Abstract
Summary
The Preference and Satisfaction Questionnaire (PSQ) compares patient preference and satisfaction between a 6-month subcutaneous injection and weekly oral tablet for treatment of bone loss. Patients preferred and were more satisfied with a treatment that was administered less frequently, suggesting the acceptability of the 6-month injection for treatment of bone loss.
Introduction
The PSQ compares patient preference and satisfaction between a 6-month subcutaneous injection and a weekly oral tablet for treatment of bone loss.
Methods
Postmenopausal women with low bone mass who enrolled in two separate randomized phase 3 double-blind, double-dummy studies received a 6-month subcutaneous denosumab injection (60 mg) plus a weekly oral placebo or a weekly alendronate tablet (70 mg) plus a 6-month subcutaneous placebo injection. After 12 months, patients completed the PSQ to rate their preference, satisfaction, and degree of bother with each regimen.
Results
Most enrolled patients (1,583 out of 1,693; 93.5%) answered ≥1 item of the PSQ. Significantly more patients preferred and were more satisfied with the 6-month injection versus the weekly tablet (P < 0.001). More patients reported no bother with the 6-month injection (90%) than the weekly tablet (62%).
Conclusion
Patients preferred, were more satisfied, and less bothered with a 6-month injection regimen for osteoporosis.
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References
Osterberg L, Blaschke T (2005) Adherence to medication. N Engl J Med 353:487–497
Wahl C, Gregoire JP, Teo K et al (2005) Concordance, compliance and adherence in healthcare: closing gaps and improving outcomes. Healthc Qual 8:65–70
Kothawala P, Badamgarav E, Ryu S et al (2007) Systematic review and meta-analysis of real-world adherence to drug therapy for osteoporosis. Mayo Clin Proc 82:1493–1501
Reginster JY, Rabenda V, Neuprez A (2006) Adherence, patient preference and dosing frequency: understanding the relationship. Bone 38:S2–S6
Siris ES, Harris ST, Rosen CJ 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
Gold DT, Martin BC, Frytak JR et al (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
van den Boogaard CH, Breekveldt-Postma NS, Borggreve SE et al (2006) Persistent bisphosphonate use and the risk of osteoporotic fractures in clinical practice: a database analysis study. Curr Med Res Opin 22:1757–1764
Caro JJ, Ishak KJ, Huybrechts KF et al (2004) The impact of compliance with osteoporosis therapy on fracture rates in actual practice. Osteoporos Int 15:1003–1008
Huybrechts KF, Ishak KJ, Caro JJ (2006) Assessment of compliance with osteoporosis treatment and its consequences in a managed care population. Bone 38:922–928
McCombs JS, Thiebaud P, McLaughlin-Miley C et al (2004) Compliance with drug therapies for the treatment and prevention of osteoporosis. Maturitas 48:271–287
Papaioannou A, Ioannidis G, Adachi JD 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
Stafford RS, Drieling RL, Hersh AL (2004) National trends in osteoporosis visits and osteoporosis treatment, 1988–2003. Arch Intern Med 164:1525–1530
Watson J, Wise L, Green J (2007) Prescribing of hormone therapy for menopause, tibolone, and bisphosphonates in women in the UK between 1991 and 2005. Eur J Clin Pharmacol 63:843–849
Black DM, Thompson DE, Bauer DC et al (2000) Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial. FIT Research Group. J Clin Endocrinol Metab 85:4118–4124
Cummings SR, Black DM, Thompson DE et al (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
Kendler D, Kung AW, Fuleihan Gel H et al (2004) Patients with osteoporosis prefer once weekly to once daily dosing with alendronate. Maturitas 48:243–251
Simon JA, Lewiecki EM, Smith ME et al (2002) Patient preference for once-weekly alendronate 70 mg versus once-daily alendronate 10 mg: a multicenter, randomized, open-label, crossover study. Clin Ther 24:1871–1886
Burgess TL, Qian Y, Kaufman S et al (1999) The ligand for osteoprotegerin (OPGL) directly activates mature osteoclasts. J Cell Biol 145:527–538
Kostenuik P, Nguyen H, McCabe J et al (2009) Denosumab, a fully human monoclonal antibody to RANKL, inhibits bone resorption and increases bone density in knock-in mice that express chimeric (murine/human) RANKL. J Bone Miner Res 24:182–195
Lacey DL, Timms E, Tan HL et al (1998) Osteoprotegerin ligand is a cytokine that regulates osteoclast differentiation and activation. Cell 93:165–176
Bone HG, Bolognese MA, Yuen CK et al (2008) Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab 93:2149–2157
Cummings SR, McClung MR, Christiansen C et al (2008) The effects of denosumab on fracture risk in women with osteoporosis. Osteoporos Int 20:167
Lewiecki EM, Miller PD, McClung MR et al (2007) Two-year treatment with denosumab (AMG 162) in a randomized phase 2 study of postmenopausal women with low bone mineral density. J Bone Miner Res 22:1832–1841
McClung MR, Lewiecki EM, Cohen SB et al (2006) Denosumab in postmenopausal women with low bone mineral density. N Engl J Med 354:821–831
Miller PD, Bolognese MA, Lewiecki EM et al (2008) Effect of denosumab on bone density and turnover in postmenopausal women with low bone mass after long-term continued, discontinued, and restarting of therapy: a randomized blinded phase 2 clinical trial. Bone 43:222–229
Emkey R, Koltun W, Beusterien K et al (2005) Patient preference for once-monthly ibandronate versus once-weekly alendronate in a randomized, open-label, cross-over trial: the Boniva Alendronate Trial in Osteoporosis (BALTO). Curr Med Res Opin 21:1895–1903
Hadji P, Minne H, Pfeifer M et al (2008) Treatment preference for monthly oral ibandronate and weekly oral alendronate in women with postmenopausal osteoporosis: A randomized, crossover study (BALTO II). Joint Bone Spine 75:303–310
McClung M, Recker R, Miller P et al (2007) Intravenous zoledronic acid 5 mg in the treatment of postmenopausal women with low bone density previously treated with alendronate. Bone 41:122–128
Gold DT, Horne R, Hill C et al (2008) Development, reliability, and validity of a new preference satisfaction questionnaire. J Bone Miner Res 23:S210–S211
Kendler DL, Benhamou CL, Brown JP et al (2008) Effects of denosumab in postmenopausal women transitioning from alendronate therapy in comparison with continued alendronate. Osteoporos Int 9(Suppl 2):S385–S386
Brown JP, Prince RL, Deal C et al (2008) Comparison of the effect of denosumab and alendronate on bone mineral density and biochemical markers of bone turnover in postmenopausal women with low bone mass: a randomized, blinded, phase 3 trial. J Bone Miner Res . doi:10.1359/jbmr.080910
Cramer JA, Gold DT, Silverman SL et al (2007) A systematic review of persistence and compliance with bisphosphonates for osteoporosis. Osteoporos Int 18:1023–1031
Reginster JY, Burlet N (2006) Osteoporosis: a still increasing prevalence. Bone 38:S4–S9
Solomon DH, Avorn J, Katz JN et al (2005) Compliance with osteoporosis medications. Arch Intern Med 165:2414–2419
Saltman DC, Sayer GP, O'Dea NA (2006) Dosing frequencies in general practice—whose decision and why? Aust Fam Physician 35:915–919
Claxton AJ, Cramer J, Pierce C (2001) A systematic review of the associations between dose regimens and medication compliance. Clin Ther 23:1296–1310
Brankin E, Walker M, Lynch N et al (2006) The impact of dosing frequency on compliance and persistence with bisphosphonates among postmenopausal women in the UK: evidence from three databases. Curr Med Res Opin 22:1249–1256
Cramer JA, Amonkar MM, Hebborn A et al (2005) Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis. Curr Med Res Opin 21:1453–1460
Cramer JA, Lynch NO, Gaudin AF et al (2006) The effect of dosing frequency on compliance and persistence with bisphosphonate therapy in postmenopausal women: a comparison of studies in the United States, the United Kingdom, and France. Clin Ther 28:1686–1694
Ettinger MP, Gallagher R, MacCosbe PE (2006) Medication persistence with weekly versus daily doses of orally administered bisphosphonates. Endocr Pract 12:522–528
Payer J, Killinger Z, Sulkova I et al (2008) Preferences of patients receiving bisphosphonates—how to influence the therapeutic adherence. Biomed Pharmacother 62:122–124
Cooper A, Drake J, Brankin E (2006) Treatment persistence with once-monthly ibandronate and patient support vs. once-weekly alendronate: results from the PERSIST study. Int J Clin Pract 60:896–905
Saag K, Lindsay R, Kriegman A et al (2007) A single zoledronic acid infusion reduces bone resorption markers more rapidly than weekly oral alendronate in postmenopausal women with low bone mineral density. Bone 40:1238–1243
Horne R, Kovacs C, Katlama C et al (2009) Prescribing and using self-injectable antiretrovirals: how concordant are physician and patient perspectives? AIDS Res Ther 6:2
Gruffydd-Jones K, Hood CA, Price DB (1997) A within-patient comparison of subcutaneous and oral sumatriptan in the acute treatment of migraine in general practice. Cephalalgia 17:31–36
Acknowledgements
Funding for these studies was provided by Amgen Inc., Thousand Oaks, CA USA. Sacha Satram-Hoang, Ph.D. and Amy Foreman-Wykert, Ph.D. (Amgen, Inc.) provided editorial and writing assistance.
Conflicts of interest
The authors have the following disclosures:
David L. Kendler has served as an investigator for Merck, Amgen, Eli Lilly, Novartis, Takeda, GlaxoSmithKline, Pfizer, Servier, Biosante, and Wyeth, and a speaker, consultant, or advisor for and/or received honoraria from Merck, Amgen, Eli Lilly, Novartis, Servier, Nycomed, and Wyeth.
Louis Bessette has served as an investigator and advisory board member for Amgen.
Deborah Gold has served as a consultant for Amgen, Procter & Gamble, GlaxoSmithKline, F. Hoffman-La Roche Ltd., Sanofi-Aventis, Roche Diagnostics, Eli Lilly, and Merck. Additionally, she has received travel grants, speaking or writing fees, or other honoraria, and has served as a member of an advisory board for Amgen, Procter & Gamble, GlaxoSmithKline, F. Hoffman-La Roche Ltd., Sanofi-Aventis, Roche Diagnostics, and Eli Lilly.
Rob Horne has received unrestricted grants to the University of London from Procter & Gamble, Gilead Life Sciences, and Hayward Medical Communications/Shire Pharmaceuticals. Professor Horne also has conducted occasional paid consultancy, medical education lectures, and advisory committees for Abbott, Adelphi, Amgen, Astellas, Astrazeneca, Boehringer Ingelheim, Gilead, GlaxoSmithKlein, Hayward Medical Communications, Merck Outcomes Research, Novartis, Pfizer, Procter & Gamble, and Shire Pharmaceuticals. Some consultancies included travel and accommodations paid by pharmaceutical companies.
Cheryl D. Hill is a paid consultant for Amgen Inc.
Sepideh Farivar-Varon is a former employee of Amgen and current employee of Allergan Inc. Dr. Varon owns stock and/or stock options in both Amgen and Allergan Inc.
Jeff Borenstein, Rachel Wagman, Suresh Siddhanti, David Macarios, Huei Wang, and Hoi-Shen Man are employees and shareholders of Amgen.
Henry G. Bone has served as an investigator for Amgen, Eli Lilly, Merck, Nordic Biosciences, and Zelos; as a consultant for Amgen, Merck, Nordic Bioscience, Osteologix, Pfizer, and Zelos; and has received speaker honoraria from Merck and Novartis.
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Supplementary Table 1
PSQ responses by language and country for the questions: “Which do you prefer?” and “With which frequency of administration have you been more satisfied?” (DOC 44 kb)
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Kendler, D.L., Bessette, L., Hill, C.D. et al. Preference and satisfaction with a 6-month subcutaneous injection versus a weekly tablet for treatment of low bone mass. Osteoporos Int 21, 837–846 (2010). https://doi.org/10.1007/s00198-009-1023-x
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DOI: https://doi.org/10.1007/s00198-009-1023-x