Treating osteoporosis with bisphosphonates and addressing adherence: A review of oral ibandronate

Drugs

Volumn 66, Issue 10, 2006, Pages 1351-1359

  Chesnut III, Charles H ^a  

^a UNIVERSITY OF WASHINGTON MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALENDRONIC ACID; BISPHOSPHONIC ACID DERIVATIVE; HISTAMINE H2 RECEPTOR ANTAGONIST; IBANDRONIC ACID; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; PROTON PUMP INHIBITOR;

BONE DENSITY; BONE TURNOVER; CLINICAL TRIAL; DISEASE MARKER; DRUG APPROVAL; DRUG EFFICACY; DRUG POTENTIATION; DRUG SAFETY; DRUG STRUCTURE; ESOPHAGUS INJURY; EVIDENCE BASED MEDICINE; FEASIBILITY STUDY; HEALTH CARE SYSTEM; HOSPITALIZATION; HUMAN; INCIDENCE; MORTALITY; NONHUMAN; OSTEOPOROSIS; POPULATION RESEARCH; POSTMARKETING SURVEILLANCE; POSTMENOPAUSE OSTEOPOROSIS; PRIMARY MEDICAL CARE; QUALITY OF LIFE; REVIEW; RISK FACTOR; UNITED STATES; UPPER GASTROINTESTINAL BLEEDING; VERTEBRA FRACTURE;

ADMINISTRATION, ORAL; BONE DENSITY; BONE DENSITY CONSERVATION AGENTS; DIPHOSPHONATES; FEMALE; HUMANS; OSTEOPOROSIS, POSTMENOPAUSAL;

EID: 33747346708     PISSN: 00126667     EISSN: 00126667     Source Type: Journal    
DOI: 10.2165/00003495-200666100-00004     Document Type: Review

References (92)

1. National Institutes of Health USA. Osteoporosis prevention, diagnosis, and therapy. NIH Consensus Statement 2000; 17: 1-45
2. Riggs BL, Melton LJ III. The prevention and treatment of osteoporosis. N Engl J Med 1992; 327: 620-7
3. Melton LJ III, Chrischilles EA, Cooper C, et al. Perspective: how many women have osteoporosis? J Bone Miner Res 1992; 7: 1005-10
4. Chrischilles EA, Butler CD, Davis CS, et al. A model of lifetime osteoporosis impact. Arch Intern Med 1991; 151: 2026-32
5. Nevitt MC, Ettinger B, Black DM, et al. The association of radiographically detected vertebral fractures with back pain and function: a prospective study. Ann Intern Med 1998; 128: 793-800
6. Ensrud KE, Thompson DE, Cauley JA, et al. Prevalent vertebral deformities predict mortality and hospitalization in older women with low bone mass. Fracture Intervention Trial Research Group. J Am Geriatr Soc 2000; 48: 241-9
7. Kado DM, Browner WS, Palermo L, et al. Vertebral fractures and mortality in older women: a prospective study. Study of Osteoporotic Fractures Research Group. Arch Intern Med 1999; 159: 1215-20
8. Wasnich RD. Vertebral fracture epidemiology. Bone 1996; 18: 179-183S
9. Kotowicz MA, Melton LJ III, Cooper C, et al. Risk of hip fracture in women with vertebral fracture. J Bone Miner Res 1994; 9: 599-605
10. Ross PD, Davis JW, Epstein RS, et al. Pre-existing fractures and bone mass predict vertebral fracture incidence in women. Ann Intern Med 1991; 114: 919-23
11. Kanis JA, Johnell O, De Laet C, et al. A meta-analysis of previous fracture and subsequent fracture risk. Bone 2004; 35: 375-82
12. Kanis JA, Delmas P, Burckhardt P, et al. Guidelines for diagnosis and management of osteoporosis. The European Foundation for Osteoporosis and Bone Disease. Osteoporos Int 1997; 7: 390-406
13. Heinemann DF. Osteoporosis: an overview of the National Osteoporosis Foundation clinical practice guide. Geriatrics 2000; 55: 31-6
14. National Osteoporosis Foundation. Physician's guide to prevention and treatment of osteoporosis. Washington, DC: National Osteoporosis Foundation, 2003
15. Hodgson SF, Watts NB, Bilezikian JP, et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the prevention and treatment of postmenopausal osteoporosis: 2001 edition, with selected updates for 2003. Endocr Pract 2003; 9: 544-64
16. 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
17. ACOG Practice Bulletin Number 50. Recommendations for the prevention and treatment of glucocorticoid-induced osteoporosis: 2001 update. Obstet Gynecol 2004; 103: 203-16
18. Kanis JA, Johnell O. Requirements for DXA for the management of osteoporosis in Europe. Osteoporos Int 2005; 16: 229-38
19. 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
20. 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 1998; 280: 2077-82
21. 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 1999; 282: 1344-52
22. Liberman UA, Weiss SR, Broll J, et al. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. The Alendronate Phase III Osteoporosis Treatment Study Group. N Engl J Med 1995; 333: 1437-43
23. 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 2001; 344: 333-40
24. Pols HA, Felsenberg D, Hanley DA, et al. Multinational, placebo-controlled, randomized trial of the effects of alendronate on bone density and fracture risk in postmenopausal women with low bone mass: results of the FOSIT study. Foxamax International Trial Study Group. Osteoporos Int 1999; 9: 461-8
25. 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
26. 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 1996; 348: 1535-41
27. Chesnut CG III, Skag A, Christiansen C, et al. Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res 2004; 19: 1241-9
28. Miller NH. Compliance with treatment regimens in chronic asymptomatic diseases. Am J Med 1997; 102: 43-9
29. McCombs JS, Thiebaud P, McLaughlin-Miley C, et al. Compliance with drug therapies for the treatment and prevention of osteoporosis. Maturitas 2004; 48: 271-87
30. Unson CG, Siccion E, Gaztambide J, et al. Nonadherence and osteoporosis treatment preferences of older women: a qualitative study. J Womens Health (Larchmt) 2003; 12: 1037-45
31. Horne R, Weinman J. Patients' beliefs about prescribed medicines and their role in adherence to treatment in chronic physical illness. J Psychosom Res 1999; 47: 555-67
32. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther 2001; 23: 1296-310
33. Richter A, Anton SE, Koch P, et al. The impact of reducing dose frequency on health outcomes. Clin Ther 2003; 25: 2307-35
34. Cramer JA, Amonkar MM, Hebborn A, et al. Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis. Curr Med Res Opin 2005; 21: 1453-60
35. Recker RR, Gallagher R, MacCosbe PE. Effect of dosing frequency on bisphosphonate medication adherence in a large longitudinal cohort of women. Mayo Clin Proc 2005; 80: 856-61
36. Hamilton B, McCoy K, Taggart H. Tolerability and compliance with risedronate in clinical practice. Osteoporos Int 2003; 14: 259-62
37. Tosteson AN, Grove MR, Hammond CS, et al. Early discontinuation of treatment for osteoporosis. Am J Med 2003; 115: 209-16
38. Segal E, Tamir A, Ish-Shalom S. Compliance of osteoporotic patients with different treatment regimens. Isr Med Assoc J 2003; 5: 859-62
39. Yood RA, Emani S, Reed JI, et al. Compliance with pharmacologic therapy for osteoporosis. Osteoporos Int 2003; 14: 965-8
40. Caro JJ, Ishak KJ, Huybrechts KF, et al. The impact of compliance with osteoporosis therapy on fracture rates in actual practice. Osteoporos Int 2004; 15: 1003-8
41. Ettinger M, Gallagher R, Amonkar M, et al. Medication persistence is improved with less frequent dosing of bisphosphonates, but remains inadequate [abstract]. Arthritis Rheum 2004; 50: S513
42. Bone Health and Osteoporosis: a report of the Surgeon General. Vol. 2005 [online]. Available from URL: http://www.hhs.gov/surgeongeneral/library/ bonehealth/content.html [Accessed 2006 Jun 20]
43. Simon JA, Beusterien KM, Hebborn A, et al. Women with postmenopausal osteoporosis express a preference for once-monthly versus once-weekly bisphosphonate treatment. Female Patient 2005; 30: 31-6
44. Salzman C. Medication compliance in the elderly. J Clin Psychiatry 1995; 56: 18-22
45. Bjerrum L, Andersen M, Petersen G, et al. Exposure to potential drug interactions in primary health care. Scand J Prim Health Care 2003; 21: 153-8
46. Linjakumpu T, Hartikainen S, Klaukka T, et al. Use of medications and polypharmacy are increasing among the elderly. J Clin Epidemiol 2002; 55: 809-17
47. Gold DT, Ettinger M, Gallagher R, et al. Medication burden among women with postmenopausal osteoporosis. Washington, DC: National Osteoporosis Foundation, 2005 Apr 5-10
48. Mühlbauer RC, Bauss F, Schenk R, et al. BM 21.0955, a potent new bisphosphonate to inhibit bone resorption. J Bone Miner Res 1991; 6: 1003-11
49. Bauss F, Russell RG. Ibandronate in osteoporosis: preclinical data and rationale for intermittent dosing. Osteoporos Int 2004; 15: 423-33
50. Schimmer RC, Bauss F. Effect of daily and intermittent use of ibandronate on bone mass and bone turnover in postmenopausal osteoporosis: a review of three phase II studies. Clin Ther 2003; 25: 19-34
51. Bauss F, Schenk RK, Hort S, et al. New model for simulation of fracture repair in full-grown beagle dogs: model characterization and results from a long-term study with ibandronate. J Pharmacol Toxicol Methods 2004; 50: 25-34
52. Bauss F, Wagner M, Hothorn LH. Total administered dose of ibandronate determines its effects on bone mass and architecture in ovariectomized aged rats. J Rheumatol 2002; 29: 990-8
53. Bauss F, Lalla S, Endele R, et al. Effects of treatment with ibandronate on bone mass, architecture, biomechanical properties, and bone concentration of ibandronate in ovariectomized aged rats. J Rheumatol 2002; 29: 2200-8
54. Monier-Faugere MC, Friedler RM, Bauss F, et al. A new bisphosphonate, BM 21.0955, prevents bone loss associated with cessation of ovarian function in experimental dogs. J Bone Miner Res 1993; 8: 1345-55
55. Monier-Faugere MC, Geng Z, Paschalis EP, et al. Intermittent and continuous administration of the bisphosphonate ibandronate in ovariohysterectomized beagle dogs: effects on bone morphometry and mineral properties. J Bone Miner Res 1999; 14: 1768-78
56. Smith SY, Recker RR, Hannan M, et al. Intermittent intravenous administration of the bisphosphonate ibandronate prevents bone loss and maintains bone strength and quality in ovariectomized cynomolgus monkeys. Bone 2003; 32: 45-55
57. Burr DB, Miller L, Grynpas M, et al. Tissue mineralization is increased following 1-year treatment with high doses of bisphosphonates in dogs. Bone 2003; 33: 960-9
58. Adami S, Zamberlan N. Adverse effects of bisphosphonates: a comparative review. Drug Saf 1996; 14: 158-70
59. Riis BJ, Ise J, von Stein T, et al. Ibandronate: a comparison of oral daily dosing versus intermittent dosing in postmenopausal osteoporosis. J Bone Miner Res 2001; 16: 1871-8
60. Schnitzer T, Bone HG, Crepaldi G, et al. Therapeutic equivalence of alendronate 70mg once-weekly and alendronate 10mg daily in the treatment of osteoporosis. Alendronate Once-Weekly Study Group. Aging (Milano) 2000; 12: 1-12
61. Miller PD, McClung MR, Macovei L, et al. Monthly oral ibandronate therapy in postmenopausal osteoporosis: 1-year results from the MOBILE study. J Bone Miner Res 2005; 20: 1315-22
62. Hochberg MC, Greenspan S, Wasnich RD, et al. Changes in bone density and turnover explain the reductions in incidence of nonvertebral fractures that occur during treatment with antiresorptive agents. J Clin Endocrinol Metab 2002; 87: 1586-92
63. Wasnich RD, Miller PD. Antifracture efficacy of antiresorptive agents are related to changes in bone density. J Clin Endocrinol Metab 2000; 85: 231-6
64. Cummings SR, Karpf DB, Harris F, et al. Improvement in spine bone density and reduction in risk of vertebral fractures during treatment with antiresorptive drugs. Am J Med 2002; 112: 281-9
65. Heaney RP. Is the paradigm shifting? Bone 2003; 33: 457-65
66. Marcus R, Wong M, Heath H III, et al. Antiresorptive treatment of postmenopausal osteoporosis: comparison of study designs and outcomes in large clinical trials with fracture as an point. Endocr Rev 2002; 23: 16-37
67. Eastell R, Barton I, Hannon RA, et al. Relationship of early changes in bone resorption to the reduction in fracture risk with risedronate. J Bone Miner Res 2003; 18: 1051-6
68. Bauer DC, Black D, Ensrud K, et al. Upper gastrointestinal tract safety profile of alendronate: the fracture intervention trial. Arch Intern Med 2000; 160: 517-25
69. Bone HG, Hosking D, Devogelaer JP, et al. Ten years' experience with alendronate for osteoporosis in postmenopausal women. N Engl J Med 2004; 350: 1189-99
70. Mellstrom DD, Sorensen OH, Goemaere S, et al. Seven years of treatment with risedronate in women with postmenopausal osteoporosis. Calcif Tissue Int 2004; 75: 462-8
71. Maconi G, Porro GB. Multiple ulcerative esophagitis caused by alendronate. Am J Gastroenterol 1995; 90: 1889-90
72. Naylor G, Davies MH. Oesophageal stricture associated with alendronic acid. Lancet 1996; 348: 1030-1
73. Cameron RB. Esophagitis dissecans superficialis and alendronate: case report. Gastrointest Endosc 1997; 46: 562-3
74. Levine J, Nelson D. Esophageal stricture associated with alendronate therapy. Am J Med 1997; 102: 489-91
75. Levine MAH. Proportion of osteoporotic post-menopausal women at increased risk for upper GI adverse events associated with bisphosphonate therapy. Pharmacoepidemiol Drug Saf 2000; 9: 367-70
76. Ettinger B, Pressman A, Schein J, et al. Alendronate use among 812 women: prevalence of gastrointestinal complaints, noncompliance with patient instructions, and discontinuation. J Manag Care Pharm 1998; 4: 488-92
77. Blank MA, Ems BL, Gibson GW, et al. Nonclinical model for assessing gastric effects of bisphosphonates. Dig Dis Sci 1997; 42: 281-8
78. Graham DY, Malaty HM. Alendronate and naproxen are synergistic for development of gastric ulcers. Arch Intern Med 2001; 161: 107-10
79. Rothschild BM, Helbling ME. Alendronate (Fosamax) interactions with nonsteroidal anti-inflammatory agents: a dangerous combination [abstract]? Arthritis Rheum 2000; 43: S199
80. Delmas PD, Emkey R, Gilbride J, et al. Oral ibandronate has a similar gastrointestinal (GI) safety profile to placebo in patients with a history of GI disorders or receiving concomitant NSAIDS [abstract no. P267]. Osteoporos Int 2003; 14: S74
81. Miller PD, Drezner MK, Delmas PD, et al. Monthly oral ibandronate is at least as effective as oral daily ibandronate in postmenopausal osteoporosis: 1-year results from MOBILE [abstract no. F408]. J Bone Miner Res 2004; 19: S94
82. Cooper C, Emkey RD, McDonald RH, et al. Efficacy and safety of oral weekly ibandronate in the treatment of postmenopausal osteoporosis. J Clin Endocrinol Metab 2003; 88: 4609-15
83. Ravn P, Clemmesen B, Riis BJ, et al. The effect on bone mass and bone markers of different doses of ibandronate: a new bisphosphonate for prevention and treatment of postmenopausal osteoporosis: a 1-year, randomized, double-blind, placebo-controlled dose-finding study. Bone 1996; 19: 527-33
84. McClung MR, Wasnich RD, Recker R, et al. Oral daily ibandronate prevents bone loss in early postmenopausal women without osteoporosis. J Bone Miner Res 2004; 19: 11-8
85. Tanko LB, Felsenberg D, Czerwinski E, et al. Oral weekly ibandronate prevents bone loss in postmenopausal women. J Intern Med 2003; 254: 159-67
86. Libow LS. Geriatrics in the United States baby boomers' boon? N Engl J Med 2005; 352: 750-2
87. Gourlay M. Osteoporosis management: out of subspecialty practice and into primary care. Am Fam Physician 2004; 70: 1219-20
88. Melton LJ III. Epidemiology of spinal osteoporosis. Spine 1997; 22: 2-11S
89. Zizic TM. Pharmacologic prevention of osteoporotic fractures. Am Fam Physician 2004; 70: 1293-300
90. Jaglal SB, McIsaac WJ, Hawker G, et al. Information needs in the management of osteoporosis in family practice: an illustration of the failure of the current guideline implementation process. Osteoporos Int 2003; 14: 672-6
91. Newton KM, Lacroix AZ, Leveille SG, et al. The physician's role in women's decision making about hormone replacement therapy. Obstet Gynecol 1998; 92: 580-4
92. Clowes JA, Peel NF, Eastell R. The impact of monitoring on adherence and persistence with antiresorptive treatment for postmenopausal osteoporosis: a randomized controlled trial. J Clin Endocrinol Metab 2004; 89: 1117-23