Objective: This study aims to evaluate patient perceptions of subcutaneous denosumab or oral alendronate in postmenopausal women with or at risk for osteoporosis and how these perceptions influence adherence.
Methods: Postmenopausal women with low bone mass were randomized to denosumab 60 mg every 6 months for 1 year (treatment period 1 [TP1]) followed by alendronate 70 mg once weekly for 1 year (treatment period 2 [TP2]), or vice versa. Beliefs about Medicines Questionnaire data were collected at baseline and at 6, 12, 18, and 24 months; a necessity-concerns differential (NCD) was calculated for each time point. Logistic regression analyses were performed to evaluate the influences of baseline characteristics on nonadherence.
Results: Participants included 250 women (alendronate/denosumab, n = 124; denosumab/alendronate, n = 126). During TP1, the NCD at month 6 was higher with denosumab than with alendronate (P = 0.0076). In TP2, the NCD was higher for women switched to denosumab than for women switched to alendronate at 6 months (P = 0.0126) and 12 months (P = 0.4605). Denosumab was preferred to alendronate regardless of treatment sequence (P < 0.0001). Covariate analysis revealed that higher TP2 baseline necessity scores were associated with lower odds of nonadherence (P = 0.0055), whereas higher concerns about medication scores were associated with higher odds of nonadherence (P = 0.0247). Higher NCD scores were also associated with lower odds of nonadherence (P = 0.0015).
Conclusions: Participants preferred denosumab to alendronate while on treatment and had more positive perceptions of denosumab than alendronate. These perceptions were associated with better adherence.
From the 1University of British Columbia, Vancouver, BC, Canada; 2Amgen Inc., Thousand Oaks, CA; 3Internal Medicine Associates, Fargo, ND; 4OB-GYN Associates of Mid-Florida, PA, Leesburg, FL; 5QD Research Inc., Granite Bay, CA; and 6University College London, London, UK.
Received December 20, 2012; revised and accepted February 26, 2013.
Portions of this article were presented at the 2012 annual meeting of The North American Menopause Society, October 3 to 6, Orlando, FL.
Funding/support: This study was funded by Amgen Inc. Gail Flores, whose work was supported by Amgen Inc., and Holly Brenza Zoog and Amy Foreman-Wykert, of Amgen Inc., provided medical writing assistance.
Financial disclosure/conflicts of interest: D.L.K. has received grants from Amgen Inc., Eli Lilly, Johnson & Johnson, Roche, Novartis, Pfizer, and GSK; has received support for travel to meetings from Amgen Inc., Eli Lilly, Novartis, and Pfizer; and has served on the speakers bureau for Amgen Inc., Eli Lilly, Novartis, Pfizer, GSK, and Warner Chilcott. M.J.L. has received grants from Amgen Inc., Abbott, Alexion, Ardea, Array, AstraZeneca, Bausch & Lomb, Biota, BioSante, Boehringer-Ingelheim, Bristol Myers Squibb, CardioKine, Cerimon, CombinatoRx, Covance, Daiichi Sankyo, DP Clinical, Duke CRI, Endo Pharmaceuticals, Epigenomics, Forest, Furiex, Genentech, GlaxoSmithKline, Hisamitsu, i3 Research, IL Pharma, Lexicaon, Lilly, Merck, Novartis, Novo Nordisk, NPS Allelix, NPS Pharmaceuticals, Ortho-MacNeill, Otsuka, Pfizer, PPD, Quintiles, Roche, Salix, Sanofi-Aventis, Schering-Plough, Sepacor, Smith Kline Beecham, Takeda, Tioga, Viropharma, and Wyeth. A.M. has no conflicts to disclose. S.S.-H. has served as a consultant to Amgen Inc. D.M., P.K., E.-T.T., and R.B.W. are employees of Amgen Inc. and hold stocks or stock options in Amgen Inc. At the time this work was performed, J.H. was employed with Amgen Inc. and owned stocks in Amgen Inc. R.H. has served as a director for Pharmed Research Partnership; has received honoraria for speaking engagements on behalf of Abbott, Amgen Inc., AstraZeneca, Boehringer Ingelheim, Gilead Sciences, GlaxoSmithKline, Merck, Merck Serono, Novartis, NovoNordisk, Pfizer, Roche, Servier, Shire Pharmaceuticals, Warner Chilcott, and Wyeth; has received grants from the National Institute for Health Research, Amgen Inc., MRC, Wellcome Trust, Crohn’s & Colitis, and National Institute for Health Research–Research for Patient Benefit; has patents for and led the development of the Beliefs about Medicines Questionnaire and other research tools for assessing patients’ perceptions of health and illness; and is a shareholder in a university spinout consultancy company, Spoonful of Sugar.
Address correspondence to: David L. Kendler, MD, FRCPC, University of British Columbia, Prohealth, 150-943 W Broadway, Vancouver, BC, Canada V5Z 4E1. E-mail: firstname.lastname@example.org