Efectos de alfacalcidol en los marcadores óseos y la densidad mineral ósea en mujeres posmenopáusicas tratadas con alendronato con osteopenia u osteoporosis: análisis intermedio de un año de estudio ALFA

The purpose of the ALFA study (three-year prospective. randomized, double-blind, placebo-controlled trial) is to evaluate the effect of alfacalcidol ug daily on the number of falls in postmenopausal, alendronate-treated, osteopcnicor osteoporotic women. A pre-planned one year intenm analysis was perfomed to examine the eftict of alfacalcidol on bone turnover markers ad bone n'¡ineral clensity for safety reasons. A total of 278 postmenopausal women (mean age 73.7 years. SD 4.8) received either alfacalcidol I ug or placebo daily, in addidon to alendronate 70 mg weekly and calcium 500 mg daily. Lumbar spine and hip BMD were measured by DXA at baseline and after 12 months of treatment. Biochemical marken reflecting calcium metabolism and bone turnover serum calcium, 25-OH-vitamin D, calcitriol. intact pamthyroid homore (iPTH), bone-specific alkaline phosphatase (BAP) and semm N-telopeptide (sNTX)] were measured at the beginning of the study, before treatment and after 3, 6 and 12 moüths of treatment.