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

Yan Jiang,1,* Zhen-Lin Zhang,2,* Zhong-Lan Zhang,3 Han-Min Zhu,4 Yi-Yong Wu,5 Qun Cheng,4 Feng-Li Wu,5 Xiao-Ping Xing,1 Jian-Li Liu,3 Wei Yu,6 Xun-Wu Meng11Department of Endocrinology, Key Laboratory of Endocrinology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijin...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Jiang Y, Zhang ZL, Zhu HM, Wu YY, Cheng Q, Wu FL, Xing XP, Liu JL, Yu W, Meng XW
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2014
Materias:	menatetrenone alfacalcidol postmenopausal osteoporosis mineral bone density undercarboxylated osteocalcin Geriatrics RC952-954.6
Acceso en línea:	https://doaj.org/article/1914110c98d9478986cdcba2c6582d5c
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:1914110c98d9478986cdcba2c6582d5c
record_format	dspace
spelling	oai:doaj.org-article:1914110c98d9478986cdcba2c6582d5c2021-12-02T05:10:45ZMenatetrenone versus alfacalcidol in the treatment of Chinese postmenopausal women with osteoporosis: a multicenter, randomized, double-blinded, double-dummy, positive drug-controlled clinical trial1178-1998https://doaj.org/article/1914110c98d9478986cdcba2c6582d5c2014-01-01T00:00:00Zhttps://www.dovepress.com/menatetrenone-versus-alfacalcidol-in-the-treatment-of-chinese-postmeno-peer-reviewed-article-CIAhttps://doaj.org/toc/1178-1998Yan Jiang,1,* Zhen-Lin Zhang,2,* Zhong-Lan Zhang,3 Han-Min Zhu,4 Yi-Yong Wu,5 Qun Cheng,4 Feng-Li Wu,5 Xiao-Ping Xing,1 Jian-Li Liu,3 Wei Yu,6 Xun-Wu Meng11Department of Endocrinology, Key Laboratory of Endocrinology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 2Metabolic Bone Disease and Genetic Research Unit, Department of Osteoporosis and Bone Disease, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 3Department of Gynecology and Obstetrics, General Hospital of the People's Liberation Army, Beijing, 4Department of Geriatrics, Shanghai Huadong Hospital, Shanghai, 5Department of Gynecology and Obstetrics, Beijing Hospital, Ministry of Public Health, Beijing, 6Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China*These authors contributed equally to this workObjective: 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: menatetrenone, alfacalcidol, postmenopausal, osteoporosis, bone mineral density, undercarboxylated osteocalcinJiang YZhang ZLZhang ZLZhu HMWu YYCheng QWu FLXing XPLiu JLYu WMeng XWDove Medical Pressarticlemenatetrenonealfacalcidolpostmenopausalosteoporosismineral bone densityundercarboxylated osteocalcinGeriatricsRC952-954.6ENClinical Interventions in Aging, Vol Volume 9, Pp 121-127 (2014)
institution	DOAJ
collection	DOAJ
language	EN
topic	menatetrenone alfacalcidol postmenopausal osteoporosis mineral bone density undercarboxylated osteocalcin Geriatrics RC952-954.6
spellingShingle	menatetrenone alfacalcidol postmenopausal osteoporosis mineral bone density undercarboxylated osteocalcin Geriatrics RC952-954.6 Jiang Y Zhang ZL Zhang ZL Zhu HM Wu YY Cheng Q Wu FL Xing XP Liu JL Yu W Meng XW Menatetrenone versus alfacalcidol in the treatment of Chinese postmenopausal women with osteoporosis: a multicenter, randomized, double-blinded, double-dummy, positive drug-controlled clinical trial
description	Yan Jiang,1,* Zhen-Lin Zhang,2,* Zhong-Lan Zhang,3 Han-Min Zhu,4 Yi-Yong Wu,5 Qun Cheng,4 Feng-Li Wu,5 Xiao-Ping Xing,1 Jian-Li Liu,3 Wei Yu,6 Xun-Wu Meng11Department of Endocrinology, Key Laboratory of Endocrinology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 2Metabolic Bone Disease and Genetic Research Unit, Department of Osteoporosis and Bone Disease, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 3Department of Gynecology and Obstetrics, General Hospital of the People's Liberation Army, Beijing, 4Department of Geriatrics, Shanghai Huadong Hospital, Shanghai, 5Department of Gynecology and Obstetrics, Beijing Hospital, Ministry of Public Health, Beijing, 6Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China*These authors contributed equally to this workObjective: 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: menatetrenone, alfacalcidol, postmenopausal, osteoporosis, bone mineral density, undercarboxylated osteocalcin
format	article
author	Jiang Y Zhang ZL Zhang ZL Zhu HM Wu YY Cheng Q Wu FL Xing XP Liu JL Yu W Meng XW
author_facet	Jiang Y Zhang ZL Zhang ZL Zhu HM Wu YY Cheng Q Wu FL Xing XP Liu JL Yu W Meng XW
author_sort	Jiang Y
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
title_short	Menatetrenone versus alfacalcidol in the treatment of Chinese postmenopausal women with osteoporosis: a multicenter, randomized, double-blinded, double-dummy, positive drug-controlled clinical trial
title_full	Menatetrenone versus alfacalcidol in the treatment of Chinese postmenopausal women with osteoporosis: a multicenter, randomized, double-blinded, double-dummy, positive drug-controlled clinical trial
title_fullStr	Menatetrenone versus alfacalcidol in the treatment of Chinese postmenopausal women with osteoporosis: a multicenter, randomized, double-blinded, double-dummy, positive drug-controlled clinical trial
title_full_unstemmed	Menatetrenone versus alfacalcidol in the treatment of Chinese postmenopausal women with osteoporosis: a multicenter, randomized, double-blinded, double-dummy, positive drug-controlled clinical trial
title_sort	menatetrenone versus alfacalcidol in the treatment of chinese postmenopausal women with osteoporosis: a multicenter, randomized, double-blinded, double-dummy, positive drug-controlled clinical trial
publisher	Dove Medical Press
publishDate	2014
url	https://doaj.org/article/1914110c98d9478986cdcba2c6582d5c
work_keys_str_mv	AT jiangy menatetrenoneversusalfacalcidolinthetreatmentofchinesepostmenopausalwomenwithosteoporosisamulticenterrandomizeddoubleblindeddoubledummypositivedrugcontrolledclinicaltrial AT zhangzl menatetrenoneversusalfacalcidolinthetreatmentofchinesepostmenopausalwomenwithosteoporosisamulticenterrandomizeddoubleblindeddoubledummypositivedrugcontrolledclinicaltrial AT zhangzl menatetrenoneversusalfacalcidolinthetreatmentofchinesepostmenopausalwomenwithosteoporosisamulticenterrandomizeddoubleblindeddoubledummypositivedrugcontrolledclinicaltrial AT zhuhm menatetrenoneversusalfacalcidolinthetreatmentofchinesepostmenopausalwomenwithosteoporosisamulticenterrandomizeddoubleblindeddoubledummypositivedrugcontrolledclinicaltrial AT wuyy menatetrenoneversusalfacalcidolinthetreatmentofchinesepostmenopausalwomenwithosteoporosisamulticenterrandomizeddoubleblindeddoubledummypositivedrugcontrolledclinicaltrial AT chengq menatetrenoneversusalfacalcidolinthetreatmentofchinesepostmenopausalwomenwithosteoporosisamulticenterrandomizeddoubleblindeddoubledummypositivedrugcontrolledclinicaltrial AT wufl menatetrenoneversusalfacalcidolinthetreatmentofchinesepostmenopausalwomenwithosteoporosisamulticenterrandomizeddoubleblindeddoubledummypositivedrugcontrolledclinicaltrial AT xingxp menatetrenoneversusalfacalcidolinthetreatmentofchinesepostmenopausalwomenwithosteoporosisamulticenterrandomizeddoubleblindeddoubledummypositivedrugcontrolledclinicaltrial AT liujl menatetrenoneversusalfacalcidolinthetreatmentofchinesepostmenopausalwomenwithosteoporosisamulticenterrandomizeddoubleblindeddoubledummypositivedrugcontrolledclinicaltrial AT yuw menatetrenoneversusalfacalcidolinthetreatmentofchinesepostmenopausalwomenwithosteoporosisamulticenterrandomizeddoubleblindeddoubledummypositivedrugcontrolledclinicaltrial AT mengxw menatetrenoneversusalfacalcidolinthetreatmentofchinesepostmenopausalwomenwithosteoporosisamulticenterrandomizeddoubleblindeddoubledummypositivedrugcontrolledclinicaltrial
_version_	1718400516069785600

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

Ejemplares similares