11 research outputs found

    Osteoporosis Medication Use and Fracture Risk in the Women’s Health Initiative

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    Thesis (Ph.D.)--University of Washington, 2015BACKGROUND: Evidence is inconclusive about whether long-term (>3-5 years) bisphosphonate therapy reduces or increases fracture risk. This dissertation examined the association of long-term bisphosphonate use with fracture, using short-term use as the referent group, among older women and postmenopausal women with breast cancer. Additionally, this dissertation, which used self-reported medication data, included a validity study of self-reported medication use. METHODS: Participants were Women’s Health Initiative participants who completed a mailed medication inventory. Fracture outcomes were ascertained by self-report on an annual study form; a subset was confirmed with medical records. The analyses examined hip, wrist/forearm, clinical vertebral, and any clinical fracture among older women (n=5,137) and any clinical fracture among women with breast cancer (n=902). The association between bisphosphonate use and fracture was estimated using multivariate Cox proportional hazards models that compared 3-5, 6-9, and 10 or more years of use with 2 years among older women and compared 4-7 and 8 or more years of use with 2-3 years among women with breast cancer. Self-reported medication use was compared with pharmacy records for four chronically-used classes of medications (statins, calcium channel blockers, beta blockers, and bisphosphonates) among 223 participants using sensitivity, specificity, and positive predictive value for current medication use and kappa statistic for duration of use (5 years). RESULTS: Among older women, 10 or more years of bisphosphonate use was associated with increased risk of any clinical fracture compared with 2 years of use (HR: 1.29 [95% CI: 1.06-1.56]). Among women with breast cancer, 8 or more years of bisphosphonate use was associated with increased risk of fracture compared with 2-3 years of use (HR: 1.65 [95% CI: 1.01-2.58]). Compared with pharmacy records, sensitivity, specificity, positive predictive value, and kappa statistic were near perfect for all medication classes, except for bisphosphonates, which had sensitivity and positive predictive value of 80%. CONCLUSION: The longest duration of bisphosphonate use was associated with increased risk of any clinical fracture compared with short-term use among older women and women with breast cancer. The medication inventory was a highly accurate source of self-reported current medication use for chronically-used medications

    Evaluating clinic and community-based lifestyle interventions for obesity reduction in a low-income Latino neighborhood: Vivamos Activos Fair Oaks Program

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    Abstract Background Obesity exerts an enormous health impact through its effect on coronary heart disease and its risk factors. Primary care-based and community-based intensive lifestyle counseling may effectively promote weight loss. There has been limited implementation and evaluation of these strategies, particularly the added benefit of community-based intervention, in low-income Latino populations. Design The Vivamos Activos Fair Oaks project is a randomized clinical trial designed to evaluate the clinical and cost-effectiveness of two obesity reduction lifestyle interventions: clinic-based intensive lifestyle counseling, either alone (n = 80) or combined with community health worker support (n = 80), in comparison to usual primary care (n = 40). Clinic-based counseling consists of 15 group and four individual lifestyle counseling sessions provided by health educators targeting behavior change in physical activity and dietary practices. Community health worker support includes seven home visits aimed at practical implementation of weight loss strategies within the person's home and neighborhood. The interventions use a framework based on Social Cognitive Theory, the Transtheoretical Model of behavior change, and techniques from previously tested lifestyle interventions. Application of the framework was culturally tailored based on past interventions in the same community and elsewhere, as well as a community needs and assets assessment. The interventions include a 12-month intensive phase followed by a 12-month maintenance phase. Participants are obese Spanish-speaking adults with at least one cardiovascular risk factor recruited from a community health center in a low-income neighborhood of San Mateo County, California. Follow-up assessments occur at 6, 12, and 24 months for the primary outcome of percent change in body mass index at 24 months. Secondary outcomes include specific cardiovascular risk factors, particularly blood pressure and fasting glucose levels. Discussion and Conclusions If successful, this study will provide evidence for broad implementation of obesity interventions in minority populations and guidance about the selection of strategies involving clinic-based case management and community-based community health worker support. Clinical Trial Registration ClinicalTrials.gov: NCT01242683</p

    Validity of Self-Reported Medication Use Compared With Pharmacy Records in a Cohort of Older Women: Findings From the Women's Health Initiative.

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    Inaccurate self-reported data on medication exposure lead to less reliable study findings. From 2013 to 2015, we assessed the validity of information on medication use collected via a mailed medication inventory among 223 Women's Health Initiative participants who were members of a health-care delivery system. Self-reported information on medication use was compared with pharmacy records for statins, calcium channel blockers, ÎČ-blockers, and bisphosphonates. We assessed sensitivity, specificity, and positive predictive value (PPV) for current medication use. We assessed agreement on duration of use (&lt;2, 2, 3, 4, or ≄5 years) by means of the weighted Îș statistic. The mean age of participants was 77 years. Statins, ÎČ-blockers, and calcium channel blockers were each reported by over 15% of women, and bisphosphonates were reported by 4.5%. Compared with pharmacy records, the sensitivity, specificity, and PPV for self-reported use of statins, ÎČ-blockers, and calcium channel blockers were all 95% or greater. The sensitivity and PPV for bisphosphonate use were both 80% (95% confidence interval: 44, 97), and specificity was 99% (95% confidence interval: 97, 100). The Îș statistic for duration of use was 0.87 or greater for all 4 medication classes. Compared with pharmacy records, self-reported information on current medication use and duration of use collected via mailed medication inventory among older women had almost perfect agreement for use of statins, ÎČ-blockers, and calcium channel blockers

    Long-Term Oral Bisphosphonate Therapy and Fractures in Older Women: The Women's Health Initiative.

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    ObjectivesTo examine the association between long-term bisphosphonate use and fracture in older women at high risk of fracture.DesignRetrospective cohort.SettingWomen's Health Initiative.ParticipantsOlder women who reported at least 2 years of bisphosphonate use in 2008-09 (N = 5,120).MeasurementsExposure data were from a current medications inventory. Outcomes (hip, clinical vertebral, wrist or forearm, any clinical fracture) were ascertained annually. Using multivariate Cox proportional hazards models, the association between duration of bisphosphonate use (3-5, 6-9, 10-13 years) and fracture was estimated, using 2 years as the referent group.ResultsOn average participants were 80 years old and were followed for 3.7 ± 1.2 years. There were 127 hip, 159 wrist or forearm, 235 clinical vertebral, and 1,313 clinical fractures. In multivariate-adjusted analysis, 10 to 13 years of bisphosphonate use was associated with higher risk of any clinical fracture than 2 years of use (hazard ratio (HR) = 1.29, 95% confidence interval (CI) = 1.07-1.57). This association persisted in analyses limited to women with a prior fracture (HR = 1.30, 95% CI = 1.01-1.67) and women with no history of cancer (HR = 1.36, 95% CI = 1.10-1.68). The association of 10 to 13 years of use, compared with 2 years of use, was not statistically significant for hip (HR = 1.66, 95% CI = 0.81-3.40), clinical vertebral (HR = 1.65, 95% CI = 0.99-2.76), or wrist fracture (HR = 1.16, 95% CI = 0.67-2.00).ConclusionIn older women at high risk of fracture, 10 to 13 years of bisphosphonate use was associated with higher risk of any clinical fracture than 2 years of use. These results add to concerns about the benefit of very long-term bisphosphonate use
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