Objective: To evaluate whether the efficacy and safety of menatetrenone for the treatment of osteoporosis is noninferior to alfacalcidol in Chinese postmenopausal women. Method: This multicenter, randomized, double-blinded, double-dummy, noninferiority, positive drug-controlled clinical trial was conducted in five Chinese sites. Eligible Chinese women with postmenopausal osteoporosis (N=236) were randomized to Group M or Group A and received menatetrenone 45 mg/day or alfacalcidol 0.5 mug/day, respectively, for 1 year. Additionally, all patients received calcium 500 mg/day. Posttreatment bone mineral density (BMD), new fracture onsets, and serum osteocalcin (OC) and undercarboxylated OC (ucOC) levels were compared with the baseline value in patients of both groups. Results: A total of 213 patients (90.3%) completed the study. After 1 year of treatment, BMD among patients in Group M significantly increased from baseline by 1.2% and 2.7% at the lumbar spine and trochanter, respectively (P,0.001); and the percentage increase of BMD in Group A was 2.2% and 1.8%, respectively (P,0.001). No difference was observed between groups. There were no changes in femoral neck BMD in both groups. Two patients (1.9%, 2/108) in Group M and four patients (3.8%, 4/105) in Group A had new fracture onsets (P.0.05). In Group M, OC and ucOC decreased from baseline by 38.7% and 82.3%, respectively (P,0.001). In Group A, OC and ucOC decreased by 25.8% and 34.8%, respectively (P,0.001). Decreases in serum OC and ucOC were more obvious in Group M than in Group A (P,0.001). The safety profile of menatetrenone was similar to alfacalcidol. Conclusion: Menatetrenone is an effective and safe choice in the treatment of postmenopausal osteoporosis in Chinese women. © 2014 Jiang et al.
Y., J., X.-P., X., X.-W., M., Z.-L., Z., J.-L., L., H.-M., Z., … W., Y. (2014). Menatetrenone versus alfacalcidol in the treatment of chinese postmenopausal women with osteoporosis: A multicenter, randomized, double-blinded, double-dummy, positive drug-controlled clinical trial. Clinical Interventions in Aging, 9, 121–127. Retrieved from http://europepmc.org/search?query=(DOI:%2210.2147/CIA.S54107%22) https://doi.org/10.2147/CIA.S54107 https://www.ncbi.nlm.nih.gov/pmc/?term=10.2147/CIA.S54107[DOI] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3890406/