title: 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: OBJECTIVE
  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.affiliation: Medical Surgical Research Centre, Havana, Cuba.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Ceballos
authors.forename: Gladys
authors.initials: G
authors.lastname: Castaño
authors.forename: Sarahí
authors.initials: S
authors.lastname: Mendoza
authors.forename: Juan
authors.initials: J
authors.lastname: González
authors.forename: Rosa
authors.initials: R
authors.lastname: Mas
authors.forename: Lilia
authors.initials: L
authors.lastname: Fernández
authors.forename: José
authors.initials: J
authors.lastname: Illnait
authors.forename: Meilis
authors.initials: M
authors.lastname: Mesa
authors.forename: Rafael
authors.initials: R
authors.lastname: Gámez
authors.forename: Julio César
authors.initials: JC
authors.lastname: Fernández
authors.forename: Ricardo
authors.initials: R
authors.lastname: Telles
authors.forename: Duany
authors.initials: D
authors.lastname: Marrero
authors.forename: Mainel Gómez
authors.initials: MG
authors.lastname: Eng
authors.forename: Dalmer
authors.initials: D
authors.lastname: Ruiz
authors.forename: Yunaisi
authors.initials: Y
authors.lastname: Jardines
mesh_terms: D015502:Absorptiometry, Photon; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003462:Cuba; D004311:Double-Blind Method; D005227:Fatty Acids / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005272:Femur Neck / Q000000981:diagnostic imaging / Q000187:drug effects*; D006801:Humans; D008055:Lipids / Q000097:blood; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000187:drug effects*; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000097:blood / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D050071:Bone Density Conservation Agents; C418063:D-003 sugarcane wax acid mixture; D005227:Fatty Acids; D008055:Lipids