2013, Number 1
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Invest Medicoquir 2013; 5 (1)
Effects of D-003 on quality of life in postmenopausal women at moderate to high risk of osteoporosis
Ceballos MA, Fernández-Travieso JC, Mendoza-Castaño S, Más-Ferreiro R, Gámez-Menéndez R, Mesa-Angarica M
Language: Spanish
References: 48
Page: 25-43
PDF size: 394.27 Kb.
ABSTRACT
Introduction. Osteoporosis, a disease characterized by reduction of bone mineral density and alteration of bone microarchitecture that increases bone fragility and fracture risk, affects the quality of life of the sufferers.
Pharmacological management of osteoporosis includes the use of drugs that reduce bone resorption and/or increase bone synthesis. D-003 is a mixture of high molecular weight aliphatic acids purified from sugar cane wax with antiresorptive effects
demonstrated in experimental and clinical studies.
Methods. This randomized, double-blinded, placebo-controlled study investigated the effects of D-003 on the quality of life of postmenopausal women at moderate to high risk of Osteoporosis.
Forty postmenopausal women were randomized to receive placebo or D-003 (10 mg/d) for three months. Significant reductions on Qualeffo total score and serum low-density lipoprotein-cholesterol (LDL-C) levels versus placebo group were considered as
the primary and secondary efficacy variables, respectively. Evaluation of safety and tolerability included the analyses of the effects on physical and blood indicators, and the adverse events reports, as well.
Data were analyzed as per the intention-to-treat method. Both groups displayed similar baseline characteristics.
Results. After complete three months on therapy, D-003 significantly decreased Qualeffo total scores (p‹0.0001 vs baseline, p‹0.05 vs placebo),
as well as LDL-C values (17.1 %). The treatment was safe and well tolerated. Only one patient (D-003-treated) withdrew from the study, and it was due to protocol violation. Four patients, all from placebo group, reported some adverse event.
Conclusions. D-003 (10 mg/d) administered during three months improved quality of life in postmenopausal women at moderate to high risk of OP and produced additional benefit on serum LDL-C values.
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