Prescrire Int. 2005 Feb;14(75):5-9.
(1) Oral alendronic acid is the reference drug for women with osteoporosis and a previous vertebral fracture. In a placebo-controlled trial in women who were also taking calcium and vitamin D, treatment with alendronic acid for three years reduced the incidence of symptomatic vertebral fractures (2.3% versus 5%) and wrist fractures (2.2% versus 4.1%) and, albeit with a lower level of evidence, the incidence of hip fractures (1.1% versus 2.2%). (2) Teriparatide, a biotech drug, reproduces the 34 N-terminal amino acids of parathormone. It is marketed in Europe for subcutaneous treatment of "proven" postmenopausal osteoporosis. (3) The cornerstone of the clinical evaluation dossier is a randomised placebo-controlled double-blind trial in 1637 women also taking calcium and vitamin D. The two doses of teriparatide (20 micrograms/day and 40 micrograms/day), given for a median of 19 months, reduced the risk of new radiologically documented vertebral fractures (about 4% versus 14% in the placebo group) and spinal pain (about 16% versus 23% in the placebo group), but not the risk of hip fracture. (4) In a double-blind trial in 146 postmenopausal women also taking calcium and vitamin D, 40 micrograms/day teriparatide given subcutaneously for 14 months increased spinal mineral bone density significantly more than 10 mg/day alendronic acid given orally. The trial was not designed to show a difference in clinical outcome (fractures). (5) The main adverse effects of teriparatide reported to date are nausea, headache, cramp, hypercalcemia and hyperuricemia. (6) A rat study showed an increased risk of osteosarcoma. This tumour is rare in humans, and the number of patients so far enrolled in clinical trials is insufficient to document a possible increase in risk associated with teriparatide. (7) The need for daily subcutaneous injections and for refrigeration of the prefilled syringes are two notable disadvantages of teriparatide therapy. (8) In practice, alendronic acid is better assessed and remains the reference treatment, combined with calcium and vitamin D, for secondary prevention of osteoporotic fracture in postmenopausal women.
（1）口服阿仑膦酸钠是患有骨质疏松症且既往有椎体骨折的女性的参照药物。在一项针对同时服用钙和维生素D的女性的安慰剂对照试验中，用阿仑膦酸钠治疗三年可降低有症状椎体骨折的发生率（2.3%对5%）和腕部骨折的发生率（2.2%对4.1%），并且尽管证据等级较低，但也能降低髋部骨折的发生率（1.1%对2.2%）。（2）特立帕肽是一种生物科技药物，它复制了甲状旁腺激素的34个N端氨基酸。它在欧洲上市，用于皮下治疗“确诊的”绝经后骨质疏松症。（3）临床评估档案的基石是一项针对1637名同时服用钙和维生素D的女性的随机安慰剂对照双盲试验。两种剂量的特立帕肽（20微克/天和40微克/天），给药中位时间为19个月，降低了新的经放射学记录的椎体骨折风险（约4%对安慰剂组的14%）和脊柱疼痛风险（约16%对安慰剂组的23%），但未降低髋部骨折风险。（4）在一项针对146名同时服用钙和维生素D的绝经后女性的双盲试验中，皮下注射40微克/天的特立帕肽14个月，比口服10毫克/天的阿仑膦酸钠显著提高了脊柱矿物质骨密度。该试验并非设计用于显示临床结局（骨折）方面的差异。（5）迄今为止报道的特立帕肽的主要不良反应有恶心、头痛、抽筋、高钙血症和高尿酸血症。（6）一项大鼠研究显示骨肉瘤风险增加。这种肿瘤在人类中很罕见，且目前参与临床试验的患者数量不足以证明与特立帕肽相关的风险可能增加。（7）需要每日皮下注射以及预填充注射器需要冷藏是特立帕肽治疗的两个显著缺点。（8）在实际应用中，阿仑膦酸钠的评估更完善，并且仍然是联合钙和维生素D用于绝经后女性骨质疏松性骨折二级预防的参照治疗方法。
