Objectives: Diagnosis and treatment of osteoporosis are instrumental in obtaining good outcomes of hip surgery.Measuring bone mineral density (BMD) using dual-energy X-ray absorptiometry (DXA) is the gold standard for diagnosing osteoporosis. However, due to limited access to DXA, there is a need for a screening tool to identify patients at a higher risk of osteoporosis. We analyzed the potential utility of the Osteoporosis Self-assessment Tool for Asians (OSTA) as a screening tool for osteoporosis. Methods: A total of 1378 female patients who underwent hip surgery at 8 institutions were analyzed. For each patient, the BMD of the proximal femoral region was measured by DXA (DXA-BMD), and the correlation with OSTA score (as a continuous variable) was assessed. Receiver operating characteristic (ROC) curve analysis was performed to assess the ability of OSTA score to predict osteoporosis. Lastly, the OSTA score was truncated to yield an integer (OSTA index) to clarify the percentage of patients with osteoporosis for each index. Results: DXA-BMD showed a strong correlation with OSTA (r = 0.683; P < 0.001). On ROC curve analysis, the optimal OSTA score cut-off value of − 5.4 was associated with 73.8% sensitivity and 80.9% specificity for diagnosis of osteoporosis (area under the curve: 0.842). A decrease in the OSTA index by 1 unit was associated with a 7.3% increase in the probability of osteoporosis. Conclusions OSTA is a potentially useful tool for screening osteoporosis in patients undergoing hip surgery. Our findings may help identify high-risk patients who require further investigation using DXA.

Objective: The purposes of this trial were to demonstrate the feasibility and effectiveness of the hybrid of intracavitary and interstitial brachytherapy (HBT) for locally advanced cervical cancer patients in the phase I/II prospective clinical trial. Methods: Patients with FIGO stage IB2-IVA uterine cervical cancer pretreatment width of which was ≥5 cm measured by magnetic resonance imaging were eligible for this clinical trial. The protocol therapy included 30–30.6 Gy in 15–17 fractions of whole pelvic radiotherapy concurrent with weekly CDDP, followed by 24 Gy in 4 fractions of HBT and pelvic radiotherapy with a central shield up to 50–50.4 Gy in 25–28 fractions. The primary endpoint of phase II part was 2-year pelvic progression-free survival (PPFS) rate higher than historical control of 64%. Results: Between October 2015 and October 2019, 73 patients were enrolled in the initial registration and 52 patients proceeded to the secondary registration. With the median follow-up period of 37.3 months (range, 13.9–52.9 months), the 2- PPFS was 80.7% (90% confidence interval [CI]=69.7%–88%). Because the lower range of 90% CI of 2-year PPFS was 69.7%, which was higher than the historical control ICBT data of 64%, therefore, the primary endpoint of this study was met. Conclusion The effectiveness of HBT were demonstrated by a prospective clinical study. Because the dose goal determined in the protocol was lower than 85 Gy, there is room in improvement for local control. A higher dose might have been needed for tumors with poor responses.

Objectives：MID-NET® has contributed to post-marketing drug safety assessment through various pharmacoepidemiological studies. To further promote an appropriate use of MID-NET®, this paper describes points to consider in conducting studies utilizing MID-NET® based on results from the two MID-NET® studies.Study design：Cohort study based on the secondary utilization of medical information databaseMethods：In the first study, the incidence of decreased liver function in patients prescribed drugs for pulmonary arterial hypertension was compared with the results from all-case surveillance (primary data collection). In the second study, real world utilization of biosimilar (hereinafter referred to as “BS”) was investigated to understand characteristics of BS prescription in clinical practice. Results：Although the incidence of decreased liver function varied depending on outcome definitions, the proportion on the definition identifying severe cases was similar to that in the all-case surveillance. It suggests that use of multiple outcomes including a definition taking into consideration a degree of severity is important to evaluate study results with robustness appropriately. In the second study, increased trends of BS prescriptions and various patterns of switching (from original biopharmaceutical to BS or from BS to original biopharmaceutical) depending on age and other factors were confirmed. It indicates that considerations about real world utilization of original biopharmaceutical and BS are necessary for future studies targeting BS.Conclusion：These studies further expanded an understanding and knowledge about data characteristics of MID-NET® and provide useful points to consider for promoting appropriate data utilization in future MID-NET® studies.

Non-traumatic osteonecrosis of the femoral head (ONFH) usually affects adults younger than 50 years and frequently leads to femoral head collapse and subsequent arthritis of the hip.It is becoming more prevalent along with increasing use of corticosteroids for the adjuvant therapy of leukemia and other myelogenous diseases as well as management of organ transplantation. This review updated knowledge on the pathogenesis, classification criteria, staging system, and treatment of ONFH.

BACKGROUND: Predicting adverse health events and implementing preventative measures are a necessary challenge. It is important for healthcare planners and policymakers to allocate the limited resource to high-risk persons. Prediction is also important for older individuals, their family members, and clinicians to prepare mentally and financially. The aim of this study is to develop a prediction model for within 11-year dependent status requiring long-term nursing care or death in older adults for each sex. METHODS: We carried out age-specified cohort study of community dwellers in Nisshin City, Japan. The older adults aged 64 years who underwent medical check-up between 1996 and 2000 were included in the study. The primary outcome was the incidence of the psychophysically dependent status or death or by the end of the year of age 75 years. Univariable logistic regression analyses were performed to assess the associations between candidate predictors and the outcome. Using the variables with p-values less than 0.1, multivariable logistic regression analyses were then performed with backward stepwise elimination to determine the final predictors for the model. RESULTS: Of the 1525 female participants at baseline, 105 had an incidence of the study outcome. The final prediction model consisted of 15 variables, and the c-statistics for predicting the outcome was 0.763 (95% confidence interval [CI] 0.714-0.813). Of the 1548 male participants at baseline, 211 had incidence of the study outcome. The final prediction model consisted of 16 variables, and the c-statistics for predicting the outcome was 0.735 (95% CI 0.699-0.771). CONCLUSIONS We developed a prediction model for older adults to forecast 11-year incidence of dependent status requiring nursing care or death in each sex. The predictability was fair, but we could not evaluate the external validity of this model. It could be of some help for healthcare planners, policy makers, clinicians, older individuals, and their family members to weigh the priority of support.
Aged ; Cohort Studies ; Female ; Geriatric Assessment/statistics & numerical data* ; Humans ; Independent Living/statistics & numerical data* ; Japan ; Male ; Middle Aged ; Nursing Homes/statistics & numerical data* ; Risk Assessment ; Risk Factors

Non-traumatic osteonecrosis of the femoral head (ONFH) usually affects adults younger than 50 years and frequently leads to femoral head collapse and subsequent arthritis of the hip.It is becoming more prevalent along with increasing use of corticosteroids for the adjuvant therapy of leukemia and other myelogenous diseases as well as management of organ transplantation. This review updated knowledge on the pathogenesis, classification criteria, staging system, and treatment of ONFH.

Background/Aims: Intestinal fibrosis is a major complication of Crohn’s disease (CD). The profibrotic protein transforming growth factor-β (TGF-β) has been considered to be critical for the induction of the fibrotic program. TGF-β has the ability to induce not only the expression of extracellular matrix (ECM) including collagen, but also the production of plasminogen activator inhibitor-1 (PAI-1) that prevents enzymatic degradation of the ECM during the onset of fibrotic diseases. However, the significance of PAI-1 in the developing intestinal fibrosis has not been fully understood. In the present study, we examined the actual expression of PAI-1 in fibrotic legion of intestinal inflammation and its correlation with the abnormal ECM deposition. Methods: Chronic intestinal inflammation was induced in BALB/c mice using 8 repeated intrarectal injections of 2,4,6-trinitrobenzene sulfonic acid (TNBS). TM5275, a PAI-1 inhibitor, was orally administered as a carboxymethyl cellulose suspension each day for 2 weeks after the sixth TNBS injection. Results: Using a publicly available dataset (accession number, GSE75214) and TNBS-treated mice, we observed increases in PAI-1 transcripts at active fibrotic lesions in both patients with CD and mice with chronic intestinal inflammation. Oral administration of TM5275 immediately after the onset of intestinal fibrosis upregulated MMP-9 (matrix metalloproteinase 9) and decreased collagen accumulation, resulting in attenuation of the fibrogenesis in TNBS-treated mice. Conclusions PAI-1-mediated fibrinolytic system facilitates collagen degradation suppression. Hence, PAI-1 inhibitor could be applied as an anti-fibrotic drug in CD treatment.

Methods: Sixty fresh-frozen lumbar vertebrae from 6-month-old pigs were used. Before screw insertion, the CT values of the screw path were obtained for each sample. Specimens were then randomly divided into three equal groups. Each group had one of three pedicle screws inserted: 4.0-mm LEGACY (4.0-LEG), 4.5-mm LEGACY (4.5-LEG), or 4.5-mm SOLERA (4.5-SOL) (all from Medtronic Sofamor Danek Inc., Memphis, TN, USA). Each screw had a consistent 30-mm thread length. Axial pull-out testing was performed at a rate of 1.0 mm/min. Correlations between the CT values and pedicle screw pull-out strength were evaluated using Pearson’s correlation coefficient analysis. Results: The correlation coefficients between the CT values of the screw path and pedicle screw pull-out strength for the 4.0-LEG, 4.5-LEG, and 4.5-SOL groups were 0.836 (p <0.001), 0.780 (p <0.001), and 0.873 (p <0.001), respectively. Greater CT values were associated with greater screw pull-out strength. Conclusions The CT values of the screw path were strongly positively correlated with pedicle screw pull-out strength, regardless of the screw type and diameter, suggesting that the CT values could be clinically useful for predicting pedicle screw pull-out strength.

BACKGROUND: To let the early elderly live well, understanding how lifestyle and psychosocial factors related to a decline in competence in daily living is important. METHODS: We investigated the associations between lifestyle and psychosocial factors at age 64 years and a decline in the Tokyo Metropolitan Institute of Gerontology Index of Competence score of ≥ 2 points at age 70 years among the participants in comprehensive medical check-ups living in a city in Japan. Multivariable logistic regression analyses were performed separately for men and women. RESULTS: Of the 1113 eligible men and 1203 eligible women, 110 men and 80 women showed a deteriorated competence in daily living during the 6 years. In men, risk was increased with ≥ 2 nighttime awakenings (multivariable odds ratio [mOR] 2.14, 95% confidence interval [CI] 1.19-3.86) and living alone (mOR 4.68, 95% CI 1.22-18.0), whereas risk was significantly decreased with a medium or fast gait (mOR 0.37 and 0.21, 95% CI 0.21-0.67 and 0.08-0.58) and high academic achievement (mOR 0.32 and 0.43, 95% CI 0.19-0.53 and 0.25-0.72). In women, risk was decreased with high life satisfaction (mOR 0.39, 95% CI 0.16-0.91) and participation in community activities (mOR 0.50, 95% CI 0.29-0.86) but increased with depressive mood (mOR 1.86, 95% CI 1.09-3.18). CONCLUSION Living alone for men and low life satisfaction for women at age 64 years were markedly associated with the risk of a subsequent declining competence in daily living.
Activities of Daily Living ; psychology ; Aged ; Cohort Studies ; Community-Based Participatory Research ; Female ; Geriatric Assessment ; Healthy Aging ; Humans ; Independent Living ; psychology ; statistics & numerical data ; Japan ; Life Style ; Male ; Middle Aged ; Physical Functional Performance ; Protective Factors ; Risk Factors ; Surveys and Questionnaires