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Context The Kabi/Pfizer International Growth Database (KIGS) is a large, international database (1987-2012) of children treated with recombinant human growth hormone (rhGH) in real-world settings. Objective This work aimed to evaluate the safety and efficacy of rhGH from the full KIGS cohort. Methods Data were collected by investigators from children with growth disorders treated with rhGH (Genotropin [somatropin]; Pfizer). Safety was evaluated in all treated patients, and efficacy in those treated for 1 year or more. A subgroup included patients treated for 5 years or more (≥ 2 years prepubertal) who had reached near-adult height (NAH). Main outcomes included adverse events (AEs), serious AEs (SAEs), and height growth. Results The full KIGS cohort (N = 83 803 [58% male]) was treated for idiopathic GH deficiency (IGHD; 46.9%), organic GHD (10.0%), small for gestational age (SGA; 9.5%), Turner syndrome (TS; 9.2%), idiopathic short stature (ISS; 8.2%), and others (16.2%). Median rhGH treatment duration was 2.7 years and observation 3.1 years. SAEs occurred in 3.7% of patients and death in 0.4%. The most common SAEs were recurrence of craniopharyngioma (n = 151), neoplasm (n = 99), and cancer (n = 91); and scoliosis (n = 91). Median first-year delta height-SD score (SDS) (Prader) in prepubertal patients was 0.66 (IGHD), 0.55 (ISS), 0.58 (TS), and 0.71 (SGA). Median gains in NAH-SDS were 1.79 (IGHD), 1.37 (ISS), and 1.34 (SGA) for boys, and 2.07 (IGHD), 1.62 (ISS), 1.07 (TS), and 1.57 (SGA) for girls. Conclusion Data from KIGS, the largest and longest running international database of rhGH-treated children, show that rhGH is safe and increases short-term height gain and adult height across GHD and non-GHD conditions.

What is this summary about? This is a summary of a study originally published in Neurourology and Urodynamics . Overactive bladder is a medical condition that causes an urgent need to urinate, which can cause accidental urination. Fesoterodine is a medication used to treat overactive bladder. Because we don't know how likely it is that an individual patient will achieve a level of improvement in their overactive bladder symptoms, researchers analyzed results of 6 studies of patients with overactive bladder who were treated with fesoterodine. What were the results? Although complete resolution of all symptoms was rare with fesoterodine treatment, a resolution of accidental urination was more common, which is the most important treatment goal for many patients. After taking fesoterodine, episodes of accidental urination were more likely to be reduced or completely absent than episodes of an urgent need to urinate. What do the results of the study mean? These results can help patients with overactive bladder understand their own chances of treatment success with fesoterodine and can help doctors support their patients on what to expect regarding their specific symptoms and concerns. ▪ Toviaz (fesoterodine) is approved to treat the condition that is discussed in this summary. Approval varies from country to country; please check with your local health provider for more details. ▪ This summary reports the combined results of 6 studies. The results of individual studies may vary from the combined study results presented here. Individuals should make treatment decisions based on all available evidence. ClinicalTrials.gov NCT number: NCT01302054 , NCT01302067 , NCT00444925 , NCT00611026 , NCT00220363 , and NCT00138723

Context Data on long-term safety of growth hormone (GH) replacement in adults with GH deficiency (GHD) are needed. Objective We aimed to evaluate the safety of GH in the full KIMS (Pfizer International Metabolic Database) cohort. Methods The worldwide, observational KIMS study included adults and adolescents with confirmed GHD. Patients were treated with GH (Genotropin [somatropin]; Pfizer, NY) and followed through routine clinical practice. Adverse events (AEs) and clinical characteristics (eg, lipid profile, glucose) were collected. Results A cohort of 15 809 GH-treated patients were analyzed (mean follow-up of 5.3 years). AEs were reported in 51.2% of patients (treatment-related in 18.8%). Crude AE rate was higher in patients who were older, had GHD due to pituitary/hypothalamic tumors, or adult-onset GHD. AE rate analysis adjusted for age, gender, etiology, and follow-up time showed no correlation with GH dose. A total of 606 deaths (3.8%) were reported (146 by neoplasms, 71 by cardiac/vascular disorders, 48 by cerebrovascular disorders). Overall, de novo cancer incidence was comparable to that in the general population (standard incidence ratio 0.92; 95% CI, 0.83-1.01). De novo cancer risk was significantly lower in patients with idiopathic/congenital GHD (0.64; 0.43-0.91), but similar in those with pituitary/hypothalamic tumors or other etiologies versus the general population. Neither adult-onset nor childhood-onset GHD was associated with increased de novo cancer risks. Neutral effects were observed in lipids/fasting blood glucose levels. Conclusion These final KIMS cohort data support the safety of long-term GH replacement in adults with GHD as prescribed in routine clinical practice.

PurposeIn this paper, the authors empirically and theoretically analyze the scaling and control of talent development to highlight an important part of commercialization in football clubs, especially in the light of a growing transfer market.Design/methodology/approachConducting a single case study of a Swedish football club, the authors adapt a view of the club as a “high-intensity” organization (Alvesson and Kärreman, 2004), one that inherently relies on strong identification of employees and the fostering of talent. This view allows us to detail the importance of both socio-ideological and technocratic forms of control involved in the talent development process.FindingsThe authors show how socio-ideological and technocratic forms of control were combined to establish the football club as a “talent factory” in the league, as well as the corresponding challenges when scaling talent development activities and how these challenges were handled. In doing so, the authors contribute to the broader accounting literature on talent- and human resource management, as the authors provide an example of how football clubs may commercialize without necessarily violating their fundamental sports values.Originality/valueTalent management has mainly been studied in terms of increasing player wages and a focus on the cost of talent. As opposed to these perspectives, the authors highlight the revenue potential in developing players in the light of a growing transfer market and the relevance of talent development for the commercialization of football clubs.

Aim This study describes patients with different degrees and combinations of symptom resolution in response to fesoterodine exposure to aid physicians in counselling patients with overactive bladder (OAB) on the likelihood of treatment success. Methods Data came from 12‐week fixed‐dose studies of fesoterodine. The proportions of patients experiencing symptom resolution and change in patient‐reported outcome measures (PROM) at 4, 8, and 12 weeks were calculated. Treatment‐emergent adverse events (TEAE) were reported according to response in urinary urgency episodes (UUE). The relationship between PROM and response was examined. Results Out of 6689 patients, 81.6% female, urgency urinary incontinence (UUI) episodes/24 h were more responsive to fesoterodine than UUE; with roughly 50% of patients reporting a 50% reduction and fewer than 10% reporting absence of UUE at 12 weeks compared to approximately 40%–50% reporting absence of UUI. TEAE was numerically lower in patients with greater response. There was a statistically significant relationship between improvement in urinary urgency and associated change in OAB‐q symptom bother scores, r = 0.54, p

Purpose This paper aims to explore the role of management controls in managing heterogeneous interests during extreme situations. Design/methodology/approach Through interviews and observations, the authors analyse the Swedish Migration Agency’s management controls and study routines during the peak of the European Migrant Crisis. Findings Prior to the crisis, the strategy used by the employees was to mediate between two interests (labelled legal security and empathy) to create a workable compromise. During the crisis, however, the authors observed filtering in the form of the previous hierarchical ordering of interests was further strengthened as the employees increasingly relied on just a single interest (the interest which they previously had deemed to be the most important) at the expense of the other interest. The findings suggest that behavioural and social controls helped such filtering; social controls helped certain employees to filter the empathy interest as more important during extreme situations and behavioural controls helped other employees to filter the legal security interest as more important. This help us explain why the authors observe less mediation between the two heterogeneous interests and rather a stricter dominance of one of the interests. The authors also illustrate how especially behavioural controls may become unsupportive of the operations during extreme situations as it consisted of rule-based standards, built to cope with “normal” situations. The heterogeneous interests affected the probability of actors, at times, ignoring behavioural controls when such controls were unsupportive. Actors whose day-to-day operations were mainly guided by the legal security interest remained tightly coupled to behavioural controls even when they felt that these controls were no longer useful. On the other hand, actors who were mainly guided by the empathy interest ignored behavioural controls when they felt that they were unsupportive. Research limitations/implications The authors acknowledge that bias might arise from the reliance on retrospective views of past processes and events, which the authors primarily gathered through interviews. Practical implications The authors highlight an important relationship between heterogeneous interests (i.e. legal security and empathy) and management controls during the crisis and how this relationship can lead actors to fundamentally different actions. Originality/value The two bodies of study on the role of management controls in managing heterogeneous interests and the role of management controls during the crisis have been largely unconnected and it is in this intersection that this study contributes.

This paper shows how certain management controls become more guiding than others in the management of new product development (NPD). We detail how the opportunity space within which managers maneuv...

This paper traces the evolution of risk management practices in a global technology company between 2000 and 2015. We extend recent research that has highlighted the emotional aspects of riskwork. We detail how a passionate interest—‘we can do better at risk management’—emotionally ‘hooked’ the staff in the company's Sourcing Unit. Risk management, emotion, and management controls were intertwined. When top management singled out one of the key metrics clearly as a risk‐related metric for the Sourcing Unit, the employees felt a strong sense of relief, which gave rise to subsequent extensive risk measurement. We also contribute to the more general debate about accounting and its entanglement with emotions. Little is known about the ‘birth’ and the reasons for durability of passionate interests. Following Tarde (1903/2013), such ‘birth’ and endurance can be explained by analyzing how passionate imitation emerges as a result of a series of dislocal events—in our case a fire, new performance metrics, and natural disasters. These events triggered emotions that provided the necessary energy for three forms of passionate imitation: a) ‘we need to imitate our main competitor’ and risk mapping; b) ‘others in the organization are imitating us and our suppliers should imitate us’ and risk measurement; and c) ‘others in the organization (more specifically the Product Development Unit) should imitate us’ and proactive risk avoidance. This passionate imitation helped explain why the sourcing staff continued to be emotionally ‘hooked’ to risk management, that is, how the passionate interest endured and became vested.

Background The precision of adult height prediction by bone age determination in children with idiopathic growth hormone deficiency (IGHD) is unknown. Methods The near adult height (NAH) of patients with IGHD in the KIGS database was compared retrospectively to adult height prediction calculated by the Bayley–Pinneau (BP) prediction based on bone age by Greulich–Pyle (GP) in 315 children and based on the Tanner-Whitehouse 2 (TW2) method in 121 children. Multiple linear regression analyses adjusted for age at GH start, age at puberty, mean dose and years of of GH treatment, and maximum GH peak in stimulation test were calculated. Results The mean underestimation of adult height based on the BP method was at baseline 4.1 ± 0.7 cm in girls and 6.1 ± 0.6 cm in boys, at 1 year of GH treatment 2.5 ± 0.5 cm in girls and 0.9 ± 0.4 cm in boys, while at last bone age determination adult height was overestimated in mean by 0.4 ± 0.6 cm in girls and 3.8 ± 0.5 cm in boys. The mean underestimation of adult height based on the TW2 method was at baseline 5.3 ± 2.0 cm in girls and 7.9 ± 0.8 cm in boys, at 1 year of GH treatment adult height was overestimated in girls 0.1 ± 0.6 cm in girls and underestimated 4.1 ± 0.4 cm in boys, while at last bone age determination adult height was overestimated in mean by 3.1 ± 1.5 cm in girls and 3.6 ± 0.8 cm in boys. Conclusions Height prediction by BP and TW2 at onset of GH treatment underestimates adult height in prepubertal IGHD children, while in mean 6 years after onset of GH treatment these prediction methods overestimated adult height.

We recruited 78 men and 94 women to investigate if the proportion of subjects with well-controlled home blood pressure levels could be increased when treatment was guided by smartphone-based telemonitoring. All patients were prescribed one to three antihypertensive drugs. The Accumbo smartphone telemonitoring application was downloaded to the Iphones of the participants and home blood pressure information was gathered from semi-automatic oscillometric blood pressure-recorders by Bluetooth. The study physician adjusted the medications based on home blood pressure for 3 months. home blood pressure was controlled (

Context Children born prematurely have been treated with growth hormone (GH), and a significant improvement in height during the first years of treatment has been described. Objective To evaluate the influence of prematurity on near-adult height (NAH) after GH treatment. Design KIGS (Pfizer International Growth Database) was queried for children born preterm treated with GH. Setting KIGS database. Patients A total of 586 children short in stature born preterm with various GH status and with available gestational age (GA), birth weight, and NAH, all treated with GH. Intervention GH treatment. Main Outcome Measure NAH. Results Values were expressed as median. From the 586 children included, 482 born appropriate for GA (AGA; median age 8.26 years) and 104 born small for gestational age (SGA) (median age 8.54 years); 66.6% of preterm AGA had GH peak Conclusion GH treatment resulted in significant improvement in height in children born preterm, particularly during prepubertal years and for those with GH deficiency. The degree of prematurity did not influence the growth response.

Purpose The purpose of this paper is to extend the understanding of “the” accounting entity, demonstrating how it is a contestable socio-political construction informed by a nexus of market, state and community actors. Design/methodology/approach A case study method is utilised to follow debate relating to Swedish football clubs’ responsibility for the payment/non-payment of policing costs between 1999 and 2014. The case study uses documentary and interview data, focusing on one of the high-risk Stockholm clubs. Findings The paper makes four main contributions: first, demonstrating how the accounting entity is a changeable and contestable construction; second, outlining how distinctions informing contests about the accounting arena are materialised through accounting calculations and other devices; third, showing the importance of community in a coordinated sense in mediating accounting practices; and fourth, contributing to the literature on accounting and sport, highlighting the importance of state actors in this arena. Originality/value This research draws on original empirical data providing unique insights into debates regarding the responsibility for the payment of police costs in the context of sports-related violence. The authors show the importance of characterising accounting for sporting organisations as a shifting and contestable nexus of market, state and community actors.

Purpose This paper aims to analyse how a multinational organisation uses technocratic and socio-ideological controls to manage tensions arising when integrating its international subsidiaries. Design/methodology/approach Through interviews and company documentation, the authors analyse how a global German family business firm integrates its international subsidiaries into the corporate context. Findings The findings suggest that technocratic and socio-ideological controls in combination help the firm manage three tensions – vertical vs lateral relations, standardisation vs differentiation of practices and centralisation vs decentralisation of decision-making – arising in the course of internationalisation. These results have important analytical implications for the understanding of how a high level of compliance to technocratic control initiatives is achieved. Prior work has, in the main, focussed on the resistance to technocratic controls without paying much attention to compliance. Specifically, the authors show how managers can use socio-ideological control to achieve a high level of compliance among employees when implementing technocratic controls. Practical implications The results suggest that managers in multinational firms need to pay careful attention to the tensions that are created when they internationalise and to apply a combination of technocratic and socio-ideological controls to manage these tensions. Originality/value There is limited knowledge of how managers use socio-ideological control to enact a particular form of experience for their employees and to create a highly valued sense of purpose. The findings suggest that these controls, in combination with technocratic ones, serve important roles when organisations expand internationally.

This paper seeks to (re)theorise the interpenetration of accounting and emotionality. Whilst researchers have devoted increasing attention to the effects of emotions, we argue that extant research is problematic in two ways. First, emotions have been treated as an intrapsychological phenomenon rather than an inter- or relational phenomenon. Second, current work focusses on how accounting produces emotions, failing to consider how emotions inform accounting. To address these two shortcomings, we mobilise the economic anthropology of Tarde (1902), and the subsequent work by Latour and Lepinay (2009) and Latour (2010; 2013), to argue that all interests are inherently 'passionate interests'; they are matters that 'hook' actors emotionally. This theoretical lens is used to narrate a field study considering the (changing) passionate interests and their connections to accounting in an elite Swedish football club. Specifically, we analyse a nexus of four passionate interests that 'hook' many (in different ways and with different degrees of intensity) – violent behaviour, winning the league, preserving the club family, and derbies. More generally, this paper argues that: first, organisations are a nexus of passionate interests; second, such interests recursively inform the doing of accounting; third, passionate interests are quantifiable via a range of financial and non-financial performance measures, enabling the construction and coordination of collectives; and, fourth, some performance measures matter more than others when (a) they are simple and unambiguous, (b) grounded in enduring passionate interests with deep historical roots that tie together members of proximate communities, and (c) travel beyond organisations and penetrate diverse arenas of everyday life, reproducing the emotive intensity of passionate interests.

Purpose Several medications are known to cause vitamin D deficiency. The aim of this study is to describe vitamin D testing and supplementation in patients using these "risk medications", thereby assessing adherence to medical guidelines. Patients and methods A database with electronic health records for the population in a Swedish County (≈240,000 inhabitants) was screened for patients prescribed the pre-defined "risk medications" during a 2-year period (2014-2015). In total, 12,194 patients were prescribed "risk medications" pertaining to one of the three included pharmaceutical groups. Vitamin D testing and concomitant vitamin D supplementation, including differences between the included pharmaceutical groups, was explored by matching personal identification numbers. Results Corticosteroids were prescribed to 10,003 of the patients, antiepileptic drugs to 1,101, and drugs mainly reducing vitamin D uptake to 864. Two hundred twenty-six patients were prescribed >1 "risk medication". Seven hundred eighty-seven patients (6.5%) had been tested during the 2-year period. There were no differences regarding testing frequency between groups. Concomitant supplements were prescribed to 3,911 patients (32.1%). It was more common to be prescribed supplements when treated with corticosteroids. Vitamin D supplementation was more common among tested patients in all three groups. Women were tested and supplemented to a higher extent. The mean vitamin D level was 69 nmol/L. Vitamin D deficiency was found in 24.1% of tested patients, while 41.3% had optimal levels. It was less common to be deficient and more common to have optimal levels among patients prescribed corticosteroids. Conclusion Adherence to medical guidelines comprising testing and supplementation of patients prescribed drugs causing vitamin D deficiency needs improvement in Sweden.

Background Somatrogon is a long-acting recombinant human growth hormone (hGH) currently in development as a once-weekly injectable treatment for children with growth hormone deficiency (GHD). In a phase 2 (NCT01592500) and a phase 3 (NCT02968004) study, patients received either once-weekly somatrogon or once-daily Genotropin. Aims Compare the phase 2 and 3 study results with growth data from published literature and a database of children treated with once-daily Genotropin. Methods In the 12-month main portion of the phase 2 study (004), patients were randomized to 1 of 3 once-weekly somatrogon doses (0.25, 0.48, and 0.66 mg/kg/week) or once-daily Genotropin (0.24 mg/kg/week). After the main portion of 004, patients continued into the open-label extension (OLE), consisting of an additional 12 months at the original somatrogon dose (Genotropin recipients were randomized to 1 of the 3 somatrogon dose regimens), after which all patients received somatrogon at 0.66 mg/kg/week. In the 12-month main portion of the phase 3 study (006), patients were randomized to once-weekly somatrogon (0.66 mg/kg/week) or once-daily Genotropin (0.24 mg/kg/week). After the main portion of 006, all patients received somatrogon (0.66 mg/kg/week) in an OLE. Four year growth data from 004 and 006 were pooled and analyzed, then compared with growth data from matched subsets of hGH-treated patients as reported by Ranke and Lindberg1 (Genotropin dose: 0.22-0.31 mg/kg/week) and Bakker et al,2 (hGH dose: most patients received 0.3 mg/kg/week) and with data from a matched cohort from the Pfizer International Growth Study Database (KIGS), in which patients received once-daily Genotropin (0.20-0.28 mg/kg/week). Results The combined mean height velocity (HV) at the end of the 12-month main portions of study 004 and 006 was 10.37 cm/year for somatrogon-treated patients. The Year 1 mean HV reported by Ranke and Lindberg for children with a chronological average-centered age of 7.5 years was 9.4 cm/year and 8.3 cm/year for children with severe and moderate GHD, respectively. The Year 1 mean HV reported by Bakker et al for children with idiopathic GHD aged 7.5 years at the beginning of hGH therapy was ∼10 cm/year (for males and females). The mean annual HVs during the OLE period were 9.37, 8.97, and 9.03 cm/year at OLE Year 1, 2 and 3 in somatrogon-treated patients, which were numerically greater than HVs of 7.09, 6.35, and 6.08 cm/year at the corresponding annual visit in the matched KIGS cohort (Genotropin dose: 0.20–0.28 mg/kg/week). Conclusions Comparisons with published literature and the KIGS database indicate that children treated with once-weekly somatrogon (0.66 mg/kg/week) showed good growth, compared with children treated with once-daily hGH, strengthening the expectation that somatrogon-treated children are likely to achieve a satisfactory final adult height. References 1.Ranke and Lindberg. JCEM. 2010;95(3): 1229-1237. 2.Bakker, Frane, et al. JCEM. 2008;93(2): 352-357. Presentation: Saturday, June 11, 2022 1:00 p.m. - 3:00 p.m., Monday, June 13, 2022 12:37 p.m. - 12:42 p.m.

Purpose Adult women with long-time anorexia nervosa (AN) are believed to have osteopenia (T-score ≤ 1.0) in 93 % and osteoporosis (T-score ≤ 2.5) in 38 %. Bone microarchitecture assessed by Trabecular Bone Score (TBS) predicts osteoporotic fractures. Our aim was to evaluate the microarchitecture in adult females with AN by determining TBS and to identify factors potentially associated with TBS, such as bone turnover markers. Methods 20 female patients with AN (DSM IV), aged 27.8 ± 4.4 years, BMI 16.6 ± 0.6 kg/m2 and duration of illness of 8.5 ± 5 years had previously been evaluated with dual-energy X-ray absorptiometry (DXA). TBS measurements were now obtained, using iNsight software, from spinal DXA images. Serum levels of bone turnover markers were determined in patients and healthy normal-weight controls. Results Compared to controls serum values of osteopontin were higher (p = 0.009). BMD in patients with AN was reduced by at least 1.0 SD at one or more skeletal sites in 65 % of patients and by at least 2.5 SD in 20 %. Only one of the patients (5%) had suffered a fracture. TBS (mean 1.35 ± 0.06; median 1.36 (1.23–1.44) was in the lower normal range (≥ 1.35). 40 % of patients showed partially (> 1.20 and < 1.35) but none showed a fully degraded micro-architecture. Conclusions In Swedish AN patients we found a low reduction of BMD and fracture history. The bone microarchitecture, evaluated for the first time for this group by TBS, was only modestly compromised, and to a lesser extent than expected for this group of patients with AN. Level of evidence Level V; cross-sectional descriptive study.

AIM To study the prevalence of coeliac disease (CD) in children with Juvenile idiopathic arthritis (JIA), by screening a population-based cohort of children with JIA using autoantibodies against tissue transglutaminase (anti-TG2). METHODS All children diagnosed with JIA in three Swedish counties, with disease onset between 2007 and 2014, were included prospectively. Serum levels of IgA anti-TG2 antibodies, IgG anti-TG2 antibodies, and total IgA were analysed. Children with positive levels of IgA anti-TG2 antibodies and children with IgA deficiency in combination with positive levels of IgG anti-TG2 antibodies were referred to the paediatric gastroenterology unit for gastroscopy and small intestine biopsy. RESULTS A total of 216 children were included, and analysis of IgA and IgG anti-TG2 antibodies was performed in 213 children. Three children were diagnosed with CD prior to the diagnosis of JIA, and three additional children were found through screening, resulting in a CD point prevalence of 2.8% (95% CI 0.6-5.0%). CONCLUSION We found a point prevalence of CD close to previous described prevalence in the general population of Swedish children. Therefore, general screening for CD in children with JIA is not supported by our data. However, this study shows that asymptomatic CD in children with JIA may be found by screening.

Background Clinical study and practice data have shown sildenafil improves sexual function in men with erectile dysfunction (ED). However, some men treated with placebo in double-blind, placebo-controlled sildenafil studies also report improved erectile function as measured by International Index of Erectile Function (IIEF)–Erectile Function Domain (EFD) scores. Aim This analysis estimated the relationship between post-baseline IIEF-EFD scores and demographic variables, including co-morbidities, in men with ED receiving placebo in flexible-dose sildenafil studies. Methods Placebo-treated participants in the intent-to-treat population of 42 double-blind, placebo-controlled, flexible-dose, sildenafil studies were included. A participant was classified as a placebo responder if the IIEF-EFD score was ≥26 at the last visit. Outcomes Variables assessed were age ( Results A total of 4,360 men were included; 13.5% were responders. Odds estimates indicated the largest likelihood of placebo response occurred in men who were black (odds = 20.2, P < .0001), were younger than 45 years (odds = 7.3, P < .0001), had mild ED (baseline IIEF-EFD ≥17; odds >100, P < .0001), and did not have diabetes (odds = 4.5, P < .0001). The likelihood of a placebo response decreased as ED duration increased (odds = 0.74, P < .0001). The frequency of common adverse events was similar between placebo responders and non-responders. Clinical Translation These findings contribute to the improved understanding of predictors of placebo response in sildenafil clinical studies. Elucidation of these factors may contribute to the development of further interventions and treatment strategies and best practices for clinical trials. Strengths and conclusions Strengths of this analysis include the large and diverse population and the duration of follow-up. Limitations include those associated with retrospective analyses and the inability to ascertain to what extent other demographic factors might have contributed to the placebo responses or how these placebo responses might be related to the natural course of ED. Conclusions Certain demographics, co-morbidities, and condition characteristics predicted the odds of a placebo response in sildenafil clinical studies of ED. Underlying reasons behind a placebo response warrant further evaluation.

We sought to determine whether baseline characteristics predict which overactive bladder (OAB) patients benefit from fesoterodine 8 mg versus 4 mg. In double-blind, placebo-controlled, flexible-dose trials, baseline characteristics of OAB patients with ≥ 1 urgency urinary incontinence (UUI) episodes/24 h who escalated from fesoterodine 4 mg to 8 mg were evaluated. Possible dose-escalation predictors (age; sex; previous antimuscarinic use; UUI, micturitions, and urgency episodes/24 h; race; body mass index; time to dose escalation; OAB duration) were compared in escalators versus non-escalators. Patients from fixed-dose trials with dose-escalator characteristics were identified (matched dose-escalator sample) to assess changes from baseline with fesoterodine 4 mg, 8 mg, and placebo. In flexible-dose trials, significant predictors of fesoterodine dose escalation were younger age (≤ 65.8 years), greater number of baseline micturitions (≥ 13.1) and urgency episodes/24 h (≥ 10.9), greater OAB duration (≥ 9.1 years), and more frequent previous antimuscarinic use (58.3%), but not baseline UUI episodes/24 h. In the matched dose-escalator sample (fesoterodine 4 mg: n = 215; 8 mg: n = 198; placebo: n = 217), change from baseline in UUI episodes significantly improved with fesoterodine 8 mg versus 4 mg (P = 0.043) and with both doses versus placebo (P

A recent study demonstrated improvement in nocturnal urgency in patients with overactive bladder when treated with fesoterodine. In the current study we aimed to determine which bladder diary parameters predict the response to fesoterodine in these patients.Patients with nocturnal urgency completed a 2-week, single-blind placebo run-in followed by 1:1 double-blind randomization to 12 weeks of fesoterodine or placebo. We analyzed bladder diary parameter changes from baseline to week 12, including the actual number of night voids (total number of nocturia episodes), maximum voided volume, nocturnal bladder capacity, Nocturnal Bladder Capacity Index (NBCi) (actual number of night voids - nocturnal urine volume/maximum voided volume - 1), nocturnal urine volume, the nocturia index (nocturnal urine volume/maximum voided volume) and the nocturnal polyuria index (nocturnal urine volume/24-hour volume). Additionally, we analyzed OAB-q (Overactive Bladder Questionnaire) changes.There was a linear relationship between the likelihood of being a responder for NBCi and the nocturia index. Responders had a significant decrease in nocturnal urine volume relative to baseline (-181.7 ml, p0.01). Neither group showed a significant change in maximum voided volume relative to baseline. There was a significant decrease in NBCi and the nocturia index in responders (-0.82 and -0.61, respectively, each p0.01). Responders demonstrated improvement in the OAB-q concern, coping, sleep, bother and total score metrics.Patients with nocturnal urgency secondary to overactive bladder syndrome and low nocturnal bladder capacity with a mismatch between nocturnal urine production and bladder capacity may benefit from fesoterodine. Symptom improvement appears to be mediated by increases in typical rather than maximum nocturnal voided volumes. Symptom improvement was associated with improved quality of life.

Spinal cord injury (SCI) is estimated to affect approximately 276,000 individuals in the United States. Since 2010, the mean age of individuals at the time of the SCI has been 42 years, with nearly 80% of cases involving men. This means that individuals with SCI generally are young men who typically place a great deal of importance on normal sexual and reproductive function.To assess the effect of sildenafil treatment on erectile function and the frequency of ejaculation in men with SCI.This study was a post hoc analysis of pooled data from two randomized, double-blinded, placebo-controlled, flexible-dose, crossover sildenafil trials conducted in Europe, Australia, and Turkey. Two hundred forty-eight men at least 18 years old with traumatic SCI of at least 6 months' duration, with erectile dysfunction solely attributed to SCI, and in a stable heterosexual relationship were treated sequentially with sildenafil and placebo. Exclusion criteria included taking nitrate therapy, severe cardiac failure, and recent stroke or myocardial infarction. The starting sildenafil dose was 50 mg, taken approximately 1 hour before sexual activity, with subsequent dose adjustment to 100 or 25 mg based on efficacy and safety during treatment. There was a 2-week washout between 6-week treatments.Change from baseline in International Index of Erectile Function question 3 (frequency of penetration), question 4 (maintaining erection after penetration), question 9 (frequency of ejaculation), and erectile function domain scores; intercourse success; and treatment preference.All International Index of Erectile Function outcomes, including achieving and maintaining erections and ejaculation frequency, were statistically significantly greater with sildenafil vs placebo, including the subgroup with complete SCI (P.01 for all comparisons). The percentage of successful intercourse attempts with sildenafil (53% vs 12%) and preference for sildenafil (96% vs 4%) vs placebo were significant (P.001), including the subgroup with complete SCI. The most common all-cause adverse events with sildenafil were headache (16.1%) and urinary tract infection (11.6%).Sildenafil significantly improves erections, intercourse success, and ejaculation frequency vs placebo, including in men with complete SCI. Sildenafil is an effective and well-tolerated treatment for sexual dysfunction in men with SCI. The increase in frequency of ejaculation could allow the possibility of having children without medical intervention in this patient population. Ohl DA, Carlsson M, Stecher VJ, Rippon GA. Efficacy and Safety of Sildenafil in Men With Sexual Dysfunction and Spinal Cord Injury. Sex Med Rev 2017;5:521-528.

Major events comprise an important aspect of popular culture. The pulsating nature of event organisations implies that they quickly expand at the time of the event and then contract. By examining six sport event organisations, detailed action planning was found to be crucial to ensure that both the structure and flexibility were guaranteed when the event took place. Detailed action planning served as the backbone in the chain of control in each case, connecting the evaluation based on non-financial measures with the budgeting, and with policies and procedures that were applied during the process. It created a shared understanding of the breakdown of responsibilities and duties and made it possible to clarify the role each individual played within the system and to determine when and how improvisation was needed. Our findings thereby provide important boundary conditions to the literature on ‘minimal structures’ by making it clear that ‘minimal’ management controls are not sufficient to handle the balance between structure and flexibility in pulsating organisations, which often rely on thousands of inexperienced employees to work together for a very short period of time. Detailed action planning helped create ‘operational representation’ (Bigley and Roberts, 2001), i.e. the basic cognitive infrastructure permitting individuals and groups to effectively integrate their behaviours with those of others on a moment-to-moment basis as the event unfolds. We also contribute by explaining important management control differences across the six organisations through the distinction between participation- and spectator-driven events.

Months of conference planning can take mere minutes with a dash of optimisation. By Jason Pan, Kelly H. Zou, Ching-Ray Yu, Franklin W. Sun, and Martin O. Carlsson

Anorexia nervosa (AN) is an eating disorder characterized by low fat mass complicated by osteoporosis. The role of circulating vitamin D in the development of bone loss in AN is unclear. Fat mass is known to be inversely associated with vitamin D levels measured as serum levels of total, protein-bound 25-hydroxyvitamin D, but the importance of directly measured, free levels of 25(OH)D has not been determined in AN. The aim of this study was to investigate vitamin D status, as assessed by serum concentrations of total and free serum 25(OH)D in patients with AN and healthy controls. In female AN patients (n = 20), and healthy female controls (n = 78), total 25(OH)D was measured by LC–MS/MS, and free 25(OH)D with ELISA. In patients with AN bone mineral density (BMD) was determined with DEXA. There were no differences between patients and controls in total or free S-25(OH)D levels (80 ± 31 vs 72 ± 18 nmol/L, and 6.5 ± 2.5 vs 5.6 ± 1.8 pg/ml, respectively), and no association to BMD was found. In the entire group of patients and controls, both vitamin D parameters correlated with BMI, leptin, and PTH. The current study did not demonstrate a vitamin D deficiency in patients with AN and our data does not support vitamin D deficiency as a contributing factor to bone loss in AN. Instead, we observed a trend toward higher vitamin D levels in AN subjects compared to controls. Measurement of free vitamin D levels did not contribute to additional information.

Aims Overactive bladder (OAB) and benign prostatic hyperplasia (BPH) are highly prevalent conditions that place a large burden on the United States (US) health care system. We sought to analyze patterns of prescription medication usage for incident OAB in men and women, and for incident BPH in men using US health insurance claims data. Materials and Methods This study used Truven Health MarketScan® Commercial and Medicare Supplemental Research databases. The data were pooled from diverse points of care. BPH subjects included men age 18+ with the first and last two diagnoses of BPH ≥30 days apart and no BPH diagnosis for 1 year prior. OAB subjects included men and women age 18+, who were diagnosed similarly with incident OAB. The type of medication, medication continuation (persistence), and switching to a different medication were analyzed through September 30, 2013. Results Medication persistence was much higher overall for BPH than OAB (56% vs 34%, respectively, P

The 33-item Overactive Bladder questionnaire (OAB-q; 1-week recall version) has been psychometrically validated in middle-aged, generally healthy patients with overactive bladder. The present analysis was conducted to determine the psychometric validity of the OAB-q in medically complex elderly patients.OAB-q structure was evaluated using a second-order confirmatory factor analysis (CFA) model with five domains and one aggregated domain, using pooled data from two clinical trials (786 observations) for urgency urinary incontinence (UUI). Psychometric validity was evaluated with CFA, Cronbach coefficient α (CCA) for reliability, Spearman correlations for convergent validity, differences in OAB-q scores in relation to UUI severity and Patient Perception of Bladder Condition (PPBC) scores for known-groups validity, and effect size (ES) of differences in mean scores of OAB-q domains over time for treatment responsiveness.Participants were predominantly female (82.2%) and white (85.9%); mean age was 75.0 years. The second-order CFA was confirmed with a Bentler's comparative fit index of 0.90, t values for path coefficients of1.96, and standardized path coefficients of0.40. OAB-q domains demonstrated good internal consistency (CCA0.7). Convergent validity was supported by moderate correlations (0.4-0.7) between OAB-q domain and PPBC scores. Significant differences in OAB-q domain scores between groups with different symptom severity established known-groups validity. Significant changes in mean OAB-q scores from baseline to week 12 with moderate-to-large ES (0.50-0.80) demonstrated treatment responsiveness.The OAB-q demonstrates reliability, concurrent and discriminant validity, and responsiveness to treatment. The evidence shows that the OAB-q is psychometrically sound for use in medically complex elderly patients with overactive bladder.

Objectives Cancer survivors with GH deficiency (GHD) receive GH therapy (GHT) after 1+ year observation to ensure stable tumor status/resolution. Hypothesis Radiation therapy (RT) to brain, spine, or extremities alters growth response to GHT. Aim Identify differences in growth response to GHT according to type/location of RT. Methods The Pfizer International Growth Database was searched for cancer survivors on GHT for ≥5 years. Patient data, grouped by tumor type, were analyzed for therapy (surgery, chemotherapy, RT of the focal central nervous system, cranial, craniospinal, or total body irradiation [TBI] as part of bone marrow transplantation), sex, peak stimulated GH, age at GHT start, and duration from RT to GHT start. Kruskal-Wallis test and quantile regression modeling were performed. Results Of 1149 GHD survivors on GHT for ≥5 years (male 733; median age 8.4 years; GH peak 2.8 ng/mL), 431 had craniopharyngioma (251, cranial RT), 224 medulloblastoma (craniospinal RT), 134 leukemia (72 TBI), and 360 other tumors. Median age differed by tumor group (P < 0.001). Five-year delta height SD score (SDS) (5-year ∆HtSDS; median [10th-90th percentile]) was greatest for craniopharyngioma, 1.6 (0.3-3.0); for medulloblastoma, 5-year ∆HtSDS 0.9 (0.0-1.9); for leukemia 5-year ∆HtSDS, after TBI (0.3, 0-0.7) versus without RT (0.5, 0-0.9), direct comparison P < 0.001. Adverse events included 40 treatment-related, but none unexpected. Conclusions TBI for leukemia had significant impact on growth response to GHT. Medulloblastoma survivors had intermediate GHT response, whereas craniopharyngioma cranial RT did not alter GHT response. Both craniospinal and epiphyseal irradiation negatively affect growth response to GH therapy compared with only cranial RT or no RT.

In their chapter, Carlsson-Wall and Newland introduce the sportstech dilemma. They describe how sport is an industry driven by emotion and the importance of maintaining competitive balance, which distinguishes it from other industries. Then, they survey the blockchain tech landscape in sport and differentiate seven market segments depending on customer type and the type of impact sought. They propose three strategic questions—concerning the level of integration into the sport ecosystem, potential for a hybrid business model, and geographic footprint—to guide companies navigating the sportstech dilemma. Finally, they look further into the future and see unexpected possibilities for blockchain in sport.

Background: The use of virtual health intervention and the use of home blood pressure monitoring (HBPM) has been shown to improve empowerment, compliance and blood pressure control. Aims: The aim of the present study was to use a smartphone application for hypertension treatment to investigate the patients' perception of how hypertension affected their lives. Methods: The target group was patients with primary hypertension without diabetes or major cardiovascular complications living in Stockholm, Sweden (males/females 132/153, mean age 58 years). When a patient had been included, a smartphone application (Accumbo, Sweden) was downloaded. HBPM were measured with a Bluetooth connected oscillometric BP monitor. A questionnaire was filled in electronically. Results: Mean blood pressure was 135/87 mmHg. Based on the questionnaire 71 % (190 out of 267) of the patients had never received information from their doctor regarding the aetiology of their disease. Only 37 % (103 out of 277) had received individual health advice. When asked “How is your health in general”? 54% (154 out of 285) responded good or very good. On the other hand 47% (128 out of 281) of patients answered that having an elevated blood pressure affected their daily activities. Most patients, 79 % (222 out of 282) wanted to lose weight. Forty percent (110 out of 278) stated that they received little or very little daily exercise. Sixty eight % (190 out of 279) wanted to increase their daily physical activity if possible. Only 8% (26 out of 279) did not want to increase their daily exercise. Fifty six percent (156 out of 276) patients used a lifestyle or health app in their smartphone and 43 % (121 out of 280) patients had taken dietary supplements, or vitamins the month before the study. Conclusion: Few hypertensive patients had received individual lifestyle advice although the majority of patients had a desire for weight loss and increased physical activity. Most patients were aware of the complications of hypertension and the use of alternative therapies such as dietary supplements and health and lifestyle apps were very common. Traditional health care should increase the use of digital questionnaires in order to obtain increased information about patient's lifestyle factors for better targeted treatment.

Purpose Several medications are known to cause vitamin D deficiency. The aim of this study is to describe vitamin D testing and supplementation in patients using these “risk medications”, thereby assessing adherence to medical guidelines. Patients and methods A database with electronic health records for the population in a Swedish County (≈240,000 inhabitants) was screened for patients prescribed the pre-defined “risk medications” during a 2-year period (2014–2015). In total, 12,194 patients were prescribed “risk medications” pertaining to one of the three included pharmaceutical groups. Vitamin D testing and concomitant vitamin D supplementation, including differences between the included pharmaceutical groups, was explored by matching personal identification numbers. Results Corticosteroids were prescribed to 10,003 of the patients, antiepileptic drugs to 1,101, and drugs mainly reducing vitamin D uptake to 864. Two hundred twenty-six patients were prescribed >1 “risk medication”. Seven hundred eighty-seven patients (6.5%) had been tested during the 2-year period. There were no differences regarding testing frequency between groups. Concomitant supplements were prescribed to 3,911 patients (32.1%). It was more common to be prescribed supplements when treated with corticosteroids. Vitamin D supplementation was more common among tested patients in all three groups. Women were tested and supplemented to a higher extent. The mean vitamin D level was 69 nmol/L. Vitamin D deficiency was found in 24.1% of tested patients, while 41.3% had optimal levels. It was less common to be deficient and more common to have optimal levels among patients prescribed corticosteroids. Conclusion Adherence to medical guidelines comprising testing and supplementation of patients prescribed drugs causing vitamin D deficiency needs improvement in Sweden.

In vitro, mono- and polyunsaturated fatty acids (FAs) may decrease the binding affinity of vitamin D metabolites for vitamin D-binding protein, which in turn may influence their bioavailability. FAs incorporated as phospholipids in erythrocyte (ery-) cell membranes reflect dietary intake. The purpose of this study was to investigate ery-FA composition in relation to markers for vitamin D. In healthy females (age 22.6 ± 2.0 years) total 25(OH)D was measured by LC-MS/MS (n = 78), free 25(OH)D with ELISA (n = 64 of 78), and bioavailable 25(OH)D was calculated. Analysis of ery-FA composition was by gas chromatography (n = 56 of 78). A strong correlation between total 25(OH)D and free 25(OH)D was seen (r = .66, p .001), and between total-25(OH)D and bioavailable 25(OH)D (r = .68, p .001). No correlations between 25(OH)D fractions and specific fatty acids were found, and in particular, no associations with mono- and poly-unsaturated FA compositions. All 25(OH)D fractions were correlated with leptin (total 25(OH)D (r = -.33, p .003); bioavailable 25(OH)D (r = -.47, p .001); free 25(OH)D (r = -.44, p .001). Associations were found between PTH and total 25(OH)D (r = -.35, p = .002) and weaker between bioavailable 25(OH)D (r = -.35, p = .040) and free 25(OH)D (r = -.28, p = .079). All fractions of 25(OH)D appear to correlate in a similar way to PTH, BMI and body fat (leptin). No association was found between ery-FA composition and free/bioavailable 25(OH)D. It is unlikely that FAs are a strong uncoupling factor of DBP-bound 25(OH)D.

This paper examines the role of performance measurement systems (PMS) in managing the co-existence of different institutional logics in a football organization. We show that while the sports and business logics at times compete with each other, in other situations they are in harmony. We explain this with reference to an ambiguous cause-effect relationship between these logics which allows for different ways of enacting the logics. Our study thus demonstrates that compatibility of logics may vary not just between fields and organizations, as the literature has emphasized, but also between situations within an organization. Furthermore, our paper highlights how varying outcomes of the performance measures affect the way in which compromises between the two logics are made. While the literature has mostly focused on examining how compromises can be designed into the PMS, we draw attention to how situation-specific compromises are made on the basis of such PMS. The meaning attributed to different levels of sports performance was key for understanding the differences in compromising behaviour.

Background/Aims: There is little information how rhGH treatment affects height in NS. This study aims to analyze data from the NS patients assembled in KIGS over 25 years. Patients/Methods: Of 613 (389 m/224 f) NS patients documented, 476 (302 m/174 f) were treated for 1 year, 237 (160 m/77 f) of which served to develop a 1st year height velocity (HV) prediction algorithm. One-hundred and forty (74 m/66 f) had reached near adult height (NAH). Factors affecting NAH on rhGH were determined. Results: At the start of rhGH, the NAH groups were (median, m, f) 11.0 and 10.3 years, with a height SDS of –3.2 and –3.8 SDS (Prader), respectively. The total gain after 6.3 and 5.6 years on rhGH (0.27 and 0.30 mg/kg/week) was 1.2 and 1.3 SDS. Age at the start of rhGH (negative), height at the start of rhGH, rhGH dose, number of rhGH injections/wk and birth weight (all positive) explained 36% of the variability of 1st year HV. Height at the start of rhGH, 1st year growth on rhGH, birth weight, and gender explained 74% of the variability of NAH. Causes for rhGH treatment discontinuation and adverse events were also analyzed. Conclusion: rhGH treatment increases NAH in NS. Prediction algorithms may optimize treatment in the future.

Objective To understand whether spontaneous vs induced puberty and the type and route of estrogen influence the height of girls with Turner syndrome on growth hormone (GH). Study design Search of an international database of children treated with GH revealed 772 girls with Turner syndrome followed from GH initiation to near adult height. Data from girls with sustained spontaneous puberty (n = 145) were compared with those requiring estrogens for induction or maintenance of puberty (n = 627). Results At GH start, mean age (7.5 vs 7.9 years), weight (−1.7 vs −1.7 SDS), and body mass index (0.2 SDS vs 0.1 SDS) were similar for girls with spontaneous puberty and with induced puberty. Although those girls with spontaneous puberty were shorter than those with induced puberty, when midparental height was taken into consideration, starting heights in both groups averaged −2.8 SDS. Both groups received approximately 0.3 mg/kg/week of GH. Girls with spontaneous puberty initiated puberty and reached near adult height earlier than girls with induced puberty (12.6 ± 1.8 years vs 13.4 ± 1.4 years and 16.0 ± 1.3 years vs 16.9 ± 1.4 years, respectively). Although girls with spontaneous puberty grew more in the first year of GH therapy and between the onset of puberty and near adult height (11.0 cm vs 9.3 cm), height SDS at near adult height and the length of time in puberty before reaching near adult height were comparable. A 45,X karyotype was detected in 22.1% of girls with spontaneous puberty and in 58.4% of girls with induced puberty. Patients receiving transdermal estrogens did not grow better than those on oral estrogens. Adverse event reporting was comparable between groups. Conclusions Girls with Turner syndrome with spontaneous puberty tended to grow better in response to GH than girls with induced puberty, but not enough to produce a difference in height SDS at near adult height.

BACKGROUND: Transthyretin amyloidosis (ATTR) is often associated with cardiac involvement manifesting as conduction disease as well as a restrictive cardiomyopathy causing heart failure and death. Myocardial contraction fraction (MCF), the ratio of left ventricular stroke volume (SV) to myocardial volume (MV), is a volumetric measure of myocardial shortening that is superior to EF in predicting mortality in patients with primary amyloid light chain (AL) cardiac amyloidosis. We hypothesized that MCF would be an independent predictor of survival in ATTR. METHODS AND RESULTS: MCF was derived from 2D echo-guided M-mode data for 530 subjects in the Transthyretin Amyloidosis Outcomes Survey (THAOS) database (age 61 ± 16, 74% male; 158 wild-type (ATTRwt) and 372 mutant (ATTRm) with a mean follow up of 1.5 ± 1.7 years). Using multivariate Cox proportional hazards regression models, MCF above and below 25% was highly associated with survival (HR 8.5, 95% CI 4.8 – 14.9, p < 0.0001) which was stronger than the association of ejection fraction (EF) dichotomized at 50% (HR 2.8, 95% CI 1.8 – 4.4, p < 0.0001). MCF < 25 % remained significantly predictive of survival in a multivariate model that included systolic blood pressure, estimated glomerular filtration rate below vs. above 65 ml/min/m(2), NYHA class, and health status based on the EQ-5D-3L questionnaire (AUC = 0.83, 95% CI 0.78 -0.89). CONCLUSIONS: MCF was superior to EF in predicting mortality in patients with transthyretin amyloidosis. A predictive model combining MCF with systolic blood pressure, renal function, NYHA class, and health status was strongly associated with survival in patients with ATTR.

The spatial dimension has always been central to the literature on accounting and inter-organisational relationships. Inter-organisational innovation connects individuals, teams and organisations, both within firms as well as in dyads, supply chains and networks. An explicit recognition, empirically as well as theoretically, of a multi-level perspective would help to develop the literature on inter-organisational relationships in several ways. The literature on accounting and innovation shares many characteristics with the literature on inter-organisational accounting in terms of growth, positioning and research design. Studying the low-price apparels industry, Neu describe how coercive controls are used on an individual level to deal with time pressure and uneven development rhythms in the sweatshops that produce the clothing. The literature on inter-organisational innovation has a long history. Despite studying many process characteristics, the inter-organisational innovation literature has paid limited attention to accounting. In fact, the literature has traditionally seen accounting as hindering the innovation process.

The co-existence of vitamin D deficiency with obesity and type 2 diabetes is highly prevalent in the United Arab Emirates. We do not have studies evaluating the vitamin D dose response and sufficiency, and if sufficient substitution dose during a longer period could decrease obesity or change fat distribution in obese type 2 diabetic vitamin D deficient Emiratis.A randomized double-blind clinical trial was conducted for 6 months followed by another 6 months of un-blinded follow up with 87 obese, type 2 diabetic participants. Serum 25-hydroxy vitamin D (S-25(OH)D), anthropometric data, and life-style factors such as diet and sunlight exposure were measured. The study was executed in 3 phases in two arms vitamin D arm (n = 45) and placebo arm (n = 42); in Phase 1 the vitamin D arm received 6000 IU vitamin D3/day (3 months) followed by Phase 2 with 3000 IU vitamin D3/day. During follow up (phase 3) both the arms were un-blinded and supplemented with 2200 IU vitamin D3/day for another 6 months.At the baseline a significant (p0.01) positive association between body fat mass and body weight (r = 0.97) muscle mass (r = 0.47), water mass (r = 0.54), waist circumference (r = 0.82) and serum PTH (r = 0.28) was observed. On supplementation no significant changes in anthropometric dimensions was observed. S-25(OH) D peaked in phase 1 (77.2 ± 30.1 vs 28.5 ± 9.2, p = 0.003) followed by a decrease in phase 2 (62.3 ± 20.8, p = 0.006) paralleled by a decrease in parathyroid hormone in phase 2 (5.9 ± 2.4 vs 4.5 ± 1.8, p0.01) compared to baseline in vitamin D group.This study shows no significant influence of vitamin D supplementation on weight, fat mass or waist circumference in type 2 diabetic obese vitamin D deficient participants of Arab ethnicity after one year. Despite a relatively high daily dose of vitamin D3 we did not achieve target levels of S-25(OH)D above 75 nmol/L in this population. However, supplementation was safe, improved s- 25 (OH)D also reducing the incidence of eucalcemic parathyroid hormone elevation.ClinicalTrials.gov Identifier: NCT02101151.