RESUMEN
Baseline and on-treatment characteristics, including age, obesity, calcium intake, and bone turnover markers, may predict the bone mineral density (BMD) response in women with postmenopausal osteoporosis (PMO) to 1 to 2 years of antiresorptive therapy and/or vitamin D supplementation. This study aimed to explore clinical characteristics associated with 12-month BMD improvement in Chinese women with postmenopausal osteoporosis (PMO).In this post hoc analysis of a previous phase 3 multicenter, randomized controlled trial, Chinese PMO women who were treated with once weekly alendronate 70âmg/vitamin D3 5600 IU (ALN/D5600) or once daily calcitriol 0.25âmcg, and had measurements of 1-year lumbar spine BMD (LS-BMD) and on-treatment bone turnover markers (BTMs) were included in the analysis.In Chinese PMO patients on ALN/D5600, 1-year LS-BMD change was negatively correlated with age (ßâ=â-0.00084, Pâ<â.01), dietary calcium (ßâ=â-0.0017, Pâ=â.07), and procollagen type 1 N-terminal propeptide (P1NP) change at month 6 (ßâ=â-0.000469, Pâ=â.0016), but positively with body mass index (BMI) (ßâ=â0.00128, Pâ=â.08); baseline P1NP above the median was associated with a significantly greater BMD percentage change at the lumbar spine (Pâ=â.02) and the total hip (Pâ=â.0001). In the calcitriol group, a significant 1-year LS-BMD increase was associated with BMI (ßâ=â0.0023, Pâ=â.02), baseline P1NP (ßâ=â0.00035, Pâ=â.0067), history of prior vertebral fracture(s) (ßâ=â0.034, Pâ<â.0001) and baseline serum 25(OH)D level (ßâ=â-0.00083, Pâ=â.02).The presented findings from Chinese postmenopausal osteoporotic women suggested clinically meaningful baseline and on-treatment characteristics predicting BMD improvement after 1 year of ALN/D5600 treatment, which differed from calcitriol treatment with baseline identifiable associations. The study remained exploratory and further accumulation of evidence is needed.