Menatetrenone versus alfacalcidol in the treatment of Chinese postmenopausal women with osteoporosis: a multicenter, randomized, double-blinded, double-dummy, positive drug-controlled clinical trial

Clin Interv Aging. 2014;9:121-7. doi: 10.2147/CIA.S54107. Epub 2014 Jan 8.

Abstract

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 μg/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.

Keywords: alfacalcidol; bone mineral density; menatetrenone; osteoporosis; postmenopausal; undercarboxylated osteocalcin.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Alkaline Phosphatase / blood
  • Bone Density / drug effects
  • Bone Density Conservation Agents / therapeutic use*
  • Calcium / blood
  • Double-Blind Method
  • Female
  • Fractures, Bone / epidemiology
  • Fractures, Bone / prevention & control
  • Humans
  • Hydroxycholecalciferols / therapeutic use*
  • Middle Aged
  • Osteocalcin / blood
  • Osteoporosis, Postmenopausal / drug therapy*
  • Phosphorus / blood
  • Treatment Outcome
  • Vitamin K 2 / analogs & derivatives*
  • Vitamin K 2 / therapeutic use

Substances

  • Bone Density Conservation Agents
  • Hydroxycholecalciferols
  • Osteocalcin
  • Vitamin K 2
  • menatetrenone
  • Phosphorus
  • Alkaline Phosphatase
  • Calcium
  • alfacalcidol