ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 322

The Activating Patients at Risk for Osteoporosis Study: A Randomized Trial within the Global Longitudinal Study of Osteoporosis in Women Cohort

Maria I. Danila1, Ryan C. Outman1, Elizabeth J. Rahn2, Amy S. Mudano3, David T. Redden4, Peng Li4, Fred A. Anderson5, Julia P. Anderson6, Susan L. Greenspan7, Andrea Z. LaCroix6,8, Jeri W. Nieves9, Stuart L. Silverman10, Ethel S. Siris11, Nelson B. Watts12, Michael J. Miller13, Jeffrey R. Curtis14, Amy H. Warriner3, Nicole C. Wright15 and Kenneth G. Saag16, 1Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, 2Department of Medicine, Division of Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, 3University of Alabama at Birmingham, Birmingham, AL, 4Biostatistics, University of Alabama at Birmingham, Birmingham, AL, 5University of Massachusetts Medical School, Worcester, MA, 6Group Health Cooperative, Seattle, WA, 7University of Pittsburgh, Pittsburgh, PA, 8University of California San Diego, La Jolla, CA, 9Helen Hayes, West Haverstraw, NY, 10Cedars-Sinai Medical Center, Los Angeles, CA, 11Columbia University Medical Center, New York, NY, 12Endocrinology, Diabetes & Metabolism, University of Cincinnati, Cincinnati, OH, 13University of Oklahoma, Tulsa, OK, 14Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, 15Epidemiology, University of Alabama at Birmingham, Birmingham, AL, 16Division Clinical Immunology & Rheumatology, University of Alabama at Birmingham, Birmingham, AL

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: , , ,

Session Information

Date: Sunday, November 13, 2016

Session Title: Osteoporosis and Metabolic Bone Disease – Clinical Aspects and Pathogenesis - Poster

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: To improve the rate of osteoporosis medication use in women with a prior fracture we developed and implemented a tailored, educational, direct-to-patient video intervention to provide information about reducing fracture risk with osteoporosis medications.

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 follow-up was self-report of osteoporosis medication use. Secondary outcomes included self-reported use of calcium and vitamin D supplementation and bone density testing. Missing data were treated with multiple imputation and the outcomes (proportions) were compared by chi square test using intent-to-treat analysis.

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, had some college education (76.7%), in good health (84.6%), 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 (64.1.% vs. 68.8%, raw p =0.028). 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 (28.9% vs 24.6%, raw p=0.031) and difficulty in taking/remembering to take osteoporosis medications (22.0% vs 18.1%, raw p=0.03).

Conclusion: 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.

Disclosure: M. I. Danila, None; R. C. Outman, None; E. J. Rahn, None; A. S. Mudano, None; D. T. Redden, None; P. Li, None; F. A. Anderson, Millennium Pharmaceuticals, 5; J. P. Anderson, None; S. L. Greenspan, Amgen, 2,Lilly, 2,Merck, 9; A. Z. LaCroix, Amgen, 9,Pfizer Inc, 9,Sermonix, 9; J. W. Nieves, None; S. L. Silverman, Amgen, 2,Lilly, 2,Amgen, 5; E. S. Siris, None; N. B. Watts, AbbVie, 5,Amgen, 5,Janssen Pharmaceutica Product, L.P., 5,Merck, 5,Radius, 5,Sanofi, 5,OsteoDynamics, 1,OsteoDynamics, 7,OsteoDynamics, 4,OsteoDynamics, 6; M. J. Miller, None; J. R. Curtis, Amgen, 5,Amgen, 2; A. H. Warriner, None; N. C. Wright, Amgen, 2; K. G. Saag, Amgen, 5,Lilly, 5,Merck, 5,Amgen, 2,Lilly, 2,Merck, 2.

To cite this abstract in AMA style:

Danila MI, Outman RC, Rahn EJ, Mudano AS, Redden DT, Li P, Anderson FA, Anderson JP, Greenspan SL, LaCroix AZ, Nieves JW, Silverman SL, Siris ES, Watts NB, Miller MJ, Curtis JR, Warriner AH, Wright NC, Saag KG. The Activating Patients at Risk for Osteoporosis Study: A Randomized Trial within the Global Longitudinal Study of Osteoporosis in Women Cohort [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/the-activating-patients-at-risk-for-osteoporosis-study-a-randomized-trial-within-the-global-longitudinal-study-of-osteoporosis-in-women-cohort/. Accessed February 25, 2020.

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