Rossini Maurizio, Alberti Valerio, Flor Luciano, Masiero Lucia, Giannini Sandro, Gatti Davide, Adami Silvano
Azienda Sanitaria Locale 20, Regione Veneto, Italy.
Aging Clin Exp Res. 2004 Dec;16(6):432-6. doi: 10.1007/BF03327397.
Vitamin D deficiency is a well-known risk for hip fracture, and vitamin D insufficiency is so frequent in the elderly that population-wide preventive intervention would be useful. The objective of the study was to evaluate the efficacy of vitamin D bolus on hip fracture incidence in elderly women.
All women aged > 65 years registered at Health District 20 of the Regione Veneto, Italy, were eligible for this quasi-experimental, prospective community intervention study. A vial containing 400,000 IU vitamin D2 (Ostelin 800, Teofarma, Italy) was offered for oral administration to all women in the winters of 2000-2001 and 2001-2002. The only exclusion criteria for treatment were age and gender, and the control group included women who did not participate in the Health District initiative. Analysis of hip fracture incidence was carried out for 4 years, from 1999 to 2002. Patients with incident hip fracture were identified as soon as they were admitted to one of the 3 hospitals of the health district and interviewed regarding their participation in the vitamin D preventive intervention program. In 120 of the women (age range 68-90 years), serum concentrations of 25-OH vitamin D were measured from October to June, both before and 1 and 4 months after vitamin D administration.
23,325 and 24,747 women received the vitamin D bolus during winters 2000-2001 and 2001-2002 respectively, i.e. 45-47% of eligible women. The proportion of women who accepted the bolus declined with advancing age, from 50-55% in women aged 60-70 years to 22-26% in those aged > 90 years. The two-year intervention on the community decreased the incidence of fracture by 10% (p = 0.050) in comparison with the previous two years. The age-adjusted risk reduction (RR) of hip fracture during 2001 and 2002 in women who had received vitamin D, with respect to women who had not, decreased by 17% (p = 0.056) and 25% (p = 0.005) respectively. The RR was considerably greater and statistically significant over both 2001 and 2002 in the cohort aged > 75 years. 25-OH vitamin D concentrations, in the subset of women in whom it was measured, rose significantly (p < 0.0001) by 9 ng/ml over 4 months after administration.
Despite several obvious limitations due to its nature, this study sufficiently documents that yearly vitamin D bolus supplements, given as primary prevention to elderly Caucasian women, may decrease the incidence of hip fracture. For its probable safety and excellent feasibility and cost-effectiveness, this primary intervention has a great potential for generalisability.
维生素D缺乏是髋部骨折的一个众所周知的风险因素，而维生素D不足在老年人中非常普遍，因此针对全体人群的预防性干预措施将是有益的。本研究的目的是评估大剂量维生素D对老年女性髋部骨折发生率的疗效。
在意大利威尼托大区第20健康区登记的所有65岁以上女性均符合这项准实验性、前瞻性社区干预研究的条件。在2000 - 2001年和2001 - 2002年冬季，向所有女性提供了一瓶含40万国际单位维生素D2（Ostelin 800，Teofarma，意大利）用于口服。唯一的治疗排除标准是年龄和性别，对照组包括未参与健康区倡议的女性。对1999年至2002年的4年期间的髋部骨折发生率进行了分析。髋部骨折患者一旦入住健康区的3家医院之一，就会被识别出来，并就其参与维生素D预防干预项目的情况进行访谈。在120名女性（年龄范围68 - 90岁）中，在10月至6月期间，于维生素D给药前、给药后1个月和4个月测量血清25 - 羟基维生素D浓度。
在2000 - 2001年和2001 - 2002年冬季，分别有23325名和24747名女性接受了大剂量维生素D，即符合条件女性的45% - 47%。接受大剂量维生素D的女性比例随着年龄的增长而下降，从60 - 70岁女性中的50% - 55%降至90岁以上女性中的22% - 26%。与前两年相比，对社区进行的为期两年的干预使骨折发生率降低了10%（p = 0.050）。在2001年和2002年，接受维生素D的女性相对于未接受维生素D的女性，年龄调整后的髋部骨折风险降低率（RR）分别降低了17%（p = 0.056）和25%（p = 0.005）。在75岁以上的队列中，2001年和2002年期间RR显著更高且具有统计学意义。在测量了25 - 羟基维生素D浓度的女性亚组中，给药后4个月内该浓度显著升高（p < 0.0001），升高了9 ng/ml。
尽管由于其性质存在一些明显的局限性，但本研究充分证明，作为对老年白人女性的一级预防措施，每年给予大剂量维生素D补充剂可能会降低髋部骨折的发生率。由于其可能的安全性、出色的可行性和成本效益，这种一级干预措施具有很大的推广潜力。
