Browsing by Author "Leon, J"

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    A comparative pharmacokinetic study of micronized estradiol valerate administered alone and in combination with medroxyprogesterone acetate in postmenopausal women
    (LIPPINCOTT WILLIAMS & WILKINS, 2004) Saavedra, I; Leon, J; Prado, J; Sanchez, MP; Lopez, F; Gaete, L
    The objective of this study was to evaluate a possible pharmacokinetic interaction between 17beta-estradiol (E-2) and medroxyprogesterone (MP) when administered together in a combined tablet because both hormones have common metabolic routes of biotransformation. The study assessed the mean pharmacokinetics parameters of E2 found after 1-dose administration of 2 different tablets containing E-2, 1 containing 2 mg of micronized 17beta-estradiol valerate (E2V) and the other, administered after 2 weeks, 2 mg of E,V in combination with 5 mg of medroxyprogesterone acetate (MPA). The subjects were 15 healthy postmenopausal women with normal laboratory and clinic tests. The study was randomized, double blind, crossover, with 2 periods and 2 sequences. The blood samples were obtained at 0, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours after each administration. The F, serum concentrations were determined by electrochemoluminiscence assay. From these data, the following pharmacokinetic parameters were calculated for E, alone and E, in combination with MPA (E2V/MPA): C-max = 104.89 +/- 26.96, 103.27 +/- 44.40; AUC(0-24) = 1900.30 +/- 392.23, 1783.70 +/- 756.39; AUC(0-infinity) = 5576.06 +/- 4065.87, 5317.89 +/- 3702.54; k(a) = 1.06 +/- 0.31, 1.09 +/- 0.13; t1/2 = 35.65 +/- 20.62, 36.12 +/- 18.04; MRT = 16.29 +/- 8.77,16.27 +/- 4.88; V/F = 16.29 +/- 8.76, 16.27 +/- 4.88. No significant differences between the pharmacokinetic parameters of E-2 and E-2/MPA were found, which led us to conclude that there is no pharmacokinetic interaction.
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    Oral alendronate induces progressive increases in bone mass of the spine, hip, and total body over 3 years in postmenopausal women with osteoporosis
    (1996) Devogelaer, JP; Broll, H; CorreaRotter, R; Cumming, DC; DeDeuxchaisnes, CN; Geusens, P; Hosking, D; Jaeger, P; Kaufman, JM; Leite, M; Leon, J; Liberman, U; Menkes, CJ; Meunier, PJ; Reid, I; Rodriguez, J; Romanowicz, A; Seeman, E; Vermeulen, A; Hirsch, LJ; Lombardi, A; Plezia, K; Santora, AC; Yates, AJ; Yuan, W
    To determine the effects of long-term daily oral alendronate sodium (ALN) on bone mass in postmenopausal women with osteoporosis, 19 centers enrolled 516 postmenopausal women aged 45-80 gears with spine bone mineral density (BMD) at least 2.5 SD below the mean for young premenopausal women in a 3-year, double-blind, placebo-controlled study, Subjects were randomly allocated to one of four treatment groups: placebo; alendronate, 5 or 10 mg/day for 3 years; or alendronate, 20 mg/day for 2 years followed by 5 mg/day for the 3rd year, All patients received 500 mg/day of supplemental calcium to ensure adequate calcium intake. BMD was measured by dual-energy X-ray absorptiometry at several skeletal sites, Nonsignificant mean decreases in BMD of the spine, femoral neck, and trochanter of 0.6, 0.7, and 0.4%, respectively, occurred in the placebo group at 3 gears, Relative to placebo-treated patients, spine BMD increased by 5.4%, 7.4%, and 8.4% in the 5, 10, and 20/5 mg ALN groups, respectively, Increases at the femoral neck were 3.5%, 5.5%, and 4.3%, and those at the trochanter were 5.1%, 7.2%, and 7.2%, respectively, Thus, efficacy of 10 and 20/5 mg ALN was similar, whereas the 5 mg dose was less effective, BMD continued to increase over the entire 3-year study duration in the ALN-treated groups and, compared with the other dosage groups, 10 mg ALN produced the largest gains in BMD during the 3rd year, Changes in biochemical markers of bone turnover and mineral homeostasis confirmed the effect of ALN to decrease bone turnover to a new steady-state level, The safety and tolerability of ALN were comparable with those of placebo, In summary, 10 mg daily oral ALN given for 3 years significantly and progressively increases bone mass and is a generally well-tolerated treatment for osteoporosis in postmenopausal women.