Ibandronate produces significant, similar antifracture efficacy in North American and European women: New clinical findings from BONE

Current Medical Research and Opinion

Volumn 21, Issue 3, 2005, Pages 391-401

  Chesnut, Charles H ^a,k   Ettinger, Mark P ^b   Miller, Paul D ^c   Baylink, David J ^d   Emkey, Ronald ^e   Harris, Steven T ^f   Wasnich, Richard D ^g   Watts, Nelson B ^h   Schimmer, Ralph C ⁱ   Recker, Robert R ^j  

^a UNIVERSITY OF WASHINGTON   (United States)

^b Regional Osteoporosis Center   (United States)

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

^d LOMA LINDA UNIVERSITY   (United States)

^e RADIANT RESEARCH   (United States)

^f UNIVERSITY OF CALIFORNIA   (United States)

^g Hawaii Osteoporosis Center   (United States)

^h UNIVERSITY OF CINCINNATI   (United States)

ⁱ F HOFFMANN LA ROCHE LTD   (Switzerland)

^j CREIGHTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^k UNIVERSITY OF WASHINGTON MEDICAL CENTER   (United States)

more..

Author keywords

Bisphosphonate; Bone mineral density; Fracture; Ibandronate; Osteoporosis

Indexed keywords

CALCIUM; IBANDRONIC ACID; PLACEBO; VITAMIN D;

ADULT; AGED; ARTICLE; BONE DENSITY; BONE TURNOVER; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE REGIMEN; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; EUROPE; FEMALE; GASTROINTESTINAL SYMPTOM; HUMAN; NORTH AMERICA; OSTEOPOROSIS; PHASE 3 CLINICAL TRIAL; POSTMENOPAUSE; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; VERTEBRA FRACTURE;

ADMINISTRATION, ORAL; AGED; AGED, 80 AND OVER; BONE DENSITY; BONE RESORPTION; DIPHOSPHONATES; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; EUROPE; EUROPEAN CONTINENTAL ANCESTRY GROUP; FEMALE; HUMANS; MIDDLE AGED; NORTH AMERICA; OSTEOPOROSIS; POSTMENOPAUSE; SPINAL FRACTURES;

EID: 20144389195     PISSN: 03007995     EISSN: None     Source Type: Journal    
DOI: 10.1185/030079905X30752     Document Type: Article

References (56)

1. NIH Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Therapy. Osteoporosis prevention, diagnosis, and therapy. J Am Med Assoc 2001;285:785-95
2. Riggs BL, Melton III LJ. The prevention and treatment of osteoporosis. New Engl J Med 1992;327:620-7
3. Ross PD. Osteoporosis. Frequency, consequences and risk factors. Arch Intern Med 1996;156:1399-411
4. Melton III LJ. Epidemiology of spinal osteoporosis. Spine 1997;22(Suppl 24S):2S-11S
5. Kanis JA, Delmas P, Burckhardt P, Cooper C, Torgerson D. Guidelines for the diagnosis and management of osteoporosis. Osteoporos Int 1997;7:390-406
6. Wasnich RD. Vertebral fracture epidemiology. Bone 1996;18 (Suppl 3):179S-83S
7. Nevitt MC, Ettinger B, Black DM, et al. The association of radiographically detected vertebral fracture with back pain and function: a prospective study. Ann Intern Med 1998;128:793-800
8. 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
9. Kado DM, Browner WS, Palermo L, et al. Vertebral fractures and mortality in older women: a prospective study. Arch Intern Med 1999;159:1215-20
10. Ross PD, Davis JW, Epstein RS, Wasnich RD. Pre-existing fractures and bone mass predict vertebral fracture incidence in women. Ann Intern Med 1991;114:919-23
11. Kotowicz MA, Melton III LJ, Cooper C, et al. Risk of hip fracture in women with vertebral fracture. J Bone Miner Res 1994;9:599-605
12. Ray NF, Chan JK, Thamer M, Melton III LJ. Medical expenditures for the treatment of osteoporotic fractures in the United States in 1995: report from the National Osteoporosis Foundation. J Bone Miner Res 1997;12:24-35
13. 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
14. Brown JP, Josse RG. 2002 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada. Can Med Assoc J 2002;167(Suppl 10):S1-34
15. 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
16. 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. J Am Med Assoc 1998;280:2077-82
17. 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]. J Am Med Assoc 1999;282:1344-52
18. 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]. New Engl J Med 1995;333:1437-43
19. 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]. New Engl J Med 2001;344:333-40
20. 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 [Fosamax International Trial Study Group]. Osteoporos Int 1999;9:461-8
21. 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
22. 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
23. Schnitzer T, Bone HG, Crepaldi G, et al. Therapeutic equivalence of alendronate 70 mg once-weekly and alendronate 10 mg daily in the treatment of osteoporosis [Alendronate Once-Weekly Study Group]. Aging (Milano) 2000;12:1-12
24. 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
25. Miller NH. Compliance with treatment regimens in chronic asymptomatic diseases. Am J Med 1997;102:43-9
26. Hamilton B, McCoy K, Taggart H. Tolerability and compliance with risedronate in clinical practice. Osteoporos Int 2003;14:259-62
27. Tosteson AN, Grove MR, Hammond CS, et al. Early discontinuation of treatment for osteoporosis. Am J Med 2003;115:209-16
28. Segal E, Tamir A, Ish-Shalom S. Compliance of osteoporotic patients with different treatment regimens. Isr Med Assoc J 2003;5:859-62
29. Bandeira F, Kayath M, Marques-Neto J, et al. Patient's clinical features and compliance associated with raloxifene or alendronate after a 6 month-observational Brazilian study [abstract]. J Bone Miner Res 2003;18(Suppl 2):S379
30. Yood RA, Emani S, Reed JI, Lewis BE, Charpentier M, Lydick E. Compliance with pharmacologic therapy for osteoporosis. Osteoporos Int 2003;14:965-8
31. Caro JJ, Ishak KJ, Huybrechts KF, Raggio G, Naujoks C. The impact of compliance with osteoporosis therapy on fracture rates in actual practice. Osteoporos Int 2004;15:1003-8
32. Unson CG, Siccion E, Gaztambide J, et al. Nonadherence and osteoporosis treatment preferences of older women: a qualitative study. J Womens Health 2003;12:1037-45
33. 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
34. 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
35. 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
36. Papapoulos SE. Ibandronate: a potent new bisphosphonate in the management of postmenopausal osteoporosis. Int J Clin Pract 2003;57:417-22
37. Bauss F, Russell RGG. Ibandronate in osteoporosis: preclinical data and rationale for intermittent dosing. Osteoporos Int 2004;15:423-33
38. Reginster JY, Christiansen C, Roux C, et al. Intermittent cyclic tiludronate in the treatment of osteoporosis. Osteoporos Int 2001;12:169-77
39. Adami S, Zamberlan N. Adverse effects of bisphosphonates: a comparative review. Drug Safety 1996;14:158-70
40. Riis BJ, Ise J, von Stein T, Bagger Y, Christiansen C. Ibandronate: a comparison of oral daily dosing versus intermittent dosing in postmenopausal osteoporosis. J Bone Miner Res 2001;16:1871-8
41. Holt G, Khaw KT, Reid DM, et al. Prevalence of osteoporotic bone mineral density at the hip in Britain differs substantially from the US over 50years of age: implications for clinical densitometry. Br J Radiol 2002;75:736-42
42. Melton III LJ. Differing patterns of osteoporosis across the world. In: Chesnut CH, editor. New dimensions in osteoporosis in the 1990s [Asia Pacific Conference Series 125]. Hong Kong: Excerpta Medica; 1991. p. 13-8
43. Melton III LJ, Cooper C. Magnitude and impact of osteoporosis and fractures. In: Marcus R, Feldman D, Kelsy J, editors. Osteporosis: 2nd ed. San Diego: Academic Press; 2001. p. 557-65
44. Lunt M, Felsenberg D, Reeve J, et al. Bone density variation and its effects on risk of vertebral deformity in men and women studied in thirteen European centers: the EVOS Study. J Bone Miner Res 1997;12:1883-94
45. 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 2004;19:241-9
46. Delmas PD, Recker RR, Chesnut CH, et al. Daily and intermittent oral ibandronate normalize bone turnover and provide significant reduction in vertebral fracture risk: results from the BONE study. Osteoporos Int 2004;15:792-8
47. McCombs JS, Thiebaud P, McLaughlin-Miley C, Shi J. Compliance with drug therapies for the treatment and prevention of osteoporosis. Maturitas 2004;48:271-87
48. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther 2001;23:1296-310
49. Richter A, Anton SE, Koch P, Dennett SL. The impact of reducing dose frequency on health outcomes. Clin Ther 2003;25:2307-35
50. Meunier PJ, Roux C, Seeman E, et al. The effects of strontium ranelate on the risk of vertebral fracture in women with postmenopausal osteoporosis. New Engl J Med 2004;350:459-68
51. 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
52. Wasnich RD, Miller PD. Antifracture efficacy of antiresorptive agents are related to changes in bone density. J Clin Endocrinol Metab 2000;85:231-6
53. 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
54. Eastell R, Barton I, Hannon RA, et al. Relationship of early changes in bone resorption to reduction of fracture risk with risedronate. J Bone Miner Res 2003;18:1051-6
55. Bauer DC, Black DM, Garnero P, et al. Reduction in bone turnover predicts hip, nonspine, and vertebral fracture in alendronate treated women: the Fracture Intervention Trial. Osteoporos Int 2000;13:521
56. Recker RR, Weinstein RS, Chesnut CH, et al. Histomorphometric evaluation of daily and intermittent oral ibandronate in women with postmenopausal osteoporosis: results from the BONE study. Osteoporos Int 2004;15:231-7