1.
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, Y, Zhang, ZL, Zhang, ZL, Zhu, HM, Wu, YY, Cheng, Q, Wu, FL, Xing, XP, Liu, JL, Yu, W, et al
Clinical interventions in aging. 2014;:121-7
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.
2.
[Alendronate in postmenopausal women with osteopenia and osteoporosis: effects on bone mineral density during treatment and after withdrawal].
Jiang, Y, Li, M, Xia, W, Xing, X, Yu, W, Tian, J, Meng, X, Zhou, X
Zhonghua yi xue za zhi. 2002;(18):1254-6
Abstract
OBJECTIVE To determine the efficacy of alendronate (Fosamax) administration and withdrawal on the bone mineral density (BMD) in postmenopausal women with osteopenia and osteoporosis. METHODS Alendronate (10 mg) and calcium carbonate (containing calcium 500 mg) were administered daily to 25 Chinese menopausal women with osteopenia and osteoporosis for 6 months and to 15 women for 12 months. After the withdrawal of alendronate, calcium carbonate was administered continuously. Follow-up was made three times for the 6-month group: before treatment, 6 months after treatment, and 13 +/- 4 months (6 - 24 months) after aldoronate withdrawal, and was made four times for the 12-month group: before treatment, 6 months and 12 months after treatment, and 23 +/- 7 months (14 - 36 months) after alendronate withdrawal to determine the BMD of lumbar spine 2 approximately 4, neck of femur, Wards triangle, and greater trochanter and blood alkaline phosphatase (ALP). RESULTS Compared to the baseline value, the BMD in lumbar spine and hip increased significantly 6 months after treatment in 6-month group, with the BMD in lumbar spine 2 - 4 increased by 5.3% (P < 0.001). In the 6 month group, no significant decline was found in the BMD in lumbar spine and hip 13 +/- 4 months after alendronate withdrawal, the BMD in greater trochanter even increased further compared with that 6 months after treatment. In the 12-month group, the BMD significantly increased except in the Wards triangle after 6 months' treatment with an increase by 4.2% in lumbar spine 2 - 4 (P < 0.001). After 12 months' treatment the increment of BMD in lumbar spine 2 - 4 was 6.1% (P < 0.001) and the BMD of the hip remained unchanged. 23 +/- 7 months after the alendronte withdrawal the values of BMD in lumbar spine and hip were almost the same as that 12 months after treatment. CONCLUSION Alendronate increases the BMD in spine and hip, especially in lumbar spine. The skeletal benefits are maintained for at least 13 - 23 months in spine and hip after withdrawal of alendrenate.