ZORG (Zurich Osteoporosis Research Group), Zollikerberg, Switzerland.
Rheumatol Int. 2012 Jan;32(1):207-15. doi: 10.1007/s00296-010-1607-y. Epub 2010 Sep 9.
We investigated the effect of daily therapy with 1 mcg alfacalcidol (Doss(®)-TEVA/AWD-pharma) on muscle power, muscle function, balance performance and fear of falls in an open, multi-centered, uncontrolled, prospective study on a cohort of patients with reduced bone mass. Among the 2,097 participants, 87.1% were post-menopausal women and 12.9% were men. Mean age was 74.8 years and mean body mass index (BMI) 26.3 kg/m². A total of 75.3% of the study population had osteoporosis, 81% a diagnosis of "increased risk of falls" and 70.1% had a creatinine clearance (CrCl) of <65 ml/min. Participants underwent muscle function and muscle power tests at onset and after 3 and 6 months: the timed up and go test (TUG) and the chair rising test (CRT). At baseline and after 6 months, participants performed the tandem gait test (TGT) and filled out a questionnaire evaluating fear of falling. Successful performance in the muscle tests is associated with a significantly lower risk of falls and non-vertebral fractures in elderly patients (successful test performance: TUG ≤ 10 s (sec), CRT ≤ 10 s, TGT ≥ 8 steps). A significant improvement in the performance of the two muscle tests was proved already after 3 months of treatment with alfacalcidol and further increased by the end of the therapeutic intervention. There were significant increases in the number of participants able to successfully perform the tests: 24.6% at baseline and 46.3% at the end of trial for the TUG (P < 0.0001) and 21.7% at baseline and 44.2% at the end for the CRT test (P = 0.0001). The mean time used for the TUG was decreased by 3.0 s from the average onset value of 17.0 s and by 3.1 s from the initial average 16.5 s for the CRT. The percentage of participants able to perform the balance test (TGT) increased from 36.0% at onset to 58.6% at the end of the trial (P < 0.0001). An increased fear of falling was reduced by the end of the study in 74.4% of the patients. Throughout the study, there were 26 adverse drug reactions in 11 out of 2,097 patients (incidence 0.52%). No serious adverse drug reactions and no cases of hypercalcemia were documented. We conclude that treatment with alfacalcidol is safe, increases muscle power, muscle function and balance and reduces fear of falls. The significant improvement in the three muscle and balance tests and fear of falls may have a preventative effect on falls and fractures. We suggest that the quantitative risk tests used in this study could be reliable surrogate parameters for the risk of falls and fractures in elderly patients.
我们研究了每日治疗 1 微克骨化三醇（Doss（®）-TEVA/AWD-pharma）对肌肉力量、肌肉功能、平衡表现和跌倒恐惧的影响，这是一项针对骨量减少患者队列的开放、多中心、非对照、前瞻性研究。在 2097 名参与者中，87.1%为绝经后女性，12.9%为男性。平均年龄为 74.8 岁，平均体重指数（BMI）为 26.3kg/m²。研究人群中共有 75.3%患有骨质疏松症，81%被诊断为“跌倒风险增加”，70.1%的肌酐清除率（CrCl）<65ml/min。参与者在开始时和 3 个月和 6 个月后接受肌肉功能和肌肉力量测试：计时起立行走测试（TUG）和椅子上升测试（CRT）。在基线和 6 个月时，参与者进行了并足行走测试（TGT）并填写了一份评估跌倒恐惧的问卷。在老年患者中，肌肉测试的成功表现与跌倒和非椎体骨折的风险显著降低相关（成功测试表现：TUG≤10s（秒），CRT≤10s，TGT≥8 步）。在接受骨化三醇治疗 3 个月后，已经证明了两项肌肉测试表现的显著改善，并且在治疗干预结束时进一步增加。能够成功完成测试的参与者人数显著增加：TUG 基线时为 24.6%，试验结束时为 46.3%（P<0.0001），CRT 测试基线时为 21.7%，试验结束时为 44.2%（P=0.0001）。TUG 的平均用时从起始值 17.0 秒平均减少 3.0 秒，从起始值 16.5 秒平均减少 3.1 秒。能够进行平衡测试（TGT）的参与者比例从起始时的 36.0%增加到试验结束时的 58.6%（P<0.0001）。在研究结束时，74.4%的患者跌倒恐惧减轻。整个研究期间，11 名 2097 名患者中有 26 名出现药物不良反应（发生率 0.52%）。没有记录到严重的药物不良反应和高钙血症病例。我们得出结论，骨化三醇治疗安全，可增加肌肉力量、肌肉功能和平衡，并降低跌倒恐惧。三项肌肉和平衡测试以及跌倒恐惧的显著改善可能对跌倒和骨折有预防作用。我们建议，本研究中使用的定量风险测试可以成为老年患者跌倒和骨折风险的可靠替代参数。
