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The ratio of PGI(2)/TxA(2) was significantly increased for raloxifene. No other treatments showed statistically significant changes.
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BMD (lumbar spine, total femur, femoral neck, distal forearm, and total body) and biochemical markers (serum intact amino-terminal propeptide of type I procollagen, type 1 collagen cross-linked C-telopeptide, and osteocalcin) were measured at baseline and follow-up visits.
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The therapeutic efficacy of tamoxifen (TAM) in cancer therapy is thought to arise primarily from its ability to compete with estrogens for binding to the estrogen receptor (ER). We show that TAM and its active metabolite, 4-hydroxytamoxifen (OHT), can actively induce programmed cell death through distinct ER-dependent and ER-independent pathways. The ER-independent pathway is activated by 10-20 microm TAM and OHT and by 10-20 microm 17beta-estradiol and raloxifene, and occurs in ER-negative cells. The ER dependence of a second pathway, caused by submicromolar concentrations of TAM and OHT, was demonstrated by the ability of the ER ligands 17beta-estradiol, raloxifene, and ICI 182,780 to effectively block the cell death-inducing effects of TAM and OHT. Because the p38-specific inhibitor SB203580 blocks OHT.ER-induced cell death, stress kinase pathways are likely involved. ER-independent cell death triggers classic caspase-dependent apoptosis. However, although OHT.ER triggers some hallmarks of apoptosis, including Bax translocation and cytochrome c release, the absence of poly(ADP-ribose) polymerase cleavage or DNA laddering indicates that the death pathway involved is caspase-independent. The OHT.ER-dependent cell death pathway appears to diverge from classical apoptosis at the level of caspase 9 activation. The ability to promote ER-dependent programmed cell death represents a novel activity of TAM and OHT.
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Growth of raloxifene-resistant MCF-7/Ral cells in vitro and in vivo is repressed by estradiol treatment by a mechanism involving G2/M-phase arrest, decreased NF-kappaB activity, and increased Fas expression to induce apoptosis.
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Vertebral fractures are a common complication of osteoporosis and may cause a decrease of health-related quality of life (HRQOL). This study was designed to determine the impact of incident vertebral fractures on HRQOL. The Multiple Outcomes of Raloxifene Evaluation (MORE), a multicenter, randomized, double blind trial, in which women were taking raloxifene or placebo. This study was done in European centers only in a subset of 361 women from seven European countries, all with prevalent vertebral fractures. A specific questionnaire for osteoporosis developed by the International Osteoporosis Foundation was used for assessment at baseline, 1, 2 and 3 years. This questionnaire, Qualeffo, contains 41 questions in the domains pain, physical function, social function, general health perception and mental function. Domain and total scores are expressed on a 100-point scale with 0 corresponding to the best HRQOL. Standardized lateral spinal radiographs were made at baseline, 2 and 3 years and evaluated in a central facility. Sixty-seven patients sustained a fracture in a vertebra that was not fractured at baseline (incident vertebral fractures). Twenty of these were accompanied by signs and symptoms necessitating immediate doctor's attention (clinical vertebral fractures) and 47 vertebral fractures were only diagnosed on radiographs (subclinical vertebral fractures). Incident vertebral fractures (clinical and subclinical) were associated with an increase of back pain (mean score change 6.4; 95% CI 2.1-10.7), deterioration of physical function (mean score change 2.4; 95% CI 0.1-4.8), and worse general health perception (mean score change 3.8; 95% CI 0.1-7.5). Score changes for patients with subclinical vertebral fractures were intermediate between those for patients with clinical vertebral fractures and patients without incident vertebral fracture. Clinical and subclinical incident vertebral fractures both have an adverse impact on HRQOL.
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In general, all four instruments followed more or less the same pattern. In most analyses, the reported QoL was lowest in Asia and Europe and highest in North America and Oceania. To examine the influence of ethnicity, North and South America were stratified on race. In both continents, a lower QoL was observed in Hispanic people.
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Raloxifene (RLX), a selective estrogen receptor modulator (SERM), is currently indicated for the prevention and treatment of post-menopausal osteoporosis. At present, RLX is evaluated in other areas of study that include the reduction of the risk of breast cancer and cardiovascular (CV) disease in post-menopausal women. This SERM acts as an estrogen agonist in the skeleton, on serum lipid metabolism and on a number of coagulation factors, while it is an estrogen antagonist in the breast and uterus. Although our current data are incomplete, RLX has a favourable risk-benefit safety profile and is one of the most promising medical agents not only for the prevention of osteoporosis, but also for a large number of other disorders in post-menopausal women.
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The women receiving each dose of raloxifene had significant increases from base-line values in bone mineral density of the lumbar spine, hip, and total body, whereas those receiving placebo had decreases in bone mineral density. For example, at 24 months, the mean (+/-SE) difference in the change in bone mineral density between the women receiving 60 mg of raloxifene per day and those receiving placebo was 2.4+/-0.4 percent for the lumbar spine, 2.4+/-0.4 percent for the total hip, and 2.0+/-0.4 percent for the total body (P<0.001 for all comparisons). Serum concentrations of total cholesterol and low-density lipoprotein cholesterol decreased in all the raloxifene groups, whereas serum concentrations of high-density lipoprotein cholesterol and triglycerides did not change. Endometrial thickness was similar in the raloxifene and placebo groups at all times during the study. The proportion of women receiving raloxifene who reported hot flashes or vaginal bleeding was not different from that of the women receiving placebo.
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A double-blind, randomized trial was conducted in osteopenic postmenopausal women aged 60-79 years to compare the effects of tibolone 1.25 mg/day to raloxifene 60 mg/day on bone mineral density (BMD). Serum osteocalcin and serum type I collagen C-telopeptides were measured as biochemical markers of bone metabolism.
Enrollees in the National Health Insurance Research Database (NHIRD) from 2003 to 2007, aged above 50 years, with vertebral/hip fracture, and new to osteoporosis therapy were recruited. Patients with Paget's disease or cancer during the baseline period were excluded. Patients were classified into either the alendronate or the calcitonin/raloxifene (control) group according to their exposure during follow-up. Previously proposed possible ONJ diagnosis codes were adopted as potential ONJ cases, but qualifying cases also had a repeated ONJ diagnosis within 8 weeks of the first diagnosis and received one or more broad-spectrum oral antibiotics. Cox modeling compared the risk of ONJ between the alendronate and the control groups, which were matched using propensity scores. Results were examined in series sensitivity analyses, including different cumulative dose groups.
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Intervention participants had significantly lower decisional conflict levels at post-test (p<0.001) and significantly higher odds of making a decision about whether or not to take prophylactic tamoxifen or raloxifene at 3-month follow-up (p<0.001) compared to control participants.
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Competitive receptor binding and luciferase-based reporter methods were used to study the bioactivities of raloxifene analogues, followed by efficacy determination in breast cancer cell proliferation assay. ER antagonist effects were investigated in female rats by measuring uterine and mammary gland growth, using wet weight, BrdU incorporation and terminal end bud (TEB) as indicators.
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To update an evidence-based technology assessment of chemoprevention strategies for breast cancer risk reduction. POTENTIAL INTERVENTIONS: Tamoxifen, raloxifene, aromatase inhibition, and fenretinide.
DCIS incidence rose from 1.87 per 100,000 in 1973-1975 to 32.5 per 100,000 in 2005. Increases in incidence were greatest in tumors without comedo necrosis. Incidence increased in all ages but more in women older than 50 years. Increased use of mammography explains some but not all of the increased incidence. Risk factors for incident DCIS include older age and positive family history. Whereas tamoxifen prevents both invasive breast cancer and DCIS, raloxifene is associated with decreased invasive breast cancer but not decreased DCIS.
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Risedronate, 30 mg, was administered once weekly before breakfast to patients with osteoporosis or osteopenia. All patients were also treated with calcium, 1,500 mg daily, and supplemental vitamin D. Patients receiving treatment with other antiresorptive agents were not excluded. BMD was assessed with dual-energy x-ray absorptiometry (DEXA) at baseline and 1 year.