Abstract
BackgroundOsteoporosis is a major health problem in postmenopausal women. Evidence suggests the importance of oxidative stress in bone metabolism and bone loss. Tea consumption may be beneficial to osteoporosis due to its antioxidant capability. However, lack of objective data characterizing tea consumption has hindered the precise evaluation of the association between tea ingestion and bone mineral density in previous questionnaire-based epidemiological studies. On the other hand, although published studies suggest that Tai Chi (TC) exercise can benefit bone health and may reduce oxidative stress, all studies were conducted using a relatively healthy older population, instead of a high-risk one such as osteopenic postmenopausal women. Therefore, this study was designed to test an intervention including green tea polyphenol (GTP) and TC exercise for feasibility, and to quantitatively assess their individual and interactive effects on postmenopausal women with osteopenia.Methods/DesignOne hundred and forty postmenopausal women with osteopenia (defined as bone mineral density T-score at the spine and/or hip between 1 to 2.5 SD below the reference database) were randomly assigned to 4 treatment arms: (1) placebo group receiving 500 mg medicinal starch daily, (2) GTP group receiving 500 mg of GTP per day, (3) placebo+TC group receiving both placebo treatment and TC training (60-minute group exercise, 3 times per week), and (4) GTP+TC group receiving both GTP and TC training for 24 weeks. The outcome measures were bone formation biomarker (serum bone alkaline phosphatase), bone resorption biomarker (serum tartrate resistant acid phosphatase), and oxidative DNA damage biomarker (urinary 8-hydroxy-2'-deoxyguanosine). All outcome measures were determined at baseline, 4, 12, and 24 weeks. Urinary and serum GTP concentrations were also determined at baseline, 4, 12, and 24 weeks for bioavailability. Liver function was monitored monthly for safety. A model of repeated measurements with random effect error terms was applied. Traditional procedures such as ANCOVA, chi-squared analysis, and regression were used for comparisons.DiscussionWe present the rationale, design, and methodology of a placebo-controlled randomized trial to investigate a new complementary and alternative medicine strategy featuring a dietary supplement and a mind-body exercise for alleviating bone loss in osteopenic postmenopausal women.Trial registrationClinicalTrials.gov identifier: NCT00625391
Highlights
Osteoporosis is a major health problem in postmenopausal women
It is believed that the rate of bone formation gradually diminishes, while the rate of bone resorption is unaltered or accelerated with advancing age in humans, resulting in net bone loss leading to the development of osteoporosis
The Tai Chi (TC) class attendance record was kept for each participant in the placebo+TC and green tea polyphenol (GTP)+TC groups
Summary
Osteoporosis is a major health problem in postmenopausal women. Evidence suggests the importance of oxidative stress in bone metabolism and bone loss. Published studies suggest that Tai Chi (TC) exercise can benefit bone health and may reduce oxidative stress, all studies were conducted using a relatively healthy older population, instead of a high-risk one such as osteopenic postmenopausal women. The rapid decrease in bone mineral density (BMD) that occurs in the first 3 to 5 years immediately following menopause, and the slower decrease that continues throughout the remainder of a women's life, markedly increase the risk of a hip or vertebral fracture, which is a major cause of morbidity and mortality in older women [1,2]. Estrogen deficiency, which occurs after menopause, leads to bone loss through increased osteoclastic function, and represents the major pathological determinant responsible for postmenopausal bone loss, as ROS stimulate osteoclasts that are responsible for bone resorption [7,8]
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