Prediction of osteoporotic fragility re-fracture with lumbar spine DXA-based derived bone strain index: a multicenter validation study.

A new qualitative index of bone strength, based on finite element analysis and named bone strain index, has been recently developed from lumbar DXA scan. This study shows that BSI predicts subsequent re-fracture in osteoporotic patients affected by fragility fractures. INTRODUCTION: Dual-energy X-ray absorptiometry (DXA) can provide quantitative (bone mineral density, BMD) and qualitative (trabecular bone score, TBS) indexes of bone status, able to predict fragility fractures in most osteoporotic patients. A new qualitative index of bone strength, based on finite element analysis and named bone strain index (BSI), has been recently developed from lumbar DXA scan. This study presents the validation results of BSI prediction for re-fracture in osteoporotic patients with fragility fractures. METHODS: In three academic hospitals, 234 consecutive fractured patients with primary osteoporosis (209 females) performed a spine X-ray for the calculation of spine deformity index (SDI) and DXA densitometry for BMD, TBS and BSI at the basal time and in the follow-up at each clinical check. A subsequent fracture was considered as one unity increase of SDI. RESULTS: For each unit increase of the investigated indexes, the univariate hazard ratio of re-fracture, 95% CI, p value and proportionality test p value are for age 1.040, 1.017-1.064, 0.0007 and 0.2529, respectively, and for BSI 1.372, 1.038-1.813, 0.0261 and 0.5179, respectively. BSI remained in the final multivariate model as a statistically significant independent predictor of a subsequent re-fracture (1.332, 1.013-1.752 and 0.0399) together with age (1.039, 1.016-1.064 and 0.0009); for this multivariate model proportionality test, p value is 0.4604. CONCLUSIONS: BSI appears to be a valid DXA index of prediction of re-fracture, and it can be used for a more refined risk assessment of osteoporotic patients.

Bone strain index reproducibility and soft tissue thickness influence: a dual x-ray photon absorptiometry phantom study.

BACKGROUND: Bone strain index (BSI) is a tool measuring bone strain, derived from dual x-ray photon absorptiometry. It is able to characterise an aspect of bone quality that, joined to the quantity and quality parameters of bone mineral density (BMD) and trabecular bone score (TBS), permits an accurate definition of fracture risk. As no data are available about BSI precision, our aim was to assess its in vitro reproducibility. METHODS: A Hologic spine phantom was used to perform BSI scans with three different scan modes: fast array (FA), array (A), and high definition (HD). Different soft tissue thicknesses (1, 3, 6 cm) of fresh pork rind layers as a surrogate of abdominal fat were interposed. For each scan mode, the phantom was consecutively scanned 25 times without repositioning. RESULTS: In all scan modes (FA, A, HD) and at every fat thickness, BSI reproducibility was lower than that of BMD. The highest reproducibility was found using HD-mode with 1 cm of pork rind and the lowest one using HD-mode with 6 cm of pork rind. Increasing fat thickness, BSI reproducibility tended to decrease. BSI least significant change appeared to be about three times that of BMD in all modalities and fat thicknesses. Without pork rind superimposition and with 1-cm fat layer, BSI reproducibility was highest with HD-mode; with 3 or 6 cm fat thickness, it was higher with A-mode. CONCLUSIONS: BSI reproducibility was worse than that of BMD, but it is less sensitive to fat thickness increase, similarly to TBS.

Role of symptoms, trend of liver tests, and endotherapy in management of post-cholecystectomy biliary leak.

AIM: Biliary leaks are widely reported complications of cholecystectomy, but standard management remains undecided. The objective of our study was to report the role of symptoms, biochemical tests, and ERCP in patients with a leak. MATERIALS AND METHODS: Twenty-one patients (8 M, 26-77 years) with suspected post-cholecystectomy biliary leak were retrospectively studied. Symptoms and liver tests (LTs) after surgery were monitored. Trends of LTs were considered positive if increases at >48 h were seen. ERCP was performed in all patients. Findings at endoscopy and treatments were reported. Outcome results were obtained for all patients. RESULTS: Seventeen of 21 patients had persistent biliary leak at ERCP, because of direct injury (n = 10), accessory duct (n = 4), or cystic duct stump (n = 3). Eleven of 17 patients (six without symptoms), had distal obstruction because of surgical injury (n = 8), stone (n = 2), or cholangiocarcinoma (n = 1) and underwent stenting (n = 4), naso-biliary drainage, NBD (n = 3), or surgery (n = 4). Among the six patients without obstruction (four without symptoms), stenting was performed in two and NBD in four. The four patients without apparent leak underwent NBD. Impairment of LTs was present in ten out of eleven (91%) patients with obstruction versus six of ten (60%) without obstruction. No complications occurred after ERCP. During a median follow-up of 33 months (cholangiocarcinoma excluded) all but one remained asymptomatic. CONCLUSIONS: Symptoms and trend of LTs were not predictive of biliary obstruction in patients with a leak after cholecystectomy. Both endotherapy and surgery had favorable outcomes.

ERCP and short-term stent-trial in patients with anastomotic biliary stricture following liver transplantation.

BACKGROUND: Anastomotic biliary stricture represents one of the possible factors leading to liver dysfunction after transplantation. PURPOSE: Our aims were to evaluate the role of endoscopic retrograde cholangio-pancreatography and a short-term stenting (stent-trial) in assessment of the clinical relevance of the biliary stricture. MATERIALS AND METHODS: Thirty transplanted patients for HCV (n=17) or non-HCV (n=13)-related cirrhosis (27M, median age 53 yr, range 24-67 yr) who developed persistently abnormal liver function tests and presented with an anastomotic biliary stricture suggested by non-invasive cholangiography, underwent endoscopic retrograde cholangio-pancreatography. If the stricture was confirmed, dilation was performed and a plastic stent was placed. Clinical and biochemical evaluation was done one and two months later. Resolution of symptoms and normalization or > 50% reduction of at least one liver function test were needed to consider the stricture as clinically relevant. Patients were followed up for a median of 19 months. RESULTS: Endoscopic retrograde cholangio-pancreatography was successful in 29 patients and confirmed the anastomotic biliary stricture in 19 (66%); 14 patients underwent endoscopic dilation and stenting and five patients underwent surgery. The stent-trial suggested the stricture to be clinically relevant in 7 of 14 patients, confirmed by prolonged stenting and follow-up. A trend towards a higher likelihood of a clinically relevant stricture was observed in HCV-negative compared to HCV-positive patients (5 of 7, 71% vs 2 of 7, 29% , respectively; p=0.1). CONCLUSIONS: Our data suggest that endoscopic retrograde cholangio-pancreatography is a valuable tool to evaluate the clinical relevance of an anastomotic stricture, when coupled with a short-term stent-trial.

Long-term intermittent treatment with low-dose 5-aminosalicylic enemas is efficacious for remission maintenance in ulcerative colitis.

BACKGROUND: The standard remission maintenance treatment for ulcerative colitis (UC) is 5-amino-salicylic acid (5-ASA), given orally and topically and in different doses, with various frequencies and duration of administration. Both the efficacy of long-term intermittent therapy with low-dose 5-ASA enemas in preventing UC relapses and its economic implications were evaluated. METHODS: In accordance with a prospective case control study, 42 adult UC outpatients (29 M and 13 F) were treated with 5-ASA tablets (1.6 g/day) and 5-ASA enemas (2 g/50 mL) twice weekly, and 42 concurrent UC outpatients, matched for sex, age, extension and duration of disease, received only the oral therapy; the median treatment period was 6 years. RESULTS: There was a significant reduction in the number (42%: P = 0.034) and incidence of relapses (43%: P = 0.022) in the patients receiving combined oral + topical 5-ASA, who also had a significantly higher cumulative probability of not experiencing a first relapse (P = 0.001). There were no dropouts or side effects. Local therapy increased drug costs, but decreased the costs of relapses by 48% and completely precluded hospitalization costs. CONCLUSIONS: The scheduled oral + topical 5-ASA treatment, at the lowest cumulative topical dosage tested over the longest known observation period, is efficacious in improving clinical outcome and decreasing overall costs in UC patients.

Bone mineral density and body composition in ulcerative colitis: a six-year follow-up.

Reduced bone mineral density (BMD) has been reported in ulcerative colitis (UC), but there are no data concerning body composition (fat and lean mass) in such patients. We used whole body dual-energy X-ray absorptiometry (Hologic QDR 1000 W) at baseline and after 6 years of follow-up to study bone density, and fat and lean mass in 43 outpatients with mild UC (21 men, mean age 36 years, range 21-57 years, and 22 women, mean age 35 years, range 23-45 years at baseline; disease extent: 2 proctitis, 18 proctosigmoiditis, 8 left colitis, 5 substantial colitis, 10 pancolitis; mean disease duration 8 years, range 2-18 years; no hospitalization; few relapses during the follow-up) and 111 healthy volunteers matched by sex, age and body mass index. There were 5 drop-outs. We observed no significant difference in BMD, or fat and lean mass between the male patients and controls at baseline or after 6 years. The total lean mass (Z-score = -3.2, p = 0.001) and trunk lean mass (Z-score = -2.01, p = 0.03) of the female patients were lower than those of the controls at baseline, whereas their limb lean mass was higher at both the beginning and the end of the study (Z-score = 2.14, p = 0.03; Z-score = 2.8, p = 0.004, respectively). At baseline there was a significant negative correlation between lifetime steroid intake (enteral and parenteral) and lumbar spine BMD, obtained as whole body subregion (r = -0.53, p = 0.0006). After 6 years there was a significant negative correlation in women between whole body and lumbar spine BMD and both steroid intake (r = -0.53, p = 0.01; and r = -0.62, p = 0.003) and the number of relapses (r = -0.49, p = 0.02; and r = -0.44, p = 0.05). Mild UC thus does not represent a risk factor for osteopenia per se. The differences in lean mass between the female patients and controls do not seem to be clinically relevant.

Bone mineral density and body composition in patients with ulcerative colitis.

OBJECTIVE: Reduced bone mineral density (BMD) has been reported in ulcerative colitis (UC) patients, but body composition (fat and lean mass) has never been concomitantly studied. We sought to investigate BMD and body composition in a group of UC outpatients with the following characteristics: age 18-60 yr (men) and 18-45 yr (women); no intestinal resection; no immunosuppressive treatment; and regular menstruation. METHODS: Whole body and subregional BMD and body composition in 43 UC patients (21 men, 22 women; male mean age, 36.5 [21-57] yr; female mean age, 35.3 [23-45] yr) and 121 healthy volunteers were studied by means of dual X-ray photon absorptiometry. RESULTS: There were no differences in total and subregional BMD, or fat and lean mass between the patients and controls, except that the total and trunk lean mass of the UC women was lower than that in the normal controls. No correlation was found between lifetime steroid intake and BMD. CONCLUSIONS: UC outpatients do not differ from normal subjects in terms of BMD and fat mass. Mild and moderate UC does not represent a risk factor for osteopenia.

Controlled trial of oral 5-aminosalicylic acid for the prevention of early relapse in Crohn's disease.

BACKGROUND: Recent data indicate that 5-aminosalicylic acid (5-ASA) is most effective in preventing relapse of Crohn's disease in patients with a short duration of remission before enrollment. AIM: To evaluate the efficacy of oral 5-ASA treatment, started immediately after achieving steroid-induced remission, in preventing clinical relapses of Crohn's disease. METHODS: Patients with active Crohn's disease, achieving remission on steroids, were randomized to oral 5-ASA 3 g/day or placebo, while steroids were tapered over 6 weeks. The trial was terminated after interim analysis showed a slightly higher relapse rate in the 5-ASA group, and the calculated probability of seeing a statistically significant difference by completing the study was minimal. RESULTS: Final analysis included 117 patients (58 taking 5-ASA and 59 taking placebo; follow-up 9.2 +/- 6.5 months). Cumulative relapse rates at 6 and 12 months were 34% and 58% in 5-ASA patients and 31% and 52% in placebo patients, respectively (rate difference +0.095; 95% CI = -0.085 to +0.274). Subgroups analysis showed that 5-ASA was equally ineffective in patients with ileal, colonic or ileocolonic disease. CONCLUSIONS: Contrary to previous results, in our study early introduction of treatment with oral 5-ASA did not prevent relapse in Crohn's disease patients treated with steroids to induce remission.