Korean J Intern Med.  2011 Jun;26(2):168-178. 10.3904/kjim.2011.26.2.168.

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 A
• Castano G
• Mendoza S
• Gonzalez J
• Mas R
• Fernandez
• Illnait J
• Mesa M
• Gamez R
• Fernandez
• Telles R
• Marrero D
• Eng MG
• Ruiz D
• Jardines Y

• KMID: 1776589
• DOI: http://doi.org/10.3904/kjim.2011.26.2.168

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.

Keyword

Bone density conservation agents; Bone density; Bone remodeling; Osteoporosis, postmenopausal; Saccharum wax acids

MeSH Terms

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/*drug effects/radiography
Humans
Lipids/blood
Lumbar Vertebrae/*drug effects/radiography
Middle Aged
Osteoporosis, Postmenopausal/blood/*drug therapy/psychology/radiography
Quality of Life
Questionnaires
Time Factors
Treatment Outcome