OBJECTIVES: The aim of this study was to examine the efficacy, safety, and adherence of ibandronate (IBN) treatment with or without vitamin D supplementation for 3 years in Japanese women with postmenopausal osteoporosis. METHODS: This prospective investigation included 27 patients treated with IBN alone (monotherapy group) and 29 patients receiving IBN and alfacalcidol (ALF) (combination group). Bone metabolism and bone mineral density (BMD) were measured before and at 18, 24, 30, and 36 months of therapy. Treatment discontinuation and fracture occurrence were assessed as well. RESULTS: Lumbar 1–4 BMD (L-BMD) was significantly increased in the monotherapy and combination groups by 3.9% and 7.2%, respectively, at 36 months, with significant gains in total hip BMD (H-BMD) of 3.7% and 4.9%, respectively. There were significant differences in L-BMD improvement between the groups at 18, 24, and 30 months (P < 0.05) and at 36 months (P < 0.01). Compared with pretreatment levels, the percentage changes of L-BMD and H-BMD were significant at all time points in the combination group and at all points apart from L-BMD at 36 months in the monotherapy group. In the monotherapy group, 14 patients dropped out during 3 years and 2 vertebral fractures occurred during the first year. In the combination group, 16 cases dropped out during 3 years and 1 nonvertebral fracture was noted during the first year. CONCLUSIONS: Our findings suggest that combination therapy of IBN and vitamin D is superior to monotherapy with regard to L-BMD improvements for 3 years, with both groups showing comparable safety and adherence to treatment.
Asian Continental Ancestry Group ; Bone Density ; Compliance ; Female ; Hip ; Humans ; Metabolism ; Osteoporosis ; Osteoporosis, Postmenopausal ; Prospective Studies ; Vitamin D

OBJECTIVES: Increasing bone mineral density (BMD) to reduce fracture risk is a primary goal of osteoporosis treatment. This prospective, observational study evaluates the effects of monthly minodronate (MIN; 50 mg) with or without eldecalcitol (ELD) addition in osteoporosis patients with rheumatoid arthritis (RA) during 18 months. METHODS: The cohort was prospectively and randomly split into the MIN monotherapy group (14 cases) and MIN plus ELD group (combination group; 14 cases) due to no reports on the effectiveness and safety of MIN therapy in relation to ELD addition for comparisons of serum tartrate-resistant acid phosphatase (TRACP)-5b, bone alkaline phosphatase (BAP), and BMD of the lumbar 1–4 vertebrae (L-BMD), bilateral total hips (H-BMD; the mean value of the right and left hips), and bilateral femoral necks (FN-BMD) at baseline and at 6, 12, and 18 months of treatment. RESULTS: Baseline values were comparable between the groups apart from a tendency for higher TRACP5b in the combination group. Seven of 14 patients in the combination group had received previous bisphosphonate treatment. BAP was significantly more reduced in the monotherapy group at 6 months, with no other remarkable differences for TRACP5b, L-BMD, H-BMD, or FN-BMD during the observation period. CONCLUSIONS The above findings suggest that regardless of ELD addition, MIN potentially improves BMD during 18 months in osteoporosis patients with RA.

This study aimed to explore the association between various levels of training-energy expenditure (TrEE) and nutritional response during the phases of periodization among male collegiate rugby players. Seventeen Japanese male collegiate rugby players were enrolled in the study. Their TrEE and dietary intake were assessed each day during three separate microcycle training phases in the preparatory phase of periodization (P1 and P2: general training phase consisting of two sessions per day over the term during which the school held classes and during a summer vacation, respectively; and P3: intensive training phase consisting of four sessions per day during a summer vacation) using the factorial method and dietary records, respectively. The TrEE for P3 (1644±273 kcal) was significantly higher than that for P1 (891±230 kcal). However, the total energy intake (EI) for P3 (3274±889 kcal) was significantly lower than that for P1 (3978±938 kcal). The daytime (after waking in the morning and before the evening training session) EI (242±159 kcal) and protein intake (19±12 g) from the ‘high-protein foods group’ during P3 was significantly reduced compared with that during P1 (465±252 kcal, 37±15 g), whereas, EI and carbohydrate intake from the ‘supplements group’ of P3 was significantly increased compared with P1. The increased TrEE during P3 was not compensated by EI; instead, there was a decreased nutrient intake from the high-protein foods group and increased intake from the supplements group. The time of day of multiple or intensive training sessions, i.e. different TrEE, might affect the food choices made by male rugby players.

OBJECTIVES: The aim of this study was to examine the discontinuation and occurrence of fracture during denosumab treatment in Japanese women with primary osteoporosis or rheumatoid arthritis (RA) with osteoporosis. METHODS: This retrospective study included 143 patients with primary osteoporosis and 96 patients with RA and osteoporosis who were treated with denosumab. Treatment discontinuation, fracture occurrence, lumbar spine (L1–4) bone mineral density (LS-BMD), and bilateral total hip BMD (TH-BMD) were examined before and at 1 and 2 years after treatment commencement. RESULTS: In the primary osteoporosis group, 32 cases dropped out and no fractures occurred from 0 to 1 year. Eighteen cases were lost to follow-up and no fractures were noted from 1 to 2 years. In the RA with osteoporosis group, 7 cases dropped out and no fracture occurred from 0 to 1 year. Twenty-one cases were lost to follow-up and 2 nonvertebral fractures were noted from 1 to 2 years. In this group, 13 cases dropped out from 1 to 2 years and 16 cases dropped out during the 2-year study period due to economic reasons. LS-BMD and TH-BMD values increased continuously for 2 years of treatment in both primary osteoporosis and RA with osteoporosis groups. CONCLUSIONS: These results suggest that during denosumab therapy, the discontinuation rate is expected to remain low during 2 years of treatment in primary osteoporotic patients. In RA patients with osteoporosis, however, the discontinuation rate may increase due to economic reasons from 1 to 2 years of therapy.
Arthritis, Rheumatoid* ; Asian Continental Ancestry Group* ; Bone Density ; Compliance* ; Denosumab* ; Female ; Hip ; Humans ; Lost to Follow-Up ; Osteoporosis* ; Retrospective Studies ; Spine

Objective: Anticancer drugs have carcinogenic potential and are associated with occupational exposure risks among healthcareprofessionals who handle them. To minimize occupational exposure, healthcare workers must be adequately aware of the risks ofanticancer drugs and the appropriate techniques for their preparation. However, there is little information on the awareness ofpharmacists who prepare anticancer drugs in medical settings. The aim of this study was to investigate awareness of hazardous drugs(HD) and appropriate preparation techniques among pharmacists, and identify problems that pharmacists experience in managing theirexposure to anticancer drugs.Design: Questionnaire.Method: The questionnaire was sent by e-mail or mail to pharmacists employed at 270 institutions who belonged to the Chiba Societyof Hospital Pharmacists. From September 2015 to March 2016, respondents completed the questionnaires voluntarily and returnedthem by mail. Returning the questionnaire was regarded as informed consent to participate in this survey. Based on the completedquestionnaires, we examined the awareness of pharmacists in their daily work.Results: In total, 218 questionnaires were returned (collection rate: 10%). Awareness of the risks of anticancer drugs was high, and ahigh percentage of respondents use personal protective equipment during drug preparation, but the use of closed system drug transferdevices was low. Overall, however, it was found that many pharmacists had insufficient understanding of safe handling techniques.Discussion: Despite some recognition of the risks associated with exposure to HD, the measures taken to prevent exposure toHDs―including anticancer drugs―were inadequate and this issue must be urgently addressed by medical institutions and pharmacists.Countermeasures such as training sessions in the handling of HDs and the development of manuals are needed for each facility.

BACKGROUND/AIMS: Noninvasive objective monitoring is advantageous for optimizing treatment strategies in patients inflammatory bowel disease (IBD). Fecal calprotectin (FCP) is superior to traditional biomarkers in terms of assessing the activity in patients with IBD. However, there are the differences among several FCP assays in the dynamics of FCP. In this prospective multicenter trial, we investigated the usefulness of FCP measurements in adult Japanese patients with IBD by reliable enzyme immunoassay using a monoclonal antibody. METHODS: We assessed the relationship between FCP levels and disease or endoscopic activity in patients with ulcerative colitis (UC, n=64) or Crohn’s disease (CD, n=46) compared with healthy controls (HCs, n=64). RESULTS: FCP levels in UC patients strongly correlated with the Disease Activity Index (rs =0.676, P < 0.0001) and Mayo endoscopic subscore (MES; rs =0.677, P < 0.0001). FCP levels were significantly higher even in patients with inactive UC or CD compared with HCs (P=0.0068, P < 0.0001). The optimal cutoff value between MES 1 and 2 exhibited higher sensitivity (94.1%). FCP levels were significantly higher in active UC patients than in inactive patients (P < 0.001), except those with proctitis. The Crohn’s Disease Activity Index tended to correlate with the FCP level (rs =0.283, P=0.0565). CONCLUSIONS: Our testing method using a monoclonal antibody for FCP was well-validated and differentiated IBD patients from HCs. FCP may be a useful biomarker for objective assessment of disease activity in adult Japanese IBD patients, especially those with UC.
Adult* ; Antibodies, Monoclonal ; Asian Continental Ancestry Group* ; Biomarkers ; Colitis, Ulcerative ; Crohn Disease ; Humans ; Immunoenzyme Techniques ; Inflammatory Bowel Diseases* ; Leukocyte L1 Antigen Complex* ; Methods ; Multicenter Studies as Topic ; Proctitis ; Prospective Studies*

Aims : To clarify any difficulties that pharmacists and nurses may have when prescribing Kampo medicines to newly-admitted patients with a survey questionnaire at a local hospital ward.Methods : Questions for pharmacists on the handling of Kampo herbs, any perceived risks in the preparation of Kampo formulae powder extracts/pills, or in explaining Kampo medicines, based on their experiences. Also questions for nurses on the handling of Kampo medicines, as compared to western medicines, and any perceived risks in their administration at their ward.Result : All 7 pharmacists and 14 out of the 16 nurses surveyed completed their questionnaires. The pharmacists pointed out that Kampo preparation takes more time, although none perceived an increased risk with Kampo medicines, as compared to western medicines. Only 1 pharmacist had ever had experience explaining Kampo medicines to patients. The nurses, on the other hand, felt that Kampo treatments were somewhat more difficult to use, and perceived similar risk in their administration to patients.Conclusion : Both the pharmacists and nurses surveyed believed that the handling of herb medicines was somewhat difficult, but that these difficulties could be overcome with risk management. This suggests that pharmacist, nurse and office personnel education would be useful before Kampo medicines are administered to newly-admitted hospital patients.
Medicine, Kampo ; perceived risk ; seconds ; Therapeutic procedure ; Risk

BACKGROUND/AIMS: Recent genome-wide analyses have provided strong evidence concerning adverse events caused by thiopurine drugs such as azathioprine (AZA) and 6-mercaptopurine. The strong associations identified between NUDT15 p.Arg139Cys and thiopurine-induced leukopenia and severe hair loss have been studied and confirmed over the last 2 years. However, other coding variants, including NUDT15 p.Val18_Val19insGlyVal, NUDT15 p.Val18Ile, and FTO p.Ala134Thr, and a noncoding variation in RUNX1 (rs2834826) remain to be examined in detail in this respect. Therefore, we investigated the correlation between these adverse events and the 5 recently identified variants mentioned above among Japanese patients with inflammatory bowel diseases (IBD). METHODS: One hundred sixty thiopurine-treated patients with IBD were enrolled. Genotyping was performed using TaqMan SNP Genotyping Assays or Sanger sequencing. RESULTS: None of the 5 variants were associated with gastrointestinal intolerance to AZA. However, NUDT15 p.Arg139Cys was significantly associated with the interval between initiation and discontinuation of AZA among patients with gastrointestinal intolerance. This variant was strongly associated with early (<8 weeks) and late (≥8 weeks) leukopenia and severe hair loss. Moreover, it correlated with the interval between initiation of thiopurine therapy and leukopenia occurrence, and average thiopurine dose. NUDT15 p.Val18_Val19insGlyVal, NUDT15 p.Val18Ile, FTO p.Ala134Thr, and RUNX1 rs2834826 exhibited no significant relationship with the adverse events examined. CONCLUSIONS: Of the 5 variants investigated, NUDT15 p.Arg139Cys had the strongest impact on thiopurine-induced leukopenia and severe hair loss; therefore, its genotyping should be prioritized over that of other variants in efforts to predict these adverse events in Japanese patients with IBD.
6-Mercaptopurine ; Asian Continental Ancestry Group* ; Azathioprine ; Clinical Coding ; Hair ; Humans ; Inflammatory Bowel Diseases* ; Leukopenia

Prevention, early diagnosis, and early treatment of skeletal-related events (SREs) are important in the treatment of potential or current cases of bone metastasis. In August 2020, our hospital established the bone metastasis team and the bone metastasis board (BMB) started actively engaging in activities aimed at improving the outcome of bone metastasis. We retrospectively examined whether a combined modality therapy started in the diagnosis of bone metastases could prevent the onset of SREs and whether it could prolong survival and improve activities of daily living. The 75 advanced cancer patients who underwent BMB at our hospital from August 1, 2020 to July 31, 2022 were divided into two groups according to when BMB performed before and after SREs for comparative analysis. Numerical Rating Scale improved, however Performance Status did not improve in both groups, and there was no difference in survival between the both groups (15.3 vs. 9.0 months, HR: 0.74, 95%; CI: 0.42–1.29, p=0.29). In conclusion, patients who suffered from SREs from the time of bone metastasis diagnosis were treated early. However, the incidence of SREs after BMB in our hospital was 22.6%, and it is necessary to actively work to prevent SREs in the future.