Colon cleansing efficacy and safety with 1 L NER1006 versus sodium picosulfate with magnesium citrate: a randomized phase 3 trial.

BACKGROUND: Polyethylene glycol (PEG) bowel preparations are widely used for precolonoscopy bowel cleansing. This phase 3 trial assessed the efficacy, safety, and tolerability of the novel 1 L PEG-based NER1006 vs. sodium picosulfate plus magnesium citrate (SP + MC) in day-before dosing. METHODS: Patients requiring colonoscopy were randomized (1 : 1) to receive NER1006 or SP + MC. Cleansing was assessed on the Harefield Cleansing Scale (HCS) and Boston Bowel Preparation Scale (BBPS) using central readers. Two primary end points were assessed: overall colon cleansing success and high-quality cleansing of the right colon. Intention-to-treat (modified full analysis set [mFAS]) and per protocol (PP) analyses were performed. RESULTS: Of 515 patients, efficacy was analyzed in 501 (NER1006, n = 250; SP + MC, n = 251) and 379 patients (NER1006, n = 172; SP + MC, n = 207) in the mFAS and PP analyses, respectively. Non-inferiority of NER1006 vs. SP + MC was established in the mFAS for both overall cleansing (62.0 % vs. 53.8 %; P = 0.04) and high-quality cleansing in the right colon (4.4 % vs. 1.2 %; P = 0.03). Superiority of NER1006 was demonstrated using HCS in the PP set for overall cleansing success (68.0 % vs. 57.5 %; P = 0.02) and right colon high-quality cleansing (5.2 % vs. 1.0 %; P = 0.02) and using BBPS in the mFAS for overall cleansing success (58.4 % vs. 45.8 %; P = 0.003) and right colon high-quality cleansing (4.0 % vs. 0.8 %; P = 0.02). Mean segmental scores for 4/5 segments were higher with NER1006 (P ≤ 0.04). Both treatments were well tolerated, with more mild adverse events for NER1006 (17.0 % vs. 10.0 %; P = 0.03). CONCLUSIONS: Colon cleansing with NER1006 vs. SP + MC was non-inferior (mFAS) and superior (PP), with acceptable safety.European Clinical Trials Database (EudraCT)2014-002186-30TRIAL REGISTRATION: Multicenter, randomized, parallel group, phase 3 study 2014-002186-30 at https://eudract.ema.europa.eu/.

Alpha-ketoglutarate decreases serum levels of C-terminal cross-linking telopeptide of type I collagen (CTX) in postmenopausal women with osteopenia: six-month study.

Several studies have shown that alpha-ketoglutaric acid (AKG) increases serum levels of proline and has beneficial effects on skeletal development. We studied the effect of alpha-ketoglutaric (AKG) acid calcium salt (6 g AKG and 1.68 Ca/day) or calcium alone (1.68 Ca/day) on serum C-terminal cross-linked telopeptide of type I collagen (CTX) and osteocalcin (OC), as well as on lumbar spine bone mineral density (BMD) in a randomized, parallel group, double-blind, 6-month study conducted on 76 postmenopausal women with osteopenia. The maximum decrease of the mean CTX level in the AKG-Ca group was observed after 24 weeks (37.0%, p = 0.006). The differences in CTX between study groups were statistically significant after 12 and 24 weeks. The OC serum level was not affected by treatments. The BMD of the AKG-Ca group increased by 1.6% from baseline; however, the difference between treatment groups was estimated as 0.9% (non-significant). This study suggests the potential usefulness of AKG-Ca in osteopenic postmenopausal women. AKG-Ca induced beneficial changes in serum CTX, which was consistent with preserving the bone mass in the lumbar spine; however, the long-term effect needs to be further investigated.

Health promotion and health education with particular emphasis on bone diseases among rural population in Poland.

Osteoporosis and osteoarthrosis are the most common diseases of bone tissue affecting both rural and urban populations. The aim of the study was to investigate the level of education and requirement for health promotion within the scope of common diseases of the skeletal system among rural population in Poland. This was an exploratory study with a cross-sectional design performed between May 2004-September 2005 in rural areas of 16 Voivodeships (main provinces) of Poland. The study population comprised of 404 (62.9%) rural women and 238 (37.1%) rural men (total 642). All subjects were randomly sampled and recruited by personal contact in primary health care centres. Study data were obtained using a specially prepared questionnaire. The most commonly reported diseases were: arterial hypertension (26.1%), joint degenerative disease (24.6%) and osteoarthritis (14.7%). The occurrence of osteoarthritis and joint degenerative disease increased with age and was highest in the group aged over 50 (21% and 38.7% respectively). Osteoarthitis was more frequent in women compared to men (16% and 12.2% respectively). In most cases, the basic information about methods of prevention and treatment given by a General Practitioner or a specialist was characterized as "satisfactory" (73.6% and 62.9% respectively). The most popular prophylactic action performed in local communities was bone densitometry (14.1%), and the most important source of knowledge - TV and radio (65%). Populations living in rural areas have limited access to health education and health prophylaxis actions, irrespective of the geographical region of Poland. Inhabitants with secondary or higher education, as well as those with a higher household income, have better knowledge about skeletal system diseases compared to those with a lower educational level. The practical implications of this study suggest the necessity for paying more attention to etiology, symptoms and methods of prevention and treatment of bone diseases when attending to patients in specialist practice.

Serum lipid profile and metabolic syndrome occurrence among obese rural women from Lublin Region (Eastern Poland).

Obesity is a multivariate syndrome which can negatively affect whole body functioning. It is most common in highly developed countries, and in recent years a progressive increase in obesity occurrence is noticeable. The aim of the study was to assess serum lipid profile and metabolic syndrome occurrence among obese rural women from Lublin Region in Eastern Poland. The study was conducted in the Institute of Agricultural Medicine in Lublin (IAM). All subjects had a negative history of diseases and treatment that could affect serum lipid profile or glucose measurements. The inclusion criterion for the study group was overweight and obesity, defined as a body mass index above 25 (BMI > 25) and living in a rural area. 44 women participated in the study. There were no women fulfilling the criteria or who had a history of incorrect fasting glucose (IFG) or incorrect glucose tolerance (IGT). In contrast, the prevalence of arterial hypertension (or treatment) was high - 53%. 22.7% women had normal serum TC values. The proportion of those with hyper-LDL-C was 38.6% and with hyper-TG - 18.2%. 20.5% of studied women had incorrect serum HDL-C levels, and in 15.9% hypo- HDL-C was accompanied by high serum TC levels. Analysis of correlation showed that serum TC was positively correlated with both LDL- and HDL-C. 55% of the studied obese or overweight women had at least 2 additional components of the metabolic syndrome.

Osteoporosis risk factors in rural and urban women from the Lublin Region of Poland.

In various epidemiological and clinical studies, bone quality, bone mineral density (BMD), as well as risk of falling have been associated with lifestyle and anthropometric/demographic characteristics. The objective of this study was to evaluate the osteoporosis risk factors occurrence and its association with BMD in rural and urban women from the Lublin Region in Poland. A cross-sectional study of risk factors of osteoporosis and fracture was carried out in a cohort of 900 rural and urban women aged 30-79 years, representative of the general population the Lublin Region. Data pertaining to osteoporosis risk factors as well as medical history were taken using a specially designed 31 item questionnaire divided in seven sections: social history, past medical history, reproductive history, drug history, family history of osteoporosis, nutritional habits and lifestyle factors. The lumbar spine (L(2)-L(4)) was examined in a-p position using the dual X-ray absorptiometry- DXA (LUNAR Corp.). The differences between urban and rural women in the appearance of particular osteoporosis risk factors, such as gynecological, dietary calcium intake, smoking and coffee consumption, was noticeable. Age, years of menopause and family history of osteoporosis (in mothers) were found to have strong negative independent associations with lumbar spine BMD. Body Mass Index (BMI) was found to have strong positive association with BMD. Dietary calcium intake, coffee consumption and level of physical activity had noticeable positive and independent, but not significant association with BMD.

Rapid progression of primary sclerosing cholangitis complicated with ulcerative colitis.

Primary sclerosing cholangitis is a cholestatic condition with unknown etiology and long-standing, progressive course, leading to cirrhosis and requiring orthotropic liver transplant. In approximately 80%, primary sclerosing cholangitis is accompanied by inflammatory bowel disease, and in most cases the recognition of bowel disease precedes the diagnosis of primary sclerosing cholangitis. We describe a case of 22-year-old male diagnosed simultaneously with primary sclerosing cholangitis and ulcerative colitis, with a medical history suggesting uncommon prior development of the liver disease. Five months after the initial diagnosis, we observed advanced lesions of bile tree due to progression of primary sclerosing cholangitis, which led to the unusually fast necessity for the orthotopic liver transplant.

Age- and BMD-related differences in biochemical markers of bone metabolism in rural and urban women from Lublin Region, Poland.

The utility of biochemical markers of bone metabolism has not been proven in the diagnosis of metabolic diseases of the bone tissue; however they are widely used as a tools for treatment monitoring. Their serum concentrations are influenced by a number of factors, like gender, health status, anthropometric and environmental factors. All the factors listed above should be taken into consideration during clinical use. The aim of the study was to determine the reference values and evaluate the influence of environmental and anthropometric variables on biochemical markers of bone turnover for women from Lublin Region (Poland). Subjects of the study were 188 normal women aged 30-79, all residents of Lublin Region. Analysed markers of bone turnover were: osteocalcin (OC) and C-terminal cross-linking telopeptide of type I collagen (CTX-I), both assessed using ELISA method. All blood samples were taken and analyzed at the Clinical Chem. Laboratory and Patho-morphology Department at the Institute of Agricultural Medicine in Lublin. The lumbar spine (L2-L4) of all subjects was examined in a-p position using the dual X-ray absorptiometry-DXA (DPX-A LUNAR Corp.) at the Department of Metabolic and Degenerative Diseases of Bone Tissue of Institute of Agricultural Medicine in Lublin. Data pertaining to factors affecting bone tissue were collected using a specially prepared questionnaire. Serum levels of OC and CTX-I in women in every age range were different, generally increasing with age. Serum levels of OC and CTX-I in the analysed population strongly depended of both menopausal status and bone mineral density. In conclusion, this study demonstrates that age and menopausal status variations need to be considered when interpreting laboratory measurements of biochemical markers of bone metabolism.