Abstract
Summary
Osteoporosis treatment has low adherence and persistence. This study evaluated if greater patient involvement could improve them. At 12 months, only 114 out of 344 participants were “fully adherent and persistent” (all drug doses taken throughout the study). Only frequency of drug administration had a significant influence on adherence.
Introduction
Osteoporosis affects millions of individuals worldwide. There are now several effective drugs, but adherence to and persistence with treatment are low. This 12-month multicenter, prospective, randomized study evaluated the efficacy of two different methods aimed at improving adherence and persistence through greater patient involvement, compared with standard clinical practice.
Methods
Three hundred thirty-four post-menopausal women, receiving an oral prescription for osteoporosis for the first time, were recruited and randomized into three groups: group 1 (controls, managed according to standard clinical practice) and groups 2 and 3 (managed with greater patient and caregiver involvement and special reinforcements: group 2, instructed to use several different “reminders”; group 3, same “reminders” as group 2, plus regular phone calls from and meetings at the referring Center). All enrolled women had two visits (baseline and 12 months).
Results
Of 334 enrolled women, 247 (74 %) started the prescribed therapy. Of those who started, 219 (88.7 %) persisted in therapy for at least 10 months. At final evaluation, only 114 women were considered as “fully adherent and persistent” (all doses taken throughout the 12 months). There were no significant differences regarding “full adherence” among the three randomized groups. The frequency of drug administration had a significant influence: weekly administration had a >5-fold higher adherence and monthly administration an 8-fold higher adherence (p < 0.0001) than daily administration.
Conclusions
The special effort of devising and providing additional reminders did not prove effective. Additional interventions during the follow-up, including costly interventions such as phone calls and educational meetings, did not provide significant advantages.
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Abbreviations
- AIDS:
-
Acquired immunodeficiency syndrome
- BMD:
-
Bone mineral density
- CI:
-
Confidence interval
- DXA:
-
Dual X-ray absorptiometry
- EU:
-
European Union
- FDA:
-
Food and Drug Administration
- HRT:
-
Hormone replacement therapy
- LSR:
-
Least significant response
- NTx:
-
N-terminal telopeptide of type 1 collagen
- OC:
-
Osteocalcin
- OR:
-
Odds ratio
- SERMs:
-
Selective estrogen receptor modulators
- WHO:
-
World Health Organization
References
Cooper C, Campion G, Melton LJ 3rd (1992) Hip fractures in the elderly: a world-wide projection. Osteoporos Int 2:285–289
Hernlund E, Svedbom A, Ivergård M, Compston J, Cooper C, Stenmark J, McCloskey EV, Jönsson B, Kanis JA (2013) Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA). Arch Osteoporos 8:136
Piscitelli P, Gimigliano F, Gatto S, Marinelli A, Gimigliano A, Marinelli P, Chitano G, Greco M, Di Paola L, Sbenaglia E, Benvenuto M, Muratore M, Quarta E, Calcagnile F, Colì G, Borgia O, Forcina B, Fitto F, Giordano A, Distante A, Rossini M, Angeli A, Migliore A, Guglielmi G, Guida G, Brandi ML, Gimigliano R, Iolascon G (2010) Hip fractures in Italy: 2000-2005 extension study. Osteoporos Int 21:1323–1330
Kanis JA, Johansson H, Oden A, McCloskey EV (2011) A meta-analysis of the effect of strontium ranelate on the risk of vertebral and non-vertebral fracture in postmenopausal osteoporosis and the interaction with FRAX(®). Osteoporos Int 22:2347–2355
Mackey DC, Black DM, Bauer DC, McCloskey EV, Eastell R, Mesenbrink P, Thompson JR, Cummings SR (2011) Effects of antiresorptive treatment on nonvertebral fracture outcomes. J Bone Miner Res 26:2411–2418
Ostenberg L, Blaschke T (2005) Adherence to medication. N Engl J Med 353:487–497
Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X (2008) Interventions for enhancing medication adherence. Cochrane Database Syst Rev 16(2):CD000011
Hiligsmann M, Boonen A, Rabenda V, Reginster JY (2012) Patient decision to initiate therapy for osteoporosis: the influence of knowledge and beliefs. The importance of integrating medication adherence into pharmacoeconomic analyses: the example of osteoporosis. Expert Rev Pharmacoecon Outcomes Res 12:159–166
Kothawala P, Badamgarav E, Ryu S, Miller RM, Halbert RJ (2007) Systematic review and meta-analysis of real-world adherence to drug therapy for osteoporosis. Mayo Clin Proc 82:1493–1501
Caro JJ, Ishak KJ, Huybrechts KF, Raggio G, Naujoks C (2004) The impact of compliance with osteoporosis therapy on fracture rates in actual practice. Osteoporos Int 15:1003–1008
Cramer JA, Amonkar MM, Hebborn A, Altman R (2005) Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis. Curr Med Res Opin 21:1453–1460
Recker RR, Gallagher R, MacCosbe PE (2005) Effect of dosing frequency on bisphosphonate medication adherence in a large longitudinal cohort of women. Mayo Clin Proc 80:856–861
Silverman SL, Gold DT, Cramer JA (2007) Reduced fracture rates observed only in patients with proper persistence and compliance with bisphosphonate therapies. South Med J 100:1214–1218
Wilkes MM, Navickis RJ, Chan WW, Lewiecki EM (2010) Bisphosphonates and osteoporotic fractures: a cross-design synthesis of results among compliant/persistent postmenopausal women in clinical practice vs randomized controlled trials. Osteoporos Int 21:679–688
Nielsen D, Ryg J, Nielsen W, Knold B, Nissen N, Brixen K (2010) Patient education in groups increases knowledge of osteoporosis and adherence to treatment: a two-year randomized controlled trial. Patient Educ Couns 81:155–160
Solomon DH, Iversen MD, Avorn J, Gleeson T, Brookhart MA, Patrick AR, Rekedal L, Shrank WH, Lii J, Losina E, Katz JN (2012) Osteoporosis telephonic intervention to improve medication regimen adherence: a large, pragmatic, randomized controlled trial. Arch Intern Med 172:477–483
Silverman SL, Nasser K, Nattrass S, Drinkwater B (2012) Impact of bone turnover markers and/or educational information on persistence to oral bisphosphonate therapy: a community setting-based trial. Osteoporos Int 23:1069–1074
Fairman K, Matheral B (2000) Evaluating medication adherence: which measure is right for your program? J Manag Care Pharm 6:499–504
Reynolds K, Muntner P, Cheetham TC, Harrison TN, Morisky DE, Silverman S, Gold DT, Vansomphone SS, Wei R, O'Malley CD (2013) Primary non-adherence to bisphosphonates in an integrated healthcare setting. Osteoporos Int 24:2509–2517
Briesacher BA, Andrade SE, Fouayzi H, Chan KA (2008) Comparison of drug adherence rates among patients with seven different medical conditions. Pharmacotherapy 28:437–443
Cadarette SM, Solomon DH, Katz JN, Patrick AM, Brookhart MA (2011) Adherence to osteoporosis drugs and fracture prevention: no evidence of healthy adherer bias in a frail cohort of seniors. Osteoporos Int 22:943–954
Lin T-C, Yang C-Y, Kao Yang Y-H, Lin S-J (2011) Alendronate adherence and its impact on hip-fracture risk in patients with established osteoporosis in Taiwan. Clin Pharmacol Ther 90:109–116
Lee S, Glendenning P, Inderjeeth CA (2011) Efficacy, side effects and route of administration are more important than frequency of dosing of anti-osteoporosis treatments in determining patient adherence: a critical review of published articles from 1970 to 2009. Osteoporos Int 22:741–753
Makita K, Okano H, Furuya T, Urano T, Hirabayashi H, Kumakubo T, Iwamoto J (2014) Survey of the utility of once-monthly bisphosphonate treatment for improvement of medication adherence in osteoporosis patients in Japan. J Bone Miner Metab 18
Fan T, Zhang Q, Sen SS (2013) Persistence with weekly and monthly bisphosphonates among postmenopausal women: analysis of a US pharmacy claims administrative database. Clinicoecon Outcomes Res 5:589–595
Carr AJ, Thompson PW, Cooper C (2006) Factors associated with adherence and persistence to bisphosphonate therapy in osteoporosis: a cross-sectional survey. Osteoporos Int 17:1638–1644
van Boven JF, de Boer PT, Postma MJ, Vegter S (2013) Persistence with osteoporosis medication among newly-treated osteoporotic patients. J Bone Miner Metab 31:562–570
Curtis JR, Cai Q, Wade SW, Stolshek BS, Adams JL, Balasubramanian A, Viswanathan HN, Kallich JD (2013) Osteoporosis medication adherence: physician perceptions vs. patients’ utilization. Bone 55:1–6
Sabaté E (ed) (2003) Adherence to long-term therapies: evidence for action. World Health Organization, Geneva
Schousboe JT (2013) Adherence with medications used to treat osteoporosis: behavioral insights. Curr Osteoporos Rep 11:21–29
Acknowledgments
The study was funded by the Agenzia Italiana del Farmaco (AIFA), www.agenziafarmaco.gov.it/. The authors thank Donatella Casati and Claudio Cappuccino of the Lega Italiana Osteoporosi (LIOS) onlus for helping with the preparation of educational materials and Cristina Spinazzola for the data entry and management.
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Bianchi, M.L., Duca, P., Vai, S. et al. Improving adherence to and persistence with oral therapy of osteoporosis. Osteoporos Int 26, 1629–1638 (2015). https://doi.org/10.1007/s00198-015-3038-9
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DOI: https://doi.org/10.1007/s00198-015-3038-9