KMID : 1039620150050040421
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Korean Journal of Family Practice 2015 Volume.5 No. 4 p.421 ~ p.429
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Effect of DM-BSF on Bone Mineral Density in Postmenopausal Women: Randomized, Double-Blind, Placebo-Controlled, Parallel Trial
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Ahn Eun-Kyeong
Kim Kyung-Soo Park Sang-Mi Choi Joon-Young
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Abstract
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Background : The purpose of this study was to evaluate the effect of DM-BSF treatment for 6 months on bone mineral density (BMD) in postmenopausal women.
Methods : This was a 24-week parallel-group, double-blind, randomized, placebo-controlled trial consisting of 5 visits. A total of 20 participants were randomized to either DM-BSF (n=10) group or the placebo group (n=10). Subjects were administered with a capsule of DM-BSF or placebo 3 times a day. BMD, bone-specific alkaline phosphatase (BSAP), serum C-telopeptide of collagen cross-links (CTx), and insulin-like growth factor-1 (IGF-1) were measured at baseline (visit 2) and at 24-week (visit 5).
Results : A total of 20 women were included in this study (mean¡¾standard deviation [SD] age, 57.7¡¾2.68 years; mean¡¾SD lumbar spine BMD T-score, -1.91¡¾0.95; mean¡¾SD right femur BMD T-score, -1.89¡¾0.74; DM-BSF group, N=10; placebo group, N=10). In the DM-BSF group, the mean percentage change of the total T-score of the right femur after 24 weeks compared to the baseline period increased by 0.01¡¾0.11, as opposed to the placebo group, whose mean percentage change decreased by 0.12¡¾0.10 (P=0.0110). No statistically significant difference was observed between the DM-BSF group and the placebo group with regard to the mean percentage change of BSAP, serum CTx, and IGF-1 at week 24 (visit 5) compared to the baseline period (visit 2). No adverse events were reported in either group.
Conclusion : DM-BSF was well tolerated and had significant beneficial effects on local bone mineral density in postmenopausal women. In these postmenopausal women, 24-week treatment with 3 DM-BSF capsules a day was associated with the potential prevention of bone loss at the hip (based on a significant increase in BMD in the femur).
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KEYWORD
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Double-Blind Method, Bone Density, Bone Specific Alkaline Phosphatase, Serum C-Terminal Telopeptide, Insulin-Like Growth Factor
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