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.
10.3904/kjim.2011.26.2.168
- Author:
Alfredo CEBALLOS
1
;
Gladys CASTANO
;
Sarahi MENDOZA
;
Juan GONZALEZ
;
Rosa MAS
;
Lilia FERNANDEZ
;
Jose ILLNAIT
;
Meilis MESA
;
Rafael GAMEZ
;
Julio Cesar FERNANDEZ
;
Ricardo TELLES
;
Duany MARRERO
;
Mainel Gomez ENG
;
Dalmer RUIZ
;
Yunaisi JARDINES
Author Information
1. Medical Surgical Research Centre, Havana, Cuba.
- Publication Type:Original Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
- Keywords:
Bone density conservation agents;
Bone density;
Bone remodeling;
Osteoporosis, postmenopausal;
Saccharum wax acids
- MeSH:
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
- From:The Korean Journal of Internal Medicine
2011;26(2):168-178
- CountryRepublic of Korea
- Language:English
-
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.
