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Abstract Background The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is gaining popularity as a new treatment option. Many prospective and retrospective studies have reported on the effectiveness and safety of PV, but no large randomized controlled trial (RCT) has been published. Objective To estimate cost-effectiveness of PV compared to conservative therapy in terms of: pain reduction, quality of life, complications, secondary fractures and mortality. Materials and methods The VERTOS II study is designed as a prospective, multicenter RCT. Patients with a painful VCF with bone edema on MR imaging, local back pain for 6 weeks or less, osteopenia and aged 50 years or older, after obtaining informed consent are included and randomized for PV or conservative therapy. In total 200 patients will be enrolled. Follow-up is at regular intervals during a 1-year period with standard questionnaires, addressing: clinical symptoms, pain medication, Visual Analogue Scale (VAS) score, quality of life and cost-effectiveness. Secondary fractures, necessary additional therapies and complications are recorded. Conclusion The VERTOS II study is the first methodologically sound RCT designed to assess the cost-effectiveness of PV compared to conservative therapy in patients with an acute osteoporotic VCF. Trial registration http://www.clinicaltrials.gov, NCT00232466

Objective: The DiaMind trial showed beneficial immediate effects of mindfulness-based cognitive therapy (MBCT) on emotional distress, but not on diabetes distress and HbA1c. The aim of the present report was to examine if the effects would be sustained after six month follow-up., Methods: In the DiaMind trial, 139 outpatients with diabetes (type-I or type-II) and a lowered level of emotional well-being were randomized into MBCT (n=70) or a waiting list with treatment as usual (TAU: n=69). Primary outcomes were perceived stress, anxiety and depressive symptoms, and diabetes distress. Secondary outcomes were, among others, health status, and glycemic control (HbA1c)., Results: Compared to TAU, MBCT showed sustained reductions at follow-up in perceived stress (p<.001, d=.76), anxiety (p<.001, assessed by HADS d=.83; assessed by POMS d=.92), and HADS depressive symptoms (p=.004, d=.51), but not POMS depressive symptoms when using Bonferroni correction for multiple testing (p=.016, d=.48). No significant between-group effect was found on diabetes distress and HbA1c., Conclusion: This study showed sustained benefits of MBCT six months after the intervention on emotional distress in people with diabetes and a lowered level of emotional well-being., Trial Registration: Dutch Trial Register NTR2145, http://www.trialregister.nl., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objective: Emotional distress is common in outpatients with diabetes, affecting ∼20-40% of the patients. The aim of this study was to determine the effectiveness of group therapy with Mindfulness-Based Cognitive Therapy (MBCT), relative to usual care, for patients with diabetes with regard to reducing emotional distress and improving health-related quality of life and glycemic control., Research Design and Methods: In the present randomized controlled trial, 139 outpatients with diabetes (type 1 or type 2) and low levels of emotional well-being were randomized to MBCT (n = 70) or a waiting list group (n = 69). Primary outcomes were perceived stress (Perceived Stress Scale), anxiety and depressive symptoms (Hospital Anxiety and Depression Scale), mood (Profiles of Mood States), and diabetes-specific distress (Problem Areas In Diabetes). Secondary outcomes were health-related quality of life (12-Item Short-Form Health Survey), and glycemic control (HbA(1c)). Assessments were conducted at baseline and at 4 and 8 weeks of follow-up., Results: Compared with control, MBCT was more effective in reducing stress (P < 0.001, Cohen d = 0.70), depressive symptoms (P = 0.006, d = 0.59), and anxiety (P = 0.019, d = 0.44). In addition, MBCT was more effective in improving quality of life (mental: P = 0.003, d = 0.55; physical: P = 0.032, d = 0.40). We found no significant effect on HbA(1c) or diabetes-specific distress, although patients with elevated diabetes distress in the MBCT group tended to show a decrease in diabetes distress (P = 0.07, d = 0.70) compared with the control group., Conclusions: Compared with usual care, MBCT resulted in a reduction of emotional distress and an increase in health-related quality of life in diabetic patients who had lower levels of emotional well-being.

Summary: Implementation of case findings according to guidelines for osteoporosis in fracture patients presenting at a Fracture Liaison Service (FLS) was evaluated. Despite one guideline, all FLSs differed in the performance of patient selection and prevalence of clinical risk factors (CRFs) indicating the need for more concrete and standardised guidelines., Introduction: The aim of the study was to evaluate the implementation of case findings according to guidelines for osteoporosis in fracture patients presenting at FLSs in the Netherlands., Methods: Five FLSs were contacted to participate in this prospective study. Patients older than 50 years with a recent clinical fracture who were able and were willing to participate in fracture risk evaluation were included. Performance was evaluated by criteria for patient recruitment, patient characteristics, nurse time, evaluated clinical risk factors (CRFs), bone mineral density (BMD) and laboratory testing and results of CRFs and BMD are presented. Differences between FLSs were analysed for performance (by chi-square and Student's t test) and for prevalence of CRFs (by relative risks (RR))., Results: All FLSs had a dedicated nurse spending 0.9 to 1.7 h per patient. During 39 to 58 months follow-up, 7,199 patients were evaluated (15 to 47 patients/centre/month; mean age, 67 years; 77% women). Major differences were found between FLSs in the performance of patient recruitment, evaluation of CRFs, BMD and laboratory testing, varying between 0% and 100%. The prevalence of CRFs and osteoporosis varied significantly between FLSs (RR between 1.7 and 37.0, depending on the risk factor)., Conclusion: All five participating FLSs with a dedicated fracture nurse differed in the performance of patient selection, CRFs and in the prevalence of CRFs, indicating the need for more concrete and standardised guidelines to organise evaluation of patients at the time of fracture in daily practice.

Background: Percutaneous vertebroplasty is increasingly used for treatment of pain in patients with osteoporotic vertebral compression fractures, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain. We aimed to clarify whether vertebroplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures., Methods: Patients were recruited to this open-label prospective randomised trial from the radiology departments of six hospitals in the Netherlands and Belgium. Patients were aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss; level of fracture at Th5 or lower; bone oedema on MRI), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment by computer-generated randomisation codes with a block size of six. Masking was not possible for participants, physicians, and outcome assessors. The primary outcome was pain relief at 1 month and 1 year as measured by VAS score. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT00232466., Findings: Between Oct 1, 2005, and June 30, 2008, we identified 431 patients who were eligible for randomisation. 229 (53%) patients had spontaneous pain relief during assessment, and 202 patients with persistent pain were randomly allocated to treatment (101 vertebroplasty, 101 conservative treatment). Vertebroplasty resulted in greater pain relief than did conservative treatment; difference in mean VAS score between baseline and 1 month was -5·2 (95% CI -5·88 to -4·72) after vertebroplasty and -2·7 (-3·22 to -1·98) after conservative treatment, and between baseline and 1 year was -5·7 (-6·22 to -4·98) after vertebroplasty and -3·7 (-4·35 to -3·05) after conservative treatment. The difference between groups in reduction of mean VAS score from baseline was 2·6 (95% CI 1·74-3·37, p<0·0001) at 1 month and 2·0 (1·13-2·80, p<0·0001) at 1 year. No serious complications or adverse events were reported., Interpretation: In a subgroup of patients with acute osteoporotic vertebral compression fractures and persistent pain, percutaneous vertebroplasty is effective and safe. Pain relief after vertebroplasty is immediate, is sustained for at least a year, and is significantly greater than that achieved with conservative treatment, at an acceptable cost., Funding: ZonMw; COOK Medical., (Copyright © 2010 Elsevier Ltd. All rights reserved.)

Background and Purpose: PV is increasingly used as treatment for osteoporotic VCFs. However, controversy exists as to whether PV increases the risk for new VCFs during follow-up. The purpose of our research was to assess the incidence of new VCFs in patients with acute VCFs randomized to PV and conservative therapy., Materials and Methods: VERTOS II is a prospective multicenter randomized controlled trial comparing PV with conservative therapy in 202 patients. Incidence, distribution, and timing of new VCFs during follow-up were assessed from spine radiographs. In addition, further height loss during follow-up of treated VCFs was measured., Results: After a mean follow-up of 11.4 months (median, 12.0; range, 1-24 months), 18 new VCFs occurred in 15 of 91 patients after PV and 30 new VCFs in 21 of 85 patients after conservative therapy. This difference was not significant (P = .44). There was no higher fracture risk for adjacent-versus-distant vertebrae. Mean time to new VCF was 16.2 months after PV and 17.8 months after conservative treatment (logrank, P = .45). The baseline number of VCFs was the only risk factor for occurrence (OR, 1.43; 95% CI, 1.05-1.95) and number (P = .01) of new VCFs. After conservative therapy, further height loss of treated vertebrae occurred more frequently (35 of 85 versus 11 of 91 patients, P < .001) and was more severe (P < .001) than after PV., Conclusions: Incidence of new VCFs was not different after PV compared with conservative therapy after a mean of 11.4 months' follow-up. The only risk factor for new VCFs was the number of VCFs at baseline. PV contributed to preservation of stature by decreasing both the incidence and severity of further height loss in treated vertebrae.

Introduction: A Fracture and Osteoporosis (F&O) clinic started in two major general hospitals in the South of the Netherlands on April 1st 2004. Its objectives were to perform easy and complete assessment of female and male patients aged 50 years and over, initially treated for a low-energy trauma fracture, and to evaluate its effectiveness for early diagnosis and treatment of osteoporosis., Methods: All eligible patients were selected from the digital X-ray system of the Emergency Department. DXA-scans and, if indicated, spinal radiographs were made. If osteoporosis was diagnosed, the F&O nurse explained the treatment strategy. Treatment advice was sent to the general practitioner (GP), who prescribed medication and provided further support. After 3 months, all osteoporosis patients received a compliance and side effects follow-up questionnaire., Results: Up to June 1st 2005, 1058 patients followed the diagnostic procedure; 584 patients did not. Three times more women (804) than men (254) suffered a fracture. Osteoporosis occurred 10% more often in women. Overall, 37.1% had osteoporosis, based on DXA-scan only, and 39.6% when spinal radiographs were added. Spinal radiographs of the thoracic and or lumbar spine were made in 166 patients, radiographs of the thorax in 114 patients. Overall, fractures of the wrist were most common, with fractures of the hand occurring most frequently in men (20.0%). All fracture sites, except foot and clavicula, were associated with a higher frequency of osteoporosis than in the Dutch population. The response rate to the 3-month compliance questionnaire was 73% increasing to 96% after telephone contact. 86% visited their GP; 11% did not because they already received anti-osteoporotic medication prior to the fracture. Bisphosphonates were prescribed to 84% and discontinued by 7%. 13% reported side effects of bisphosphonates. Only half of the patients received the recommended calcium supplementation., Conclusions: The F&O clinic with its digital X-ray system facilitated easy, complete identification of fracture patients and early treatment of osteoporosis, which was frequently diagnosed. Self-reported compliance was high.

The aim of our study was to assess the long-term (24 months) efficacy of a comprehensive weight reduction programme as compared to that of a conventional programme. The Comprehensive Programme comprised, besides the Conventional Programme (diet counselling), behavioural modification and exercise training. The 2-year follow-up period was completed by 53 patients (19M/34F; 88.3%). The differences (95% confidence intervals; CI) between the change in body weight of patients in the Comprehensive Programme compared to the Conventional Programme after 6 and 24 months of treatment were -2.2 (-4.0, -0.3) kg, p = 0.03 and -1.3 (-3.3, 0.7) kg, p = 0.21, respectively. In comparison to the Conventional Programme, the Comprehensive Programme resulted in a greater decrease (95% CI) of HbA1c after 6 months: -0.8 (-1.2, -0.2)%, p = 0.01, but not after 2 years: -0.4 (-1.0, 0.1)%, p = 0.12. The effects on blood pressure and serum lipids of the Comprehensive Programme and the Conventional Programme were comparable. Changes in body weight at 6 months correlated well with changes in HbA1c, fasting plasma insulin, and blood pressure, whereas at 24 months no such correlation was found with HbA1c. Pretreatment variates that were associated with the greatest 2-year weight loss were a high HbA1c value, a low energy per cent carbohydrate intake and a low percentage of obese subjects within the family. In conclusion, the long-term outcome of the Comprehensive Programme was not different from that of the Conventional Programme. The achieved body weight reduction was associated with a sustained fall in blood pressure, but with only a transient beneficial effect on the glycaemic control in the Type 2 diabetic patient.

The aim of the present study was to investigate the possible determinants of insulin sensitivity and the relationships of these determinants and insulin sensitivity to lipoprotein levels and blood pressure in patients with non-insulin-dependent diabetes mellitus (NIDDM). We studied 46 patients with NIDDM (26 women, 20 men) treated either with diet alone or in combination with sulfonylureas. Insulin sensitivity was assessed as the insulin-mediated glucose uptake rate (M value) with the hyperinsulinemic euglycemic clamp technique. In a multiple regression model, only percent body fat, waist to hip ratio (WHR), and resting energy expenditure (REE) emerged as significant independent determinants of the M value, with a multiple R2 for the model of 44%, whereas age, hemoglobin A1c (HbA1c) level, thyroid function, fitness level, smoking status, alcohol consumption, and dietary habits did not contribute significantly. The M value was independently and negatively associated with the concentrations of triglyceride (TG) and very-low-density lipoprotein (VLDL) cholesterol and positively associated with high-density lipoprotein (HDL) cholesterol subfractions and apolipoprotein A1. In our predominantly normotensive subjects, we found no association between the M value and blood pressure. Moreover, fasting insulin contributed directly, ie, independent of the M value, to the variation of TG, but not to the other lipoproteins and not to blood pressure. The results suggest that in NIDDM (1) insulin sensitivity is determined mainly by percentage body fat and REE, (2) the insulin level determines the TG level directly, whereas the lipoproteins are influenced indirectly as a reflection of the degree of insulin resistance, and (3) insulin sensitivity is not related to blood pressure in a normotensive population.

A patient is described with chronic myelogenous leukemia (CML) and an unusual karyotype 46XY,t(Y;12) (q11;p12), whose clinical course was complicated by T-cell lymphoma 5 years later. At that time bone marrow cells showed an additional karyotypic abnormality 46XY,t(Y;12) (q11;p12) del(7) (pter-p21), which remained unchanged until blastic transformation of the CML 8 months later. The bone marrow biopsy specimen, which revealed the blastic transformation of the CML, also showed evidence for localization of T-cell lymphoma. This case, added to two previously reported cases of the concurrence of CML and T-cell lymphoma, suggests a relationship between the two diseases, which is discussed.

This case report describes a patient with severe stenosis of the right pulmonary artery due to an expanding arteriosclerotic aneurysm of the ascending aorta. The clinical data and the lung perfusion ventilation scintigrams supported the diagnosis of pulmonary embolism, and initially the patient was treated accordingly.