Comparison of concurrent treatment with vitamin K and risedronate compared with treatment with risedronate alone in patients with osteoporosis: Japanese Osteoporosis Intervention Trial-03.

The aim of this study was to investigate the efficacy of concurrent treatment with vitamin K and risedronate compared with treatment with risedronate alone in patients with osteoporosis and to explore subsets of patients for which concurrent treatment is particularly efficacious. Women with osteoporosis aged 65 years or older were recruited from 123 institutes in Japan and allocated to take either vitamin K (45 mg/day) and risedronate (2.5 mg/day or 17.

[Bone and Calcium Research Update 2015. Therapy of osteoporosis--Now and future consideration of long-term therapy].

The target to treat osteoporosis is prevention for future fractures. After the evaluation of cathepsin K inhibitors (CKIs) which was developed as antresorptive agents, there is evidence that these agents also possess anabolic activity, suggesting that CKIs differ from so called antiresorptive agents such as bisphosphonates and denosumab. The classification of agents for treatment of osteoporosis has been changed.

Bridging analysis of the efficacy and safety of bazedoxifene in Japanese and global populations of postmenopausal women with osteoporosis.

This study examined whether the global clinical data for bazedoxifene could be extrapolated to a Japanese population by evaluating the results of a phase 2 study in postmenopausal Japanese women with osteoporosis as compared to those of a pivotal, phase 3 study. The efficacy of bazedoxifene 20 and 40 mg versus placebo on lumbar spine bone mineral density (BMD), bone turnover markers, lipid profile, incidence of fractures, and safety parameters was compared between the Japanese phase 2 study (N = 429) and the global phase 3 study (N = 7,492) during a 2-year period. In the primary population for assessment of bridging, differences in the mean percent change from baseline in lumbar spine BMD at 2 years relative to placebo were greater for women treated with bazedoxifene 20 and 40 mg in the phase 2 study than in the phase 3 study.

Diagnostic criteria for primary osteoporosis: year 2012 revision.

In 1995, the Japanese Society for Bone and Mineral Metabolism (now the Japanese Society for Bone and Mineral Research) established the Osteoporosis Diagnostic Criteria Review Committee. Following discussion held at the 13th scientific meeting of the Society in 1996, the Committee, with the consensus of its members, proposed diagnostic criteria for primary osteoporosis. The Committee revised those criteria in 1998 and again in 2000.

Alfacalcidol-supplemented raloxifene therapy has greater bone-sparing effect than raloxifene-alone therapy in postmenopausal Japanese women with osteoporosis or osteopenia.

Vitamin D insufficiency is prevalent in osteopenic and osteoporotic postmenopausal women. The persistent increase in circulating parathyroid hormone (PTH) caused by vitamin D insufficiency reduces bone density response to antiresorptive agents in these postmenopausal women. It is not well known whether administration of raloxifene might increase serum PTH secondary to the suppression of serum calcium in postmenopausal women with osteopenia or osteoporosis.

Cytologic detection of recurrence in extramammary Paget's disease of the vulva: a report of two cases.

Background: Extramammary Paget's disease of the vulva (EMPDV) is a rare gynecologic malignancy. We examined two cases of EMPDV in which cytologic study led to early detection of disease recurrence.

Cases: In case 1, a 71-year-old woman, recurrence was detected with malignant cells from the vaginal Papanicolaou smear a few months after radical surgery for endometrial cancer.

Effects of bazedoxifene on bone mineral density, bone turnover, and safety in postmenopausal Japanese women with osteoporosis.

This randomized, double-blind, placebo-controlled, dose-response late phase 2 study evaluated the efficacy and safety of bazedoxifene in postmenopausal Japanese women 85 years of age or younger with osteoporosis. Eligible subjects received daily treatment with oral doses of bazedoxifene 20 or 40 mg or placebo for 2 years. Efficacy assessments included bone mineral density (BMD) at the lumbar spine and other skeletal sites, bone turnover marker levels, lipid parameters, and incidence of new fractures.

Design of a pragmatic approach to evaluate the effectiveness of concurrent treatment for the prevention of osteoporotic fractures: rationale, aims and organization of a Japanese Osteoporosis Intervention Trial (JOINT) initiated by the Research Group of Adequate Treatment of Osteoporosis (A-TOP).

The aim of osteoporosis treatment is to prevent future fractures. Although concurrent treatment has been used very frequently for osteoporosis in clinical practice, there are no data on accurate and verified effectiveness of concurrent treatment for fracture prevention in patients with osteoporosis. To clarify the clinical usefulness of concurrent treatment, the Japan Osteoporosis Society has authorized the establishment of the A-TOP (Adequate Treatment of Osteoporosis) research group.

Chemical peritonitis caused by an iatrogenic rupture of mature cystic teratoma of the ovary during labor: a report of a case didactic to all the maternity health care workers.

A 37-year-old postpartum woman was presented with abdominal pain supposed to be caused by uterine involution or puerperal endometritis after vaginal delivery. During the pregnancy, she was suspected to have a subserosal myoma by ultrasound examination. The pain was finally revealed to be originated from the chemical peritonitis caused by the rupture of the mature cystic teratoma of the ovary by Kristeller's maneuver performed during vaginal delivery.

[Effects of SERMs on bone health. Combination therapy with raloxifene].

It is generally considered that drugs with different pharmacological actions are prescribed when combination therapy is undertaken. Vitamin D insufficiency or deficiency is prevalent in osteopenic and osteoporotic postmenopausal women. Combination therapy of raloxifene with other agents including vitamin D has been reported and its effect on fracture prevention remains to be elucidated.

Validation of the Japanese Osteoporosis Quality of Life Questionnaire.

The Japanese Society for Bone and Mineral Research developed the Japanese Osteoporosis Quality of Life Questionnaire (JOQOL) to evaluate the disease-specific Health-Related QOL, which is specific for osteoporosis of Japanese patients. JOQOL was revised in 2000; it consisted of 38 items with the scale graded from 0 to 4 and a total full score of 152. To elucidate the reliability and validity of the revised JOQOL, we enrolled 193 postmenopausal women as subjects and diagnosed them as having osteoporosis or osteopenia.

Assessment of adherence to treatment of postmenopausal osteoporosis with raloxifene and/or alfacalcidol in postmenopausal Japanese women.

Patients who are diagnosed with osteoporosis and beginning treatment often discontinue their osteoporosis medication relatively early after the start of treatment because of their poor recognition of fracture risk and the asymptomatic nature of osteoporosis. In this study we aimed to assess adherence to treatment with 1 microg alfacalcidol (D), 60 mg raloxifene (R) or a combination of both (D + R) for 1 year in postmenopausal Japanese women with osteoporosis or osteopenia. We defined persistence of D and R as continuing to take tablets for more than 7 of any 14 days immediately before the 1-year visit.

[Daily practice using the guidelines for prevention and treatment of osteoporosis. Use of clinical risk factors for osteoporotic fractures in the evaluation of risk of future fracture].

A number of clinical risk factors that provide information on fracture risk over and above that given by BMD have been defined. WHO proposed FRAX (fracture risk assessment tool) in which the fracture probability could be calculated by the use of risk factors with or without BMD. The proposed independent risk factors are age, a prior fragility fracture, a parental history of hip fracture, smoking, use of systemic corticosteroids, excess alcohol intake, secondary osteoporosis, and rheumatoid arthritis.

[Absolute risk for fracture and WHO guideline. Selection of drugs for the prevention of fractures in postmenopausal women].

It is crucial to select drugs for the prevention of fracture in postmenopausal osteoporosis. In early postmenopausal women with climacteric symptoms hormone replacement therapy (HRT) would be a first choice. Selective estrogen receptor modulator (SERM) could be prescribed in postmenopausal women who had been treated with HRT.

CYP17 and COMT gene polymorphisms can influence bone directly, or indirectly through their effects on endogenous sex steroids, in postmenopausal Japanese women.

We aimed to assess whether circulating sex steroids would influence bone density and bone loss, whether part of this influence could be explained by genetic variation measured as polymorphisms in candidate genes affecting circulating hormone levels, or whether gene polymorphisms would have direct effects on bone in 229 postmenopausal Japanese women aged 46 years and over who had been followed for eight years (Yokohama Cohort). Bone mineral density (BMD) in the lumbar spine (L), femoral neck (FN), total hip (T) and distal radius (R) was measured every year, and endogenous sex steroid levels were determined at the start of the study. We investigated the polymorphisms of estrogen-metabolizing enzyme gene, CYP17; estrogen biosynthesis (high activity, A2/A2), CYP1A1; hydroxylation (high inducibility, vt/vt) and COMT; inactivation (low activity, L/L) with PCR-based restriction fragment length polymorphism assays.

[Bone and bone related biochemical examinations. Bone and collagen related metabolites. Bone resorption marker; urinary and serum CTX].

The determination of C-terminal telopeptide of type I collagen degradation products (CTX) was made by using the monoclonal antibody recognizing the eight amino acids that are specific for alpha1 chain of type I collagen. CTX values show a diurnal variation, with a nadir from 1 to 11 o'clock in the afternoon, increase at midnight with peaks from 2 to 8 o'clock in the morning. The levels of CTX at peaks are approximately twice those at a nadir, which implies the sampling of serum and urine should be made at an identical time at each patient.

Randomized trial comparing low-dose hormone replacement therapy and HRT plus 1alpha-OH-vitamin D3 (alfacalcidol) for treatment of postmenopausal bone loss.

We conducted a prospective, randomized, multicenter, open-label 2-year trial with 76 postmenopausal women aged > or =60 years with low (T-score less than -1) lumbar bone mineral density (BMD). The hormone replacement therapy (HRT) group received a low dose of conjugated estrogen (CEE) at a dose of 0.31 mg/day +/- medroxyprogesterone acetate (MPA) 2.

[Tibolone].

Tibolone is so called tissue specific compound, which works as estrogen in bone and inhibits postmenopousal bone loss and does not stimulate mammary tissue. Tibolone has been used as medication for postmenopausal vasomotor symptoms.

Analysis of gene expression induced by diethylstilbestrol (DES) in human primitive Mullerian duct cells using microarray.

The Mullerian ducts are strongly influenced by natural estrogen, estradiol (E2) and diethylstilbestrol (DES) in their development. We screened E2 and DES responsive genes using a microarray analysis in human primitive Mullerian duct cell line, EMTOKA cells expressed estrogen receptor (ER) beta. c-myc oncogene and other target genes expression was detected in cells treated by high-dose DES, but ER antagonist ICI 182,780 could not prevent c-myc induction above.

Estrogen-metabolizing gene polymorphisms, but not estrogen receptor-alpha gene polymorphisms, are associated with the onset of menarche in healthy postmenopausal Japanese women.

Both onset and cessation of menstruation have strong genetic inclination. We aimed to identify genetic factors influencing the onset of menarche and natural menopause in a Japanese population by investigating the polymorphisms of estrogen receptor-alpha and estrogen-metabolizing enzyme genes. Three hundred seventeen postmenopausal Japanese women, aged 46 yr and over, were enrolled in this study under informed consent.