Methods to examine the impact of compliance to osteoporosis pharmacotherapy on fracture risk: Systematic review and recommendations

Therapeutic Advances in Chronic Disease

Volumn 1, Issue 4, 2010, Pages 149-162

  Nikitovic, Milica ^a   Solomon, Daniel H ^b   Cadarette, Suzanne M ^a  

^a UNIVERSITY OF TORONTO   (Canada)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

bone; fracture; medication adherence; osteoporosis; research design

Indexed keywords

ALENDRONIC ACID; BISPHOSPHONIC ACID DERIVATIVE; CALCITONIN; ETIDRONIC ACID; GLUCOCORTICOID; IBANDRONIC ACID; PARATHYROID HORMONE[1-34]; RALOXIFENE; RISEDRONIC ACID; STRONTIUM RANELATE;

BONE DENSITY; COMORBIDITY; DRUG EFFICACY; DRUG REEXPOSURE; DRUG SUBSTITUTION; FRACTURE; HEALTH CARE UTILIZATION; HUMAN; LONG TERM CARE; METHODOLOGY; OSTEOLYSIS; OSTEOPOROSIS; OUTCOME ASSESSMENT; PATIENT ATTITUDE; PATIENT COMPLIANCE; PHARMACOEPIDEMIOLOGY; PRIMARY PREVENTION; PRIORITY JOURNAL; REVIEW; RISK FACTOR; SECONDARY PREVENTION; SENSITIVITY ANALYSIS; SYSTEMATIC REVIEW;

EID: 79952945103     PISSN: 20406223     EISSN: None     Source Type: Journal    
DOI: 10.1177/2040622310376137     Document Type: Review

References (63)

1. Adami, S., Isaia, G., Luisetto, G., Minisola, S., Sinigaglia, L., Gentilella, R. et al. (2006) Fracture incidence characterization in patients on osteoporosis treatment: the ICARO study. J Bone Miner Res 21: 1565-1570.
2. Andrade, S.E., Kahler, K.H., Frech, F. and Chan, K.A. ( 2006) Methods for evaluation of medication adherence and persistence using automated databases. Pharmacoepidemiol Drug Saf 15: 565-574.
3. Anonymous (1993) Consensus development conference: diagnosis, prophylaxis, and treatment of osteoporosis. Am J Med 94: 646-650.
4. Black, D.M., Schwartz, A.V., Ensrud, K.E., Cauley, J.A., Levis, S., Quandt, S.A. et al. (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.
5. Blouin, J., Dragomir, A., Moride, Y., Ste-Marie, L.G., Fernandes, J.C. and Perreault, S. ( 2008) Impact of noncompliance with alendronate and risedronate on the incidence of nonvertebral osteoporotic fractures in elderly women. Br J Clin Pharmacol 66: 117-127.
6. Briesacher, B.A., Andrade, S.E., Yood, R.A. and Kahler, K.H. ( 2007) Consequences of poor compliance with bisphosphonates. Bone 41: 882-887.
7. Brookhart, M.A., Avorn, J., Katz, J.N., Finkelstein, J.S., Arnold, M., Polinski, J.M. et al. (2007 a) Gaps in treatment among users of osteoporosis medications: the dynamics of noncompliance. Am J Med 120: 251-256.
8. Brookhart, M.A., Patrick, A.R., Dormuth, C., Avorn, J., Shrank, W.S., Cadarette, S.M. et al. (2007 b) Adherence to lipid-lowering therapy and the use of preventive health care services: an investigation of the healthy user effect. Am J Epidemiol 166: 348-354.
9. Brookhart, M.A., Patrick, A.R., Shrank, W.H. and Dormuth, C.R. (2010) Validating studies of adherence through the use of control outcomes and exposures. Am J Hypertens 23: 110.
10. Cadarette, S.M. and Burden, A.M. (2010) Measuring and improving adherence to osteoporosis pharmacotherapy. Curr Opin Rheumatol 22: 397-403.
11. Cadarette, S.M., Katz, J.N., Brookhart, M.A., Stürmer, T., Stedman, M.R. and Solomon, D.H. ( 2008) Relative effectiveness of osteoporosis drugs for preventing nonvertebral fracture. Ann Intern Med 148: 637-646.
12. Cadarette, S.M., Solomon, D.H., Katz, J.N., Patrick, A.R. and Brookhart, M.A. ( 2010) Adherence to osteoporosis drugs and fracture prevention: no evidence of healthy adherer bias in a frail cohort of seniors. Osteoporos Int, in press (DOI: 10.1007/ s00198-010-1309-z).
13. Caro, J.J., Ishak, K.J., Huybrechts, K.F., Raggio, G. and Naujoks, C. ( 2004) The impact of compliance with osteoporosis therapy on fracture rates in actual practice. Osteoporos Int 15: 1003-1008.
14. Cotte, F.E., Mercier, F. and de Pouvourville, G. ( 2008) Relationship between compliance and persistence with osteoporosis medications and fracture risk in primary health care in France: a retrospective case-control analysis. Clin Ther 30: 2410-2422.
15. Cramer, J.A., Silverman, S.L. and Gold, D.T. ( 2007) Methodological considerations in using claims databases to evaluate persistence with bisphosphonates for osteoporosis. Curr Med Res Opin 23: 2369-2377.
16. Cranney, A., Guyatt, G., Griffith, L., Wells, G., Tugwell, P., Rosen, C. et al. (2002) IX: Summary of meta-analyses of therapies for postmenopausal osteoporosis. Endocrine Rev 23: 570-578.
17. Curtis, J.R., Westfall, A.O., Cheng, H., Delzell, E. and Saag, K.G. ( 2008a) Risk of hip fracture after bisphosphonate discontinuation: implications for a drug holiday. Osteoporos Int 19: 1613-1620.
18. Curtis, J.R., Westfall, A.O., Cheng, H., Lyles, K., Saag, K.G. and Delzell, E. ( 2008b) Benefit of adherence with bisphosphonates depends on age and fracture type: results from an analysis of 101,038 new bisphosphonate users. J Bone Miner Res 23: 1435-1441.
19. Curtis, J.R., Westfall, A.O., Cheng, H., Saag, K.G. and Delzell, E. ( 2009) RisedronatE and ALendronate Intervention over Three Years (REALITY): minimal differences in fracture risk reduction. Osteoporos Int 20: 973-978.
20. Feldstein, A.C., Weycker, D., Nichols, G.A., Oster, G., Rosales, G., Boardman, D.L. et al. (2009) Effectiveness of bisphosphonate therapy in a community setting. Bone 44: 153-159.
21. Gallagher, A.M., Rietbrock, S., Olson, M. and van Staa, T.P. ( 2008) Fracture outcomes related to persistence and compliance with oral bisphosphonates. J Bone Miner Res 23 (10): 1569-1575.
22. Geusens, P. ( 2009) Bisphosphonates for postmenopausal osteoporosis: determining duration of treatment. Curr Osteoporos Rep 7: 12-17.
23. Gold, D.T., Martin, B.C., Frytak, J.R., Amonkar, M.M. and Cosman, F. ( 2007) A claims database analysis of persistence with alendronate therapy and fracture risk in post-menopausal women with osteoporosis. Curr Med Res Opin 23: 585-594.
24. Granger, B.B., Swedberg, K., Ekman, I., Granger, C.B., Olofsson, B., McMurray, J.J. et al. (2005) Adherence to candesartan and placebo and outcomes in chronic heart failure in the CHARM programme: double-blind, randomised, controlled clinical trial. Lancet 366: 2005-2011.
25. Grymonpre, R., Cheang, M., Fraser, M., Metge, C. and Sitar, D.S. ( 2006) Validity of a prescription claims database to estimate medication adherence in older persons. Med Care 44: 471-477.
26. Gwadry-Sridhar, F.H., Manias, E., Zhang, Y., Roy, A., Yu-Isenberg, K., Hughes, D.A. et al. (2009) A framework for planning and critiquing medication compliance and persistence research using prospective study designs. Clin Ther 31: 421-435.
27. Harrington, J., St-Marie, L.G., Brandi, M., Civitelli, R., Fardellone, P., Grauer, A. et al. (2004) Risedronate rapidly reduces the risk for nonvertebral fracture in women with postmenopausal osteoporosis. Calcif Tissue Int 74: 129-135.
28. Hoer, A., Seidlitz, C., Gothe, H., Schiffhorst, G., Olson, M., Hadji, P. et al. (2009) Influence on persistence and adherence with oral bisphosphonates on fracture rates in osteoporosis. Patient Preference Adherence 3: 25-30.
29. Huybrechts, K.F., Ishak, K.J. and Caro, J.J. ( 2006) Assessment of compliance with osteoporosis treatment and its consequences in a managed care population. Bone 38: 922-928.
30. Imaz, I., Zegarra, P., Gonzalez-Enriquez, J., Rubio, B., Alcazar, R. and Amate, J.M. ( 2009) Poor bisphosphonate adherence for treatment of osteoporosis increases fracture risk: systematic review and meta-analysis. Osteoporos Int, in press (DOI: 10.1007/s00198-009-1134-4).
31. International Society for Pharmaco Economics and Outcomes Research (2009) ISPOR medication compliance and persistence Special Interest Group (SIG) analysis standards http://www.ispororg/sigs/SIGProject-list12-08pdf (accessed December 2009).
32. Kothawala, P., Badamgarav, E., Ryu, S., Miller, R.M. and Halbert, R.J. ( 2007) Systematic review and meta-analysis of real-world adherence to drug therapy for osteoporosis. Mayo Clin Proc 82: 1493-1501.
33. MacLean, C., Newberry, S., Maglione, M., McMahon, M., Ranganath, V., Suttorp, M. et al. (2008) Systematic review: comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis. Ann Intern Med 148: 197-213.
34. McCombs, J.S., Thiebaud, P., McLaughlin-Miley, C. and Shi, J. ( 2004) Compliance with drug therapies for the treatment and prevention of osteoporosis. Maturitas 48: 271-287.
35. Meijer, W.M., Penning-van Beest, F.J.A., Olson, M. and Herings, R.M. ( 2008) Relationship between duration of compliant bisphosphonate use and the risk of osteoporotic fractures. Curr Med Res Opin 24: 3217-3222.
36. Melo, M., Qiu, F., Sykora, K., Juurlink, D., Laupacis, A. and Mamdani, M. ( 2006) Persistence with bisphosphonate therapy in older people. J Am Geriatr Soc 54: 1015-1016.
37. Morin, S., Rahme, E., Behlouli, H., Tenenhouse, A., Goltzman, D. and Pilote, L. ( 2007) Effectiveness of antiresorptive agents in the prevention of recurrent hip fractures. Osteoporos Int 18: 1625-1632.
38. O'Donnell, S., Cranney, A., Wells, G.A., Adachi, J.D. and Reginster, J.Y. ( 2006) Strontium ranelate for preventing and treating postmenopausal osteoporosis. Cochrane Database Systematic Rev 4: CD005326.
39. Papaioannou, A., Ioannidis, G., Adachi, J.D., Sebaldt, R.J., Ferko, N., Puglia, M. et al. (2003) Adherence to bisphosphonates and hormone replacement therapy in a tertiary care setting of patients in the CANDOO database. Osteoporos Int 14: 808-813.
40. Papaioannou, A., Kennedy, C.C., Dolovich, L., Lau, E. and Adachi, J.D. ( 2007) Patient adherence to osteoporosis medications: problems, consequences and management strategies. Drugs Aging 24: 37-55.
41. Penning-van Beest, F.J.A., Erkens, J.A., Olson, M. and Herings, R.M.C. ( 2008) Loss of treatment benefit due to low compliance with bisphosphonate therapy. Osteoporos Int 19: 511-517.
42. Peterson, A.M., Nau, D.P., Cramer, J.A., Benner, J., Gwadry-Sridhar, F., Nichol, M. et al. (2007) A checklist for medication compliance and persistence studies using retrospective databases. Value Health 10: 3-12.
43. Pols, H.A., Felsenberg, D., Hanley, D.A., Stepan, J., Munoz-Torres, M., Wilkin, T.J. et al. (1999) 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 9: 461-468.
44. Qaseem, A., Snow, V., Shekelle, P., Hopkins Jr, R., Forciea, M.A. and Owens, D.K. ( 2008) Pharmacologic treatment of low bone density or osteoporosis to prevent fractures: a clinical practice guideline from the American College of Physicians. Ann Internal Med 149: 404-415.
45. Rabenda, V., Hiligsmann, M. and Reginster, J.Y. (2009) Poor adherence to oral bisphosphonate treatment and its consequences: a review of the evidence. Expert Opin Pharmacother 10: 2303-2315.
46. Rabenda, V., Mertens, R., Fabri, V., Vanoverloop, J., Sumkay, F., Vannecke, C. et al. (2008) Adherence to bisphosphonates therapy and hip fracture risk in osteoporotic women. Osteoporos Int 19: 811-818.
47. Ray, W.A. ( 2003) Evaluating medication effects outside of clinical trials: new-user designs. Am J Epidemiol 158: 915-920.
48. Ray, W.A., Griffin, M.R., Fought, R.L. and Adams, M.L. ( 1992) Identification of fractures from computerized Medicare files. J Clin Epidemiol 45: 703-714.
49. Rietbrock, S., Olson, M. and van Staa, T.P. (2009) The potential effects on fracture outcomes of improvements in persistence and compliance with bisphosphonates. Q J Med 102: 35-42.
50. Rodan, G., Reszka, A., Golub, E. and Rizzoli, R. ( 2004) Bone safety of long-term bisphosphonate treatment. Curr Med Res Opin 20: 1291-1300.
51. Roughead, E.E., Ramsay, E., Priess, K., Barratt, J., Ryan, P. and Gilbert, A.L. (2009) Medication adherence, first episode duration, overall duration and time without therapy: the example of bisphosphonates. Pharmacoepidemiol Drug Saf 18: 69-75.
52. Schneeweiss, S. ( 2006) Sensitivity analysis and external adjustment for unmeasured confounders in epidemiologic database studies of therapeutics. Pharmacoepidemiol Drug Saf 15: 291-303.
53. Schneeweiss, S. ( 2009) On guidelines for comparative effectiveness research using nonrandomized studies in secondary data sources. Value Health 12: 1041.
54. Schwartz, A.V., Bauer, D.C., Cummings, S.R., Cauley, J.A., Ensrud, K.E., Palermo, L. et al. (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.
55. Sheehy, O., Kindundu, C., Barbeau, M. and LeLorier, J. (2009) Adherence to weekly oral bisphosphonate therapy: cost of wasted drugs and fractures. Osteoporos Int 20: 1583-1594.
56. Siris, E.S., Harris, S.T., Rosen, C.J., Barr, C.E., Arvesen, J.N., Abbott, T.A. et al. (2006) Adherence to bisphosphonate therapy and fracture rates in osteoporotic women: relationship to vertebral and nonvertebral fractures from 2 US claims databases. Mayo Clin Proc 81: 1013-1022.
57. Siris, E.S., Selby, P.L., Saag, K.G., Borgström, F., Herings, R.M.C. and Silverman, S.L. (2009) Impact of osteoporosis treatment adherence on fracture rates in North America and Europe. Am J Med 122: S3-S13.
58. Stürmer, T., Rothman, K.J. and Avorn, J. ( 2008) Pharmacoepidemiology and “in silico” drug evaluation: is there common ground? J Clin Epidemiol 61: 205-206.
59. Suissa, S. ( 2008) Immeasurable time bias in observational studies of drug effects on mortality. Am J Epidemiol 168: 329-335.
60. van den Boogaard, C.H.A., Breekveldt-Postma, N.S., Borggreve, S.E., Goettsch, W.G. and Herings, R.M.C. ( 2006) Persistent bisphosphonate use and the risk of osteoporotic fractures in clinical practice: a database analysis study. Curr Med Res Opin 22: 1757-1764.
61. Watts, N.B., Chines, A., Olszynski, W.P., McKeever, C.D., McClung, M.R., Zhou, X. et al. (2008) Fracture risk remains reduced one year after discontinuation of risedronate. Osteoporos Int 19: 365-372.
62. Weycker, D., Macarios, D., Edelsberg, J. and Oster, G. ( 2007) Compliance with osteoporosis drug therapy and risk of fracture. Osteoporos Int 18: 271-277.
63. Wilkes, M.M., Navickis, R.J., Chan, W.W. and Lewiecki, E.M. (2010) Bisphosphonates and osteoporotic fractures: a cross-design synthesis of results among compliant / persistent postmenopausal women in clinical practice versus randomized controlled trials. Osteoporos Int 21: 679-688.