The frequent finding of a high prevalence of vitamin D deficien­cy, in spite of the large amount of scientific data regarding the important role in the pathogenesis of skeletal and non-skeletal disease, indicates that the treatments used up to now are in­sufficient or inadequate.

A) Yearly bolus

Vitamin D deficiency is a well recognized risk for hip fracture and vitamin D insufficiency is so frequent in the elderly that a population-wide preventive intervention might be desirable, es­pecially in winter. Recently we have reported the results from the first community intervention on hip fracture using a single yearly bolus of vitamin D in women aged 65 years or more, car­ried out in a health district of the Veneto region in Italy. A vial containing 400,000 IU vitamin D2 was offered for oral ad­ministration to all women aged 65 years at several outpatient clinics together with the influenza vaccination which is adminis­tered to > 70% of the elderly. The intervention took place during 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 25OHD were measured from October to June, both be­fore and 1 and 4 months after vitamin D administration. Results: 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 number 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 (Figure 2). 25OHD concentrations, in the subset of women in whom it was measured, rose significantly (p < 0.0001) by 9 ng/mL over the months after administration.

Figure 2 - Effect of vitamin D yearly bolus

Figure 2 – Effect of vitamin D yearly bolus in winter on age-adjusted hip fracture risk in elderly women: a community primary prevention study

Despite several obvious limitations due to its nature, this study ufficiently documents that yearly vitamin D bolus supple­ments, given as primary prevention to elderly Caucasian women, may decrease the incidence of hip fracture. For its safety and excellent feasibility and cost-effectiveness, this pri­mary intervention has a great potential for community distribu- ion. Safety, feasibility and cost-effectiveness are crucial for a successful primary pharmacological prevention program. Al- hough we did not thoroughly investigate the incidence of side- fects, no reports of drug-related side-effects were reported to he Health District. The risk of vitamin D intoxication is negligi­ble for the increases in 25OHD that follow treatment, even in atients already taking daily vitamin D supplements (400-800 U). The feasibility of this primary pharmacological prevention s very good and comparable to that of a vaccination program. he cost-effectiveness is also quite obvious. The cost of one /ial of 400,000 IU vitamin D2 is e 2.12. Thus, for an estimated Number Needed to Treat (NNT) of 200 women, a hip fracture an be prevented for only e 424. As expected, vitamin D was more effective in women aged > 75 years, in whom the risk of both vitamin D insufficiency and hip fracture is higher. By con­centrating efforts to increase participation in the prevention urogram among these women, cost-effectiveness is expected :o be even more rewarding. We must also take into account he additional benefits expected for the risk of other fractures and other conditions associated with vitamin D insufficiency.
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