The Korean journal of internal medicine

The Korean Association of Internal Medicine (대한내과학회)
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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

  • Ceballos, Alfredo (Medical Surgical Research Centre) ;
  • Castano, Gladys (Medical Surgical Research Centre) ;
  • Mendoza, Sarahi (Centre of Natural Products, National Centre for Scientific Research) ;
  • Gonzalez, Juan (Medical Surgical Research Centre) ;
  • Mas, Rosa (Centre of Natural Products, National Centre for Scientific Research) ;
  • Fernandez, Lilia (Centre of Natural Products, National Centre for Scientific Research) ;
  • Illnait, Jose (Centre of Natural Products, National Centre for Scientific Research) ;
  • Mesa, Meilis (Medical Surgical Research Centre) ;
  • Gamez, Rafael (Centre of Natural Products, National Centre for Scientific Research) ;
  • Fernandez, Julio Cesar (Centre of Natural Products, National Centre for Scientific Research) ;
  • Telles, Ricardo (Medical Surgical Research Centre) ;
  • Marrero, Duany (Medical Surgical Research Centre) ;
  • Eng, Mainel Gomez (Software and Database Group of the National Centre for Scientific Research) ;
  • Ruiz, Dalmer (Software and Database Group of the National Centre for Scientific Research) ;
  • Jardines, Yunaisi (Software and Database Group of the National Centre for Scientific Research)
  • Published : 2011.06.01
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Abstract

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.

Keywords

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