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...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2014-01-01
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| Series: | Clinical Interventions in Aging |
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| Online Access: | https://www.dovepress.com/menatetrenone-versus-alfacalcidol-in-the-treatment-of-chinese-postmeno-peer-reviewed-article-CIA |
| _version_ | 1819015959520739328 |
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| 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 |
| collection | DOAJ |
| 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 |
| first_indexed | 2024-12-21T02:40:01Z |
| format | Article |
| id | doaj.art-1914110c98d9478986cdcba2c6582d5c |
| institution | Directory Open Access Journal |
| issn | 1178-1998 |
| language | English |
| last_indexed | 2024-12-21T02:40:01Z |
| publishDate | 2014-01-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Clinical Interventions in Aging |
| spelling | doaj.art-1914110c98d9478986cdcba2c6582d5c2022-12-21T19:18:42ZengDove Medical PressClinical Interventions in Aging1178-19982014-01-01Volume 912112715451Menatetrenone versus alfacalcidol in the treatment of Chinese postmenopausal women with osteoporosis: a multicenter, randomized, double-blinded, double-dummy, positive drug-controlled clinical trialJiang YZhang ZLZhang ZLZhu HMWu YYCheng QWu FLXing XPLiu JLYu WMeng XWYan 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 osteocalcinhttps://www.dovepress.com/menatetrenone-versus-alfacalcidol-in-the-treatment-of-chinese-postmeno-peer-reviewed-article-CIAmenatetrenonealfacalcidolpostmenopausalosteoporosismineral bone densityundercarboxylated osteocalcin |
| spellingShingle | 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 Clinical Interventions in Aging menatetrenone alfacalcidol postmenopausal osteoporosis mineral bone density undercarboxylated osteocalcin |
| 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_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_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_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 |
| topic | menatetrenone alfacalcidol postmenopausal osteoporosis mineral bone density undercarboxylated osteocalcin |
| url | https://www.dovepress.com/menatetrenone-versus-alfacalcidol-in-the-treatment-of-chinese-postmeno-peer-reviewed-article-CIA |
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