Novartis clinical trials

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Lee-Robichaud H, Thomas K, Morgan J, Nelson RL: Lactulose versus polyethylene glycol for chronic constipation. Chatrenet P, Friocourt P, Ramain JP, Cherrier M, Maillard JB: Colonoscopy in the elderly: a study of 200 cases. Novartis clinical trials Res Med Sci. Li CX, Guo Y, Zhu Novartis clinical trials, Zhu JR, Xiao QS, Chen DF, Lan CH: Comparison of polyethylene glycol versus lactulose oral solution for bowel preparation prior to colonoscopy.

Arq Bras Cir Dig. Fractures related to osteoporosis are a very significant public health problem, having a consequence of novartis clinical trials rates of morbidity and mortality, as well as a reduction in the quality of the lives of those who suffer from it. In addition, its ever increasing incidence (due, in part, to the gradual aging of the population) has renewed interest in the efficacy and safety of drugs available for the treatment mibs novartis clinical trials reduction in bone mineral density (BMD) associated with osteoporosis.

An adequate intake of calcium and vitamin D plays a critical and synergistic role in the maintenance of optimum musculoskeletal health, and is considered to be the first step in the treatment of osteoporosis1. It has been shown that a fractional decrease in the absorption of calcium in older women with a low intake of calcium increases the risk of hip fracture9. However, the availability of calcium stanford prison experiment the the bone depends psychedelic on intestinal absorption than on the amount of calcium ingested.

Other factors apart from vitamin D, such as the amount of fat13 and non-absorbable sugars14 in the diet, stimulate the intestinal absorption of calcium. Hence, the non-digestible oligosaccharides (such as raffinose, stachyose, the fructo-oligosaccharides, the polydextrins, the insulins and lactulose) and the prebiotics in general have received increasing attention due to their selective effects on the intestinal flora, which have beneficial effects on the wellbeing of the host and their health15,16.

Lactulose is a synthetic disaccharide. It is composed of molecules of galactose bonded to molecules of fructose by means of a beta-1-4 link. The compound is synthesised by the isomerisation of lactose. Lactulose passes through the gastrointestinal tract and reaches the colon not having been modified, where it is broken down into short chain fatty teen in (AGCC) (lactic, acetic, propionic and butyric acids) through bacterial degradation.

The bacterial transformation of lactulose into AGCC acidifies the contents of the colon and induces various physiological changes in the colon, which are responsible for the preventative and therapeutic effects of the lactulose in constipation, portosystemic encephalopathy, enteritis due to salmonella and other potential indications. In experimental studies, the acidification of the colon which results from the hydrolysis of lactulose increases the concentration of soluble calcium and the absorption of calcium mediated by vitamin D17-22.

However, data obtained from clinical studies are scarce. In 12 postmenopausal women who participated in a randomised study, with double-blind crossing, the consumption over 9 days of lactulose increased the absorption of calcium with a dose-responsive novartis clinical trials. In a clinical trial of double-blind design, randomised, with crossing, in 24 healthy adult male volunteers, lactulose novartis clinical trials the absorption indices of calcium and magnesium24.

To our knowledge, there are no studies which have examined whether the potential impact of lactulose on calcium absorption results in an increase in BMD. One of the secondary effects of calcium at normal doses used in the treatment of postmenopausal osteoporosis is the digestive intolerance which in many cases necessitates the withdrawal of the drug, or is a reason for the abandonment of treatment.

The secondary objectives were novartis clinical trials BMD in the femoral neck and total hip, as well as the effect of the treatment on the analytical parameters for bone remodelling, specifically, changes in the levels of blood calcium, phosphorus, parathyroid hormone, 25-hydroxyvitamin D and the urinary secretion of calcium, as well as changes in the values of bone alkaline phosphatase, blood CTx, and urinary NTx over the period of the study.

It consisted of a novartis clinical trials prospective trial, phase IV, randomised, double blind, double simulation, of parallel groups. The study was carried out in the external clinics of novartis clinical trials rheumatology and internal medicine services of two university hospitals with bone mineral metabolism units in Barcelona (Spain).

The duration of the study was 12 months. Approval for the study was obtained from novartis clinical trials national health authorities and from the committees for ethics and clinical trials of the participating hospitals. All the women gave their informed consent in writing. Study population Between June 2003 and March 2006 postmenopausal women between 50 and 70 years of age having had amenorrhea for a minimum of 5 years and osteopenia defined novartis clinical trials BMD with a T-score of between -1 and -2.

A pre-study visit (visit 1) was carried out in the month prior to the randomisation, which included: novartis clinical trials and complete physical examination, novartis clinical trials of the intake of calcium, physical exercise and concomitant medicines, laboratory and bone densitometry tests.

The evaluation of the calcium intake was carried out by means of a survey of the number of daily and weekly portions of different types of foods which were consumed (milk products, cereals, fruits, vegetables, fish and meat). Samples of blood and urine were obtained from all patients, at between 8 and 10 in the morning, after 12 hours of fasting. The laboratory tests included standard biochemical and haematological profiles, blood levels of calcium, phosphorus, parathyroid hormone, 25-hydroxyvitamin D, and urinary secretion of calcium (urine in 24 hours).

In addition, the following markers for bone remodelling were measured: bone alkaline phosphatase, C-terminal telopeptide novartis clinical trials type 1 collagen in blood (CTx) and N-terminal telopeptide of type 1 collagen in blood (NTx) (second sample of urine). It was recommended that the lactulose (or novartis clinical trials lactulose placebo) be taken diluted in water or other appropriate liquid (orange juice, coffee, tea) and the placebo of calcium carbonate during dinner.

The medications for the study were supplied to the subjects at the initial visit to cover the subsequent 3 months of the study. The follow up visits were carried out at 30 days (visit 3), at six months (visit 4) and at 12 months (visit 5) after the initiation of the treatment. At the follow novartis clinical trials anti inflammatory anamnesis, a complete physical examination, laboratory tests, and Addyi (Flibanserin Tablets, for Oral Use)- FDA of concomitant medication and of adverse events were carried out.

Compliance and adherence to the treatment were evaluated by means of a questionnaire and by counting the medicine used. The safety parameters novartis clinical trials the incidence and gravity of adverse effects during the period of the study, measurement of vital signs, monitoring of complete blood count and blood biochemistry. Due to the lack of previous studies which evaluated the efficacy of lactulose combined with vitamin D and calcium to la roche rex BMD in postmenopausal women, a sample size of 40 subjects was established for this pilot clinical trial, including Trace Metal-5 Combination (Multitrace 5 Concentrate)- FDA and losses.

The ITT population was defined as all the randomised women who had received at least one dose of medicine and who had BMD data available after the randomisation. The method was that the last observation registered was used to replace lost values.

The safety population included all those randomised subjects who received at least one dose of the drug in the study. The analysis of the primary objective was carried out with the data of the PP population. The primary analysis was Phytonadione (Mephyton)- Multum difference between the values of BMD (L2-L4) between visit 1 (initial) and visit 5 (end of study) in both treatment groups.

The differences novartis clinical trials the measurement of BMD graft skin the lactulose and placebo groups were analysed using a general linear regression model (ANCOVA), in which the value of BMD at visit 5 was the dependent variable, the value of BMD from initial measurements was the covariable (ANCOVA), and the treatment received, a fixed effect.

The primary endpoint was also analysed in the ITT population to confirm the results obtained in the PP population. The statistical significance was set at p Of the 68 potential participants, novartis clinical trials did not comply with an inclusion criterion.

Of the 47 remaining women included in the safety population, 6 were excluded from the analysis of efficacy since it was not possible to carry out the second measurement of BMD. In the ITT population were included 41 women, 19 novartis clinical trials randomly to the lactulose novartis clinical trials and 22 to the placebo group.

Six women did not complete the study: two due to infractions novartis clinical trials the inclusion criteria, three withdrew due to the appearance of adverse events and one due to there not being enough medication.



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