AGA Abstracts Treatment adherence was assessed by number of consumed sachets and by self reporting, using a visual analogue scale (VAS). Acceptability of the dose regime was self reported using VAS scoring. RESULTS:362 patients were randomised (54.3% male; mean age 48.7 years). Applying Kaplan Meier analysis on the intention to treat population, the od regimen (n= 169) resulted in a 11.9% higher probability of remaining in remission for 12 months compared to bd (n=184); p=0.024. Self-reported treatment compliance was improved at 4 months (96% vs 94%; P = 0.012), 8 months (96% vs 93%; p = 0.002), and at end-of-study (95% vs 93%; p=0.15, Wilcoxon test) Compliance measured by number of sachets consumed was better in the od group at all time points but did not reach significance. The treatment acceptability score was significantly higher with od treatment compared to bd treatment at all time points: 96 vs 84, p=0.003; 97 vs 89, p=0.049; 96 vs 86, p<0.001 (Wilcoxon test) at 4 and 8 months and at end-of-study respectively. CONCLUSION: Treatment with a single 2g sachet of mesalazine once daily resulted in significantly higher chances of remaining in remission at 12 months compared to the twice daily regimen. Objectively measured, the compliance rate was numerically, not significantly better in od treatment regimen. Subjects judged their compliance to be higher on the od treatment regimen but the clinical relevance of the difference is to be discussed. The study was not powered for detection of small compliance differences, but the design allowed sensitive assessment of acceptability.The acceptability of the od treatment regimen was significantly higher which may positively impact patient compliance in real life, non-trial environment. T1155 A Randomized Double-Blind Placebo-Controlled Trial of Zoledronic Acid for the Treatment of Osteopenia in Children and Adolescents with Crohn's Disease Anne Marie Sbrocchi, Sylviane Forget, Celia Rodd Introduction Children with Crohn's disease often have poor bone mineral density (BMD), which can lead to fragility fractures. Bisphosphonates constitute the mainstay for treatment of adults with glucocorticoid-induced osteoporosis. Studies on biphosphonate therapy in children are limited, and were not performed in pediatric patients with Crohn's disease. This study assesses the safety and efficacy of a single infusion of zoledronic acid in pediatric patients with Crohn's disease and osteopenia. Osteopenia was defined as either a lumbar spine (LS) BMD measured by DXA scan less than 2 standard deviations below the mean, or a LS BMD less than 1.5 standard deviation below the mean with an additional risk factor, within the previous 3 months of the study. Methods Patients aged 6-18 years with Crohn's disease and osteopenia were randomly assigned to receive either a single infusion of zoledronic acid (0.066 mg/kg, maximum of 4 mg), or intravenous saline as placebo. Use of prednisone, concomitant immunosuppressors, nutritional status, pubertal status, level of physical activity and disease severity were recorded. Patients were followed for 1 year. The primary outcome was change in z-score LS BMD 6 months after infusion. Secondary outcomes included change in LS BMD at 12 months, change in total body BMD at 12 months, markers of bone formation and resorption, and side effects. Results Thirteen pubertal patients were recruited (9 males, 4 females, mean age 15.1 years, mean disease duration 3.5 y) and all had adequate calcium and vitamin D intake for at least 6 months prior to enrolment. Seven patients received zoledronic acid (5M, 2F, mean age 15.5 y) and six received placebo (4M, 2F, mean age 14.6 y). Results are presented in the table. Side-effects included fever, arthralgia and nausea (3 subjects in each group). These were mild, and similar between groups. There was no significant difference in disease activity (PCDAI), body mass index (BMI) or LS BMD z scores between groups at baseline, and no significant difference in PCDAI or BMI z score between groups at 6m. LS BMD z-score increased significantly at 6m in the treated group (p=.02), but not in the placebo group (p=.15). Conclusion A single infusion of zoledronic acid significantly increased LS BMD in pediatric patients with Crohn's disease and osteopenia, and was well tolerated. * p=0.02 T1156 Risk-Aversion Profile of Crohn's Patients: A Feasibility Study for Stem Cell Transplantation Samuel Asfaha, Michelle Geddes, Yvette Leung, Jan Storek, Shane M. Devlin, Jennifer Jones, Gilaad G. Kaplan, Joan A. Heatherington, Robert J. Hilsden, Paul L. Beck, Remo Panaccione BACKGROUND: The optimal therapy for patients with severe Crohn's disease (CD) refractory to standard immunosuppressive and biologic therapies is unclear. Case reports and an ongoing prospective clinical trial report promising long term Crohn's remission with high dose immunosuppressive therapy followed by infusion of autologous stem cells to “reset” the immune system; possible cure of Crohn's is reported in patients given allogeneic stem cell transplant (SCT) for hematologic diseases. We designed a questionnaire to assess the willingness of Crohn's patients in Calgary to accept risk of adverse effects to assess the feasibility of future SCT trials for treatment of CD. METHODS: All CD patients >18 yrs of age assessed in the Inflammatory Bowel Disease Clinic at the University of Calgary were eligible to complete the questionnaire. Based on an autologous SCT scenario with an estimated 80%, or alternatively, 60% chance of a disease-free interval for 18 months and 10% long- term morbidity risk, patients were asked if they were willing to undergo an experimental treatment given a 0%, 2.5%, 5% or 10% risk of death. Based on an allogeneic SCT scenario, A-496 AGA Abstracts with an estimated 80% chance of being cured or symptom-free for 8 years and a 20% long- term morbidity risk, patients were asked if they were willing to undergo treatment with a 10%, 15%, 20% or 30% chance of death. RESULTS: To date 50 CD patients (26 females; 24 males) have completed the questionnaire. Given a 0%, 2.5%, 5% or 10% risk of treatment- related mortality, 81%, 48%, 26% and 17% of patients were willing to undergo the autologous scenario with an 80% chance of an 18 month disease-free interval, and 70%, 33%, 19%, and 11% for a 60% chance of remission, respectively. Given a 10%, 15%, 20% or 30% chance of death in association with allogeneic SCT, only 36%, 17%, 10 and 9% of patients were willing to proceed with therapy. CONCLUSIONS: Approximately half of CD patients are willing to accept an experimental therapy with morbidity (10%) and mortality (2.5%) typical for autologous SCT for hematologic disease. This supports the feasibility of trials of autologous SCT for severe refractory Crohn's disease. Acceptance of trials of allogeneic SCT and thus their feasibility will likely be lower than for autologous SCT. T1157 A Population-Based Study in North-Western Italy of Drug Consumption in Inflammatory Bowel Disease (IBD). Marco Daperno, Elga E. Cagliero, Raffaello Sostegni, Anna Nigro, Elena Ercole, Angelo Pera, Rodolfo Rocca, Marilena Paire Background. The effective drug consumption in inflammatory bowel disease (IBD) is remark- ably different from what is recommended in therapeutic guidelines. Population-based studies using drug prescription databases are objective tools to analyse drug exposure in a population. No estimate of drug adherence and consumption is available in Italy. Aims. Aim of this study was to analyse drug consumption and adherence profiles in a population-based study. Patients & methods. All drug prescriptions dispensed to IBD patients in an Italian National Health System district (ASL17) were abstracted from drug prescription database in two consecutive calendar years. Hospitalizations and outpatient procedures were recorded. Results. Two-hundred ninety-three IBD cases were identified (population of 163,437 inhabit- ants, observed prevalence 179/100,000 inhabitants). During the 2-years period 79 cases (27%) were not on any medical therapy; no differences were observed for gender (p=0.394), age (p=0.861), disease type (p=0.889). Patients adherent to drug prescriptions over the 2- years period were only 67 (23%); no differences were observed for gender (p=0.558), age (p=0.617), disease type (p=0.462). Adherence to drug prescription was inversely and significantly related to the use of co-medications (p=0.0002 and p=0.0112 in first and second year of observation). The rate of hospitalization was extremely low (0.3 admission/patient/ year) and was not significantly associated to adherence (p=0.462). Details of drug prescrip- tions are reported in Table. Discussion. The results of this population-based study in a Northern Italian district outline that a remarkable proportion of IBD patients is free from drug treatment over a 2-year observation period. Adherence to medical treatments seems not to majorly influence hospitalization rates. Financial support. M.D. was supported by Fondazione IBD Onlus with funding from Compagnia di San Paolo (ref. 2002.117). 5ASA: mesalamine; Steroids: prednisone; Antibiotics: daily units of ciprofloxacine/metronida- zole/rifaximine; N: number; IQR: interquartile range T1158 Direct Costs of Inflammatory Bowel Disease (IBD): A Population-Based Study in North-Western Italy. Marco Daperno, Elga E. Cagliero, Raffaello Sostegni, Anna Nigro, Caterina Rigazio, Angelo Pera, Marilena Paire, Rodolfo Rocca Background. Inflammatory bowel disease (IBD) are chronic diseases, whose direct costs may vary largely in different Countries. Observations from referral hospitals perspective are hampered by selection bias and they are therefore unreliable for planning health policies. No estimate of direct costs is available in Italy. Aims. Aim of this study was to analyse IBD- related direct costs in a population-based study. Patients and methods. All consecutive IBD patients in an Italian National Health System district (ASL17) were abstracted from drug prescription database, through a specific disease code. General practitioners were asked to confirm diagnoses. Only confirmed cases were considered for analysis. Patients characteristics were analysed, and costs related to drug prescriptions, outpatient visits/ procedures and hospitalizations (IBD and non-IBD related, medical and surgical admissions) in 2 consecutive calendar years were recorded. Results. Two-hundred ninety-three IBD cases were identified, within a population of 163,437 inhabitants, therefore the observed prevalence was 179/100,000 inhabitants. Crohn's cases were 78 (27%), ulcerative colitis cases were 215 (73%). In 2003 median total costs were € 406/patient (interquartile range [IQR] 75-1,225), in 2004 € 476/patient (IQR 119-1,298), difference not-significant (p= 0.717). The 2-years median total costs for Crohn's cases were € 1,323/patient (IQR 421- 3,198), for ulcerative colitis cases were € 1,197/patient (IQR 308-2,577, p=0.447). Details