 mg once weekly and alendronate 10 mg daily in the treatment of postmenopausal osteoporosis. Aging Clin Exp Res 12 (2000) 1-12
35. Harris S.T., Watts N.B., Li Z., Chines A.A., Hanley D.A., and Brown J.P. Two-year efficacy and tolerability of risedronate once a week for the treatment of women with postmenopausal osteoporosis. Curr Med Res Opin 20 (2004) 757-764
36. Miller P.D., McClung M.R., Macovei L., et al. Monthly oral ibandronate therapy in postmenopausal osteoporosis: 1-year results from the MOBILE study. J Bone Miner Res 20 (2005) 1315-1322
37. Delmas P.D., McClung M.R., Zanchetta J.R., et al. Efficacy and safety of risedronate 150 mg once a month in the treatment of postmenopausal osteoporosis. Bone 42 (2008) 36-42
38. Bonnick S., Saag K.G., Kiel D.P., et al. Comparison of weekly treatment of postmenopausal osteoporosis with alendronate versus risedronate over two years. J Clin Endocrinol Metab 91 (2006) 2631-2637
39. Delmas P.D., Adami S., Strugala C., et al. Intravenous ibandronate injections in postmenopausal women with osteoporosis: one-year results from the dosing intravenous administration study. Arthritis Rheum 54 (2006) 1838-1846
40. Black D.M., Delmas P.D., Eastell R., et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 356 (2007) 1809-1822
41. Papapoulos S.E., Harinck H.I., Bijvoet O.L., Gleed J.H., Fraher L.J., and O'Riordan J.L. Effects of decreasing serum calcium on circulating parathyroid hormone and vitamin D metabolites in normocalcaemic and hypercalcaemic patients treated with APD. Bone Miner 1 (1986) 69-78
42. Chesnut III C.H., McClung M.R., Ensrud K.E., et al. Alendronate treatment of the postmenopausal osteoporotic woman: effect of multiple dosages on bone mass and bone remodeling. Am J Med 99 (1995) 144-152
43. Jodrell D.I., Iveson T.J., and Smith I.E. Symptomatic hypocalcaemia after treatment with high-dose aminohydroxypropylidene diphosphonate. Lancet 1 (1987) 622
44. Maalouf N.M., Heller H.J., Odvina C.V., Kim P.J., and Sakhaee K. Bisphosphonate-induced hypocalcemia: report of 3 cases and review of literature. Endocr Pract 12 (2006) 48-53
45. Hewitt R.E., Lissina A., Green A.E., Slay E.S., Price D.A., and Sewell A.K. The bisphosphonate acute phase response: rapid and copious production of proinflammatory cytokines by peripheral blood gd T cells in response to aminobisphosphonates is inhibited by statins. Clin Exp Immunol 139 (2005) 101-111
46. Bock O., Boerst H., Thomasius F.E., et al. Common musculoskeletal adverse effects of oral treatment with once weekly alendronate and risedronate in patients with osteoporosis and ways for their prevention. J Musculoskelet Neuronal Interact 7 (2007) 144-148
47. Reclast (zoledronic acid) injection [prescribing information] (2007), Novartis Pharmaceuticals Corporation, East Hanover, NJ
48. Data on File, Novartis Pharma AG, Basel, Switzerland.
49. National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis (2008), National Osteoporosis Foundation, Washington, DC
50. US Food and Drug Administration. Information for healthcare professionals: Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa)January 7, 2008. http://www.fda.gov/CDER/drug/InfoSheets/HCP/bisphosphonatesHCP.htm Accessed June 6, 2008
51. Adami S., Bhalla A.K., Dorizzi R., et al. The acute phase response after bisphosphonate administration. Calcif Tissue Int 41 (1987) 326-331
52. Wysowski D.K., and Chang J.T. Alendronate and risedronate: reports of severe bone, joint, and muscle pain. Arch Intern Med 165 (2005) 346-347
53. Miller P.D. Bisphosphonates: pharmacology and use in the treatment of osteoporosis. In: Marcus R., Feldman D., Nelson D., and Rosen C. (Eds). Osteoporosis. 3rd ed. (2008), Elsevier, Burlington, MA 1725-1742
54. Lewiecki E.M., and Miller P.D. Renal safety of intravenous bisphosphonates in the treatment of osteoporosis. Expert Opin Drug Saf 6 (2007) 663-672
55. Body J.J., Pfister T., and Bauss F. Preclinical perspectives on bisphosphonate renal safety. Oncologist 19 suppl 1 (2005) 3-7
56. Dumon J.C., Magritte A., and Body J.J. Efficacy and safety of the bisphosphonate tiludronate for the treatment of tumor-associated hypercalcemia. Bone Miner 15 (1991) 257-266
57. O'Sullivan T.L., Akbari A., and Cadnapaphornchai P. Acute renal failure associated with the administration of parenteral etidronate. Ren Fail 16 (1994) 767-773
58. Kanis J.A., Preston C.J., Yates A.J., Percival R.C., Mundy K.I., and Russell R.G. Effects of intravenous diphosphonates on renal function. Lancet 1 (1983) 1328
59. Adami S., and Zamberlan N. Adverse effects of bisphosphonates: a comparative review. Drug Saf 14 (1996) 158-170
60. Aredia (pamidronate) [injection prescribing information] (2007), Novartis Pharmaceuticals Corporation, East Hanover, NJ
61. Zometa (zoledronic acid) [injection prescribing information] (2007), Novartis Pharmaceuticals Corporation, East Hanover, NJ
62. Jamal S.A., Bauer D.C., Ensrud K.E., et al. Alendronate treatment in women with normal to severely impaired renal function: an analysis of the fracture intervention trial. J Bone Miner Res 22 (2007) 503-508
63. Miller P.D., Roux C., Boonen S., Barton I.P., Dunlap L.E., and Burgio D.E. Safety and efficacy of risedronate in patients with age-related reduced renal function as estimated by the Cockcroft and Gault method: a pooled analysis of nine clinical trials. J Bone Miner Res 20 (2005) 2105-2115
64. Boonen S., Sellmeyer D.E., Lippuner K., et al. Renal safety of annual zoledronic acid infusions in osteoporotic postmenopausal women. Kidney Int 741 (2008) 641-648
65. Lyles K.W., Colón-Emeric C.S., Magaziner J.S., et al. Zoledronic acid and clinical fractures and mortality after hip fracture. N Engl J Med 357 (2007) 1799-1809
66. Adami S., Prince R., Halse J., et al. Two-year safety and tolerability profile of intravenous ibandronate injections: the DIVA study. Osteoporos Int 17 suppl 1 (2006) S69 Abstract P258
67. Miller P., Leigh C., and Ward P. Renal tolerability of intravenous ibandronate allows administration by short injection. Ann Rheum Dis 65 suppl 2 (2006) 422 Abstract FRI0455
68. Actonel (risedronate sodium tablets) [prescribing information] (2006), Procter & Gamble Pharmaceuticals, Inc, Cincinnati, OH
69. Fosamax (alendronate sodium) tablets and oral solution [prescribing information] (2006), Merck & Co., Inc, Whitehouse Station, NJ
70. Boniva (ibandronate sodium) tablets [prescribing information] (2006), Roche Laboratories Inc, Nutley, NJ
71. Boniva (ibandronate sodium) injection [prescribing information] (2006), Roche Laboratories Inc, Nutley, NJ
72. Coresh J., Astor B.C., Greene T., Eknoyan G., and Levey A.S. Prevalence of chronic kidney disease and decreased kidney function in the adult US population: Third National Health and Nutrition Examination Survey. Am J Kidney Dis 41 (2003) 1-12
73. Klawansky S., Komaroff E., Cavanaugh Jr. P.F., et al. Relationship between age, renal function and bone mineral density in the US population. Osteoporos Int 14 (2003) 570-576
74. Miller P.D. Is there a role for bisphosphonates in chronic kidney disease?. Semin Dial 20 (2007) 186-190
75. Miller P.D. The role of bone biopsy in chronic renal failure. Clin J Am Soc Nephrol 3 suppl 1 (2008) S1-S11
76. von der Recke P., Hansen M.A., and Hassager C. The association between low bone mass at the menopause and cardiovascular mortality. Am J Med 106 (1999) 273-278
77. Cummings S.R., Schwartz A.V., and Black D.M. Alendronate and atrial fibrillation. N Engl J Med 356 (2007) 1895-1896
78. Benjamin E.J., Levy D., Vaziri S.M., D'Agostino R.B., Belanger A.J., and Wolf P.A. Independent risk factors for atrial fibrillation in a population-based cohort: the Framingham Heart Study. JAMA 271 (1994) 840-844
79. Psaty B.M., Manolio T.A., Kuller L.H., et al. Incidence of and risk factors for atrial fibrillation in older adults. Circulation 96 (1997) 2455-2461
80. Stewart S., Hart C.L., Hole D.J., and McMurray J.J. Population prevalence, incidence, and predictors of atrial fibrillation in the Renfrew/Paisley study. Heart 86 (2001) 516-521
81. Black D.M., Cummings S.R., Karpf D.B., et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Lancet 348 (1996) 1535-1541
82. Cummings S.R., Black D.M., Thompson D.E., et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. JAMA 280 (1998) 2077-2082
83. Heckbert S.R., Li G., Cummings S.R., Smith N.L., and Psaty B.M. Use of alendronate and risk of incident atrial fibrillation in women. Arch Intern Med 168 (2008) 826-831
84. Cauley J.A., and Ensrud K.E. Considering competing risks ... not all black and white. Arch Intern Med 168 (2008) 793-795
85. Sørensen H.T., Christensen S., Mehnert F., et al. Use of bisphosphonates among women and risk of atrial fibrillation and flutter: population based case-control study. BMJ 336 (2008) 813-816