Osteoporosis management: A perspective based on bisphosphonate data from randomised clinical trials and observational databases

International Journal of Clinical Practice

Volumn 63, Issue 12, 2009, Pages 1792-1804

  Boonen, S ^a   Kay, R ^b   Cooper, C ^c   Haentjens, P ^d   Vanderschueren, D ^a   Callewaert, F ^a   Milisen, K ^a   Ferrari, S ^e  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^b Department of Rkstatistics ^*  (United Kingdom)

^c UNIVERSITY OF SOUTHAMPTON   (United Kingdom)

^d VRIJE UNIVERSITEIT BRUSSEL   (Belgium)

^e UNIVERSITY HOSPITAL   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ALENDRONIC ACID; BISPHOSPHONIC ACID DERIVATIVE; CALCITONIN; IBANDRONIC ACID; PLACEBO; RALOXIFENE; RISEDRONIC ACID; ZOLEDRONIC ACID;

ADD ON THERAPY; BONE DENSITY; CLINICAL EVALUATION; CLINICAL TRIAL; DATA BASE; DRUG EFFICACY; DRUG MEGADOSE; DRUG WITHDRAWAL; FOLLOW UP; HORMONE SUBSTITUTION; HUMAN; MEDICAL LITERATURE; OBSERVATIONAL STUDY; OSTEOPOROSIS; OUTCOME ASSESSMENT; POSTMENOPAUSE; POSTMENOPAUSE OSTEOPOROSIS; PRIORITY JOURNAL; REVIEW; RISK REDUCTION; SAMPLE SIZE; TREATMENT DURATION; TREATMENT OUTCOME;

BONE DENSITY CONSERVATION AGENTS; BONE REMODELING; DIPHOSPHONATES; FEMALE; FRACTURES, BONE; HUMANS; OSTEOPOROSIS, POSTMENOPAUSAL; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK FACTORS;

EID: 70449445708     PISSN: 13685031     EISSN: 17421241     Source Type: Journal    
DOI: 10.1111/j.1742-1241.2009.02206.x     Document Type: Review

References (90)

1. Reginster JY, Burlet N. Osteoporosis: a still increasing prevalence. Bone 2006 38 (Suppl. 1 S4 9.
2. Häussler B, Gothe H, Göl D et al. Epidemiology, treatment and costs of osteoporosis in Germany - the BoneEVA Study. Osteoporos Int 2007 18 : 77 84.
3. Morales-Torres J, Gutiérrez-Ureña S. Osteoporosis committee of Pan-American league of associations for rheumatology. The burden of osteoporosis in Latin America. Osteoporos Int 2004 15 : 625 632.
4. Maalouf G, Gannagé-Yared MH, Ezzedine J et al. Middle East and North Africa consensus on osteoporosis. J Musculoskelet Neuronal Interact 2007 7 : 131 143.
5. Hou YL, Wu XP, Luo XH et al. Differences in age-related bone mass of proximal femur between Chinese women and different ethnic women in the United States. J Bone Miner Metab 2007 25 : 243 252.
6. Borgström F, Sobocki P, Ström O et al. The societal burden of osteoporosis in Sweden. Bone 2007 40 : 1602 1609.
7. Burge RT, Dawson-Hughes B, Solomon DH et al. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res 2007 22 : 465 475.
8. Cooper C. The crippling consequences of fractures and their impact on quality of life. Am J Med 1997 18 : 12S 7S.
9. Silverman SL. Quality-of-life issues in osteoporosis. Curr Rheumatol Rep 2005 7 : 39 45.
10. Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int 2006 17 : 1726 1733.
11. Bonnick S, Broy S, Kaiser F et al. Treatment with alendronate plus calcium, alendronate alone, or calcium alone for postmenopausal low bone mineral density. Curr Med Res Opin 2007 23 : 1341 1349.
12. 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. Osteoporos Int 1999 9 : 461 468.
13. Liberman UA, Weiss SR, Bröll J 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 1443.
14. Greenspan SL, Schneider DL, McClung MR et al. Alendronate improves bone mineral density in elderly women with osteoporosis residing in long-term care facilities. A randomized, double-blind, placebo-controlled trial. Ann Intern Med 2002 136 : 742 746.
15. Fogelman I, Ribot C, Smith R et al. Risedronate reverses bone loss in postmenopausal women with low bone mass: results from a multinational, double-blind, placebo-controlled trial. J Clin Endocrin Metab 2000 85 : 1895 1900.
16. Yan Y, Wang W, Zhu H et al. The efficacy and tolerability of once-weekly alendronate 70 mg on bone mineral density and bone turnover markers in postmenopausal Chinese women with osteoporosis. J Bone Miner Metab 2009 27 : 471 478.
17. McClung MR, Bolognese MA, Sedarati F et al. Efficacy and safety of monthly ibandronate in the prevention of postmenopausal bone loss. Bone 2009 44 : 418 422.
18. Brown JP, Albert C, Nasser BA et al. Bone turnover markers in the management of postmenopausal osteoporosis. Clin Biochem 2009 42 : 929 942.
19. Bergmann P, Body JJ, Boonen S et al. Evidence-based guidelines for the use of biochemical markers of bone turnover in the selection and monitoring of bisphosphonate treatment in osteoporosis: a consensus document of the Belgian Bone Club. Int J Clin Pract 2009 63 : 19 26.
20. Committee for Medicinal Products for Human Use (CHMP). Guideline on the Evaluation of new Medicinal Products in the Treatment of Primary Osteoporosis. CPMP-EWP-552-95 Rev. 2. European Medicines Agency, London, 2005.
21. Rosen CJ, Hochberg MC, Bonnick SL et al. Treatment with once-weekly alendronate 70 mg compared with once-weekly risedronate 35 mg in women with postmenopausal osteoporosis: a randomized double-blind study. J Bone Miner Res 2005 20 : 141 151.
22. 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 2082.
23. Bonnick S, Saag KG, Kiel DP et al. Comparison of weekly treatment of postmenopausal osteoporosis with alendronate versus risedronate over two years. J Clin Endocrinol Metab 2006 91 : 2631 2637.
24. Dowd R, Recker RR, Heaney RP. Study subjects and ordinary patients. Osteoporos Int 2000 11 : 533 536.
25. Black DM, Schwartz AV, Ensrud KE et al. Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX): a randomized trial. JAMA 2006 296 : 2927 2938.
26. Motheral B, Brooks J, Clark MA et al. A checklist for retrospective database studies - report of the ISPOR Task Force on Retrospective Databases. Value Health 2003 6 : 90 7.
27. Vray M, Hamelin B, Jaillon P et al. The respective roles of controlled clinical trials and cohort monitoring studies in the pre- and postmarketing assessment of drugs. Therapie 2005 60 : 339 344.
28. Berecki-Gisolf J, Hockey R, Dobson A. Adherence to bisphosphonate treatment by elderly women. Menopause 2008 15 : 984 990.
29. Black DM, Cummings SR, Karpf DB et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Lancet 1996 348 : 1535 1541.
30. Harris ST, Watts NB, Genant HK et al. Effects of risedronate treatment on vertebral and non-vertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. JAMA 1999 282 : 1344 1352.
31. Reginster J, Minne HW, Sorensen OH et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Osteoporos Int 2000 11 : 83 91.
32. McClung MR, Geusens P, Miller PD et al. Effect of risedronate on the risk of hip fracture in elderly women. N Engl J Med 2001 344 : 333 340.
33. Black DM, Delmas PD, Eastell R et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 2007 356 : 1809 1822.
34. Lyles KW, Colón-Emeric CS, Magaziner JS et al. Zoledronic acid and clinical fracture and mortality after hip fracture. N Engl J Med 2007 357 : 1799 1809.
35. Chesnut CH 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 1249.
36. Reid DM, Hosking D, Kendler D et al. Alendronic acid produces greater effects than risedronic acid on bone density and turnover in postmenopausal women with osteoporosis: results of FACTS-international. Clin Drug Investig 2006 26 : 63 74.
37. Miller PD, Epstein S, Sedarati F et al. Once-monthly oral ibandronate compared with weekly oral alendronate in postmenopausal osteoporosis: results from the head-to-head MOTION study. Curr Med Res Opin 2008 24 : 207 213.
38. Delmas PD, Recker RR, Chesnut CH III. 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 : 792 798.
39. Boonen S, Haentjens P, Vandenput L et al. Preventing osteoporotic fractures with antiresorptive therapy: implications of microarchitectural changes. J Intern Med 2004 255 : 1 12.
40. Watts NB, Cooper C, Lindsay R et al. Relationship between changes in bone mineral density and vertebral fracture risk associated with risedronate: greater increases in bone mineral density do not relate to greater decreases in fracture risk. J Clin Densitom 2004 7 : 255 261.
41. Watts NB, Geusens P, Barton IP et al. Relationship between changes in BMD and nonvertebral fracture incidence associated with risedronate: reduction in risk of nonvertebral fracture is not related to change in BMD. J Bone Miner Res 2005 20 : 2097 2104.
42. Sebba AI, Emkey RD, Kohles JD et al. Ibandronate dose response is associated with increases in bone mineral density and reductions in clinical fractures: results of a meta-analysis. Bone 2009 44 : 423 427.
43. 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 1056.
44. Delmas P, Munoz F, Black D et al. Effects of yearly zoledronic acid 5 mg on bone turnover markers and relation of PINP with fracture reduction in postmenopausal women with osteoporosis. J Bone Miner Res 2009 24 : 1544 1551.
45. Ensrud KE, Black DM, Palermo L et al. Treatment with alendronate prevents fractures in women at highest risk: results from the Fracture Intervention Trial. Arch Intern Med 1997 157 : 2617 2624.
46. Hochberg MC, Thompson DE, Black DM et al. Effect of alendronate on the age-specific incidence of symptomatic osteoporotic fractures. J Bone Miner Res 2005 20 : 971 976.
47. Cranney A, Guyatt G, Griffith L et al. Meta-analyses of therapies for postmenopausal osteoporosis. IX: summary of meta-analyses of therapies for postmenopausal osteoporosis. Endocr Rev 2002 23 : 570 578.
48. Black DM, Thompson DE, Bauer DC et al. Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial. J Clin Endocrinol Metab 2000 85 : 4118 4124.
49. Cranney A, Wells G, Willan A et al. Meta-analyses of therapies for postmenopausal osteoporosis. II. Meta-analysis of alendronate for the treatment of postmenopausal women. Endocr Rev 2002 23 : 508 516.
50. Seeman E. The antifracture efficacy of alendronate. Int J Clin Pract Suppl 1999 101 : 40 5.
51. Stevenson M, Jones ML, De Nigris E et al. A systematic review and economic evaluation of alendronate, etidronate, risedronate, raloxifene and teriparatide for the prevention and treatment of postmenopausal osteoporosis. Health Technol Assess 2005 9 : 1 160.
52. Boonen S, Laan RF, Barton IP et al. Effect of osteoporosis treatments on risk of non-vertebral fractures: review and meta-analysis of intention-to-treat studies. Osteoporos Int 2005 16 : 1291 1298.
53. Karpf DB, Shapiro DR, Seeman E et al. Prevention of nonvertebral fractures by alendronate. A meta-analysis. JAMA 1997 277 : 1159 1164.
54. Liberman UA, Hochberg MC, Geusens P et al. Hip and non-spine fracture risk reductions differ among antiresorptive agents: Evidence from randomised controlled trials. Int J Clin Pract 2006 60 : 1394 1400.
55. Nguyen ND, Eisman JA, Nguyen TV. Anti-hip fracture efficacy of bisphosphonates: a Bayesian analysis of clinical trials. J Bone Miner Res 2006 21 : 340 349.
56. Papapoulos SE, Quandt SA, Liberman UA et al. Meta-analysis of the efficacy of alendronate for the prevention of hip fractures in postmenopausal women. Osteoporos Int 2005 16 : 468 474.
57. Wells G, Cranney A, Peterson J et al. Alendronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database Syst Rev 2008 CD001155.
58. Felsenberg D, Miller P, Armbrecht G et al. Oral ibandronate significantly reduces the risk of vertebral fractures of greater severity after 1, 2, and 3 years in postmenopausal women with osteoporosis. Bone 2005 37 : 651 654.
59. Harris ST, Blumentals WA, Miller PD. Ibandronate and the risk of non-vertebral and clinical fractures in women with postmenopausal osteoporosis: results of a meta-analysis of phase III studies. Curr Med Res Opin 2008 24 : 237 245.
60. Roux C, Seeman E, Eastell R et al. Efficacy of risedronate on clinical vertebral fractures within six months. Curr Med Res Opin 2004 20 : 433 439.
61. Cranney A, Tugwell P, Adachi J et al. Meta-analyses of therapies for postmenopausal osteoporosis. III. Meta-analysis of risedronate for the treatment of postmenopausal osteoporosis. Endocr Rev 2002 23 : 517 523.
62. Adachi JD, Rizzoli R, Boonen S et al. Vertebral fracture risk reduction with risedronate in post-menopausal women with osteoporosis: a meta-analysis of individual patient data. Aging Clin Exp Res 2005 17 : 150 156.
63. Boonen S, McClung MR, Eastell R et al. Safety and efficacy of risedronate in reducing fracture risk in osteoporotic women aged 80 and older: implications for the use of antiresorptive agents in the old and oldest old. J Am Geriatr Soc 2004 52 : 1832 1839.
64. Heaney RP, Zizic TM, Fogelman I et al. Risedronate reduces the risk of first vertebral fracture in osteoporotic women. Osteoporos Int 2002 13 : 501 505.
65. Kanis JA, Barton IP, Johnell O. Risedronate decreases fracture risk in patients selected solely on the basis of prior vertebral fracture. Osteoporos Int 2005 16 : 475 482.
66. Watts NB, Josse RG, Hamdy RC et al. Risedronate prevents new vertebral fractures in postmenopausal women at high risk. J Clin Endocrinol Metab 2003 88 : 542 549.
67. Harrington JT, Ste-Marie LG, Brandi ML et al. Risedronate rapidly reduces the risk for nonvertebral fractures in women with postmenopausal osteoporosis. Calcif Tissue Int 2004 74 : 129 135.
68. Wells G, Cranney A, Peterson J et al. Risedronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database Syst Rev 2008 CD004523.
69. Sebba AI, Bonnick SL, Kagan R et al. Response to therapy with once-weekly alendronate 70 mg compared to once-weekly risedronate 35 mg in the treatment of postmenopausal osteoporosis. Curr Med Res Opin 2004 20 : 2031 2041.
70. Tonino RP, Meunier PJ, Emkey R et al. Skeletal benefits of alendronate: 7-year treatment of postmenopausal osteoporotic women. J Clin Endocrinol Metab 2000 85 : 3109 3115.
71. 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 1199.
72. Ensrud KE, Barrett-Connor EL, Schwartz A et al. Randomized trial of effect of alendronate continuation versus discontinuation in women with low BMD: results from the Fracture Intervention Trial long-term extension. J Bone Miner Res 2004 19 : 1259 1269.
73. Sorensen OH, Crawford GM, Mulder H et al. Long-term efficacy of risedronate: a 5-year placebo-controlled clinical experience. Bone 2003 32 : 120 126.
74. Mellstrom DD, Sorensen OH, Goemaere S et al. Seven years of treatment with risedronate in women with postmenopausal osteoporosis. Calcif Tissue Int 2004 75 : 462 468.
75. Watts NB, Chines A, Olszynski WP et al. Fracture risk remains reduced one year after discontinuation of risedronate. Osteoporos Int 2008 19 : 365 372.
76. Devogelaer JP, Brown JP, Burckhardt P et al. Zoledronic acid efficacy and safety over five years in postmenopausal osteoporosis. Osteoporos Int 2007 18 : 1211 1218.
77. Reid DM, Hosking D, Kendler D et al. A comparison of the effect of alendronate and risedronate on bone mineral density in postmenopausal women with osteoporosis: 24-month results from FACTS-International. Int J Clin Pract 2008 62 : 575 584.
78. Adami S, Isaia G, Luisetto G et al. Fracture incidence and characterization in patients on osteoporosis treatment: the ICARO study. J Bone Miner Res 2006 21 : 1565 1570.
79. Adami S, Isaia G, Luisetto G et al. Osteoporosis treatment and fracture incidence: the ICARO longitudinal study. Osteoporos Int 2008 19 : 1219 1223.
80. McCombs JS, Thiebaud P, McLaughlin-Miley C et al. Compliance with drug therapies for the treatment and prevention of osteoporosis. Maturitas 2004 48 : 271 287.
81. Siris ES, Harris ST, Rosen CJ et al. Adherence to bisphosphonate therapy and fracture rates in osteoporotic women: relationship to vertebral and nonvertebral fractures from 2 US claims databases. Mayo Clin Proc 2006 81 : 1013 1022.
82. van den Boogaard CH, Breekveldt-Postma NS, Borggreve SE et al. Persistent bisphosphonate use and the risk of osteoporotic fractures in clinical practice: a database analysis study. Curr Med Res Opin 2006 22 : 1757 1764.
83. Gold DT, Martin BC, Frytak JR et al. A claims database analysis of persistence with alendronate therapy and fracture risk in post-menopausal women with osteoporosis. Curr Med Res Opin 2007 23 : 585 594.
84. Watts NB, Worley K, Solis A et al. Comparison of risedronate to alendronate and calcitonin for early reduction of nonvertebral fracture risk: results from a managed care administrative claims database. J Manag Care Pharm 2004 10 : 142 151.
85. Silverman SL, Watts NB, Delmas PD et al. Effectiveness of bisphosphonates on nonvertebral and hip fractures in the first year of therapy: the risedronate and alendronate (REAL) cohort study. Osteoporos Int 2007 18 : 25 34.
86. Cadarette SM, Katz JN, Brookhart MA et al. Relative effectiveness of osteoporosis drugs for preventing nonvertebral fracture. Ann Intern Med 2008 148 : 637 646.
87. Curtis JR, Westfall AO, Cheng H et al. RisedronatE and ALendronate Intervention over Three Years (REALITY): minimal differences in fracture risk reduction. Osteoporos Int 2009 20 : 973 978.
88. Harris ST, Reginster JY, Harley C et al. Risk of fracture in women treated with monthly oral ibandronate or weekly bisphosphonates: The eValuation of IBandronate Efficacy (VIBE) database fracture study. Bone 2009 44 : 758 765.
89. Arabi A, Baddoura R, Awada H et al. Discriminative ability of dual-energy X-ray absorptiometry site selection in identifying patients with osteoporotic fractures. Bone 2007 40 : 1060 1065.
90. Cranney A, Tugwell P, Wells G. Osteoporosis Methodology Group and The Osteoporosis Research Advisory Group. Meta-analyses of therapies for postmenopausal osteoporosis. I. Systematic reviews of randomized trials in osteoporosis: introduction and methodology. Endocr Rev 2002 23 : 496 507.