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SummaryWe evaluated the influence of baseline age, bone mineral density (BMD), and serum levels of vitamin D on the response to risedronate treatment. Risedronate consistently increased BMD, but our results suggest vitamin D supplementation may be necessary to achieve optimal treatment effect. Furthermore, early intervention may help prevent bone fractures.IntroductionWe aimed to investigate the influence of baseline age, BMD, and vitamin D insufficiency on the response to risedronate treatment.MethodsData regarding 1447 patients was obtained from the registries of three phase III clinical trials of risedronate. The response to treatment was expressed in terms of BMD increase and occurrence of new vertebral fractures. The patients were stratified by baseline values for age (<65, 65–72, and ≥72 years), lumbar spine BMD T-score (osteoporotic, <−2.5; and non-osteoporotic, ≥− 2.5), and serum levels of 25-hydroxyvitamin D (deficient, <21 ng/mL; and non-deficient, ≥21 ng/mL).ResultsRisedronate consistently increased lumbar spine BMD in all the groups, with similar percentage and absolute increments in all the age tertiles. The percentage, but not absolute, increment in BMD was significantly higher (p = 0.0003) in the osteoporotic than that in the non-osteoporotic patients (baseline). Of the 1330 patients whose baseline serum levels of 25-hydroxyvitamin D were available, 44.7% had vitamin D deficiency (<20 ng/mL), while 89.2% had insufficiency (<30 ng/mL). The percentage and absolute increments in BMD were lower (p < 0.05 and p < 0.01, respectively) in the vitamin D-deficient than those in the non-deficient patients. New vertebral fractures occurred in 1.5 and 0.8% of the osteoporotic and non-osteoporotic patients, respectively (end of the treatment).ConclusionsTherapeutic response in elderly patients is consistent, but early initiation of risedronate treatment may help prevent fractures. Risedronate-induced increase in BMD is lower in patients with vitamin D deficiency, suggesting that vitamin D supplementation is important to achieve optimal treatment response.

Summary This study investigated the long-term survival and incidence of secondary fractures after fragility hip fractures. The 5-year survival rate was 62%, and the mortality risk was seen in patients with GNRI < 92. The 5-year incidence of secondary fracture was 22%, which was significantly higher in patients with a BMI < 20. Background Malnutrition negatively influences the postoperative survival of patients with fragility hip fractures (FHFs); however, little is known about their association over the long term. Objective This study evaluated the ability of the geriatric nutritional risk index (GNRI) as a risk factor for long-term mortality after FHFs. Methods This study included 623 Japanese patients with FHFs over the age of 60 years. We prospectively collected data on admission and during hospitalization and assessed the patients’ conditions after discharge through a questionnaire. We examined the long-term mortality and the incidence of secondary FHFs and assessed the prognostic factors. Results The mean observation period was 4.0 years (range 0–7 years). The average age at the time of admission was 82 years (range 60–101 years). The overall survival after FHFs (1 year, 91%; 5 years, 62%) and the incidence of secondary FHFs were high (1 year, 4%; 5 years, 22%). The multivariate Cox proportional hazard analysis revealed the risk factors for mortality as older age (hazard ratio [HR] 1.04), male sex (HR 1.96), lower GNRI score (HR 0.96), comorbidities (malignancy, HR 2.51; ischemic heart disease, HR 2.24; revised Hasegawa dementia scale ≤ 20, HR 1.64), no use of active vitamin D3 on admission (HR 0.46), and a lower Barthel index (BI) (on admission, HR 1.00; at discharge, HR 0.99). The GNRI scores were divided into four risk categories: major risk (GNRI, < 82), moderate risk (82–91), low risk (92–98), and no risk (> 98). Patients at major and moderate risks of GNRI had a significantly lower overall survival rate ( p < 0.001). Lower body mass index (BMI) was also identified as a prognostic factor for secondary FHFs (HR 0.88 [ p = 0.004]). Conclusions We showed that older age, male sex, a lower GNRI score, comorbidities, and a lower BI are risk factors for mortality following FHFs. GNRI is a novel and simple predictor of long-term survival after FHFs.

Objectives:Recent animal studies have revealed critical roles of interleukin (IL)17, which is produced by a newly identified subset of helper T cells, Th17 cells, in the development of autoimmune diseases including arthritis. However, in human rheumatoid arthritis (RA), detailed characteristics and the prevalence of Th17 cells are unclear.Methods:Peripheral blood mononuclear cells (PBMC) were obtained from 123 patients with RA and 28 healthy controls. Mononuclear cells were also prepared from synovial membrane or synovial fluid of 12 patients with RA. IL17 (IL17A) positive T cells were identified by a flow cytometer after ex vivo stimulation with phorbol myristate acetate and ionomycin. Disease activity was assessed with the 28-joint Disease Activity Score (DAS28).Results:IL17 positive cells were detected in CD45RO+ CD4 T cells. Most IL17 positive T cells produced neither interferon (IFN)γ nor IL4, but tumour necrosis factor (TNF)α similar to murine Th17 cells. The frequency of Th17 cells was neither increased in RA nor correlated with DAS28. Unexpectedly, the frequency of Th17 cells was significantly decreased in the joints compared with PBMC of the same patients with RA, whereas Th1 cells were more abundant in the joints than in PBMC.Conclusions:We could not obtain evidence that positively supports predominance of Th17 cells in RA. Further careful investigation is necessary before clinical application of IL17-targeting therapy.

This study sought to examine the long-term outcomes of transtrochanteric anterior rotational osteotomy (ARO) as treatment for osteonecrosis of the femoral head (ONFH) in patients with systemic lupus erythematosus (SLE). Twenty-one patients (33 hips), aged 20—40 years, underwent ARO between 1980 and 1988. We examined 16 patients (25 hips), a 76% follow-up rate. A Kaplan—Meier curve was used for survivorship analysis. Patients with surviving hips were evaluated by the modified Oxford hip score and Short Form 36 (SF-36). Twelve hips in eight patients had survived at the final follow-up. The average length of hip survival was 24.6 years (range: 20.1—27.2 years). Three patients (six hips) had died of unrelated causes without any subsequent operation. Based on Kaplan—Meier analysis with the endpoint defined as the need for a subsequent operation, the hip survival rate at 25 years was 73.7% (95% confidence interval, ±19.8%). Based on classification by the modified Oxford hip score, five hips were classified as excellent, two hips were good, and the remaining five hips were fair. The average SF-36 summary score for the physical and mental components was 38.7 and 47.2 points, respectively. The physical component summary scores for three patients exceeded the normal level of the Japanese population. Lupus (2010) 19, 860—865.

Bifidobacterium animalis subsp. lactis GCL2505 has been shown to have some positive effects on health, including improved defecation frequency and reduced visceral fat. These effects are thought to be due to GCL2505′s unique ability to reach the intestine in a viable form and proliferate after a single intake. This leads to an increased number of intestinal bifidobacteria. This randomized, double-blind, placebo-controlled, parallel-group study was conducted to confirm that intake of GCL2505 and inulin (a prebiotic) improve cognitive function (n = 80). Participants consumed test drinks containing 1 × 1010 colony-forming units of GCL2505 per 100 g and 2.0 g of inulin per 100 g for 12 weeks. The change in cognitive function assessment scores was set as the primary endpoint. There were significant improvements in scores in the neurocognitive index domain, which is an assessment of overall cognitive function, in addition to overall attention, cognitive flexibility, and executive function domains. The intervention significantly increased the number of fecal bifidobacteria and affected the levels of several inflammatory markers. These results suggest that intake of GCL2505 and inulin improves cognitive function by improving the intestinal environment and alleviating inflammation.

Background/Objectives: Lactobacillus helveticus GCL1815 is a lactic acid bacterium thought to activate dendritic cells. This randomized, placebo-controlled, double-blind study aimed to evaluate the effects of L. helveticus GCL1815 on human dendritic cells and the onset of the common cold. Methods: Two hundred participants were divided into two groups and took capsules containing either six billion L. helveticus GCL1815 cells or placebo for 8 weeks. Results: In the GCL1815 group, the cumulative incidence days of symptoms such as feverishness, fatigue, tiredness, runny nose, nasal congestion, and phlegm were significantly lower than in the placebo group. Moreover, the change in the expression of HLA-DR on plasmacytoid dendritic cells was significantly higher in the GCL1815 group than in the placebo group at 4 and 8 weeks of intake. The expression of CD86 on plasmacytoid dendritic cells was significantly increased in the GCL1815 group at 4 and 8 weeks compared with before intake. Additionally, the expression of HLA-DR on type 1 conventional dendritic cells was significantly higher in the GCL1815 group than in the placebo group at 8 weeks of intake. The expression of CD86 on type 1 conventional dendritic cells significantly decreased in the placebo group but remained statistically the same in the GCL1815 group after intake compared with before. Conclusions: These results suggest that GCL1815 intake may enhance the response to viruses by activating two types of dendritic cells, thereby preventing the onset of systemic and local common colds in healthy adults.

IntroductionIn patients with chronic pain, oral analgesics are essential treatment options to manage pain appropriately, improve activities of daily living abilities and achieve a higher quality of life (QOL). It is desirable to select analgesics for elderly patients based on comparative data on analgesic effect and risk of adverse events; however, there are few comparative studies so far. The purpose of this study is to determine whether the efficacy and safety of acetaminophen are non-inferior to non-steroidal anti-inflammatory drugs (NSAIDs) in the treatment of chronic pain associated with osteoarthritis of the hip and knee in elderly patients.Methods and analysisThis study is a multicentre, randomised controlled, double-blind, parallel-group study to compare the analgesic effect and adverse events between acetaminophen or NSAIDs (loxoprofen or celecoxib). A total of 400 elderly patients with osteoarthritis of the hip and knee will be recruited from five institutions in Japan. Patients of 65 years or older with osteoarthritis-related pain will be registered and randomly assigned to acetaminophen, loxoprofen or celecoxib with 2:1:1 allocation. The primary endpoint is change in the Brief Pain Inventory (BPI) item 3 (worst pain) score from baseline to week 8. The secondary endpoints are BPI item 3 score change from baseline to week 4, health-related QOL measured by Short Form-8 Health Survey, and occurrence of adverse events including gastrointestinal disorders and abnormal liver function. Data will be analysed in accordance with a predefined statistical analysis plan.Ethics and disseminationThis study protocol was approved by the Kyushu University Hospital Certified Institutional Review Board for Clinical Trials on 28 January 2021 (KD2020004) and the chief executive of each participating hospital. The results of the study will be submitted to international peer-reviewed journals, and the main findings will be presented at international scientific conferences.Trial registration numberjRCTs071200112.

A number of studies have shown the bifidogenic effects of either probiotic bifidobacteria or inulin, and this bifidogenic shift in the composition of the colonic microbiota is likely the basis for their positive impact on human health. This study aimed to evaluate the effects of synbiotics containing the probiotic bacterium Bifidobacterium animalis subsp. lactis (B. lactis) GCL2505 and inulin on the levels of intestinal bifidobacteria compared with B. lactis GCL2505 alone. A randomized, double‐blind, placebo‐controlled, crossover trial was carried out involving 60 healthy subjects with a tendency for constipation using fermented milk containing B. lactis GCL2505 and inulin (synbiotic), only B. lactis GCL2505 (probiotic), and placebo. Fecal samples were collected at the end of each 2‐week intervention period, and the bifidobacterial count was analyzed by quantitative real‐time PCR. The numbers of total bifidobacteria and B. lactis in feces were significantly increased during the probiotic and synbiotic intake periods compared with the placebo intake period. Furthermore, the numbers of total bifidobacteria and endogenous bifidobacteria were significantly higher in the synbiotic intake period compared with the probiotic intake period, while there was no difference in the number of B. lactis. These results suggested that the synbiotics containing B. lactis GCL2505 and inulin had a greater effect on the number of bifidobacteria than a drink containing probiotics alone and could be useful for the improvement of the intestinal environment. Consumption of synbiotics containing Bifidobacterium animalis subsp. lactis GCL2505 and inulin had a greater effect on the number of bifidobacteria than the probiotics alone. This synbiotics was also effective in subjects who had a relatively small increase of B. lactis after the ingestion of B. lactis GCL2505 alone.

Understanding the normal kinematics of the joints is important for reconstructive surgery. However, only a few extensive studies have been done on medial and lateral laxity of the normal knee. Radiographs of 50 normal knees were obtained under varus and valgus stress in both extension and flexion and the relative angle of the articular surface was measured. In extension, the mean angle was 4.9° in varus stress and 2.4° in valgus stress. In flexion, the mean angle was 4.8° in varus stress and 1.7° in valgus stress. Lateral laxity was significantly greater than medial laxity in both extension and flexion. Lateral laxity may be necessary for the medial pivot movement of the normal knee. There is some disagreement regarding the importance of pursuing the perfect rectangular gaps during total knee arthroplasty (TKA). The methods for measuring the tension of soft tissues during the operation are not accurate and do not always reflect the postoperative tensions of dynamic phases, such as walking and standing. Slight lateral laxity can be accepted with TKA, and further studies are necessary to determine whether prosthesis lift-off occurs in the replaced knee with slight lateral laxity similar to that in the normal knee.

It is important to understand anatomical feature of the distal femoral condyle for treatment of osteoarthritic knees. Detailed measurement of the femoral condyle geometry, however, has not been available in osteoarthritic knees including valgus deformity. This study evaluated femoral condyle geometry in 30 normal knees, 30 osteoarthritic knees with varus deformity, and 30 osteoarthritic knees with valgus deformity using radiographs and magnetic resonance imaging (MRI). In radiographic analysis in the coronal plane, the femoral joint angle (lateral angle between the femoral anatomic axis and a tangent to femoral condyles) was 83.3° in the normal knees, 83.8° in the varus knees, and 80.7° in the valgus knees. In MRI analysis in the axial plane, the posterior condylar tangent showed 6.4° of internal rotation relative to the transepicondylar axis in the normal knees, 6.1° in the varus knees, and 11.5° in the valgus knees. These results suggested that there was no hypoplasia of the medial condyle in the varus knees, but the lateral condyle in the valgus knees was severely distorted. Surgeons should take this deformity of the lateral femoral condyle into account when total knee arthroplasty is performed for a valgus knee.