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Exposure to Bisphosphonates and Osteonecrosis of the Jaw: Pharmacovigilance Analysis of Spontaneously Submitted Adverse Drug Reports
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Abstracts / Annals of Epidemiology 24 (2014) 682e702
P58. Unhealthy Weight Loss Strategies is Associated with Obesity Among Adolescents with Disabilities in the United States Mia A. Papas PhD, Jillian C. Trabulsi RD, PhD. University of Delaware Purpose: Childhood obesity is a major public health concern. Due to physical and environmental barriers, children with disabilities may have a difficult time controlling their weight leading to a higher prevalence of obesity. This investigation examines associations between unhealthy weight control behaviors and obesity among US adolescents with disabilities. Methods: Data for adolescents were obtained from the 2011 Youth Risk Behavior Survey (YRBS) for four states. Obesity was defined as an age and gender adjusted body mass index (BMI) at or above the 95th percentile. Unhealthy weight loss behaviors included fasting within the past 24 hours, taking diet pills, powders, or liquids, or vomiting/taking laxatives. Logistic regression models were fit to assess the effects of unhealthy weight control behaviors on obesity. Results: Twenty-two percent (1986/9775) of all survey participants reported an emotional or physical disability. Adolescents with disabilities were more likely to be obese (odds ratio (OR)¼1.65; 95% confidence interval (CI): 1.28, 2.14) and participate in at least one unhealthy weight loss behavior compared to adolescents without disabilities (OR¼3.8; 95% CI: 2.5, 5.7). Engaging in unhealthy weight loss behaviors was more prevalent in obese adolescents compared to non-obese adolescents with disabilities (OR¼2.1; 95% CI: 1.4, 3.2). Conclusions: Adolescents with a broad range of disabilities are more likely to be obese and engage in unhealthy weight loss behaviors that those without disabilities. Provision of successful weight loss strategies that address barriers for healthy dieting and physical activity for this population is critical to developing effective obesity prevention programs.
P59. Zinc Deficiency and Associated Factors in Colombian Children; Results from the 2010 National Nutrition Survey; A Cross Sectional Study Robinson Ramirez-Valez PhD, Jose F. Meneses-Echavez Javier Martínez-Torres MSc. Universidad Santo Tomas
MPH,
Purpose: Zinc (Zn) is an essential micronutrient for cell growth, protein synthesis and cell differentiation. This deficiency affects the growth, development, energy metabolism and immune response in Colombian children’s. The objective in study was to examine factors associated with Zn deficiency in a representative sample of Colombian children. Patients and Methods: A cross-sectional descriptive study was conducted of data from the 2010 National Nutrition Survey of Colombia (ENSIN 2010), in 4.279 children aged between 12-59 months of age. Plasma levels of Zn were determined by atomic absorption spectrophotometry, and associated factors (sex, age, ethnicity, SISBEN score, and geographic region) were collected by structured questionnaire. Associations were established through a multivariable regression model. Results: We found a range of Zn of 78.5 μg/dl, (95% CI 76.7 to 80.4 μg/dl). 43.3% (95% CI 42.2%-44.3%) of children had lower Zn levels to 65 μg/dl. Children belonging to an ethnic groups (indigenous) or residing in rural areas; showed Zn deficiency (56.3% and 47.8%) respectively. Regression models show that to be indigenous (OR 1.76, 95% CI 1.29 to 2.41), and to reside in rural areas (OR 1.39, 95% CI 1.16 to 1.67) were associated with Zn deficiency. Conclusions: The study population shows a high prevalence of Zn deficiency, so it is recommended that comprehensive interventions which are involved nutritional and educational component.
Purpose: Government funded food subsidies, specifically the Special Supplemental Program for Women, Infants, and Children (WIC), support nutritional needs for pregnant and postpartum women who are recommended to consume additional fruits and vegetables (F&V). We evaluated F&V intake by WIC participation/poverty among pregnant and postpartum women enrolled in the Infant Feeding Practice Study II (IFPSII) completing dietary history questionnaires. Methods: IFPSII (2005) was a prospective study following women 18 years from third trimester through their infants’ first birthday by mailed questionnaires. Poverty measurements compared household income and family size to U.S. Census Bureau Federal Poverty thresholds to calculate percent of poverty index ratio (PIR). PIR was categorized to correspond to financial eligibility for WIC (185% PIR) vs. >185% PIR. Comparison groups’ categories were: WIC participants living at 185% PIR, WIC non-participants at 185% PIR, and women at >185% PIR. Variation in F&V intake by WIC/poverty groups was assessed by Kruskal-Wallis tests and logistic regression. Wilcoxon rank sum tests examined postnatal intake by breastfeeding status. Results: Prenatal vegetable intakes significantly varied among WIC/poverty groups (p¼0.04). Prenatal and postnatal F&V intakes were lower among WIC non-participants at 185% PIR, but the difference with other groups was not statistically significant. Median postnatal F&V intake (times/day) was higher among breastfeeding than non-breastfeeding women (fruit: 1.89 vs. 1.21, p<0.0001; vegetable: 3.19 vs. 2.76, p¼0.006). Conclusions: Pregnant and postpartum women at 185% PIR should be informed about their financial eligibility for WIC benefits. Future studies should consider the 2009 F&V voucher additions to WIC food packages.
Other P61. Exposure to Bisphosphonates and Osteonecrosis of the Jaw: Pharmacovigilance Analysis of Spontaneously Submitted Adverse Drug Reports Ayad K. Ali PhD. Eli Lilly and Company Purpose: To identify and characterize signals of osteonecrosis of the jaw (ONJ) following exposure to bisphosphonates. Methods: Adverse drug events that were spontaneously submitted to the FDA Adverse Event Reporting System between 1997 and 2012 were retrieved. Bisphosphonates were identified by generic names, and ONJ was defined by the Preferred Term hierarchy of the Medical Dictionary for Regulatory Activities. Empirical Bayes Geometric Mean (EBGM) and corresponding 95% confidence interval (EB05-EB95) were used as disproportionality measures. Bisphosphonates-ONJ combinations with EB052.0 are significant signals that warrant further review. Results: A total of 4,557 ONJ reports were submitted for bisphosphonates. About 66% of users were females, 27% were males, and 7% with unknown sex (median age 64). Vast majority of ONJ reports were expedited (88%), which are submitted by the manufacturer within 15 days of event occurence, and 22 reports were classified as non-serious events. Zoledronate and alendronate contributed to most of the reported ONJ events. Significant ONJ signals were detected for bisphosphoantes (EBGM 34.4; EB05-EB95 33.6-35.3). Strongest signal was detected for clodronate among non-nitrogenated bisphosphonates (N 15; EBGM 77.3; EB05-EB95 49.3-117), and for pamidronate among nitrogenated agents (N 966; EBGM 162; EB05-EB95 154-171). Etidronate (N 6; EBGM 12.3; EB05-EB95 2.54-37.8) and ibandronate (N 243; EBGM 16.3; EB05-EB95 14.6-18.1) had the lowest signals among non-nitrogenated and nitrogenated bisphosphonates, respectively. Conclusions: This study reemphasizes the association between bisphosphonates therapy and ONJ risk. Caution should be exercised when prescribing bisphosphonates, and regular dental and maxillofacial evaluations before therapy initiation and during therapy might be recommended.
P62. Community Engaged Surveillance: The Healthstreet Model P60. Prenatal and Postnatal Fruit and Vegetable Intake Among U.S. Women: Associations with WIC Participation and Poverty Status Tiffany Lynn Stallings PhD, Julie A. Gazmararian PhD, MPH, Michael Goodman MD, MPH, David Kleinbaum PhD. Emory University, Rollins School of Public Health
Catherine Woodstock Striley PhD, MSW, MPE, Darryl C. Pastor MPH, Linda B. Cottler PhD, MPH. University of Florida Purpose: Community-engaged epidemiological surveillance provides an avenue to improve health, as well as health care itself. Methods: HealthStreet is an innovative model for epidemiological surveillance and a community health intervention, whose mission is to reduce
Abstracts / Annals of Epidemiology 24 (2014) 682e702
P58. Unhealthy Weight Loss Strategies is Associated with Obesity Among Adolescents with Disabilities in the United States Mia A. Papas PhD, Jillian C. Trabulsi RD, PhD. University of Delaware Purpose: Childhood obesity is a major public health concern. Due to physical and environmental barriers, children with disabilities may have a difficult time controlling their weight leading to a higher prevalence of obesity. This investigation examines associations between unhealthy weight control behaviors and obesity among US adolescents with disabilities. Methods: Data for adolescents were obtained from the 2011 Youth Risk Behavior Survey (YRBS) for four states. Obesity was defined as an age and gender adjusted body mass index (BMI) at or above the 95th percentile. Unhealthy weight loss behaviors included fasting within the past 24 hours, taking diet pills, powders, or liquids, or vomiting/taking laxatives. Logistic regression models were fit to assess the effects of unhealthy weight control behaviors on obesity. Results: Twenty-two percent (1986/9775) of all survey participants reported an emotional or physical disability. Adolescents with disabilities were more likely to be obese (odds ratio (OR)¼1.65; 95% confidence interval (CI): 1.28, 2.14) and participate in at least one unhealthy weight loss behavior compared to adolescents without disabilities (OR¼3.8; 95% CI: 2.5, 5.7). Engaging in unhealthy weight loss behaviors was more prevalent in obese adolescents compared to non-obese adolescents with disabilities (OR¼2.1; 95% CI: 1.4, 3.2). Conclusions: Adolescents with a broad range of disabilities are more likely to be obese and engage in unhealthy weight loss behaviors that those without disabilities. Provision of successful weight loss strategies that address barriers for healthy dieting and physical activity for this population is critical to developing effective obesity prevention programs.
P59. Zinc Deficiency and Associated Factors in Colombian Children; Results from the 2010 National Nutrition Survey; A Cross Sectional Study Robinson Ramirez-Valez PhD, Jose F. Meneses-Echavez Javier Martínez-Torres MSc. Universidad Santo Tomas
MPH,
Purpose: Zinc (Zn) is an essential micronutrient for cell growth, protein synthesis and cell differentiation. This deficiency affects the growth, development, energy metabolism and immune response in Colombian children’s. The objective in study was to examine factors associated with Zn deficiency in a representative sample of Colombian children. Patients and Methods: A cross-sectional descriptive study was conducted of data from the 2010 National Nutrition Survey of Colombia (ENSIN 2010), in 4.279 children aged between 12-59 months of age. Plasma levels of Zn were determined by atomic absorption spectrophotometry, and associated factors (sex, age, ethnicity, SISBEN score, and geographic region) were collected by structured questionnaire. Associations were established through a multivariable regression model. Results: We found a range of Zn of 78.5 μg/dl, (95% CI 76.7 to 80.4 μg/dl). 43.3% (95% CI 42.2%-44.3%) of children had lower Zn levels to 65 μg/dl. Children belonging to an ethnic groups (indigenous) or residing in rural areas; showed Zn deficiency (56.3% and 47.8%) respectively. Regression models show that to be indigenous (OR 1.76, 95% CI 1.29 to 2.41), and to reside in rural areas (OR 1.39, 95% CI 1.16 to 1.67) were associated with Zn deficiency. Conclusions: The study population shows a high prevalence of Zn deficiency, so it is recommended that comprehensive interventions which are involved nutritional and educational component.
Purpose: Government funded food subsidies, specifically the Special Supplemental Program for Women, Infants, and Children (WIC), support nutritional needs for pregnant and postpartum women who are recommended to consume additional fruits and vegetables (F&V). We evaluated F&V intake by WIC participation/poverty among pregnant and postpartum women enrolled in the Infant Feeding Practice Study II (IFPSII) completing dietary history questionnaires. Methods: IFPSII (2005) was a prospective study following women 18 years from third trimester through their infants’ first birthday by mailed questionnaires. Poverty measurements compared household income and family size to U.S. Census Bureau Federal Poverty thresholds to calculate percent of poverty index ratio (PIR). PIR was categorized to correspond to financial eligibility for WIC (185% PIR) vs. >185% PIR. Comparison groups’ categories were: WIC participants living at 185% PIR, WIC non-participants at 185% PIR, and women at >185% PIR. Variation in F&V intake by WIC/poverty groups was assessed by Kruskal-Wallis tests and logistic regression. Wilcoxon rank sum tests examined postnatal intake by breastfeeding status. Results: Prenatal vegetable intakes significantly varied among WIC/poverty groups (p¼0.04). Prenatal and postnatal F&V intakes were lower among WIC non-participants at 185% PIR, but the difference with other groups was not statistically significant. Median postnatal F&V intake (times/day) was higher among breastfeeding than non-breastfeeding women (fruit: 1.89 vs. 1.21, p<0.0001; vegetable: 3.19 vs. 2.76, p¼0.006). Conclusions: Pregnant and postpartum women at 185% PIR should be informed about their financial eligibility for WIC benefits. Future studies should consider the 2009 F&V voucher additions to WIC food packages.
Other P61. Exposure to Bisphosphonates and Osteonecrosis of the Jaw: Pharmacovigilance Analysis of Spontaneously Submitted Adverse Drug Reports Ayad K. Ali PhD. Eli Lilly and Company Purpose: To identify and characterize signals of osteonecrosis of the jaw (ONJ) following exposure to bisphosphonates. Methods: Adverse drug events that were spontaneously submitted to the FDA Adverse Event Reporting System between 1997 and 2012 were retrieved. Bisphosphonates were identified by generic names, and ONJ was defined by the Preferred Term hierarchy of the Medical Dictionary for Regulatory Activities. Empirical Bayes Geometric Mean (EBGM) and corresponding 95% confidence interval (EB05-EB95) were used as disproportionality measures. Bisphosphonates-ONJ combinations with EB052.0 are significant signals that warrant further review. Results: A total of 4,557 ONJ reports were submitted for bisphosphonates. About 66% of users were females, 27% were males, and 7% with unknown sex (median age 64). Vast majority of ONJ reports were expedited (88%), which are submitted by the manufacturer within 15 days of event occurence, and 22 reports were classified as non-serious events. Zoledronate and alendronate contributed to most of the reported ONJ events. Significant ONJ signals were detected for bisphosphoantes (EBGM 34.4; EB05-EB95 33.6-35.3). Strongest signal was detected for clodronate among non-nitrogenated bisphosphonates (N 15; EBGM 77.3; EB05-EB95 49.3-117), and for pamidronate among nitrogenated agents (N 966; EBGM 162; EB05-EB95 154-171). Etidronate (N 6; EBGM 12.3; EB05-EB95 2.54-37.8) and ibandronate (N 243; EBGM 16.3; EB05-EB95 14.6-18.1) had the lowest signals among non-nitrogenated and nitrogenated bisphosphonates, respectively. Conclusions: This study reemphasizes the association between bisphosphonates therapy and ONJ risk. Caution should be exercised when prescribing bisphosphonates, and regular dental and maxillofacial evaluations before therapy initiation and during therapy might be recommended.
P62. Community Engaged Surveillance: The Healthstreet Model P60. Prenatal and Postnatal Fruit and Vegetable Intake Among U.S. Women: Associations with WIC Participation and Poverty Status Tiffany Lynn Stallings PhD, Julie A. Gazmararian PhD, MPH, Michael Goodman MD, MPH, David Kleinbaum PhD. Emory University, Rollins School of Public Health
Catherine Woodstock Striley PhD, MSW, MPE, Darryl C. Pastor MPH, Linda B. Cottler PhD, MPH. University of Florida Purpose: Community-engaged epidemiological surveillance provides an avenue to improve health, as well as health care itself. Methods: HealthStreet is an innovative model for epidemiological surveillance and a community health intervention, whose mission is to reduce