E. Simões

Do we need bone mineral density to estimate osteoporotic fracture risk? A 10-year prospective multicentre validation study

Objective Evaluate the performance of FRAX®, with and without bone mineral densitometry (BMD), in predicting the occurrence of fragility fractures over 10 years. Methods Participants aged ≥40 years at baseline, with a complete set of data and a minimum of 8.5 years of follow-up were identified from three cohorts (n=2626). Ten-year fracture risk at baseline were estimated with FRAX® and assessed by comparison with observed fractures and receiver operating characteristic analysis. Results During a mean (SD) follow-up of 9.12 (1.5) years, 178 participants suffered a major osteoporotic (MOP) fracture and 28 sustained a hip fracture. The predictive performance of FRAX® was superior to that of BMD alone for both MOP and hip fractures. The area under the curve (AUC) of FRAX® without BMD was 0.76 (95% CI 0.72 to 0.79) for MOP fractures and 0.78 (95% CI 0.69 to 0.86) for hip fractures. No significant improvements were found when BMD was added to clinical variables to predict either MOP (0.78, 95% CI 0.74 to 0.82, p=0.25) or hip fractures (0.79, 95% CI 0.69 to 0.89, p=0.72). AUCs for FRAX® (with and without BMD) were greater for men than for women. FRAX®, with and without BMD, tended to underestimate the number of MOP fractures and to overestimate the number of hip fractures in females. In men, the number of observed fractures were within the 95% CI of the number predicted, both with and without BMD. Conclusion FRAX® without BMD provided good fracture prediction. Adding BMD to FRAX® did not improve the performance of the tool in the general population.

THU0536 Remission and Re-Treatment of Patients with Paget's Disease of Bone Treated with Zolendronic Acid – A Single Center 10 Year Experience

Background Treatment of Pagets Disease of Bone (PDB) has been revolutionized by the use of zolendronic acid (ZA). Patients usually have a dramatic response to treatment with normalization serum alkaline phosphataise (ALP) levels and a longer period of clinical remission, compared with other class agents. Data from long-term use are scarse. Objectives Evaluate the effectiveness and safety of ZA in PDB patients, as well as remission, re-treatment rates and side effects in our outpatient population since 2005. Methods A retrospective study of PDB patients treated with 5 mg ZA intravenous infusion at our day-care center. Follow up time, demographic and clinical characteristics, previous therapeutic agents, rate of response, number and reasons of re-treatment(s) and rates of adverse events were collected. A descriptive statistic analysis was made. Results 48 patients, 60% female, mean age of 75 years, with a median time since the diagnosis of 12.3 years. The disease was poliostotic in 73% of the patients and pelvis (65%), skull (29%) and spine (27%) were the most common pagetic localizations. Deafness was present in 12.5% and 65% had hip involvement. 44% patients had been treated with another biphosphonate agent previously. Response rates were 97.9% at 1 year, 87.2% after 2 years and 95.1% after 3 years. The mean ALP levels before ZA infusion was 290 UI/L and after 112 UI/L. Sixteen patients needed a re-treatment in the period of follow up, minimum of 1 year after the ZA infusion and maximum of 8 years after. 56.3% due to raised of ALP levels and 43.8% due pain/ hip involvement. Four patients needed a third infusion due to hip involvement, and 2 of them a forth infusion due to the same reason. All of the patients re-treated due to hip involvement had severe hip involvement at time of diagnosis. In our population, 2 patients achieved 10 years remission, 5 patients 9 years remission and 10 patients 8 years remission with a single ZA infusion. Recording adverse effects were: 14.6% Flu like symptoms (7 patients), 2% assintomatic hypocalcemia (1 patient) and no reports of osteonecrosis or fractures. All of these effects were reported after the first ZA infusion. Conclusions In our population, we find high long-term sustained remission rate. Only sixteen patients needed re-treatment. Patients maintained sustained remission up to 10 years of a single ZA infusion. Incidence of adverse events was similar to the reported in the literature. References Reid IR, Miller P, Lyles K et al. Comparison of a Single Infusion of Zolendronic Acid with Risendronate for Pagets Disease. N Eng J Med. 2005 Set:353(9):898–908 Reid IR, Brown JP, Levitt N et al. Re-treatment of relapse Pagets disease of bone with zolendronic acid: results from an open-label study. Natur BoneKEy Report 2. 2013 Nov: 442: 1–3 Reid IR, Lyles K, Brown JP et al. A Single Infusion of Zolendronic Acid Produces Sustained Remissions in Paget Disease: Data from 6.5 years, JBMR. 2011 Sep 26 (9):2261–70 Devogelaer JP, Geusen P, Daci E et al. Remission over 3 years in patients with Paget disease of bone treated with a single intravenous infusion of 5 mg zolendronic acid. Calcif Tissue Int. 2014 Mar:94(3):311–8 Disclosure of Interest None declared

AB1072 Work Disability, Productivity, Presenteeism and Absenteeism in Rheumatic Patients

Background Work capacity is primarily assessed by absenteeism and rheumatic patients may experience decreased productivity as well as presenteeism due to their health problems as well as its costs consequences. Objectives To evaluate the relation between work disability, productivity and disease activity, quality of life and functional disability. Methods 242 rheumatic patients were recruited, 33.3% employed (N=81) completed the questionnaires of work disability and productivity: WALS (Workplace Activity Limitations Scale), SPS 6 (Stanford Presenteeism Scale) and WPAI (Work Productivity and Activity Impairment) 4 scores - absenteeism, presenteeism, work and activity impairment. Patient-reported parameters included pain, fatigue, sleep quality and disease activity (VAS). Functional disability and quality of life outcomes were assessed by HAQ-DI, FACIT and SF-12. Data were collected during a 4-week period. The analysis included descriptive statistics, Mann-Whitney test and Spearman correlation, p <.05. Results 81 gainfully employed patients (85% female) had 48±11 years old, with 10±4 schooling years. Mean VAS were: pain 47±32, fatigue 57±33, sleep quality 46±33 and disease activity 43±30; HAQ-DI: 1.76±0.9, FACIT:17±11 and SF-12: 39±13 in PCS and 43±18 in MCS. Productivity assessment revealed limitations in all measured scores: WALS 8±6 [0-25], SPS 6 12±3 [3-15], WPAI work impairment 29±32%, activity impairment 29±29%, absenteeism 2.1±12.3% and presenteeism 28±32%. WALS was positively correlated to HAQ (r=.657, p<.0001), FACIT (r=.720, p<.0001), both SF12 scores (r>.517, p<.0001), all 4 WPAIs scores (r>.296, p<.01) and inversely with SPS 6 (r= -.341, p=.002). WPAIs scores were all significantly associated to HAQ, FACIT, SF12 PCS and sick leave in the last 12 months (p<.05). SPS 6 was inversely related to HAQ and FACIT scores, WPAI presenteeism, work and activity impairment (p<.05), but not with absenteeism. Pain and fatigue were significantly higher in patients with higher WALS and WPAI scores, in exception to absenteeism, and pain was associated with SPS 6 (p<.05). Sleep quality was decreased when related to higher WALS and WPAI scores (p<.05). When comparing the employed/unemployed patients, WPAI activity impairment, PCS, MCS, HAQ, FACIT, pain and disease activity (p<.01), we verified significantly higher limitations and impairment in the unemployed group, in exception to SPS 6, fatigue and sleep quality. Conclusions These findings suggest the significant impact of rheumatic disease in productivity losses, and that unemployed patients present worst quality of life and higher levels of pain, fatigue and disability. We found good correlations between the productivity assessment and the SF12, HAQ, FACIT, pain, fatigue, sleep quality and disease activity. This provides information about trend of work restrictions, useful in cost-effectiveness analysis for example of new treatment therapies. Moreover, these issues are particularly important because absenteeism and presenteeism have strong links to health related costs. Prevention of work disability and job changes/adaptations to the individual capabilities would be most effective in reducing socioeconomic and work related impact. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.5488

SAT0494 Protein Intake and Body Composition Relationship in A Rheumatic Patient Population

Background The relationship between protein dietary intake and Bone Mass Index (BMI) is controversial. Hyperproteic diet increases urinary calcium excretion but without obvious impact in Osteoporosis (OP). Sarcopenia in the elderly may be associated with low protein diet. High BMI and with high fat content was considered a protective factor for OP but it may be related to vitamin D deficiency and subclinical hyperparathyroidism. Objectives This study aims to evaluate the relationship between protein diet intake, BMI and and parathyroid hormone (PTH) levels. Methods A questionnaire on dietary protein intake was applied to patients at a Rheumatology clinic during 4 non-consecutive weeks from July to September 2013. Nutritional evaluation included body composition (InBody 720). Clinical data collected included: fall occurrence; history of clinical and/or radiologic vertebral fractures; total serum protein, albumin, inorganic phosphate, calcium, PTH, vitamin D and calcium urinary excretion levels and neck/lumbar densitometry. Descriptive statistics, Mann-Whitney, Kruskal-Wallis, Qui-Square and Spearman correlation were applied for a significance of p<0,05. Results 189 subjects were enrolled, 88% female, mean age 58 years, mean BMI 27kg/m2 (low weight in 1,7%, normal in 33,1%, overweight in 37,7% and obesity in 27,6%). Regarding protein intake, 66,7% drunk milk >5 times/week and 22,2% >2 glasses/day; 61,3% of the patients consumed yogurt 1-3 times/day and 20,6% <1/week; 44% consumed cheese once a day. Lean and fatty fish were consumed weekly in 75% of the subjects and canned fish in up to 86%. Codfish and eggs consumption varied between 1 to 4 times/week in 68% and 77%, respectively. Red meat ingestion was: 2-4 times/week in 51%, <3 times/month in 27%. We found an association between weight (r=-0,131;p=0,043), body fat content (r=-0,174;p=0,007) and higher ingestion of lean fish. Patients with lower body fat content had a higher milk intake (r=-0,274;p=0,001). Higher consumption of red meat was associated with higher muscle mass and protein content (r>0,142;p<0,033). We also found a relation between higher PTH and higher BMI (r=0,310;p=0,034). Conclusions Patients that had a lower BMI and reduced body fat content consumed more lean fish, also those with lower body fat content showed a higher intake of milk. Red meat was associated with higher muscle mass and protein content. High PTH levels were correlated with higher BMI, which is in concordance with new evidence suggesting that overweight and obesity do not protect against OP. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.5279

AB1122 Effects of Proprioceptive Exercises in Rheumatoid Arthritis Postmenopausal Women: GAIT Biomechanical Parameters Related with Falls, Functional Capacity and Disease Activity (Preliminary Results)

Background Rheumatoid arthritis (RA) patients1 and postmenopausal women2 showed an increased fall risk. Research pointed to some gait biomechanical parameters related with falls (GBPRF)3 and found differences in these parameters between elderly and young: elderly showed higher ratio of head to hip horizontal acceleration and higher heel horizontal velocity at heel contact with the ground3; elderly and young showed similar minimum toe clearance values however elders had greater variability.4 There is strong evidence that balance and coordination exercises (proprioceptive exercises, PE) can reduce fall rates in elderly.5 Objectives Analyze the PE effects in RA postmenopausal women relatively to disease activity, functional capacity and GBPRF. Methods RA postmenopausal women (n=7) participated in a 12-week PE individual program (3 sessions/week, 30 minutes/session). Data collected pre and post-program. DAS28 and HAQ used to evaluate disease activity and functional capacity. Vicon® Motion Capture system recorded kinematics data (9 MX1.3 cameras, 200Hz) synchronized with a force plate (AMTI BP400600-200, 1000Hz). Data analyzed by Vicon® Nexus software (1.7.1) based on an integrated model of 41 reflective markers relocation and subject anthropometric data, developing mechanical segments and joints centers. Subjects performed 14 valid trials (7 left and 7 right foot contacts with AMTI). Results Improvements in HAQ (1.00 to 0.46, t student, p=0.005) and visual analogue scale for pain (4.95 to 2.07 cm, t student, p=0.003). DAS28 results remained statistical unchanged (4.32 to 3.54, t student, p=0.127). GBPRF did not show statistical differences (t student, p<0.05): left and right heel antero-posterior velocity (0.35 to 0.30 m/s, p=0.310; 0.30 to 0.28, p=0.604; respectively); left and right minimum toe clearance (2.07 to 1.86 cm, p=0.113; 1.94 to 1.87 cm, p=0.468); head antero-posterior velocity/hip antero-posterior velocity at 4 crucial gait instants (left heel contact - 0.85 to 0.87, p=0.440; right heel contact - 0.87 to 0.88, p=0.369; left minimum toe clearance - 1.08 to 1.06, p=0.168; right minimum toe clearance - 1.10 to 1.05, p=0.309; left contralateral heel contact - 0.88 to 0.87, p=0.367; right contralateral heel contact - 0.86 to 0.86, p=0.829; left toe off - 1.03 to 1.03, p=0.862; right toe off - 1.00 to 1.02, p=0.588). Conclusions Despite the small number of participants data indicate that PE can improve functional capacity and reduce pain perception in RA postmenopausal women. In addition did not exacerbate disease activity. GBPRF did not show pre and post-program differences however a larger sample may allow observation of differences accompanying observed improvements in functional capacity. References Hayashibara M, Hagino H, Katagiri H, Okada J, Teshima R. Osteoporosis International 2010;21(11):1825–1833 Cangussu L, Nahas-Neto J, Nahas E, Barral A, Buttros D, Uemura G. BMC Musculoskeletal Disorders. 2012;13:2 Winter D. The Biomechanics and motor control of human gait: normal, elderly and pathological. 2nd ed. Waterloo: University of Waterloo Press; 1991:87–94 Barrett R, Mills P, Begg R. Gait & Posture 2010;32(4):429–435 Sherrington C, Whitney J, Lord S, Herbert R, Cumming R, Close J. Journal of the American Geriatrics Society 2008;56:2234–43 Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.3890

SAT0475 Serum Protein Levels, Fall Occurrence, Bone Fractures and Nutrition in Rheumatic Patients – is There Any Relationship?

Background Regardless of epidemiologic evidence suggesting a positive impact of protein dietary intake over bone health, the connection between dietary protein and bone metabolism remains controversial. A hyperproteic diet is linked to increased renal calcium excretion but there is no clear evidence of its relevance in the development of osteoporosis (OP). In the elderly, it is often found a low dietary protein intake and association between low serum albumin levels, femoral neck fracture and post-fracture mortality. A correlation between body composition and fall occurrence is under discussion. Objectives To study the relation between nutritional/biochemical variables and occurrence of falls and fractures. Methods A questionnaire on dietary protein intake was applied to patients at a Rheumatology clinic during 4 non-consecutive weeks from July to September 2013. Nutritional evaluation included body composition (InBody 720). Clinical data collected included: fall occurrence; history of clinical and/or radiologic vertebral fractures; total serum protein, albumin, inorganic phosphate, calcium, parathyroid hormone, vitamin D and calcium urinary excretion levels and neck/lumbar densitometry. Descriptive statistics, Mann-Whitney, Kruskal-Wallis, Qui-Square and Spearman correlation were applied for a significance of p<0,05. Results 196 subjects were included, 88% female, mean age 58 years. The most prevalent rheumatic diseases were: rheumatoid arthritis (RA), osteoarthritis (OA), Sjögrens syndrome, undifferentiated connective tissue disease, spondyloarthritis, systemic lupus erythematosus (SLE) and fibromyalgia. The average body mass index (BMI) was 27,5 kg/m2, higher in patients diagnosed with SLE, OA and RA. 20 subjects (10,2%) had previous history of fall occurrence, 24 (12,2%) had history of fractures (7 vertebral, 2 femoral neck, 4 wrist). We found correlation between the occurrence of fractures and female gender (25 vs. 0 patients, p=0,046); lower T-score at femoral neck (r=-0,521, p=0,046) and lower total serum protein levels (6,39 vs. 6,69, p=0,018). These variables were also correlated with the number of fractures. Fall occurrence was higher in older subjects (64,8 vs. 57,4 years, p=0,017), and in those with higher T-score at lumbar spine (r=0,663, p=0,014). In subjects over 58 years, we found an association with body percentage and BMI, independent of muscle mass (p<0,05). There were no differences between the groups with and without fracture concerning nutritional parameters or mean age (62 vs.57,7 years, p=0,136). Conclusions In this population, in a rheumatologic setting, fractures were commoner in women, with lower bone mineral density and lower serum protein levels. Higher BMI and body fat percentage may be risk factors for fall occurrence in the elderly, eventually related to a shift in the centre of gravity. Nutritional advice in OP patients should consider these notions. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.4357

Predictors of response and anti-TNF drugs comparative efficacy

Methods Analyses were performed upon Reuma.pt. Response to therapy was defined according to EULAR criteria. Probability of response was modeled. Multivariate logistic regression model predicting response over 1 year with all variables and automated stepwise selection models were built. In addition, we performed analyses using propensity score 1:1:1 nearest neighbor matching algorithms to obtain comparable groups regarding baseline features.