Efficacy, tolerability and safety of once-monthly administration of 75mg risedronate in Japanese patients with involutional osteoporosis: A comparison with a 2.5mg once-daily dosage regimen

AbstractOral risedronate has been shown to be effective in the treatment of osteoporosis when administered once-daily or once-weekly in Japan. This randomized, double-blind, multicenter 12-month study was conducted to compare the efficacy and tolerability of oral risedronate 75mg once-monthly with 2.5mg once-daily in Japanese patients with involutional osteoporosis. Bone mineral density (BMD), biochemical markers of bone metabolism, fractures, and adverse events (AEs) were evaluated. At the end of the study (Month 12, last observation carried forward [M12, LOCF]), mean percent change (SD) from baseline in lumbar spine (L2–L4) BMD, measured by dual energy X-ray absorptiometry (primary endpoint), was increased by 5.69 (4.00)% in the 2.5mg once-daily group (n=428), and 5.98 (4.54)% in the 75mg once-monthly group (n=422). In the non-inferiority t-test (non-inferiority margin Δ=1.5%), the 75mg once-monthly group was non-inferior to the 2.5mg once-daily group (p<0.0001). The difference between treatment groups was 0.28% (95% CI, −0.31% to 0.88%). Changes in biochemical markers of bone metabolism were generally comparable in the two groups, although decreases in the percent change from baseline in urinary NTX/CRN and CTX/CRN were statistically greater in the 2.5mg once-daily group than the 75mg once-monthly group. The frequency of new vertebral fractures (including aggravation of prevalent fractures) at the end of the study (M12, LOCF) was also similar in the two groups: 1.2% in the 2.5mg once-daily group and 1.3% in the 75mg once-monthly group.The incidence of mild/moderate/severe AEs was 75.5%/6.3%/0.5% in the 2.5mg once-daily group and 77.7%/8.1%/0.7% in the 75mg once-monthly group. AEs associated with gastrointestinal symptoms occurred in approximately 30% of subjects in each group but with no severe cases. AEs potentially associated with acute phase reaction (including symptoms of influenza-like illness or pyrexia starting within 3days of the first dose of the study drug and with a duration of 7days or less) only occurred in the 75mg once-monthly group (2.1%, 9/422 subjects; influenza-like symptoms in 1 subject and pyrexia in 8 subjects), although the incidence was low without any severe cases.In conclusion, risedronate 75mg once-monthly (a dosage which is 30 times higher than risedronate 2.5mg once-daily) had non-inferior efficacy in terms of BMD and was similarly well tolerated compared to the once-daily regimen in Japanese patients with involutional osteoporosis. Consistent with the once-daily and once-weekly dosage, the once-monthly dosage of risedronate 75mg was half that used outside Japan (150mg)

Comparison between Two Assessment Tests for Oral Hygiene : Adenosine Triphosphate + Adenosine Monophosphate Swab Test and Bacteria Number Counting by Dielectrophoretic Impedance Measurement

Objective assessments of oral hygiene are important to prevent oral and systemic diseases. Two objective assessment tests are available to assess oral hygiene; (1) the adenosine triphosphate (ATP) + adenosine monophosphate (AMP) swab test, which incorporates a luciferase assay and (2) a bacteria count using the dielectrophoretic impedance measurement (DEPIM) method. In this study, we compared the two tests using a subjective visual assessment by professional clinicians and investigated the clinical significance of these tests. Twenty-seven young participants (mean age 26.3 ± 3.2 years) and twenty-seven older participants (mean age 75.1 ± 5.9 years) were recruited. Oral bacteria were sampled from three areas, including the tongue dorsum, the buccal mucosa, and the faucal mucosa, and saliva was obtained using a cotton swab. The amount of ATP + AMP and the number of bacteria were measured by each specific apparatus. Additionally, one examiner assessed the overall condition of oral hygiene using the visual analog scale (VAS). In the ATP + AMP swab test, the means were highest in saliva. For the bacteria count, the means were higher in the tongue dorsum and saliva and lower in the faucal and buccal mucosa. The results of the subjective assessment of oral hygiene indicated that the VAS-value was 3.78 ± 0.97 for the young group and 3.35 ± 0.81 for the older group. No significant difference was observed between the two groups. Additionally, no significant relationship between the values of the ATP + AMP swab test and the bacteria count was found for any of the four sample sites. In the older group, the subjective assessment of oral hygiene was significantly correlated with the values of the ATP + AMP swab test (multiple correlation coefficient = 0.723, p = 0.002). In conclusion, the values provided by the ATP + AMP swab test were not always correlated to the bacteria count. The results of this study suggest that the subjective assessment of oral hygiene was more highly correlated with the results of the ATP + AMP swab test, as compared to the bacterial count assay