Long-term fracture rates seen with continued ibandronate treatment: Pooled analysis of DIVA and MOBILE long-term extension studies

Osteoporosis International

Volumn 25, Issue 1, 2014, Pages 349-357

  Miller, P D ^a   Recker, R R ^b   Harris, S ^c   Silverman, S ^d   Felsenberg, D ^e   Reginster, J ^f   Day, B M ^g   Barr, C ^g   Masanauskaite, D ^h  

^a Health Sciences Center and Colorado Center for Bone Research   (United States)

^b CREIGHTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d CEDARS SINAI MEDICAL CENTER   (United States)

^e CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^f UNIVERSITY OF LIÈGE   (Belgium)

^g GENENTECH INC   (United States)

^h F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

Bisphosphonate; Fracture; Ibandronate; Monthly; Osteoporosis; Quarterly

Indexed keywords

IBANDRONIC ACID; PLACEBO;

ADULT; AGED; ARTICLE; FEMALE; FOLLOW UP; FRACTURE; HUMAN; LONG TERM CARE; MAJOR CLINICAL STUDY; MIDDLE AGED; NONVERTEBRAL FRACTURE; OUTCOME ASSESSMENT; POSTMENOPAUSE OSTEOPOROSIS; PRIORITY JOURNAL; RISK FACTOR; SPINE FRACTURE;

ADMINISTRATION, ORAL; AGED; BONE DENSITY; BONE DENSITY CONSERVATION AGENTS; DIPHOSPHONATES; DRUG ADMINISTRATION SCHEDULE; EUROPE; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFUSIONS, INTRAVENOUS; MIDDLE AGED; OSTEOPOROSIS, POSTMENOPAUSAL; OSTEOPOROTIC FRACTURES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SPINAL FRACTURES; UNITED STATES;

EID: 84891890835     PISSN: 0937941X     EISSN: 14332965     Source Type: Journal    
DOI: 10.1007/s00198-013-2518-z     Document Type: Article

References (56)

1. McClung MR (2000) Bisphosphonates in osteoporosis: recent clinical experience. Expert Opin Pharmacother 1:225-238
2. Bliuc D, Nguyen ND, Milch VE, Nguyen TV, Eisman JA, Center JR (2009) Mortality risk associated with low-trauma osteoporotic fracture and subsequent fracture in men and women. JAMA 301:513-521
3. Ioannidis G, Papaioannou A, Hopman WM, Akhtar-Danesh N, Anastassiades T, Pickard L, Kennedy CC, Prior JC, Olszynski WP, Davison KS, Goltzman D, Thabane L, Gafni A, Papadimitropoulos EA, Brown JP, Josse RG, Hanley DA, Adachi JD (2009) Relation between fractures and mortality: results from the Canadian Multicentre Osteoporosis Study. Cmaj 181:265-271
4. Sweet MG, Sweet JM, Jeremiah MP, Galazka SS (2009) Diagnosis and treatment of osteoporosis. Am Fam Physician 79:193-200
5. US Food and Drug Administration (1994) Guidelines for preclinical and clinical evaluation of agents used in the prevention or treatment of postmenopausal osteoporosis, Silver Spring
6. Boonen S, Orwoll ES, Wenderoth D, Stoner KJ, Eusebio R, Delmas PD (2009) Once-weekly risedronate in men with osteoporosis: results of a 2-year, placebo-controlled, double-blind, multicenter study. J Bone Miner Res 24:719-725
7. Delmas PD, McClung MR, Zanchetta JR, Racewicz A, Roux C, Benhamou CL, Man Z, Eusebio RA, Beary JF, Burgio DE, Matzkin E, Boonen S (2008) Efficacy and safety of risedronate 150 mg once a month in the treatment of postmenopausal osteoporosis. Bone 42:36-42 (Pubitemid 350297180)
8. Schnitzer T, Bone HG, Crepaldi G, Adami S, McClung M, Kiel D, Felsenberg D, Recker RR, Tonino RP, Roux C, Pinchera A, Foldes AJ, Greenspan SL, Levine MA, Emkey R, Santora AC 2nd, Kaur A, Thompson DE, Yates J, Orloff JJ (2000) 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) 12:1-12 (Pubitemid 30136655)
9. Eisman JA, Garcia-Hernandez PA, Ortiz-Luna G, Ste-Marie LG, Hughes C, Mairon N, Masanauskaite D, Delmas PD (2006) Intermittent intravenous ibandronate injections are an effective treatment option in postmenopausal osteoporosis: 2-year results from DIVA [abstract P316SA]. Osteoporos Int 17:S212 (Pubitemid 43053583)
10. Bonnick SL, Shulman L (2006) Monitoring osteoporosis therapy: bone mineral density, bone turnover markers, or both? Am J Med 119:S25-S31
11. Hochberg MC, Greenspan S, Wasnich RD, Miller P, Thompson DE, Ross PD (2002) 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 87:1586-1592 (Pubitemid 34615244)
12. Miller PD (2005) Bone density and markers of bone turnover in predicting fracture risk and how changes in these measures predict fracture risk reduction. Curr Osteoporos Rep 3:103-110
13. Miller PD (2007) Monitoring osteoporosis therapies. Curr Osteoporos Rep 5:38-43 (Pubitemid 46447930)
14. Miller PD, Zapalowski C, Kulak CA, Bilezikian JP (1999) Bone densitometry: the best way to detect osteoporosis and to monitor therapy. J Clin Endocrinol Metab 84:1867-1871 (Pubitemid 30647000)
15. Wasnich RD, Miller PD (2000) Antifracture efficacy of antiresorptive agents are related to changes in bone density. J Clin Endocrinol Metab 85:231-236 (Pubitemid 32268819)
16. Miller PD (2012) Bone strength and surrogate markers: the first, second, and third fiddle. J Bone Miner Res 27:1623-1626
17. Chesnut CH, Ettinger MP, Miller PD, Baylink DJ, Emkey R, Harris ST, Wasnich RD, Watts NB, Schimmer RC, Recker RR (2005) Ibandronate produces significant, similar antifracture efficacy in North American and European women: new clinical findings from BONE. Curr Med Res Opin 21:391-401
18. Chesnut CH, Skag A, Christiansen C, Recker R, Stakkestad JA, Hoiseth A, Felsenberg D, Huss H, Gilbride J, Schimmer RC, Delmas PD (2004) Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res 19:1241-1249 (Pubitemid 41094364)
19. Reginster JY, Adami S, Lakatos P, Greenwald M, Stepan JJ, Silverman SL, Christiansen C, Rowell L, Mairon N, Bonvoisin B, Drezner MK, Emkey R, Felsenberg D, Cooper C, Delmas PD, Miller PD (2006) Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study. Ann Rheum Dis 65:654-661
20. Eisman JA, Civitelli R, Adami S, Czerwinski E, Recknor C, Prince R, Reginster JY, Zaidi M, Felsenberg D, Hughes C, Mairon N, Masanauskaite D, Reid DM, Delmas PD, Recker RR (2008) Efficacy and tolerability of intravenous ibandronate injections in postmenopausal osteoporosis: 2-year results from the DIVA study. J Rheumatol 35:488-497 (Pubitemid 351374427)
21. Harris ST, Blumentals WA, Miller PD (2008) 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 24:237-245 (Pubitemid 351160255)
22. Miller PD, McClung MR, Macovei L, Stakkestad JA, Luckey M, Bonvoisin B, Reginster JY, Recker RR, Hughes C, Lewiecki EM, Felsenberg D, Delmas PD, Kendler DL, Bolognese MA, Mairon N, Cooper C (2005) Monthly oral ibandronate therapy in postmenopausal osteoporosis: 1-year results from the MOBILE study. J Bone Miner Res 20:1315-1322 (Pubitemid 41033514)
23. Delmas PD, Adami S, Strugala C, Stakkestad JA, Reginster JY, Felsenberg D, Christiansen C, Civitelli R, Drezner MK, Recker RR, Bolognese M, Hughes C, Masanauskaite D, Ward P, Sambrook P, Reid DM (2006) Intravenous ibandronate injections in postmenopausal women with osteoporosis: one-year results from the dosing intravenous administration study. Arthritis Rheum 54:1838-1846 (Pubitemid 43877933)
24. Cranney A, Wells G, Adachi R (2007) Non-vertebral fracture reduction with high- versus low-dose ibandronate: a meta-analysis of individual patient data. Ann Rheum Dis 66:681
25. Harris ST, Reginster JY, Harley C, Blumentals WA, Poston SA, Barr CE, Silverman SL (2009) Risk of fracture in women treated with monthly oral ibandronate or weekly bisphosphonates: the eValuation of IBandronate Efficacy (VIBE) database fracture study. Bone 44:758-765
26. Silverman SL (2010) Osteoporosis therapies: evidence from health-care databases and observational population studies. Calcif Tissue Int 87:375-384
27. Miller PD, Recker RR, Felsenberg D, Reginster JY, Riis BJ, Czerwinski E, Lorenc RS, Stakkestad JA, Dasic G, Barr CE, Lakatos P (2009) 5-year efficacy and safety of monthly oral ibandronate: results of the MOBILE long-term extension study. Osteoporos Int 20:S191-S229
28. Stakkestad JA, Lakatos P, Lorenc R, Sedarati F, Neate C, Reginster JY (2008) Monthly oral ibandronate is effective and well tolerated after 3 years: the MOBILE long-term extension. Clin Rheumatol 27:955-960
29. Recker R, Stakkestad JA, Chesnut CH III, Christiansen C, Skag A, Hoiseth A, Ettinger M, Mahoney P, Schimmer RC, Delmas PD (2004) Insufficiently dosed intravenous ibandronate injections are associated with suboptimal antifracture efficacy in postmenopausal osteoporosis. Bone 34:890-899 (Pubitemid 38581135)
30. Cranney A, Tugwell P, Adachi J, Weaver B, Zytaruk N, Papaioannou A, Robinson V, Shea B, Wells G, Guyatt G (2002) Meta-analyses of therapies for postmenopausal osteoporosis. III. Meta-analysis of risedronate for the treatment of postmenopausal osteoporosis. Endocr Rev 23:517-523 (Pubitemid 34925645)
31. Cranney A, Wells GA, Yetisir E, Adami S, Cooper C, Delmas PD, Miller PD, Papapoulos S, Reginster JY, Sambrook PN, Silverman S, Siris E, Adachi JD (2009) Ibandronate for the prevention of nonvertebral fractures: a pooled analysis of individual patient data. Osteoporos Int 20:291-297
32. National Osteoporosis Foundation (2008) Clinician's guide to prevention and treatment of osteoporosis. Washington, 1-37
33. Bone HG, Hosking D, Devogelaer JP, Tucci JR, Emkey RD, Tonino RP, Rodriguez-Portales JA, Downs RW, Gupta J, Santora AC, Liberman UA (2004) Ten years' experience with alendronate for osteoporosis in postmenopausal women. N Engl J Med 350:1189-1199 (Pubitemid 38339363)
34. Devogelaer JP, Brown JP, Burckhardt P, Meunier PJ, Goemaere S, Lippuner K, Body JJ, Samsioe G, Felsenberg D, Fashola T, Sanna L, Ortmann CE, Trechsel U, Krasnow J, Eriksen EF, Garnero P (2007) Zoledronic acid efficacy and safety over five years in postmenopausal osteoporosis. Osteoporos Int 18:1211-1218 (Pubitemid 47300276)
35. Boonen S, Ferrari S, Miller PD, Eriksen EF, Sambrook PN, Compston J, Reid IR, Vanderschueren D, Cosman F (2012) Postmenopausal osteoporosis treatment with antiresorptives: effects of discontinuation or long-term continuation on bone turnover and fracture risk-a perspective. J Bone Miner Res 27:963-974
36. Khosla S, Bilezikian JP, Dempster DW, Lewiecki EM, Miller PD, Neer RM, Recker RR, Shane E, Shoback D, Potts JT (2012) Benefits and risks of bisphosphonate therapy for osteoporosis. J Clin Endocrinol Metab 97:2272-2282
37. McClung M, Harris ST, Miller PD, Bauer DC, Davison KS, Dian L, Hanley DA, Kendler DL, Yuen CK, Lewiecki EM (2013) Bisphosphonate therapy for osteoporosis: benefits, risks, and drug holiday. Am J Med 126:13-20
38. Whitaker M, Guo J, Kehoe T, Benson G (2012) Bisphosphonates for osteoporosis-where do we go from here? N Engl J Med 366:2048-2051
39. Reginster J, Minne HW, Sorensen OH, Hooper M, Roux C, Brandi ML, Lund B, Ethgen D, Pack S, Roumagnac I, Eastell R (2000) 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 (Pubitemid 30099515)
40. Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA, Cosman F, Lakatos P, Leung PC, Man Z, Mautalen C, Mesenbrink P, Hu H, Caminis J, Tong K, Rosario-Jansen T, Krasnow J, Hue TF, Sellmeyer D, Eriksen EF, Cummings SR (2007) Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 356:1809-1822 (Pubitemid 46698462)
41. Cummings SR, Black DM, Thompson DE, Applegate WB, Barrett-Connor E, Musliner TA, Palermo L, Prineas R, Rubin SM, Scott JC, Vogt T, Wallace R, Yates AJ, LaCroix AZ (1998) 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 (Pubitemid 29014065)
42. McClung MR, Geusens P, Miller PD, Zippel H, Bensen WG, Roux C, Adami S, Fogelman I, Diamond T, Eastell R, Meunier PJ, Reginster JY (2001) Effect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group. N Engl J Med 344:333-340 (Pubitemid 32107641)
43. Black DM, Reid IR, Boonen S, Bucci-Rechtweg C, Cauley JA, Cosman F, Cummings SR, Hue TF, Lippuner K, Lakatos P, Leung PC, Man Z, Martinez RL, Tan M, Ruzycky ME, Su G, Eastell R (2012) The effect of 3 versus 6 years of zoledronic acid treatment of osteoporosis: a randomized extension to the HORIZON-Pivotal Fracture Trial (PFT). J Bone Miner Res 27:243-254
44. Sorensen OH, Crawford GM, Mulder H, Hosking DJ, Gennari C, Mellstrom D, Pack S, Wenderoth D, Cooper C, Reginster JY (2003) Long-term efficacy of risedronate: a 5-year placebo-controlled clinical experience. Bone 32:120-126 (Pubitemid 36299139)
45. Black DM, Schwartz AV, Ensrud KE, Cauley JA, Levis S, Quandt SA, Satterfield S, Wallace RB, Bauer DC, Palermo L, Wehren LE, Lombardi A, Santora AC, Cummings SR (2006) Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX): a randomized trial. JAMA 296:2927-2938 (Pubitemid 46021497)
46. Schwartz AV, Bauer DC, Cummings SR, Cauley JA, Ensrud KE, Palermo L, Wallace RB, Hochberg MC, Feldstein AC, Lombardi A, Black DM (2010) Efficacy of continued alendronate for fractures in women with and without prevalent vertebral fracture: the FLEX trial. J Bone Miner Res 25:976-982
47. Kwek EB, Koh JS, Howe TS (2008) More on atypical fractures of the femoral diaphysis. N Engl J Med 359:316-317, author reply 317-318
48. Lee P, Seibel MJ (2008) More on atypical fractures of the femoral diaphysis. N Engl J Med 359:317, author reply 317-318 (Pubitemid 352008465)
49. Lenart BA, Lorich DG, Lane JM (2008) Atypical fractures of the femoral diaphysis in postmenopausal women taking alendronate. N Engl J Med 358:1304-1306 (Pubitemid 351439247)
50. Odvina CV, Zerwekh JE, Rao DS, Maalouf N, Gottschalk FA, Pak CY (2005) Severely suppressed bone turnover: a potential complication of alendronate therapy. J Clin Endocrinol Metab 90:1294-1301 (Pubitemid 40463979)
51. Visekruna M, Wilson D, McKiernan FE (2008) Severely suppressed bone turnover and atypical skeletal fragility. J Clin Endocrinol Metab 93:2948-2952
52. Dell RM, Adams AL, Greene DF, Funahashi TT, Silverman SL, Eisemon EO, Zhou H, Burchette RJ, Ott SM (2012) Incidence of atypical nontraumatic diaphyseal fractures of the femur. J Bone Miner Res 27:2544-2550
53. Schilcher J, Koeppen V, Ranstam J, Skripitz R, Michaelsson K, Aspenberg P (2013) Atypical femoral fractures are a separate entity, characterized by highly specific radiographic features. A comparison of 59 cases and 218 controls. Bone 52:389-392
54. Shane E, Burr D, Ebeling PR, Abrahamsen B, Adler RA, Brown TD, Cheung AM, Cosman F, Curtis JR, Dell R, Dempster D, Einhorn TA, Genant HK, Geusens P, Klaushofer K, Koval K, Lane JM, McKiernan F, McKinney R, Ng A, Nieves J, O'Keefe R, Papapoulos S, Sen HT, van der Meulen MC, Weinstein RS, Whyte M (2010) 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
55. Berlin JA, Santanna J, Schmid CH, Szczech LA, Feldman HI (2002) Individual patient- versus group-level data meta-regressions for the investigation of treatment effect modifiers: ecological bias rears its ugly head. Stat Med 21:371-387 (Pubitemid 34144648)
56. Li Z, Meredith MP (2003) Exploring the relationship between surrogates and clinical outcomes: analysis of individual patient data vs. meta-regression on group-level summary statistics. J Biopharm Stat 13:777-792 (Pubitemid 37259717)