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.

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.

• Authors: Alfredo Ceballos, Gladys Castaño, Sarahí Mendoza, Juan González, Rosa Mas, Lilia Fernández, José Illnait, Meilis Mesa, Rafael Gámez, Julio César Fernández, Ricardo Telles, Duany Marrero, Mainel Gómez Eng, Dalmer Ruiz, Yunaisi Jardines
• Journal: The Korean journal of internal medicine (Korean J Intern Med) Vol. 26 Issue 2 Pg. 168-78 (Jun 2011) ISSN: 2005-6648 [Electronic] Korea (South)
• PMID: 21716593 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Bone Density Conservation Agents
• D-003 sugarcane wax acid mixture
• Fatty Acids
• Lipids

Topics

• Absorptiometry, Photon
• Adult
• Aged
• Analysis of Variance
• Bone Density (drug effects)
• Bone Density Conservation Agents (administration & dosage, adverse effects)
• Cuba
• Double-Blind Method
• Fatty Acids (administration & dosage, adverse effects)
• Female
• Femur Neck (diagnostic imaging, drug effects)
• Humans
• Lipids (blood)
• Lumbar Vertebrae (diagnostic imaging, drug effects)
• Middle Aged
• Osteoporosis, Postmenopausal (blood, diagnostic imaging, drug therapy, psychology)
• Quality of Life
• Surveys and Questionnaires
• Time Factors
• Treatment Outcome