Agrawal Sabina, Krueger Diane C, Engelke Jean A, Nest Lori J, Krause Peggy F, Drinka Paul J, Binkley Neil C
Osteoporosis Clinical Center and Research Program, University of Wisconsin, 2870 University Avenue, Madison, WI 53705, USA.
J Am Geriatr Soc. 2006 May;54(5):790-5. doi: 10.1111/j.1532-5415.2006.00696.x.
To assess the effect of between-meal weekly risedronate and daily calcium 630 mg and vitamin D 400 IU on bone turnover markers.
Randomized,double-blind,placebo-controlled trial.
Skilled nursing home (NH).
Sixty skilled-NH residents (46 men, 14 women), mean age+/-standard deviation of 76+/-6, were randomized to receive risedronate 30 mg (n=31) or matching placebo (n=29) once weekly for 12 weeks. All received 315 mg calcium with 200 IU vitamin D twice daily.
Bone-specific alkaline phosphatase (BSAP), N-telopeptide of type 1 collagen (NTx), 25-hydroxyvitamin D (25OHD), and parathyroid hormone were measured at baseline and 6 and 12 weeks.
Risedronate reduced BSAP significantly more than placebo (P<.05) at 6 weeks but not at 12 weeks; no treatment effect on serum NTx was observed. Defining hypovitaminosis D as a serum 25OHD concentration below 32 ng/mL, 50 of 53 (94%) study participants were low at baseline (mean 25OHD 19 ng/mL). Vitamin D levels remained insufficient in 74% of participants after 12 weeks.
In this NH population, weekly risedronate administered using a between-meal dosing schedule reduced serum BSAP at 6 weeks of treatment; this effect was not observed at 12 weeks. The overall lack of change in bone turnover markers suggests that this risedronate dose and schedule would not be expected to increase bone density or reduce fracture risk in this population. Hypovitaminosis D was common and not reliably corrected by 400 IU of vitamin D daily. Despite an extremely high osteoporotic fracture risk in NH residents, additional study is required to determine under which conditions pharmacological treatment is efficacious in this population and define approaches that assure vitamin D repletion.
评估餐间每周服用利塞膦酸盐以及每日服用630毫克钙和400国际单位维生素D对骨转换标志物的影响。
随机、双盲、安慰剂对照试验。
专业疗养院（NH）。
60名专业疗养院居民（46名男性，14名女性），平均年龄±标准差为76±6岁，被随机分为接受30毫克利塞膦酸盐（n = 31）或匹配安慰剂（n = 29），每周一次，共12周。所有人每日两次接受315毫克钙和200国际单位维生素D。
在基线、6周和12周时测量骨特异性碱性磷酸酶（BSAP）、1型胶原N-端肽（NTx）、25-羟基维生素D（25OHD）和甲状旁腺激素。
在6周时，利塞膦酸盐使BSAP降低的幅度显著大于安慰剂（P <.05），但在12周时未出现这种情况；未观察到对血清NTx的治疗效果。将维生素D缺乏定义为血清25OHD浓度低于32纳克/毫升，53名研究参与者中有50名（94%）在基线时水平较低（平均25OHD为19纳克/毫升）。12周后，74%的参与者维生素D水平仍不足。
在该疗养院人群中，餐间给药方案每周服用一次利塞膦酸盐在治疗6周时降低了血清BSAP；12周时未观察到这种效果。骨转换标志物总体上缺乏变化表明，该剂量和给药方案预计不会增加该人群的骨密度或降低骨折风险。维生素D缺乏很常见，每日400国际单位的维生素D不能可靠地纠正这种情况。尽管疗养院居民骨质疏松性骨折风险极高，但需要进一步研究以确定在何种条件下药理学治疗对该人群有效，并确定确保维生素D补充的方法。
