Efficacy and tolerability of once-monthly oral ibandronate (150 mg) and once-weekly oral alendronate (70 mg): Additional results from the monthly oral therapy with ibandronate for osteoporosis intervention (MOTION) study

Background: The MOTION (Monthly Oral Therapy with Ibandronate for Osteoporosis Intervention) study reported that once-monthly ibandronate was noninferior to once-weekly alendronate in terms of increasing bone mineral density (BMD) at the lumbar spine and total hip over 12 months. On analysis of secondary and exploratory end points in MOTION, which included trochanter and femoral neck BMD, monthly ibandronate was found to be noninferior to weekly alendronate. The coprimary, secondary, and exploratory BMD end points from MOTION have been previously reported.Objective: This report presents additional results from the MOTION study, including response rates in terms of lumbar spine and total hip BMD gains above baseline; findings from a comparison of serum concentrations of bone turnover markers; and tolerability analysis, including adverse events that led to withdrawal and gastrointestinal (GI) adverse events.Methods: MOTION was a 12-month (with 15-day follow-up), randomized, multinational, multicenter, double-blind, double-dummy, parallel-group, nonin-feriority study in postmenopausal women aged 55 to <85 years with osteoporosis. Patients were randomly assigned to receive 150-mg-monthly oral ibandronate and weekly alendronate-matched placebo, or 70-mg-weekly oral alendronate and monthly ibandronate-matched placebo, for 12 months. At baseline, day 7 of treatment, 3 and 6 months, 6 months + 7 days, and 12 months, serum concentrations of markers of bone resorption (C-telopeptide of the a chain of type 1 collagen [sCTX]) and bone formation (serum N-terminal propeptides of type 1 collagen) were measured in a subset of the total trial population. At baseline and month 12, BMD was measured using dual-energy x-ray absorptiometry. Exploratory analyses of patients whose spine, total hip, and trochanter BMD at 12 months were above baseline (responders) were also performed.Results: A total of 1760 women were enrolled (ibandronate, 887 patients; alendronate, 873). The median changes in the trough concentrations of sCTX were ?75.5% with monthly ibandronate and ?81.2% with weekly alendronate. The percentage of patients with mean lumbar spine and total hip BMD gains above baseline (responders) were 90% and 87%, respectively, for ibandronate and 92% and 90%, respectively, for alendronate. GI adverse events were reported in ≤30% of patients per group during this 1-year study.Conclusion: The data from these postmenopausal women with osteoporosis suggest that once-monthly 150-mg ibandronate therapy provided clinically comparable efficacy in terms of BMD response, reductions in bone turnover, and GI tolerability similar to that of weekly 70-mg alendronate.     

THE ROLE OF COMMUNITY EDUCATORS IN ACHIEVING AUSTRALIAN HEALTH GOALS: A PUBLIC HEALTH APPROACH TO WEIGHT CONTROL ON THE NORTH COAST,NSW

This paper describes the recruitment, training and supervision of Community Educators for weight-control programs, reports the results they have achieved to date, and offers suggestions for improving similar programs. This material is discussed in relation to suggestions about nutrition published by the Better Health Commission.     

Effects of continuous 17β-estradiol administration on the periosteal and corticoendosteal envelope activity in spayed beagles

Summary Histomorphometric analyses of resorptive and formative parameters of the periosteal and corticoendosteal bone envelopes were performed on ribs from intact, spayed and spayed 17β-estradiol-supplemented Beagle dams. Dynamic formative features were evaluated after 2 pulses ofin vivo tetracycline administration. The results indicated that following oophorectomy there was an increase in resorptive surfaces on the periosteum and corticoendosteum, and a decline in formative activity on these same envelopes. With continuous 17β-estradiol supplementation, the resorptive surfaces on both the periosteum and corticoendosteum of the spayed dams decreased. The formative activity on the periosteum seemed to decline further after the administration of 17β-estradiol, while on the corticoendosteum it tended to be restored to the level obtained for the intact dams. The increase in mineralization lag-time detected on the periosteum following oophorectomy appears not to be corrected by continuous 17β-estradiol supplementation in the spayed dams.     

Detection of Salmonella in foods using a novel coloured latex test

A novel coloured latex test for the detection of Salmonella in naturally contaminated foods is described. The test consists of two reagents which are mixtures of red, blue and green latex suspensions; each colour of latex is sensitized with specific antibodies to different groups of Salmonella. In the presence of an individual group of Salmonella organisms, the latex sensitized with the antibody specific to that grouping will agglutinate to produce a crescent of single colour latex particles and a change of background colour. Seven trial centres, within the UK, evaluated the performance of the coloured latex test for the detection of Salmonella in natural and artificially contaminated foods. The results obtained by the trial laboratories are presented and show that it is possible to combine the coloured latex test with traditional or electrial methods to give detection and/or confirmation of Salmonella at least 24 hours in advance of conventional cultural methods.     

Fourier Transform-Raman Spectroscopy for the Qualitative and Quantitative Characterization of Sulfasalazine-Containing Polymeric Microspheres

FT-Raman spectroscopy (FTRS) has been used to characterize microspheres produced from the pharmaceutical polymer Eudragit RS containing a range of concentrations of the drug sulfasalazine. While pure sulfasalazine produced an intense and complex Raman spectrum, the spectrum of drug-free Eudragit RS microspheres was considerably weaker in intensity and contained only a few prominent Raman scattering peaks. In spectra of the drug–polymer micro-spheres, peaks arising from the individual components could be identified. This enabled a quantitative analysis to be undertaken by calculating the ratio between the area of a sulfasalazine peak and the area of a Eudragit RS peak for each microsphere spectrum. A correlation was shown between the peak area ratio and the microsphere sulfasalazine content. FTRS was then applied to a series of microsphere samples which had been dissoluted into pH 7 buffer for 1, 3, 6, 9, 12, or 24 hr. For each spectrum, the drug-polymer peak area ratio was determined and this in turn enabled calculation of the residual drug content of the microsphere sample. FTRS-calculated data showed good agreement with microsphere drug content values determined spectrophotometrically.     

Acute toxicity tests using rotifers : IV. Effects of cyst age, temperature, and salinity on the sensitivity of Brachionus calyciflorus

Several aspects of the response to toxicants using a standardized toxicity test with the freshwater rotifer Brachionus calyciflorus are described. Test animals are obtained by hatching cysts which produce animals of similar age and physiological condition. The acute toxicity of 28 compounds is described with 24-hr LC₅₀'s. The LC₅₀'s span five orders of magnitude, from silver at 0.008 mg · liter⁻¹ to benzene at more than 1000 mg · liter⁻¹. Control mortality in 84 tests averaged 2% with a standard deviation of 3%, indicating very consistent test sensitivity. Only once in 84 trials did a test fail because of excessive control mortality, yielding a failure rate of 1.2%. Cyst age from 0 to 18 months had no effect on the sensitivity of neonates to reference toxicants. Both high and low temperatures increased rotifer sensitivity to reference toxicants. Copper sensitivity was greater at 10, 25, and 30°C compared with results at 20°C. Likewise, sodium pentachlorophenol toxicity was greater at 10 and 30°C compared with results at 20°C. Survivorship curves at 25°C of neonates under control conditions indicated that mortality begins at about 30 hr. This places a practical limit on toxicant exposure for the assay of 24 hr. B. calyciflorus cysts hatch at salinities up to 5 ppt and acute toxicity tests using pentachlorophenol at this salinity yielded LC₅₀'s about one-half those of standard freshwater. B. calyciflorus is preferred over Brachionus plicatilis for toxicity tests in salinities up to 5 ppt because it is consistently more sensitive.