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 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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