Evaluation of a Multi-modal, Direct-to-Patient Educational Intervention Targeting Barriers to Osteoporosis Care: A Randomized Clinical Trial

Osteoporosis treatment rates are declining, even among those with past fractures. Novel, low-cost approaches are needed to improve osteoporosis care. We conducted a parallel group, controlled, randomized clinical trial evaluating a behavioral intervention for improving osteoporosis medication use. A total of 2,684 women with self-reported fracture history after age 45 not using osteoporosis therapy from U.S. Global Longitudinal study of Osteoporosis in Women (GLOW) sites were randomized 1:1 to receive a multi-modal, tailored, direct-to-patient, video intervention vs. usual care. The primary study outcome was self-report of osteoporosis medication use at 6-months. Other outcomes included calcium and vitamin D supplementation, bone mineral density (BMD) testing, readiness for behavioral change, and barriers to treatment. In intent-to-treat analyses there were no significant differences between groups (intervention vs control) in osteoporosis medication use (11.7% vs 11.4%, p=0.8), calcium supplementation (31.8% vs 32.6%, p=0.7), vitamin D intake (41.3% vs. 41.9%, p=0.8) or BMD testing (61.8% vs 57.1%, p=0.2). In the intervention group, fewer women were in the pre-contemplative stage of behavior change, more women reported seeing their primary care provider, had concerns regarding osteonecrosis of the jaw, and difficulty in taking/remembering to take osteoporosis medications. We found differences in BMD testing among the subgroup of women with no prior osteoporosis treatment, those who provided contact information, and those with no past BMD testing. In per protocol analyses, women with appreciable exposure to the online intervention (N=257) were more likely to start non-bisphosphonates (OR=2.70 [1.26, 5.79]) compared to usual care group. While our intervention did not increase the use of osteoporosis therapy at 6-months, it increased non-bisphosphonate medication use and BMD testing in select subgroups, shifted participant’s readiness for behavior change, and altered perceptions of barriers to osteoporosis treatment. Achieving changes in osteoporosis care using patient activation approaches alone is challenging.