Background Osteoporosis treatment rates are declining, even among those with past fractures. Novel, low cost approaches engaging and activating patients are needed to improve care.
Objectives To test a multi-modal, tailored, direct-to-patient, behavioral, video intervention aimed at improving rates of osteoporosis medication use.
Methods We conducted a controlled, randomized clinical trial of our novel intervention among US women in the Global Longitudinal Study of Osteoporosis in Women cohort with self-reported fracture history who were not currently using osteoporosis therapy. The primary outcome at 6-months was self-report of osteoporosis medication use. Secondary and exploratory outcomes included starting calcium and vitamin D, bone mineral density (BMD) testing, readiness for behavioral change, and barriers to treatment.
Results We randomized 2684 women to receive the intervention materials or usual care. Study participants were 92.6% Caucasian, with a mean (SD) age 74.9 (8.0) years, and a self-reported lower than average risk for osteoporosis (40.0%). In the 12 months prior to randomization, 1390 women reported talking with their doctor regarding osteoporosis, 7.4% reported a fracture, vitamin D or calcium supplementation were reported as 83.5% and 68.6%, respectively. We observed no differences in sociodemographic characteristics and no significant differences in the primary (11.7% vs 11.4%) and secondary (calcium, 31.8% vs 32.6%; vitamin D, 41.3% vs 41.9%; bone density, 61.8% vs 57.1%) end points between the intervention and usual care groups. Exploratory post-hoc analyses demonstrated that women in the intervention arm had more favorable views towards osteoporosis medications compared with the usual care arm and a lower proportion were in the unaware and uninvolved stages of behavior change regarding osteoporosis medications (OR=1.57, CI[1.11, 2.23]). We found that barriers to treatment were higher in the intervention, as compared to usual care arm at 6 months: concerns regarding osteonecrosis of the jaw (OR=1.58[1.14, 2.18]). We found significant differences in self-report BMD testing among the subgroup of women with no history of osteoporosis medication use (OR=1.30 [1.01, 1.66]), among those who provided a contact phone number or email address (OR=1.33 [1.01, 1.74]), and among those who did not report past BMD testing on the baseline survey (OR=1.53 [1.40, 1.68]) (Figure A). The proportion of self-reported osteoporosis treatment was similar between those with appreciable exposure to the online intervention compared with the control group (adjusted OR=1.22 [0.73, 2.04]) (Figure B).
Conclusions This randomized study testing a novel, personalized educational intervention, did not increase the use of osteoporosis therapy at 6 months. The intervention appeared to have influenced participants' readiness for behavior change.
Acknowledgements National Institute of Arthritis and Musculoskeletal and Skin Diseases R01 AR060240 (KS) and K23 AR062100 (MD).
Disclosure of Interest M. Danila: None declared, F. Anderson Consultant for: Millennium Pharmaceuticals, S. Greenspan Grant/research support from: Amgen, Lilly, Consultant for: Merck, A. LaCroix Consultant for: Amgen, Pfizer, Sermonix, J. Nieves: None declared, S. Silverman Grant/research support from: Amgen, Lilly, Consultant for: Amgen, N. Watts Shareholder of: OsteoDynamics, Grant/research support from: Shire, Consultant for: AbbVie, Amgen, Janssen, Merck, Radius, Sanofi, Paid instructor for: Amgen, Shire, J. Curtis Grant/research support from: Amgen, Consultant for: Amgen, K. Saag Grant/research support from: Amgen, Lilly, Merck, Consultant for: Amgen, Lilly, Merck