The concentration of bone resorption biomarker, NTX, in urine will be quantified using a commercial kit with a monoclonal antibody specific for the urinaryN-terminal telopeptide (Alere, Providence, Rhode Island, USA)

The concentration of bone resorption biomarker, NTX, in urine will be quantified using a commercial kit with a monoclonal antibody specific for the urinaryN-terminal telopeptide (Alere, Providence, Rhode Island, USA). (2) low TT group receiving 430 mg of 70% real TTs (containing 300 mg TT) and (3) high TT group receiving 860 mg of 70% real TTs (600 mg TT). The primary outcome measure will be urinaryN-terminal telopeptide. The secondary outcome measures will be serum bone-specific alkaline phosphatase, receptor activator of nuclear factor-B ligand, osteoprotegerin, urinary 8-hydroxy-2-deoxyguanosine and quality of life. At 0, 6 and 12 weeks, the following will be assessed: (1) primary and secondary outcome measures; (2) serum TT and tocopherol concentrations; (3) physical activity and food frequency questionnaires. Liver function will be monitored every 6 weeks for safety. Intent-to-treat principle will be employed for data analysis. A model of repeated measurements with random effect error terms will be applied. Analysis of covariance, 2analysis and regression will be used for comparisons. == Ethics and dissemination == This study was approved by the Bioethics Committee of the Texas Tech University Health Sciences Center. The findings of this trial will be submitted to a peer-reviewed journal in the areas of bone or nutrition and international conferences. == Trial registration number == NCT02058420; results. Keywords: intervention trial, tocotrienols, bone turnover marker, oxidative stress, women, osteoporosis == Strengths and limitations of this study. == This randomised, double-blind, placebo-controlled trial will help to assess the safety and efficacy of dietary tocotrienol supplementation on bone health in postmenopausal women who are at high risk of osteoporosis. This study will be performed at a research centre with experience in conducting independent, investigator-initiated, randomised controlled trials in nutrition and bone research. This study is a single-centre study. Tocotrienol supplement is not available over the counter worldwide. There is no long-term follow-up. == Background == Reduced bone mass, microstructural deterioration, increased bone fragility and higher susceptibility to fractures including those associated with hip, spine and wrist1are some of the characteristics of osteoporosis, a degenerative bone condition that is four times more likely found in women than in men. The gender disparity is attributed to postmenopausal decrease in oestrogen Rabbit Polyclonal to TRMT11 level and lighter and thinner bones in women in general. 2Over half of postmenopausal women will experience a bone fracture as the result of osteoporosis. 2Using the WHO definition, 3the National Osteoporosis Foundation has estimated that at present, 8 million women in the USA have osteoporosis, and an additional 22 million are estimated to have osteopenia that places them at increased risk for osteoporosis. 4Therefore, preventing and decelerating the development of osteoporosis in postmenopausal women has become a major public health strategy. Clinical application of bone densitometry, such as dual-energy X-ray absorptiometry, is generally used to measure bone mineral density (BMD) at the spine, hip and femoral neck to predict the fracture risk, to monitor Argatroban the natural progression of diseases that affect BMD, or to monitor the therapeutic response to osteoporosis-specific treatments 12 years after inception of therapies. 58In addition to BMD, serum bone turnover markers (bone formation markers and bone resorption markers) can offer another indication of the effectiveness of certain therapies9including dietary supplements for restoring BMD. 1011Bone turnover markers have shown to be Argatroban promising in predicting fractures in the elderly up to 2 years before the event. 1214A higher level of bone resorption rate is significantly associated with faster BMD loss. 1214Decreased vertebral BMD and increased bone Argatroban turnover have approximately equal power to predict the risk of bone loss and osteoporosis-related fracture rate in postmenopausal women. 1214Therefore, efforts to decrease the occurrence of dilapidation fractures should concentrate on postmenopausal women diagnosed with low BMD. Since bone turnover markers have been increasingly recognised as important for bone metabolism, using bone turnover markers should be the first step to monitor the early response of intervention in this population. Studies have shown bone loss can be attributed to dysregulation of osteoblast and osteoclast activity mediated by increased oxidative stress through.