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.
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.
['Ceballos|Alfredo|A|', 'Castaño|Gladys|G|', 'Mendoza|Sarahí|S|', 'González|Juan|J|', 'Mas|Rosa|R|', 'Fernández|Lilia|L|', 'Illnait|José|J|', 'Mesa|Meilis|M|', 'Gámez|Rafael|R|', 'Fernández|Julio César|JC|', 'Telles|Ricardo|R|', 'Marrero|Duany|D|', 'Eng|Mainel Gómez|MG|', 'Ruiz|Dalmer|D|', 'Jardines|Yunaisi|Y|']
D015502:Absorptiometry, Photon D000328:Adult D000368:Aged D000704:Analysis of Variance D015519:Bone Density D050071:Bone Density Conservation Agents D003462:Cuba D004311:Double-Blind Method D005227:Fatty Acids D005260:Female D005272:Femur Neck D006801:Humans D008055:Lipids D008159:Lumbar Vertebrae D008875:Middle Aged D015663:Osteoporosis, Postmenopausal D011788:Quality of Life D011795:Surveys and Questionnaires D013997:Time Factors D016896:Treatment Outcome
Bone density Bone density conservation agents Bone remodeling Osteoporosis, postmenopausal Saccharum wax acids