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KMID : 0338420110260020168
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The Korean Journal of Internal Medicine
2011 Volume.26 No. 2 p.168 ~ p.178
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Effects of D-003 (10 mg/day) on Bone Mineral Density of the Lumbar Spine and Femoral Neck in Postmenopausal Women: A Randomized, Double-Blinded Study
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Ceballos Alfredo
Castano Gladys
Mendoza Sarahi
Gonzalez Juan
Mas Rosa
Fernandez Julio Cesar
Illnait Jose
Mesa Meilis
Gamez Rafael
Telles Ricardo
Marrero Duany
Eng Mainel Gomez
Ruiz Dalmer
Jardines Yunaisi
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Abstract
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Background/Aims: Increased osteoclast activity is a pivotal finding in osteoporosis. This increase is mediated via the mevalonate-to-cholesterol pathway, which is involved in producing the intermediates required for osteoclast activity. D-003, a mixture of high molecular weight sugarcane wax acids, has been shown to inhibit cholesterol synthesis prior to mevalonate production, resulting in a reduction of bone loss and resorption in ovariectomized rats. Moreover, previous studies have demonstrated that short-term D-003 treatment reduces urinary excretion of deoxypyridinoline/creatinine in postmenopausal women.
Methods: We performed a double-blinded, placebo-controlled study to investigate the effects of D-003 (10 mg/day) treatment for 3 years on bone mineral density (BMD) in 83 postmenopausal women with low BMD.
Results: Over 3 years, D-003 treatment increased lumbar spine BMD (5.1%, p < 0.01) and improved osteoporosis-related quality of life scores as compared with placebo-treated controls. D-003 was also well tolerated; the frequency of adverse events in the bone, joints, or muscle with D-003 treatment (p < 0.05) was lower than in the placebo group.
Conclusions: D-003 treatment (10 mg/day) for 3 years increased lumbar spine BMD and produced clinical improvements in postmenopausal women with low BMD. Further studies, however, will be required to confirm these results.
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KEYWORD
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Bone density conservation agents, Bone density, Bone remodeling, Osteoporosis, postmenopausal, Saccharum wax acids
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