Adverse drug reactions to osteoporosis treatments

Expert Review of Clinical Pharmacology

Volumn 4, Issue 5, 2011, Pages 593-604

  Rizzoli, René ^a   Reginster, Jean Yves ^b  

^a GENEVA UNIVERSITY HOSPITALS   (Switzerland)

^b UNIVERSITY OF LIÈGE   (Belgium)

Author keywords

adverse drug reactions; bisphosphonate; denosumab; postmenopausal osteoporosis; PTH(1 84); SERM; strontium ranelate; teriparatide

Indexed keywords

ALENDRONIC ACID; BAZEDOXIFENE; DENOSUMAB; IBANDRONIC ACID; LASOFOXIFENE; PARATHYROID HORMONE; PARATHYROID HORMONE[1-34]; PLACEBO; RALOXIFENE; RISEDRONIC ACID; STRONTIUM RANELATE; ZOLEDRONIC ACID;

ABDOMINAL DISCOMFORT; ARTHRALGIA; BONE PAIN; BREAST CANCER; CELLULITIS; CONCUSSION; CREATININE BLOOD LEVEL; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG WITHDRAWAL; ECZEMA; ENDOMETRIAL DISEASE; EOSINOPHILIA; ESOPHAGUS CANCER; ESOPHAGUS DISEASE; FATIGUE; FEVER; FLATULENCE; GASTROINTESTINAL SYMPTOM; GENITAL SYSTEM DISEASE; HEADACHE; HEART ATRIUM FIBRILLATION; HOT FLUSH; HUMAN; INFLUENZA; JAW OSTEONECROSIS; KIDNEY DYSFUNCTION; LEG CRAMP; LIMB PAIN; LUNG EMBOLISM; MALAISE; MUSCLE SPASM; MUSCULOSKELETAL PAIN; MYALGIA; NAUSEA; NONHUMAN; OSTEOSARCOMA; OUTCOME ASSESSMENT; PANCREAS DISEASE; POSTMENOPAUSE OSTEOPOROSIS; PREVALENCE; REVIEW; RISK REDUCTION; SIDE EFFECT; SKIN ALLERGY; SKIN INFECTION; STROKE; TREATMENT INDICATION; URINARY TRACT INFECTION; VENOUS THROMBOEMBOLISM; WOUND HEALING IMPAIRMENT;

ANIMALS; DRUG TOXICITY; GASTROINTESTINAL DISEASES; HUMANS; MUSCULOSKELETAL PAIN; OSTEOPOROSIS, POSTMENOPAUSAL; SELECTIVE ESTROGEN RECEPTOR MODULATORS; TREATMENT OUTCOME;

EID: 80052703010     PISSN: 17512433     EISSN: 17512441     Source Type: Journal    
DOI: 10.1586/ecp.11.42     Document Type: Review

References (100)

1. Katz MD. Evaluation of adverse drug reactions. In: Decision Making in Medicine (3rd Edition).An Algorithmic Approach. Mushlin SB, Greene II HL (Eds.).Mosby Elsevier, PA, USA, 698-699 (2010).
2. Pirmohamed M, James S, Meakin S et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ 329, 15-19 (2004). (Pubitemid 38869995)
3. Rizzoli R, Reginster JY, Boonen S et al. Adverse reactions and drug-drug interactions in the management of women with postmenopausal osteoporosis. Calcif. Tissue Int. 89(2), 91-104 (2011).
4. Sambrook P, Cooper C. Osteoporosis. Lancet 367, 2010-2018 (2006). (Pubitemid 43867702)
5. Black DM, Cummings SR, Karpf DB et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 348, 1535-1541 (1996). (Pubitemid 26411651)
6. Cummings SR, Black DM, Thompson DE 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, 2077-2082 (1998). (Pubitemid 29014065)
7. 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. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. JAMA 282, 1344-1352 (1999). (Pubitemid 29483192)
8. 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. 11, 83-91 (2000). (Pubitemid 30099515)
9. McClung MR, Geusens P, Miller PD et al. Effect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group. N. Engl. J. Med. 344, 333-340 (2001). (Pubitemid 32107641)
10. Chesnut CH, Skag A, Christiansen C et al. Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J. Bone Miner. Res. 19, 1241-1249 (2004). (Pubitemid 41094364)
11. Black DM, Delmas PD, Eastell R et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N. Engl. J. Med. 356, 1809-1822 (2007). (Pubitemid 46698462)
12. Cummings SR, San Martin J, MacClung MR et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N. Engl. J. Med. 361, 756-765 (2009).
13. Ettinger B, Black DM, Mitlak BH et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene. Results from a 3 year randomized clinical trial. JAMA 282, 637-645 (1999). (Pubitemid 29384151)
14. Siris ES, Harris ST, Eastell R et al. Skeletal effects of raloxifene after 8 years: results from the continuing outcomes relevant to Evista (CORE) study. J. Bone Miner. Res. 20, 1514-1524 (2005). (Pubitemid 41243540)
15. Cummings SR, Ensrud K, Delmas PD et al. Lasofoxifene in postmenopausal women with osteoporosis. N. Engl. J. Med. 362, 686-696 (2010).
16. Silverman SL, Christiansen C, Genant HK et al. Efficacy of bazedoxifene in reducing new vertebral fracture risk in postmenopausal women with osteoporosis: results from a 3 year, randomized, placebo-, and active-controlled clinical trial. J. Bone Miner. Res. 23, 1923-1934 (2008).
17. Archer DF, Pinkerton JV, Utian WH et al. Bazedoxifene, a selective estrogen receptor modulator: effects on the endometrium, ovaries, and breast from a randomized controlled trial in osteoporotic postmenopausal women. Menopause 16, 1109-1115 (2009).
18. Meunier PJ, Roux C, Seeman E et al. The effects of strontium ranelate on the risk of vertebral fracture in women with postmenopausal osteoporosis. N. Engl. J. Med. 350, 459-468 (2004). (Pubitemid 38133766)
19. Reginster JY, Seeman E, De Vernejoul MC et al. Strontium ranelate reduces the risk of nonvertebral fractures in postmenopausal women with osteoporosis: Treatment of Peripheral Osteoporosis (TROPOS) study. J. Clin. Endocrinol. Metab. 90, 2816-2822 (2005). (Pubitemid 40686329)
20. Neer RM, Arnaud CD, Zanchetta JR et al. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N. Engl. J. Med. 344, 1434-1441 (2001). (Pubitemid 32402100)
21. Greenspan SL, Bone HG, Ettinger MP et al. Effect of recombinant human parathyroid hormone (1-84) on vertebral fracture and bone mineral density in postmenopausal women with osteoporosis: a randomized trial. Ann. Intern. Med. 146, 326-339 (2007). (Pubitemid 351650593)
22. Kennel KA, Drake MT. Adverse effects of bisphosphonates: implications for osteoporosis management. Mayo. Clin. Proc. 84, 632-637 (2009).
23. Solomon DH, Rekedal L, Cadarette SM. Osteoporosis treatments and adverse events. Curr. Opin. Rheumatol. 21, 363-368 (2009).
24. Strampel W, Emkey R, Civitelli R. Safety considerations with bisphosphonates for the treatment of osteoporosis. Drug. Saf. 30, 755-763 (2007). (Pubitemid 47351214)
25. Recker RR, Lewiecki EM, Miller PD, Reiffel J. Safety of bisphosphonates in the treatment of osteoporosis. Am. J. Med. 122, S22-S32 (2009).
26. Watts NB, Diab DL. Long-term use of bisphosphosphonates in osteoporosis. J. Clin. Endocrinol. Metab. 95, 1555-1565 (2010).
27. Papapetrou PD. Bisphosphonate-associated adverse events. Hormones 8, 96-110 (2009).
28. Abrahamsen B. Adverse effects of bisphosphonates. Calcif. Tissue Int. 86, 421-435 (2010).
29. Rizzoli R. Bisphosphonates for post-menopausal osteoporosis: are they all the same? QJM 104, 281-300 (2011).
30. Coleman RE. Risks and benefits of bisphosphonates. Br. J. Cancer 98, 1736-1740 (2008). (Pubitemid 351748847)
31. Cryer B, Bauer DC. Oral bisphosphonates and upper gastrointestinal tract problems: what is the evidence? Mayo. Clin. Proc. 77, 1031-1043 (2002).
32. Green J, Czanner G, Reeves G, Watson J, Wise L, Beral V. Oral bisphosphonates and risk of cancer of oesophagus, stomach, and colorectum: case-control analysis within a UK primary care cohort. BMJ 341, c4444 (2010).
33. Cardwell CR, Abnet CC, Cantwell MM, Murray LJ. Exposure to oral bisphosphonates and risk of esophageal cancer. JAMA 304, 657-663 (2010).
34. Dixon WG, Solomon DH. Bisphosphonates and esophageal cancer-a pathway through the confusion. Nat. Rev. Rheumatol. 7(6), 369-372 (2011).
35. Bilezikian J, Klemes A, Siris E. Esophageal cancer reports coincident with risedronate use. J. Bone Miner. Res. 24 (Suppl. 1), A09001305 (2009) (Abstract).
36. Wysowski DK. Reports of esophageal cancer with oral bisphosphonate use. N. Engl. J. Med. 360, 89-90 (2009).
37. Thompson K, Rogers MJ. Statins prevent bisphosphonate-induced γ δ-T-cell proliferation and activation in vitro. J. Bone Miner. Res. 19, 278-288 (2004). (Pubitemid 38116742)
38. Bock O, Boerst H, Thomasius FE 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, 144-148 (2007). (Pubitemid 47249003)
39. Mak A, Cheung MW, Ho RC, Cheak AA, Lau CS. Bisphosphonates and atrial fibrillation: Bayesian meta-analyses of randomized controlled trials and observational studies. BMC Musculoskelet. Disord. 10, 113 (2009).
40. Pazianas M, Compston J, Huang CL. Atrial fibrillation and bisphosphonate therapy. J. Bone Miner. Res. 25, 2-10 (2010).
41. Cummings SR, Schwartz AV, Black DM. Alendronate and atrial fibrillation. N. Engl. J. Med. 356, 1895-1896 (2007).
42. Heckbert SR, Li G, Cummings SR, Smith NL, Psaty BM. Use of alendronate and risk of incident atrial fibrillation in women. Arch. Intern. Med. 168, 826-831 (2008). (Pubitemid 351649266)
43. Sorensen HT, 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, 813-816 (2008). (Pubitemid 351548223)
44. Neviaser AS, Lane JM, Lenart BA, Edobor-Osula F, Lorich DG. Low-energy femoral shaft fractures associated with alendronate use. J. Orthop. Trauma 22, 346-350 (2008). (Pubitemid 351630250)
45. Odvina CV, Levy S, Rao S, Zerwekh JE, Rao DS. Unusual mid-shaft fractures during long-term bisphosphonate therapy. Clin. Endocrinol. 72, 161-168 (2010).
46. Ing-Lorenzini K, Desmeules J, Plachta O, Suva D, Dayer P, Peter R. Low-energy femoral fractures associated with the long-term use of bisphosphonates: a case series from a Swiss university hospital. Drug Saf. 32, 775-785 (2009).
47. Rizzoli R, Akesson K, Bouxsein M et al. Subtrochanteric fracture after long-term treatment with bisphosphonates. Osteoporos. Int. 22, 373-390 (2011).
48. 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. 25, 2267-2294 (2010).
49. Schilcher J, Michaelsson K, Aspenberg P. Bisphosphonate use and atypical fractures of the femoral shaft. N. Engl. J Med. 364, 1728-1737 (2011).
50. Lenart BA, Neviaser AS, Lyman S et al. Association of low-energy femoral fractures with prolonged bisphosphonate use: a case control study. Osteoporos. Int. 20, 1353-1362 (2009).
51. Black DM, Kelly MP, Genant HK et al. Bisphosphonates and fractures of the subtrochanteric or diaphyseal femur. N. Engl. J. Med. 362, 1761-1771 (2010).
52. Musette P, Brandi ML, Cacoub P, Kaufman JM, Rizzoli R, Reginster JY. Treatment of osteoporosis: recognizing and managing cutaneous adverse reactions and drug-induced hypersensitivity. Osteoporos. Int. 21, 723-732 (2010).
53. Migliorati CA, Siegel MA, Elting LS. Bisphosphonate-associated osteonecrosis: a long-term complication of bisphosphonate treatment. Lancet Oncol. 7, 508-514 (2006). (Pubitemid 43779167)
54. Rizzoli R, Burlet N, Cahall D et al. Osteonecrosis of the jaw and bisphosphonate treatment for osteoporosis. Bone 42, 841-847 (2008).
55. Khosla S, Burr D, Cauley J et al. Bisphosphonate-associated osteonecrosis of the jaw: report of a task force of the American Society for Bone and Mineral Research. J. Bone Miner. Res. 22, 1479-1491 (2007). (Pubitemid 351229318)
56. Cooper C, Steinbuch M, Stevenson R, Miday R, Watts NB. The epidemiology of osteonecrosis: findings from the GPRD and THIN databases in the UK. Osteoporos. Int. 24, 569-577 (2010).
57. Khan A. Osteonecrosis of the jaw and bisphosphonates. BMJ 340, c246 (2010).
58. Grbic JT, Landesberg R, Lin SQ et al. Incidence of osteonecrosis of the jaw in women with postmenopausal osteoporosis in the health outcomes and reduced incidence with zoledronic acid once yearly pivotal fracture trial. J. Am. Dent. Assoc. 139, 32-40 (2008).
59. Lesclous P, Abi NS, Carrel JP et al. Bisphosphonate-associated osteonecrosis of the jaw: a key role of inflammation? Bone 45, 843-852 (2009).
60. Boonen S, Sellmeyer DE, Lippuner K et al. Renal safety of annual zoledronic acid infusions in osteoporotic postmenopausal women. Kidney Int. 74, 641-648 (2008).
61. Miller PD, Leigh C, Ward P. Renal tolerability of intravenous ibandronate allow administration by short injection. Ann. Rheum. Dis. 65(Suppl. 1), FR10455 (2006).
62. Smith MR, Egerdie B, Hernandez TN et al. Denosumab in men receiving androgen-deprivation therapy for prostate cancer. N. Engl. J. Med. 361, 745-755 (2009).
63. Anastasilakis AD, Toulis KA, Goulis DG et al. Efficacy and safety of denosumab in postmenopausal women with osteopenia or osteoporosis: a systematic review and a meta-analysis. Horm. Metab. Res. 41, 721-729 (2009).
64. Ferrari-Lacraz S, Ferrari S. Do RANKL inhibitors (denosumab) affect inflammation and immunity? Osteoporos. Int. 22, 435-446 (2011).
65. Joshi PA, JAckson HW, Beristain AG et al. Progesterone induces adult mammary stem cell expansion. Nature 465, 803-807 (2010).
66. Schramek D, Leibbrandt A, Sigl V et al. Osteoclast differentiation factor RANKL controls development of progestin-driven mammary cancer. Nature 468, 98-102 (2010).
67. Kyrgidis A, Toulis KA. Denosumab-related osteonecrosis of the jaws. Osteoporos. Int. 22, 369-370 (2011).
68. Taylor KH, Middlefell LS, Mizen KD. Osteonecrosis of the jaws induced by anti-RANK ligand therapy. Br. J. Oral. Maxillofac. Surg. 48, 221-223 (2010).
69. Stopeck AT, Lipton A, Body JJ et al. Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J. Clin. Oncol. 28, 5132-5139 (2010).
70. Papapoulos S, Man Z, Mellstrom D et al. Five-year denosumab treatment of postmenopausal women with osteoporosis: results from the first two years of the FREEDOM trial extension. OC24. Osteoporos. Int. 22(Suppl. 1), S107 (2011).
71. Vogel VG, Costantino JP, Wickerham DL et al. Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial. JAMA 295, 2727-2741 (2006).
72. Mosca L, Barrett-Connor E, Wenger NK et al. Design and methods of the Raloxifene Use for The Heart (RUTH) study. Am. J. Cardiol. 88, 392-395 (2001). (Pubitemid 32823301)
73. Barrett-Connor E, Mosca L, Collins P et al. Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. N. Engl. J. Med. 355, 125-137 (2006). (Pubitemid 44050394)
74. Cohen FJ, Lu Y. Characterization of hot flashes reported by healthy postmenopausal women receiving raloxifene or placebo during osteoporosis prevention trials. Maturitas 34, 65-73 (2000). (Pubitemid 30015989)
75. Martino S, Disch D, Dowsett SA, Keech CA, Mershon JL. Safety assessment of raloxifene over eight years in a clinical trial setting. Curr. Med. Res. Opin. 21, 1441-1452 (2005). (Pubitemid 41368577)
76. Clemett D, Spencer CM. Raloxifene: A review of its use in postmenopausal osteoporosis. Drugs 60, 379-411 (2000).
77. Grady D, Ettinger B, Moscarelli E et al. Safety and adverse effects associated with raloxifene: multiple outcomes of raloxifene evaluation. Obstet. Gynecol. 104, 837-844 (2004). (Pubitemid 40458815)
78. Duvernoy CS, Kulkarni PM, Dowsett SA, Keech CA. Vascular events in the Multiple Outcomes of Raloxifene Evaluation (MORE) trial: incidence, patient characteristics, and effect of raloxifene. Menopause 12, 444-452 (2005). (Pubitemid 41098658)
79. De Villiers TJ, Kendler DL, Chines A et al. Safety and tolerability of bazedoxifene in postmenopausal women with osteoporosis: results of a 5 year, randomized, placebo-controlled Phase 3 trial. Osteoporos. Int. 22(2), 567-576 (2011).
80. Mosca L, Grady D, Barrett-Connor E et al. Effect of raloxifene on stroke and venous thromboembolism according to subgroups in postmenopausal women at increased risk of coronary heart disease. Stroke 40, 147-155 (2009).
81. Ensrud K, Genazzani AR, Geiger MJ et al. Effect of raloxifene on cardiovascular adverse events in postmenopausal women with osteoporosis. Am. J. Cardiol. 97, 520-527 (2006). (Pubitemid 43190043)
82. Yaffe K, Krueger K, Cummings SR et al. Effect of raloxifene on prevention of dementia and cognitive impairment in older women: the Multiple Outcomes of Raloxifene Evaluation (MORE) randomized trial. Am. J. Psychiatry 162, 683-690 (2005). (Pubitemid 40489129)
83. Jolly EE, Bjarnason NH, Neven P et al. Prevention of osteoporosis and uterine effects in postmenopausal women taking raloxifene for 5 years. Menopause 10, 337-344 (2003). (Pubitemid 36870506)
84. Naess IA, Christiansen SC, Romundstad P, Cannegieter SC, Rosendaal FR, Hammerstrom J. Incidence and mortality of venous thrombosis: a population-based study. J. Thromb. Haemost. 5, 692-699 (2007). (Pubitemid 46563566)
85. Oger E. Incidence of venous thromboembolism: a community-based study in Western France. EPI-GETBP Study Group. Groupe d'Etude de la Thrombose de Bretagne Occidentale. Thromb. Haemost. 83, 657-660 (2000). (Pubitemid 30248509)
86. Silverstein MD, Heit JA, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ. Trends in the incidence of deep vein thrombosis and pulmonary embolism. A 25 year population-based study. Arch. Intern. Med. 158, 585-593 (1998). (Pubitemid 28144815)
87. Breart G, Cooper C, Meyer O, Speirs C, Deltour N, Reginster JY. Osteoporosis and venous thromboembolism: a retrospective cohort study in the UK General Practice Research Database. Osteoporos. Int. 21, 1181-1187 (2010).
88. Perrio M, Wilton L, Shakir S. Analysis of venous thromboembolism in the strontium ranelate prescription-event monitoring (PEM) cohort: interim results. Drug Saf. 31, 1 (2008).
89. Blick SK, Dhillon S, Keam SJ. Teriparatide: a review of its use in osteoporosis. Drugs 68, 2709-2737 (2008).
90. Deal C, Omizo M, Schwartz EN et al. Combination teriparatide and raloxifene therapy for postmenopausal osteoporosis: results from a 6 month double-blind placebo-controlled trial. J. Bone Miner. Res. 20, 1905-1911 (2005). (Pubitemid 41532775)
91. Vahle JL, Long GG, Sandusky G, Westmore M, Ma YL, Sato M. Bone neoplasms in F344 rats given teriparatide [rhPTH(1-34)] are dependent on duration of treatment and dose. Toxicol. Pathol. 32, 426-438 (2004). (Pubitemid 38998935)
92. Harper KD, Krege JH, Marcus R, Mitlak BH. Osteosarcoma and teriparatide? J. Bone Miner. Res. 22, 334 (2007).
93. Berry DC, Knapp P, Raynor DK. Provision of information about drug side-effects to patients. Lancet 359, 853-854 (2002). (Pubitemid 34233761)
94. Berry DC, Raynor DK, Knapp P, Bersellini E. Patients' understanding of risk associated with medication use: impact of European Commission guidelines and other risk scales. Drug Saf. 26, 1-11 (2003). (Pubitemid 36092271)
95. Arimone Y, Miremont-Salame G, Haramburu F et al. Inter-expert agreement of seven criteria in causality assessment of adverse drug reactions. Br. J. Clin. Pharmacol. 64, 482-488 (2007). (Pubitemid 47404316)
96. Harmark L, van Grootheest AC. Pharmacovigilance: methods, recent developments and future perspectives. Eur. J. Clin. Pharmacol. 64, 743-752 (2008).
97. Naranjo CA, Busto U, Sellers EM. Difficulties in assessing adverse drug reactions in clinical trials. Prog. Neuropsychopharmacol. Biol. Psychiatry 6, 651-657 (1982). (Pubitemid 13146302)
98. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 356, 1255-1259 (2000).
99. Doherty MJ. Algorithms for assessing the probablity of an adverse drug reaction. Respiratory Medicine CME 2, 63-67 (2009).
100. Rachner TD, Khosla S, Hofbauer LC. Osteoporosis: now and the future. Lancet 377, 1276-1287 (2011).