Tipo de Articulo: Artículos Originales

Titulo: Estudio comparativo de la absorcin neta de calcio de dos formulaciones distintas de carbonato de calcio en mujeres posmenopusicas

Title: Comparative study of net calcium absorption of two different pharmaceutical formulations of calcium carbonate in posmenopausal women

Actual. Osteol 14(1):10:21, 2018

Autor(es): Silvina R. Mastaglia, Dana Z. Watson, Julia Somoza, Rosana Gianotti, Graciela Brito, Beatriz Oliveri


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La suplementacin con calcio reducira, sola o asociada a otra medicacin para osteoporosis, la prdida de masa sea y el riesgo de fracturas. Sin embargo, su tasa de adherencia es baja debido a la poca tolerancia. Objetivo: comparar la tasa de absorcin neta de calcio, entre dos formulaciones distintas de carbonato de calcio (500 mg): comprimidos vs. mousse. Materiales y mtodos: 11 pruebas fueron realizadas en mujeres posmenopusicas de 58,93 aos. El diseo fue exploratorio abierto, aleatorizado, prospectivo cruzado de fase 4. Intervencin: las participantes fueron aleatorizadas en dos grupos para recibir las dos formulaciones previa suplementacin con vitamina D3. La tasa de absorcin neta de calcio fue estudiada por la prueba de inhibicin de hormona paratiroides (PTH). Se obtuvieron muestras de sangre: basal y en la 1.a, 2.a y 3.a hora pos-administracin del calcio asignado, y de orina de 2 horas basal y al final de la prueba. Determinaciones bioqumicas: calcio, fsforo, albmina, 25-hidroxivitamina D y hormona paratiroides intacta y calciuria. Anlisis estadstico: mtodo de los trapecios para calcular el rea bajo la curva (AUC) de la concentracin de calcio en el tiempo (R Development Core Team (2008).

http://www.Rp-project.org) y Anova con dos trminos de error para evaluar el efecto secuencia, perodo y formulacin. Resultados: la mayor inhibicin de PTH se observ a dos horas de la toma de ambas formulaciones (comprimidos -39,2% vs. mousse -38,0%; p=ns), con similar AUC-0-3 h (comprimidos 3,35; IC 95%: 3,32; 3,37 vs. mousse 3,36; IC 95%: 3,33; 3,38). Cuando analizamos tolerancia y preferencias no se observaron diferencias estadsticamente significativas entre ambas formulaciones. Conclusin: el carbonato de calcio en mousse mostr similar tasa de absorcin intestinal, preferencia y tolerancia gastrointestinal que en comprimido.

Palabras clave: suplementacin de calcio, absorcin, carbonato de calcio.

Calcium supplementation, administered alone or in combination with a specific medication for osteoporosis, would reduce bone mass loss and fracture risk in postmenopausal women. However, the adherence rate to calci-um supplements is low, mainly due to low tolerance. Objective: comparisson of net calcium absorption rate between two different pharmaceutical formulations of calcium carbonate (PFCa) in postmenopausal women. Materials and Methods: 11 tests were performed in postmenopausal women aged 58.93yrs. Design: Comparative, randomized, prospective, open-label exploratory crossover study of calcium mousse versus calcium pills. Intervention: Participants were randomized in 2 groups to receive the 2 different PFCa (500mg): pills vs. mousse, with previous vitamin D3 supplementation. The parathyroid hormone (PTH) inhibition test and the area-under-the-curve (AUC) of calcium were analyzed. Blood samples were taken at baseline and 1, 2 and 3 hrs after intake of the assigned PFCa. Urine samples (2hs) were obtained at -baseline, after 2hs of PFCa intake and at the end of the test. Biochemical Determinations: Serum: calcium, phosphorus, albumin, 25-hydroxyvitamin D, and intact PTH. In urine: calcium. Statistical Analysis: The trapezoid rule was applied to assess AUC in time (R Development Core Team (2008). http://www.Rp-project.org). An ANOVA model with 2 error terms was used to assess the effect of sequence, period, and formulation. Results: The highest inhibition PTH rates were observed after 2 hrs of PFCa (pills -39.2% vs. mousse -38.0%; p=ns). The AUC0-3hrs for both PFCa was similar (pills 3.35; 95%CI: 3.32; 3.37 vs. mousse 3.36; 95%CI: 3.33; 3.38). No statistically significant differences were observed when we analyze tolerance and predilection. Conclusion: The calcium carbonate in mousse showed an adequate rate of intestinal absorption, similarly predilection and gastrointestinal tolerance than the pill presentation.

Key words: calcium supplementation, absorption, calcium carbonate

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