title: Menatetrenone versus alfacalcidol in the treatment of Chinese postmenopausal women with osteoporosis: a multicenter, randomized, double-blinded, double-dummy, positive drug-controlled clinical trial.
abstract: OBJECTIVE
  To evaluate whether the efficacy and safety of menatetrenone for the treatment of osteoporosis is noninferior to alfacalcidol in Chinese postmenopausal women.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Menatetrenone is an effective and safe choice in the treatment of postmenopausal osteoporosis in Chinese women.
authors.affiliation: Department of Endocrinology, Key Laboratory of Endocrinology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing.
authors.forename: Yan
authors.initials: Y
authors.lastname: Jiang
authors.affiliation: Metabolic Bone Disease and Genetic Research Unit, Department of Osteoporosis and Bone Disease, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai.
authors.forename: Zhen-Lin
authors.initials: ZL
authors.lastname: Zhang
authors.affiliation: Department of Gynecology and Obstetrics, General Hospital of the People's Liberation Army, Beijing.
authors.forename: Zhong-Lan
authors.initials: ZL
authors.lastname: Zhang
authors.affiliation: Department of Geriatrics, Shanghai Huadong Hospital, Shanghai.
authors.forename: Han-Min
authors.initials: HM
authors.lastname: Zhu
authors.affiliation: Department of Gynecology and Obstetrics, Beijing Hospital, Ministry of Public Health, Beijing.
authors.forename: Yi-Yong
authors.initials: YY
authors.lastname: Wu
authors.affiliation: Department of Geriatrics, Shanghai Huadong Hospital, Shanghai.
authors.forename: Qun
authors.initials: Q
authors.lastname: Cheng
authors.affiliation: Department of Gynecology and Obstetrics, Beijing Hospital, Ministry of Public Health, Beijing.
authors.forename: Feng-Li
authors.initials: FL
authors.lastname: Wu
authors.affiliation: Department of Endocrinology, Key Laboratory of Endocrinology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing.
authors.forename: Xiao-Ping
authors.initials: XP
authors.lastname: Xing
authors.affiliation: Department of Gynecology and Obstetrics, General Hospital of the People's Liberation Army, Beijing.
authors.forename: Jian-Li
authors.initials: JL
authors.lastname: Liu
authors.affiliation: Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.
authors.forename: Wei
authors.initials: W
authors.lastname: Yu
authors.affiliation: Department of Endocrinology, Key Laboratory of Endocrinology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing.
authors.forename: Xun-Wu
authors.initials: XW
authors.lastname: Meng
mesh_terms: D000368:Aged; D000469:Alkaline Phosphatase / Q000097:blood; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D002118:Calcium / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D050723:Fractures, Bone / Q000453:epidemiology / Q000517:prevention & control; D006801:Humans; D006887:Hydroxycholecalciferols / Q000627:therapeutic use*; D008875:Middle Aged; D015675:Osteocalcin / Q000097:blood; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D010758:Phosphorus / Q000097:blood; D016896:Treatment Outcome; D024482:Vitamin K 2 / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D050071:Bone Density Conservation Agents; D006887:Hydroxycholecalciferols; D015675:Osteocalcin; D024482:Vitamin K 2; C030814:menatetrenone; D010758:Phosphorus; D000469:Alkaline Phosphatase; D002118:Calcium; C008088:alfacalcidol
keywords: alfacalcidol; bone mineral density; menatetrenone; osteoporosis; postmenopausal; undercarboxylated osteocalcin