Nakamura Yukio, Suzuki Takako, Kamimura Mikio, Ikegami Shota, Uchiyama Shigeharu, Kato Hiroyuki
Department of Orthopaedic Surgery, Shinshu University School of Medicine.
Department of Orthopedic Surgery, Showa-Inan General Hospital.
Tohoku J Exp Med. 2017 Apr;241(4):319-326. doi: 10.1620/tjem.241.319.
Bisphosphonates (BPs) increase bone mineral density (BMD) through the inhibition of osteoclast activity. Among BPs, ibandronate (IBN) is a strong inhibitor of bone resorption. However, the effects of a vitamin D analogue, alfacalcidol (ALF), on IBN treatment for osteoporosis is unknown. Fifty-three treatment-naïve post-menopausal women with primary osteoporosis were recruited and divided into IBN-treatment group (IBN group) and IBN with ALF group (IBN/ALF group). IBN (1.0 mg) was intravenously injected once a month, with or without oral ALF (1.0 μg/day). Ultimately, 19 subjects in IBN group and 26 in IBN/ALF group were analyzed. Bone turnover markers were examined at 4, 6, 12, and 18 months, and BMD was measured at 6, 12, and 18 months. Compared with pre-treatment, bone turnover markers significantly decreased in both groups after 4 months. The levels of serum N-terminal propeptide of type-1 procollagen and tartrate-resistant acid phosphatase-5b, and urinary N-terminal telopeptide of type-I collagen were significantly lower in IBN/ALF group than those in IBN group at 12 months. Lumbar 1-4 (L)-BMD significantly increased from 6 months in IBN/ALF group and at 18 months in IBN group. L-BMD was significantly higher in IBN/ALF group (6.6% increase) than in IBN group (3.4%) at 18 months. Total hip (H)-BMD significantly increased from 6 months in IBN/ALF group and tended to improve in IBN group. H-BMD was significantly higher in IBN/ALF group (4.8%) than in IBN group (3.2%) at 18 months. In conclusion, treatment with ALF in combination with IBN improves BMD in post-menopausal women with osteoporosis.
双膦酸盐（BPs）通过抑制破骨细胞活性来增加骨矿物质密度（BMD）。在双膦酸盐中，伊班膦酸钠（IBN）是一种强效的骨吸收抑制剂。然而，维生素D类似物阿法骨化醇（ALF）对IBN治疗骨质疏松症的影响尚不清楚。招募了53名未经治疗的绝经后原发性骨质疏松症女性，将其分为IBN治疗组（IBN组）和IBN联合ALF组（IBN/ALF组）。IBN（1.0mg）每月静脉注射一次，同时或不同时口服ALF（1.0μg/天）。最终，对IBN组的19名受试者和IBN/ALF组的26名受试者进行了分析。在4、6、12和18个月时检测骨转换标志物，并在6、12和18个月时测量BMD。与治疗前相比，两组在4个月后骨转换标志物均显著降低。在12个月时，IBN/ALF组血清1型前胶原N端前肽和抗酒石酸酸性磷酸酶-5b以及尿I型胶原N端肽的水平显著低于IBN组。IBN/ALF组腰椎1-4（L）-BMD从6个月起显著增加，IBN组在18个月时显著增加。在18个月时，IBN/ALF组的L-BMD显著高于IBN组（增加6.6%）（增加3.4%）。全髋（H）-BMD在IBN/ALF组从6个月起显著增加，在IBN组有改善趋势。在18个月时，IBN/ALF组的H-BMD显著高于IBN组（4.8%）（3.2%）。总之，ALF联合IBN治疗可改善绝经后骨质疏松症女性的BMD。
