This paper reviews the treatment of osteoporosis, challenges to treatment adherence, and factors associated with improved adherence. This is a review of the literature. With the growing aging ...population, there is an increased number of people at risk of osteoporosis and fracture. Several medications are available that reduce the risk of fracture. However, adherence to osteoporosis medications is suboptimal. Factors related to nonadherence include dosing frequency, real side effects, and concern about potential side effects. Interventions that may improve adherence include clinician and patient education, less frequent and less complex dosing regimens, medication reminders, and adherence counseling. Improving adherence to osteoporosis medications is a complex and challenging issue. Considering and implementing strategies to improve adherence tailored to patient preferences may enhance long-term outcomes for patients with osteoporosis.
Abstract Objective To develop an innovative and effective educational intervention to inform patients about the need for osteoporosis treatment and to determine factors associated with its online ...uptake. Methods Postmenopausal women with a prior fracture and not currently using osteoporosis therapy were eligible to be included in the Activating Patients at Risk for OsteoPOroSis (APROPOS). Four nominal groups with a total of 18 racially/ethnically diverse women identified osteoporosis treatment barriers. We used the Information, Motivation, Behavior Skills conceptual model to develop a direct-to-patient intervention to mitigate potentially modifiable barriers to osteoporosis therapy. The intervention included videos tailored by participants’ race/ethnicity and their survey responses: ranked barriers to osteoporosis treatment, deduced barriers to treatment, readiness to behavior change, and osteoporosis treatment history. Videos consisted of “storytelling” narratives, based on osteoporosis patient experiences and portrayed by actresses of patient-identified race/ethnicity. We also delivered personalized brief phone calls followed by an interactive voice-response phone messages aimed to promote uptake of the videos. Results To address the factors associated with online intervention uptake, we focused on participants assigned to the intervention arm (n = 1342). These participants were 92.9% Caucasian, with a mean (SD) age 74.9 (8.0) years and the majority (77.7%) had some college education. Preference for natural treatments was the barrier ranked #1 by most (n = 130; 27%), while concern about osteonecrosis of the jaw was the most frequently reported barrier (at any level; n = 322; 67%). Overall, 28.1% (n = 377) of participants in the intervention group accessed the videos online. After adjusting for relevant covariates, the participants who provided an email address had 6.07 (95% CI 4.53–8.14) higher adjusted odds of accessing their online videos compared to those who did not. Conclusion We developed and implemented a novel tailored multi-modal intervention to improve initiation of osteoporosis therapy. An email address provided on the survey was the most important factor independently associated with accessing the intervention online. The design and uptake of this intervention may have implications for future studies in osteoporosis or other chronic diseases.
There are few data available on low hemoglobin and incident falls in the general U.S. population.
Of 30,239 black and white U.S. adults ≥45 years in the population-based REasons for Geographic And ...Racial Differences in Stroke study, 16,782 had hemoglobin measured at baseline and follow-up data on falls. Hemoglobin was categorized by 1.0 g/dL increments relative to the World Health Organization anemia threshold (<13.0 g/dL for men, <12.0 g/dL for women). Recurrent falls (≥2 falls in the 6 months after baseline) were assessed during a telephone interview.
Recurrent falls occurred in 3.9% of men and 4.8% of women. Compared with those with a hemoglobin level 1 to 2 g/dL above the anemia cut-off, multivariable adjusted odds ratios (95% confidence intervals) for recurrent falls associated with hemoglobin levels ≥3, 2 to <3 and 0 to 1 g/dL above the cut-off point, and 0 to <1 and ≥1 g/dL below the cut-off point were 0.73 (0.45-1.19), 0.84 (0.57-1.24), 1.29 (0.88-1.90), 1.32 (0.0.80-1.2.18) and 2.12 (1.23-3.63), respectively, among men (linear trend P < 0.001), and 1.59 (1.10-2.3), 1.24 (0.95-1.62), 1.42(1.11-1.81), 1.28 (0.91-1.80) and 1.76 (1.13-2.74), respectively, among women (linear trend P = 0.45; quadratic trend P = 0.016).
Among men, lower hemoglobin levels were associated with an increased risk for recurrent falls. Although our findings suggest an increased risk for recurrent falls at both lower and higher hemoglobin levels among women, these findings should be confirmed in subsequent studies.
The life expectancy of individuals infected with HIV has improved greatly since the institution of combination antiretroviral therapy. However, many metabolic derangements have been discovered with ...long-term combination antiretroviral treatment, including lipodystrophy; insulin resistance; and, more recently, abnormal bone metabolism. It is well-documented that bone mineral density (BMD) in HIV-positive patients is lower compared with the expected BMD in non–HIV-positive patients. The underlying cause of lower BMD is unknown but is thought to be a multifactorial process. Conflicting evidence exists regarding the effect of antiretroviral exposure and duration of treatment, antiretroviral type, and cumulative HIV viral exposure on bone health. Here we review the bone changes that occur with HIV infection and treatment.
Pragmatic clinical trials (PCTs) provide large sample sizes and enhanced generalizability to assess therapeutic effectiveness, but efficient patient enrollment procedures are a challenge, especially ...for community physicians. Advances in technology may improve methods of patient recruitment and screening in PCTs. Our study looked at a tablet computer versus an integrated voice response system (IVRS) for patient recruitment and screening for an osteoporosis PCT in community physician offices.
We recruited women ≥ 65 years of age from community physician offices to answer screening questions for a hypothetical osteoporosis active comparator PCT using a tablet computer or IVRS. We assessed the feasibility of these technologies for patient recruitment as well as for patient, physician, and office staff satisfaction with the process. We also evaluated the implications of these novel recruitment processes in determining the number of primary care practices and screened patients needed to conduct the proposed trial.
A total of 160 women (80% of those approached) agreed to complete the osteoporosis screening questions in ten family physicians' offices. Women using the tablet computer were able to complete all screening questions consistently and showed a nonsignificant trend towards greater ease of use and willingness to spend more time in their physician's office compared to those using IVRS. Using the proportion of women found to be eligible in this study (almost 20%) and other eligibility scenarios, we determined that between 240 and 670 community physician offices would be needed to recruit ample patients for our hypothetical study.
We found good satisfaction and feasibility with a tablet computer interface for the recruitment and screening of patients for a hypothetical osteoporosis PCT in community office settings. In addition, we used this experience to estimate the number of research sites needed for such a study.
Fructosamine is an alternative method to hemoglobin A1c (HbA1c) for determining average glycemia. However, its use has not been extensively evaluated in persons living with HIV (PLWH). We examined ...the relationship between HbA1c and fructosamine values, specifically focusing on anemia (which can affect HbA1c) and albumin as a marker of liver disease. We included 345 PLWH from two sites. We examined Spearman rank correlations between fructosamine and HbA1c and performed linear test for trends to compare fructosamine and HbA1c correlations by hemoglobin and albumin quartiles. We examined discrepant individuals with values elevated only on one test. We found a correlation of 0.70 between fructosamine and HbA1c levels. Trend tests for correlations between fructosamine and HbA1c were significant for both albumin (p=0.05) and hemoglobin (p=0.01) with the lowest correlations in the lowest hemoglobin quartile. We identified participants with unremarkable HbA1c values but elevated fructosamine values. These discrepant individuals had lower mean hemoglobin levels than those elevated by both tests. We demonstrated a large correlation between HbA1c and fructosamine across a range of hemoglobin and albumin levels. There were discrepant cases particularly among those with lower hemoglobin levels. Future studies are needed to clarify the use of fructosamine for diabetes management in PWLH.
Summary
The Effectiveness of Discontinuing Bisphosphonates (EDGE) study is a planned pragmatic clinical trial to guide “drug holiday” clinical decision making. This pilot study assessed work flow and ...feasibility of such a study. While participant recruitment and treatment adherence were suboptimal, administrative procedures were generally feasible and minimally disrupted clinic flow.
Introduction
The comparative effectiveness of continuing or discontinuing long-term alendronate (ALN) on fractures is unknown. A large pragmatic ALN discontinuation study has potential to answer this question.
Methods
We conducted a 6-month pilot study of the planned the EDGE study among current long-term ALN users (women aged ≥65 with ≥3 years of ALN use) to determine study work flow and feasibility including evaluating the administrative aspects of trial conduct (e.g., time to contract, institutional review board (IRB) approval), assessing rates of site and participant recruitment, and evaluating post-randomization outcomes, including adherence, bisphosphonate-associated adverse events, and participant and site satisfaction. We assessed outcomes 1 and 6 months after randomization.
Results
Nine sites participated, including seven community-based medical practices and two academic medical centers. On average (SD), contract execution took 3.4 (2.3) months and IRB approval took 13.9 (4.1) days. Sites recruited 27 participants (13 to continue ALN and 14 to discontinue ALN). Over follow-up, 22% of participants did not adhere to their randomization assignment: 30.8% in the continuation arm and 14.3% in the discontinuation arm. No fractures or adverse events were reported. Sites reported no issues regarding work flow, and participants were highly satisfied with the study.
Conclusions
Administrative procedures of the EDGE study were generally feasible, with minimal disruption to clinic flow. In this convenience sample, participant recruitment was suboptimal across most practice sites. Accounting for low treatment arm adherence, a comprehensive recruitment approach will be needed to effectively achieve the scientific goals of the EDGE study.
Osteoporosis is a growing health concern as the number of senior adults continues to increase worldwide. Falls and fractures are very common among frail older adults requiring home health and ...long-term care. Preventative strategies for reducing falls have been identified and many therapies (both prescription and nonprescription) with proven efficacy for reducing fracture risk are available. However, many practitioners overlook the fact that a fragility fracture is diagnostic for osteoporosis even without knowledge of bone mineral density testing. As a result, osteoporosis is infrequently diagnosed and treated in the elderly after a fracture. Based on existing literature, we have developed an algorithm for the assessment and treatment of osteoporosis among persons with known prior fracture(s) living in long-term care facilities or receiving home health care based on the data available in the literature.
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.
Objective: Interventions to initiate medication and increase adherence for postmenopausal women who have had a fragility fracture were not always successful. The purpose of this study was to derive ...an empirical framework for patient-identified barriers to osteoporosis medication initiation and adherence from physician experts. Methods: A cognitive mapping approach involving nominal group technique (NGT) meetings and a card sorting and rating task were used to obtain formative data. We first conducted four NGT meetings with 18 women patients who were not on osteoporosis treatment to identify barriers to osteoporosis medication, then invited 27 osteoporosis physicians to sort and rate 25 patients identified barriers. Descriptive analysis, multidimensional scaling analysis, and hierarchical cluster analysis were applied for data analysis. Results: A two-dimensional five-cluster cognitive map was derived to provide an organizational framework for understanding patients perceived barriers to medication initiation and adherence. The five clusters were concerns about side effects, experience of side effects, lifestyle changes, medication access and complexity, and patient uncertainty about treatment and trust in the provider. The two dimensions were interpreted as internal to patients (X-axis) and external to patients (Y-axis). Conclusions/Implications: Views of patients solicited in a structured format provided directions to help in designing interventions to improve osteoporosis medication initiation and adherence. Keywords: nominal group technique, cognitive mapping, patient barriers, osteoporosis treatment, medication initiation, medication adherence
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