Long-term safety and effectiveness of denosumab in Japanese patients with osteoporosis: 3-year post-marketing surveillance study.

INTRODUCTION: Denosumab is a humanized IgG2 monoclonal antibody that was approved for the treatment of osteoporosis in Japan in 2013. This study aimed to investigate the long-term safety and effectiveness of denosumab in Japanese patients with osteoporosis in daily clinical practice. MATERIALS AND METHODS: This 3-year, prospective, observational, post-marketing study included patients who initiated treatment with denosumab (60 mg/6 months) for osteoporosis. Data were assessed at baseline, 3, 6, 12, 24 and 36 months. Key endpoints were adverse events (AEs), adverse drug reactions (ADRs), occurrence of osteoporotic fractures, bone mineral density (BMD), and bone turnover markers. Multivariate analyses were conducted to identify predictors of hypocalcaemia and percent change in BMD. RESULTS: Overall, 3534 patients were assessed (mean 75.7 years; 89.8% women). In total, 298 patients (8.4%) developed ADRs; the most common was hypocalcaemia (3.9%). Hypocalcaemia risk was significantly increased in patients with creatinine clearance < 30 mL/min, no prior use of bisphosphonates, prior use of calcium and vitamin D preparations, baseline serum calcium < 8.5 mg/dL, and no concomitant use of calcium or vitamin D preparations. Six patients had adjudicated osteonecrosis of the jaw. Lumbar spine BMD increased significantly from baseline (mean percent change: 11.4% at 36 months). All bone turnover markers decreased significantly from baseline. Over 3 years, 3.3% of patients developed a new osteoporotic fracture. CONCLUSIONS: This study confirmed the long-term safety and effectiveness of denosumab in Japanese patients with osteoporosis in daily clinical practice. No new safety signals were identified.

Prevalence of Pruritus in the Elderly with Dementia: A Multicenter Survey of Japanese Patients.

A total of 185 elderly Japanese patients with mild to severe dementia were surveyed on itch, using multiple methods of evaluation including self-evaluation of itch conducted by patients as well as evaluation of scratching behavior and scratching marks on the body surface conducted by others. As a result, 36.8% self-evaluated that they were suffering from itch, whereas 53.5% were found to scratch. Of those who by themselves denied the presence of itch, 31.4% were found to scratch. Dry skin was found in 74.1%, the severity of which was positively correlated to the rating of scratching behavior and marks. These results indicate a high prevalence of pruritus in patients with dementia, and suggest that one should not solely rely on self-evaluation but should refer to additional clinical information such as scratching for evaluation of pruritus in patients with dementia. Skin care with moisturizer may be important to control itch in patients with dementia.

The Tokyo Oldest Old survey on Total Health (TOOTH): a longitudinal cohort study of multidimensional components of health and well-being.

BACKGROUND: With the rapid worldwide increase in the oldest old population, considerable concern has arisen about the social and economic burden of diseases and disability in this age group. Understanding of multidimensional structure of health and its life-course trajectory is an essential prerequisite for effective health care delivery. Therefore, we organized an interdisciplinary research team consisting of geriatricians, dentists, psychologists, sociologists, and epidemiologists to conduct a longitudinal observational study. METHODS/DESIGN: For the Tokyo Oldest Old Survey on Total Health (TOOTH) study, a random sample of inhabitants of the city of Tokyo, aged 85 years or older, was drawn from the basic city registry. The baseline comprehensive assessment consists of an in-home interview, a self-administered questionnaire, and a medical/dental examination. To perform a wide variety of biomedical measurements, including carotid ultrasonography and a detailed dental examination, participants were invited to our study center at Keio University Hospital. For those who were not able to visit the study center, we provided the option of a home-based examination, in which participants were simultaneously visited by a geriatrician and a dentist. Of 2875 eligible individuals, a total of 1152 people were recruited, of which 542 completed both the in-home interview and the medical/dental examination, with 442 completed the in-home interview only, and another 168 completed self or proxy-administered data collection only. Carotid ultrasonography was completed in 458 subjects, which was 99.6% of the clinic visitors (n = 460). Masticatory assessment using a colour-changeable chewing gum was completed in 421 subjects, a 91.5% of the clinic visitors. DISCUSSION: Our results demonstrated the feasibility of a new comprehensive study that incorporated non-invasive measurements of subclinical diseases and a detailed dental examination aiming at community-dwelling individuals aged 85 years or older. The bimodal recruitment strategy is critically important to capture a broad range of health profiles among the oldest old. Results form the TOOTH study will help develop new models of health promotion, which are expected to contribute to an improvement in lifelong health and well-being.

Comparison of reading capacity for Japanese, German, and English.

The amount of information which can be perceived at a glance offers important indicators for text layout. Studies of the size of the effective visual field and average saccade length, in different languages, have clarified the visual capacity for reading. However, most of these studies examined only one language, and their results are reported as number of characters perceived at a glance, which, given differences in writing systems, precludes comparing results between languages. In the present study, reading capacity for Japanese, German, and English was compared using the amount of information perceived at a glance. There was up to 20 bits per fixation for Japanese and German random character strings, and 40 to 50 bits per fixation for texts written in all three languages, with no significant difference between languages. These results suggest that capacity for reading a native language is constant, regardless of language.