Original Research

Effect of High-Dose Ergocalciferol on Rate of Falls in a Community-Dwelling, Home-Based Primary Care Veteran Population: A Case-Crossover Study

There was no difference identified in the rate of falls immediately prior to and following initiation of ergocalciferol 50,000 IU self-administered once weekly.

Fed Pract. 2018 June;35(6):32-36

Author(s):

Ryan C. Albers, PharmD

Tara N. Downs, PharmD, BCACP, Bcgp

Matthew Lane, PharmD, BCPS

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References

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4. Bischhoff-Ferrari HA, Dawson-Hughes B, Willet WC, et al. Effect of vitamin D on falls: a meta-analysis. JAMA. 2004;291(16):1999-2006.

5. Holick MF. Resurrection of vitamin D deficiency and rickets. J Clin Invest. 2006;116(8):2062-2072.

6. Bischoff-Ferrari HA, Giovannucci E, Willett WC, Dietrich T, Dawson-Hughes B. Estimation of optimal serum concentrations of 25-hydroxyvitamin D for multiple health outcomes. Am J Clin Nutr. 2006;84(1):18-28.

7. Bischoff HA, Stähelin HB, Dick W, et al. Effects of vitamin D and calcium supplementation on falls: a randomized controlled trial. J Bone Miner Res. 2003;18(2):343-351.

8. Bischoff-Ferrari HA, Dietrich T, Orav EJ, et al. Higher 25-OH vitamin D concentrations are associated with better lower-extremity function in both active and inactive persons aged > 60 years. Am J Clin Nutr. 2004;80(3):752-758.

9. Pfeifer M, Begerow B, Minne HW, Abrams C, Nachtigall D, Hansen C. Effects of a short-term vitamin D and calcium supplementation on body sway and secondary hyperparathyroidism in elderly women. J Bone Miner Res. 2000;15(6):1113-1118.

10. Sambrook PN, Chen JS, March LM, et al. Serum parathyroid hormone predicts time to fall independent of vitamin D status in a frail elderly population. J Clin Endocrinol Metab. 2004;89(4):1572-1576.

11. Flicker L, Mead K, MacInnis RJ, et al. Serum vitamin D and falls in older women in residential care in Australia. J Am Geratr Soc. 2003;51(11):1533-1538.

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13. Bischoff-Ferrari HA, Dawson-Hughes B, Staehelin HB, et al. Fall prevention with supplemental and active forms of vitamin D: a meta-analysis of randomized controlled trials. BMJ. 2009;339:b3692.

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16. Bischoff-Ferrari HA, Dawson-Hughes B, Orav EJ, et al. Monthly high-dose vitamin D treatment for the prevention of functional decline: a randomized clinical trial. JAMA Intern Med. 2016;176(2):175-183.

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Annually, about 1 in 4 individuals aged ≥ 65 years will experience at least 1 fall, resulting in nearly 2.8 million cases of emergently treated injuries and more than 800,000 hospitalizations.^1-3 Therefore, fall prevention has garnered heightened attention as the population ages. Many factors are at play in fall risk, including vitamin D levels.

Although vitamin D is essential for a multitude of physiologic processes, evidence suggests that serum concentrations of 25-hydroxy vitamin D (25[OH]D) < 30 ng/mL are associated with decreased bone mineral density, muscle weakness, impaired lower extremity function, balance problems, and high fall rates.^4-12 Through a meta-analysis published in 2009 that included 8 randomized controlled trials of 2,426 participants aged ≥ 65 years, Bischoff-Ferrari and colleagues found that a dose of 700 to 1,000 IU/d significantly reduced the risk of falling compared with doses of 200 to 600 IU/d.¹³ A subsequent meta-analysis published in 2012 including 14 randomized trials across 28,135 participants aged ≥ 65 years evaluated the efficacy of supplementation with vitamin D with or without calcium cosupplement on fall prevention.¹⁴ Although no difference was found in falls across the total sample, a subgroup analysis exploring the effect in participants with lower vitamin D levels demonstrated a statistically significant benefit of vitamin D supplementation. To decrease the risk of fractures and falls, the American Geriatric Society (AGS) recommends vitamin D supplementation of at least 1,000 IU/d in combination with calcium supplementation in older adults, with a minimum goal 25(OH)D level of 30 ng/mL.¹⁵

Alarmingly, Bischoff-Ferrari and colleagues published a double-blind, randomized trial that described an association between higher monthly doses of vitamin D₃ (cholecalciferol) and an increased risk of falls compared with 24,000 IU/mo. Particularly at higher achieved levels of 25(OH)D, with no difference in benefit was noted on the primary endpoint of lower extremity function.¹⁶

Although there exists limited representation of high-dose vitamin D₂ and its resultant effects on falls in those aged ≥ 65 years, once weekly prescribing of vitamin D₂ in the form of ergocalciferol 50,000 IU remains a commonly used option for repletion of low 25(OH)D. In this study, the authors evaluated the effect of high-dose ergocalciferol on rate of falls in a community-dwelling veteran population ≥ 65 years with low 25(OH)D.

Methods

Following approval from the Lexington Veteran Affairs Medical Center (Lexington VAMC) Institutional Review Board and Research and Development Committee, a retrospective chart review was conducted. Subjects were identified through use of Microsoft SQL (Redmond, WA). Veterans included were those enrolled in home-based primary care (HBPC), a primary care assignment for those individuals requiring skilled services and case management within the home and for whom falls are documented within the electronic health record (EHR). As fall data in a community-dwelling population are difficult to obtain in a retrospective analysis, the HBPC population offered a viable pool of data for evaluation. Some patients eligible for HBPC at the Lexington VAMC may be more dependent on specialized services offered through HBPC or have a reduced ability to perform activities of daily living (ADLs). Other patients can ambulate but may have difficulty traveling great distances to Lexington VAMC.

In addition to HBPC enrollment, veterans were included in the study if they were aged ≥ 65 years and had a 25(OH)D level < 20 ng/mL with subsequent prescribing of high-dose vitamin D₂ for repletion, namely, ergocalciferol 50,000 IU once weekly, between March 1, 2005, and September 30, 2016.

Veterans were excluded if they had been enrolled in HBPC for less than 60 days before ergocalciferol initiation, if they were deceased or had been discharged from HBPC within 60 days of ergocalciferol initiation, if they had comorbid conditions that inherently increase the risk of falls (eg, Lewy body dementia, Parkinson disease, bilateral below-the-hip amputation, and hemi- or quadriplegia), or if they had been dispensed a previous prescription of ergocalciferol in the preceding 9 months.

A case-crossover study design was used, which compared the 60-day period prior to initiation of ergocalciferol supplementation with the 60-day period following initiation of supplementation. A 7-day period between these 2 periods was allotted to allow time for mailing of the new prescription and initiation of the supplement.

Data Collection

Data collected included age, sex, levels of 25(OH)D, ergocalciferol prescription data (dose, administration frequency, quantity, day supply, and fill date), falls documented during the 60 days preceding and during supplementation, and the number of medications that posed an increased risk of falls actively prescribed prior to and during supplementation. Those medications considered to increase risk of falls were determined according to the medications listed in the AGS 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults.¹⁷