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

Jiang, Yan; Zhang, Zhenlin; Zhang, Zhonglan; Zhu, Huanfeng; Wu, Yuanyuan; Cheng, Qun; Wu, Fangfang; Xing, Xiaoping; Liu, Jianli; Yu, Wei; Meng, Xunwu

doi:10.2147/cia.s54107

Cited by 17 publications

(23 citation statements)

References 35 publications

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“…The endpoints included BMD measured by dual-energy X-ray absorptiometry and fracture incidence. Eight studies met the criteria for RCTs on the effect of menatetrenone on the skeleton of postmenopausal women with osteoporosis [ 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 ]. Of eight RCTs, one included postmenopausal women with osteopenia or osteoporosis [ 15 ].…”

Section: Approaches To Determining the Effect Of Menatetrenone On mentioning

confidence: 99%

“…Menatetrenone reduces serum ucOC concentrations [ 17 , 18 ]. The anti-fracture efficacy of menatetreone in postmenopausal osteoporosis has been shown in eight RCTs ( Table 1 ) [ 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 ]. Of the eight RCTs, six were performed in Japan, one in Indonesia, and one in China.…”

Section: Menatetrenone Monotherapymentioning

confidence: 99%

“…High-dose vitamin K is needed to prevent fractures in postmenopausal women with osteoporosis [ 9 ]. However, the effect of menatetrenone on the skeleton remains a matter of controversy [ 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 ], and the role of menatetrenone in the treatment of osteoporosis therefore needs to be clarified. In clinical practice, menatetrenone is frequently used in combination with bisphosphonates.…”

Section: Introductionmentioning

confidence: 99%

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Vitamin K2 Therapy for Postmenopausal Osteoporosis

Iwamoto

2014

Nutrients

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Vitamin K may play an important role in the prevention of fractures in postmenopausal women with osteoporosis. Menatetrenone is the brand name of a synthetic vitamin K2 that is chemically identical to menaquinone-4. The present review study aimed to clarify the effect of menatetrenone on the skeleton in postmenopausal women with osteoporosis, by reviewing the results of randomized controlled trials (RCTs) in the literature. RCTs that investigated the effect of menatetrenone on bone mineral density (BMD), measured by dual-energy X-ray absorptiometry and fracture incidence in postmenopausal women with osteoporosis, were identified by a PubMed search for literature published in English. Eight studies met the criteria for RCTs. Small RCTs showed that menatetrenone monotherapy decreased serum undercarboxylated osteocalcin (ucOC) concentrations, modestly increased lumbar spine BMD, and reduced the incidence of fractures (mainly vertebral fracture), and that combined alendronate and menatetrenone therapy enhanced the decrease in serum ucOC concentrations and further increased femoral neck BMD. This review of the literature revealed positive evidence for the effects of menatetrenone monotherapy on fracture incidence in postmenopausal women with osteoporosis. Further studies are required to clarify the efficacy of menatetrenone in combination with bisphosphonates against fractures in postmenopausal women with osteoporosis.

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Section: Approaches To Determining the Effect Of Menatetrenone On mentioning

confidence: 99%

Section: Menatetrenone Monotherapymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Vitamin K2 Therapy for Postmenopausal Osteoporosis

Iwamoto

2014

Nutrients

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“…Menaquinone enhances this 1,25(OH)2D-induced OC mRNA production but could not substitute for 1,25(OH)2D in OC mRNA expression 16 . A comparison study of postmenopausal osteoporotic Chinese women showed no significant difference in BMD increase between 45mg/d MK4 and vitamin D; interestingly vitamin D also decreased ucOC, although the decrease was greater in the MK4 group 90 . Where vitamin D is supplemented with either phylloquinone or MK4, most studies show generally improved results compared with either vitamin alone 8,91 , although some found no additional benefit to bone parameters or the carboxylation of OC 92 .…”

Section: Bonementioning

confidence: 93%

Cardiovascular Calcification and Bone: A Comparison of the Effects of Dietary and Serum Vitamin K and its Dependent Proteins

Nicoll¹,

Howard²,

Henein³

2015

ICFJ

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This review compares the effect of vitamin K on cardiovascular (CV) calcification and bone health and shows that, in principal, the γ-carboxylation of the vitamin K-dependent proteins matrix Gla protein (MGP) and its bone equivalent osteocalcin (OC), generally ensures that hydroxyapatite is kept out of the CV system and is deposited in bone. This is an important finding, since there is currently no reliable treatment for CV calcification.Vitamin K2 (menaquinone) may be more effective in the arteries, while vitamin K1 (phylloquinone) is more active in bone. Nevertheless, there remains considerable uncertainty over the precise scope of the functions of MGP and OC, and their carboxylated and under-carboxylated forms, as well as the newly discovered vitamin K-dependent proteins. Although a diet high in vegetables could deliver adequate phylloquinone, supplementation of menaquinone may be necessary for those at risk of CV calcification. Several animal studies and one human study have demonstrated that arterial calcification could be reduced with vitamin K supplementation and there are further trials in progress. Patients on warfarin are particularly prone to CV calcification but there has been concern that supplementation would either counter warfarin treatment or destabilise INR. In fact, studies suggest that low dose phylloquinone did not increase coagulation and may improve the stability of anticoagulant therapy. Furthermore, use of oral anticoagulants which do not affect vitamin K metabolism, such as ximelagatran, could be used when there is a need for vitamin K supplementation for artery or bone health.

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“…[8] If hypercalciuria or other side-effect is observed, alfacalcidol dosages could be adjusted to the range of 0.25 μg to 0.5 μg daily in clinical practice. [9–11] However, there were no enough evidences for the efficacy and safety of alfacalcidol in treating elderly patients with low bone mass in China. Our present clinical trial was designed to estimate the efficacy and safety of alfacalcidol at a daily dosage of 1 μg in postmenopausal Chinese women with osteoporosis or osteopenia.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of alfacalcidol in Chinese postmenopausal women aged over 65 with osteoporosis or osteopenia

Jiang

et al. 2018

Medicine

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This study aimed to explore the therapeutic efficacy and safety of alfacalcidol among Chinese postmenopausal women (age >65 years) with osteoporosis or osteopenia. A total of 62 postmenopausal women with osteoporosis or osteopenia (>65 years) were recruited from urban residential community of Beijing. The patients daily took oral calcium and alfacalcidol (Alpha D3, 1 μg) for 9 months. Safety and efficacy assessments were performed at baseline and regular intervals. Alfacalcidol was adjusted to a daily dose of 0.5 μg in case of hypercalcemia or hypercalciuria. A significant improvement in “timed up and go test” and “chair rising test” was achieved 3 months after treatment. Significant decreases in bone turnover markers were observed 3 months after the treatment and lasted throughout the study. Nineteen patients discontinued due to adverse events (17 hypercalciuria, 1 hydronephrosis, and 1 stomach ache), while alfacalcidol was adjusted to a daily dose of 0.5 μg in 18 patients (29.0%). Increased serum creatinine was observed when compared to baseline ( P <.001), but all the values were in normal range. The treatment with 1 μg alfacalcidol can significantly improve muscle function and bone metabolism. Regular monitoring of urine calcium and timely dosage-adjustments are very important to guarantee the safety of alfacalcidol treatment in Chinese menopausal women.

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

Cited by 17 publications

References 35 publications

Vitamin K2 Therapy for Postmenopausal Osteoporosis

Vitamin K2 Therapy for Postmenopausal Osteoporosis

Cardiovascular Calcification and Bone: A Comparison of the Effects of Dietary and Serum Vitamin K and its Dependent Proteins

Efficacy and safety of alfacalcidol in Chinese postmenopausal women aged over 65 with osteoporosis or osteopenia

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