Changes in bone remodelling and antifracture efficacy of intermittent bisphosphonate therapy: Implications from clinical studies with ibandronate

Annals of the Rheumatic Diseases

Volumn 66, Issue 7, 2007, Pages 853-858

  Papapoulos, S E ^a   Schimmer, R C ^b  

^a LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^b F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ALENDRONIC ACID; ALKALINE PHOSPHATASE BONE ISOENZYME; AMINO TERMINAL TELOPEPTIDE; BISPHOSPHONIC ACID DERIVATIVE; CARBOXY TERMINAL TELOPEPTIDE; ETIDRONIC ACID; IBANDRONIC ACID; OSTEOCALCIN; PROCOLLAGEN; RISEDRONIC ACID; ZOLEDRONIC ACID;

BONE REMODELING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG INTERMITTENT THERAPY; FRACTURE; HUMAN; OSTEOLYSIS; PHARMACODYNAMICS; POSTMENOPAUSE OSTEOPOROSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVIEW; RISK ASSESSMENT; TREATMENT DURATION; VERTEBRA FRACTURE;

ADMINISTRATION, ORAL; BONE DENSITY CONSERVATION AGENTS; BONE REMODELING; BONE RESORPTION; DIPHOSPHONATES; DRUG ADMINISTRATION SCHEDULE; FEMALE; FRACTURES, BONE; HUMANS; OSTEOPOROSIS, POSTMENOPAUSAL; TREATMENT OUTCOME;

EID: 34347231577     PISSN: 00034967     EISSN: None     Source Type: Journal    
DOI: 10.1136/ard.2006.064931     Document Type: Review

References (68)

1. Liberman UA, Weiss SR, Broll J, Minne HW, Quan H, Bell NH, et al. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. N Engl J Med 1995;333:1437-43.
2. Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt MC, et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Lancet 1996;348:1535- 41.
3. Cummings SR, Black DM, Thompson DE, Applegate WB, Barrett-Connor E, Musliner TA, 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.
4. Pols HA, Felsenberg D, Hanley DA, Stepan J, Munoz-Torres M, Wilkin TJ, 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. Osteoporos Int 1999;9:461-8.
5. Black DM, Thompson DE, Bauer DC, Ensrud K, Musliner T, Hochberg MC, et al. Fracture Intervention Trial. Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial, FIT Research Group. J Clin Endocrinol Metab 2000;85:4118-24.
6. Harris ST, Watts NB, Genant HK, McKeever CD, Hangartner T, Keller M, 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.
7. Reginster J, Minne HW, Sorensen OH, Hooper M, Roux C, Brandi ML, et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Osteoporosis Int 2000;11:83-91.
8. McClung MR, Geusens P, Miller PD, Zippel H, Bensen WG, Roux C, et al. Effect of risedronate on the risk of hip fracture in elderly women. N Engl J Med 2001;344:333-40.
9. Cranney A, Wells G, Willan A, Griffith L, Zytaruk N, Robinson V, et al. Metaanalysis of alendronate for the treatment of postmenopausal women. Endocr Rev 2002;23:508-16.
10. Cranney A, Tugwell P, Adachi J, Weaver B, Zytaruk N, Papaioannou A, et al. Meta-analysis of risedronate for the treatment of postmenopausal osteoporosis. Endocr Rev 2002;23:517-23.
11. Papapoulos SE, Quandt SA, Liberman UA, Hochberg MC, Thompson DE. Metaanalysis of the efficacy of alendronate for the prevention of hip fractures in postmenopausal women. Osteoporosis Int 2005;16:468-74.
12. Brumsen C, Papapoulos SE, Lips P, Geelhoed-Duijvestijn PH, Hamdy NA, Landman JO, et al. Daily oral pamidronate in women and men with osteoporosis: a 3-year randomised, placebo-controlled clinical trial with a 2-year extension. J Bone Miner Res 2002;17:1057-64.
13. McCloskey E, Selby P, Davies M, Robinson J, Francis RM, Adams J, et al. Clodronate reduces vertebral fracture risk in women with postmenopausal osteoporosis: results of a double-blind, placebo-controlled 3-year study. J Bone Miner Res 2004;19:728-36.
14. Chesnut CH, Skag A, Christiansen C, Recker R, Stakkestad JA, Hoiseth A, et al. Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res 2004;19:1241-9.
15. Dufresne TE, Chmielewski PA, Manhart MD, Johnson TD, Borah B. Risedronate preserves bone architecture in early postmenopausal women in 1 year as measured by three-dimensional microcomputed tomography. Calcif Tissue Int 2003;73:423-32.
16. Recker R, Masarachia P, Santora A, Howard T, Chavassieux P, Arlot M, et al. Trabecular bone microarchitecture after alendronate treatment of osteoporotic women. Curr Med Res Opin 2005;21:185-94.
17. Roschger P, Rinnerthaler S, Yates J, Rodan GA, Fratzl P, Klaushofer K. Alendronate increases degree and uniformity of mineralization in cancellous bone and decreases the porosity in cortical bone of osteoporotic women. Bone 2001;29:185-91.
18. Boivin GY, Chavassieux PM, Santora AC, Yates J, Meunier PJ. Alendronate increases bone strength by increasing the mean degree of mineralization of bone tissue in osteoporotic women. Bone 2000;27:687-94.
19. Borah B, Dufresne TE, Chmielewski PA, Johnson TD, Chines A, Manhart MD. Risedronate preserves bone architecture in postmenopausal women with osteoporosis as measured by three-dimensional microcomputed tomography. Bone 2004;34:736-46.
20. Caro JJ, Ishak KJ, Huybrechts KF, Raggio G, Naujoks C. The impact of compliance with osteoporosis therapy on fracture rates in actual practice. Osteoporosis Int 2004;15:1003-8.
21. Siris ES, Harris ST, Rosen G, Barr CE, Arvesen JN, Abbott TA, et al. Adherence to bisphosphonate therapy fracture rates in osteoporotic women: relationship to vertebral and nonvertebral fractures from 2 US claims databases. Mayo Clin Proc 2006;81:1013-22.
22. Schnitzer T, Bone HG, Crepaldi G, Adami S, McClung M, Kiel D, et al. Therapeutic equivalence of alendronate 70 mg once-weekly and alendronate 10 mg daily in the treatment of osteoporosis. Aging Clin Exp Res 2000;12:1-12.
23. Brown JP, Kendler DL, McClung MR, Emkey RD, Adachi JD, Bolognese MA, et al. The efficacy and tolerability of risedronate once a week for the treatment of postmenopausal osteoporosis. Calcif Tissue Int 2002;71:103-11.
24. Cramer JA, Amonkar MM, Hebborn A, Altman R. Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis. Curr Med Res Opin 2005;21:1453-60.
25. 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;80:856-861.
26. Simon J, Lewiecki E, Smith M, Petruschke RA, Wang L, Palmisano JJ. Patient preference for once-weekly alendronate 70 mg versus once-daily alendronate 10 mg: a multicenter, randomised, open-label, crossover study. Clin Ther 2002;24:1871-86.
27. Kendler D, Kung AW, Fuleihan Gel-H, Gonzalez Gonzalez JG, Gaines KA, Verbruggen N, et al. Patients with osteoporosis prefer once weekly to once daily dosing with alendronate. Maturitas 2004;48:243-51.
28. Emkey R, Koltum W, Beusterien K Seidman L, Kivitz A, Devas V, et al. Patient preference for once-monthly ibandronate versus once-weekly alendronate in a randomized, open-label, cross-over trial: the Boniva Alendronate Trial in Osteoporosis. Curr Med Res Opin 2005;21:1895- 903.
29. Harris ST, Watts NB, Jackson RD, Genant HK, Wasnich RD, Ross P, et al. Four-year study of intermittent cyclic etidronate treatment of postmenopausal osteoporosis: three years of blinded therapy followed by one year of open therapy. Am J Med 1993;95:557-67.
30. Reginster JY, Christiansen C, Roux C, Fechtenbaum J, Rouillon A, Tou KP. Intermittent cyclic tiludronate in the treatment of osteoporosis. Osteoporosis Int 2001;12:169-77.
31. Recker R, Stakkestad JA, Chesnut III CH, Christiansen C, Skag A, Hoiseth A, et al. Insufficiently dosed intravenous ibandronate injections are associated with suboptimal antifracture efficacy in postmenopausal osteoporosis. Bone 2004;34:890-9.
32. Manolagas SC Birth and death of bone cells: basic regulatory mechanisms and implications for the pathogenesis and treatment of osteoporosis. Endocr Rev 2000;21:115-37.
33. Reszka AA, Rodan GA. Nitrogen-containing bisphosphonate mechanism of action. Mini Rev Med Chem 2004;4:711-18.
34. Rogers MJ. New insights into the molecular mechanism of action of bisphosphonates. Curr Pharm Res 2003;11:196-204.
35. 3H-etidronate in rat and mouse bones. Bone 1996;19:281-90.
36. Bone HG, Hosking D, Devogalaer J-P, Tucci JR, Emkey RD, Tonino RP, et al. Ten years' experience with alendronate for osteoporosis in postmenopausal women. N Engl J Med 2004;350:1189-99.
37. Delmas PD, Recker RR, Chesnut CH, Skag A, Stakkestad JA, Emkey R, et al. Daily and intermittent oral ibandronate normalize bone turnover and provide significant reduction in vertebral fracture risk: results from the BONE study. Osteoporosis Int 2004;15:792-8.
38. Mellstrom DD, Sorenson OH, Goemaere S, Roux C, Johnston TD, Chines AA. Seven years of treatment with risedronate in women with postmenopausal osteoporosis. Calcif Tissue Int 2004;75:462-8.
39. Hochberg MC, Greenspan S, Wasnich RD, Miller P, Thompson DE, Ross PD. 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.
40. Bauer DC, Black DM, Garnero P, Hochberg M, Ott S, Orloff J, et al. Change in bone turnover and hip, non-spine, and vertebral fracture in alendronate-treated women: the fracture intervention trial. J Bone Miner Res 2004;19:1250-8.
41. Eastell R, Barton I, Hannon RA, Chines A, Garnero P, Delmas PD. Relationship of early changes in bone resorption to the reduction in fracture risk with risedronate. J Bone Miner Res 2003;18:1051-6.
42. Bone HG, Adami S, Rizzoli R, Favus M, Ross PD, Santora A, et al. Weekly administration of alendronate: rationale and plan for clinical assessment. Clin Ther 2000;22:15-28.
43. Cremers SCLM, Pillai G, Papapoulos SE. Pharmacokinetics/ pharmacodynamics of bisphosphonates: use for optimization of intermittent therapy for osteoporosis. Clin Pharmacokinet 2005;44:551-70.
44. Watts NB, Harris ST, Genant HK, Wasnich RD, Miller PD, Jackson RD, et al. Intermittent cyclical etidronate treatment of postmenopausal osteoporosis. N Engl J Med 1990;323:73-9.
45. Thiebaud D, Burckhardt P, Melchior J, Jacquet AF, Schnyder P, Gobelet C. Two years' effectiveness of intravenous pamidronate (APD) versus oral fluoride in osteoporosis occurring in the menopause. Osteoporosis Int 1994;4:76-83.
46. Passeri M, Baroni MC, Pedrazzoni M, Pioli G, Barbagallo M, Costi D, et al. Intermittent treatment with intravenous 4-amino-1- hydroxybutylidene-1,1-bisphosphonate (AHBuBP) in the therapy of postmenopausal osteoporosis. Bone Miner 1991;15:237-47.
47. Rossini M, Gatti D, Girardello S, Braga V, James G, Adami S. Effects of two intermittent alendronate regimens in the prevention or treatment of postmenopausal osteoporosis. Bone 2000;27:119-22.
48. Braga V, Gatti D, Colapietro F, Battaglia E, Righetti D, Prizzi R, et al. Intravenous intermittent neridronate in the treatment of postmenopausal osteoporosis. Bone 2003;33:342-45.
49. Ryan PJ, Blake GM, Davie M, Haddaway M, Gibson T, Fogelman I. Intermittent oral disodium pamidronate in established osteoporosis: a 2 year double-masked placebo-controlled study of efficacy and safety. Osteoporosis Int 2000;11:171-6.
50. Clemmesen B, Ravn P, Zegels B, Taquet AN, Christiansen C, Reginster JY. A 2-year phase II study with 1-year of follow-up of risedronate (NE-58095) in postmenopausal osteoporosis. Osteoporosis Int 1997;7:488-95.
51. Reid IR, Brown JP, Burckhardt P, Horowitz Z, Richardson P, Trechsel U, et al. Intravenous zoledronic acid in postmenopausal women with low bone mineral density. N Engl J Med 2002;346:653-61.
52. Garnero P, Hausherr E, Chapuy MC, Marcelli C, Grandjean H, Muller C, et al. Markers of bone resorption predict hip fracture in elderly women: the EPIDOS Prospective Study. J Bone Miner Res 1996;11:1531-8.
53. Thiebaud D, Burckhardt P, Kriegbaum H, Huss H, Mulder H, Juttmann JR, et al. Three monthly intravenous injections of ibandronate in the treatment of postmenopausal osteoporosis. Am J Med 1997;103:298- 307.
54. 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.
55. Hernandez CJ, Beaupre GS, Marcus R, Carter DR. Long-term predictions of the therapeutic equivalence of daily and less than daily alendronate dosing. J Bone Miner Res 2002;17:1662-6.
56. Gieschke R, Reginster J-Y. Successful prediction of biomarker response to oral monthly ibandronate [abstract]. Osteoporosis Int 2004;15(Suppl 1):S97.
57. Reginster JY, Wilson KM, Dumont E, Bonvoisin B, Barrett J. Monthly oral ibandronate is well tolerated and efficacious in postmenopausal women: results from the monthly oral pilot study. J Clin Endocrinol Metab 2005;90:5018-24.
58. Geusens P, Walliser J, Rovayo R, Kung AWC, Verbruggen N, Shivaprakash M, et al. Week-by-week effects of monthly ibandronate on biochemical markers of bone resorption: results of a 3-month randomized trial [abstract]. Calcif Tissue Int 2006;78(suppl 1):S164.
59. Miller PD, McClung M, Macovei L, Stakkestad JA, Luckey M, Bonvoisin B, et al. Monthly oral ibandronate therapy in postmenopausal osteoporosis: 1-year results from the MOBILE study. J Bone Miner Res 2005;20:1315-22.
60. Reginster J-Y, Adami S, Lakatos P, Greenwald M, Stepan JJ, Silverman SL, et al. Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study. Ann Rheum Dis 2006;65:654-61.
61. Adami S, Felsenberg D, Christiansen C, Robinson J, Lorenc RS, Mahoney P, et al. Efficacy and safety of ibandronate given by intravenous injection once every 3 months. Bone 2004;34:881-9.
62. Christiansen C, Tanko LB, Warming L, Moelgaard A, Christgau S, Ovist P, et al. Dose dependent effects on bone resorption and formation of intermittently administered intravenous ibandronate. Osteoporosis Int 2003;14:609-13.
63. Delmas PD, Adami S, Strugala C, Stakkestad JA, Reginster J-Y, Falsenberg D, et al. Intravenous ibandronate injections in postmenopausal women with osteoporosis. Arthritis Rheum 2006;54:1838-46.
64. Khan SA, Kanis JA, Vasikaran S, Kline WF, Matuszewski BK, McCloskey EV, et al. Elimination and biochemical responses to intravenous alendronate in postmenopausal osteoporosis. J Bone Miner Res 1997;12:1700-7.
65. 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.
66. Bauss F, Russell RGG. Ibandronate in osteoporosis: preclinical data and rationale for intermittent dosing. Osteoporosis Int 2004;15:423-33.
67. Nancollas GH, Tang R, Phipps RJ, Henneman Z, Guide S, Wu W, et al. Novel insights into actions of bisphosphonates on bone: differences in interactions with hydroxyapatite. Bone 2006;38:628-36.
68. Papapoulos SE. Mechanisms of action of bisphosphonates: physical chemistry revisited. Bone 2006;38:613-16.