Key Laboratory of Endocrinology, Department of Endocrinology, Ministry of Health, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Beijing, China.
Menopause. 2013 Jan;20(1):72-8. doi: 10.1097/gme.0b013e31825fe2e8.
The aim of this study was to evaluate the effect of low-dose alendronate (ALN) treatment on bone mineral density (BMD) and bone turnover markers in Chinese postmenopausal women with osteopenia and osteoporosis.
This study was a large-sample, randomized, open-label, prospective, multicenter, clinical trial with a 12-month follow-up. A total of 639 postmenopausal women (aged 62.2 ± 7.0 y) with osteopenia or osteoporosis were randomized into two groups: low-dose ALN (70 mg every two weeks) and standard-dose ALN (70 mg weekly). All patients were also supplemented with calcium (600 mg) and vitamin D3 (125 IU) daily. BMD (measured by dual-energy x-ray absorptiometry; Hologic and Lunar) and levels of serum bone turnover markers (bone resorption marker, carboxy-telopeptide of type I collagen; bone formation marker, alkaline phosphatase) were assessed at baseline and at 3, 6, and 12 months of treatment. BMD and bone turnover markers were compared between the baseline and the end of treatment, and the changes in BMD and bone turnover markers were also compared between the low-dose ALN group and the standard-dose ALN group.
No significant differences in age, years since menopause, body mass index, BMD, 25-hydroxy vitamin D level, and serum biochemical markers were found at baseline between the two dose groups. A total of 558 (87.3%) and 540 (84.5%) women completed the treatment at the 6th and 12th months, respectively. After the 12-month treatment, lumbar spine and hip BMD increased and serum bone turnover markers decreased significantly in both of the treatment groups (P < 0.01), and no differences in percentage changes in BMD at the lumbar spine, femoral neck, and hip were found between the low-dose group (5.60%, 3.87%, and 3.28%, respectively) and the standard-dose group (5.07%, 2.93%, and 3.80%, respectively; P > 0.05). However, levels of serum alkaline phosphatase and carboxy-telopeptide of type I collagen in the standard-dose group decreased moderately compared with those in the low-dose group (P < 0.05 and P < 0.01). The women tolerated the two doses of ALN quite well. Adverse effects were similar in the two groups.
Treatment with low-dose ALN (70 mg every two weeks) in women with postmenopausal osteopenia or osteoporosis effectively increases lumbar spine and hip BMD, similar to treatment with standard-dose ALN. Low-dose ALN may be a cost-effective and safe protocol for treating osteopenia or osteoporosis in Chinese women.
本研究旨在评估低剂量阿仑膦酸钠（ALN）治疗对中国绝经后骨质疏松和骨量减少妇女骨密度（BMD）和骨转换标志物的影响。
这是一项大型、随机、开放标签、前瞻性、多中心临床试验，随访 12 个月。共纳入 639 例（年龄 62.2±7.0 岁）绝经后骨质疏松或骨量减少的女性，随机分为两组：低剂量 ALN（70mg 每两周一次）和标准剂量 ALN（70mg 每周一次）。所有患者还每日补充钙（600mg）和维生素 D3（125IU）。基线和治疗 3、6 和 12 个月时，采用双能 X 线吸收法（Hologic 和 Lunar）测定 BMD，检测血清骨转换标志物（骨吸收标志物，I 型胶原羧基端肽；骨形成标志物，碱性磷酸酶）水平。比较基线与治疗结束时的 BMD 和骨转换标志物，比较低剂量 ALN 组和标准剂量 ALN 组的 BMD 和骨转换标志物变化。
两组间年龄、绝经年限、体质指数、BMD、25-羟维生素 D 水平和血清生化标志物在基线时均无显著差异。第 6 个月和第 12 个月时，分别有 558（87.3%）和 540（84.5%）名女性完成了治疗。治疗 12 个月后，两组腰椎和髋部 BMD 均显著增加，血清骨转换标志物均显著降低（P<0.01），低剂量组（腰椎 5.60%、股骨颈 3.87%、髋部 3.28%）和标准剂量组（腰椎 5.07%、股骨颈 2.93%、髋部 3.80%）的 BMD 百分比变化无差异（P>0.05）。然而，与低剂量组相比，标准剂量组的血清碱性磷酸酶和 I 型胶原羧基端肽水平适度降低（P<0.05 和 P<0.01）。两组患者均能很好地耐受两种剂量的 ALN。两组不良反应相似。
低剂量 ALN（70mg 每两周一次）治疗绝经后骨质疏松和骨量减少的女性可有效增加腰椎和髋部 BMD，与标准剂量 ALN 治疗效果相当。低剂量 ALN 可能是一种治疗中国女性骨质疏松或骨量减少的具有成本效益且安全的方案。
