Vitamin D deficiency is associated with functional decline and falls in frail elderly women despite supplementation.

We examined the impact of daily supplementation on vitamin D deficiency, function, and falls in female long-term care residents. Initial vitamin D deficiency was associated with greater functional decline and increased fall risk despite guideline-recommended supplementation, highlighting the importance of preventing vitamin D deficiency in frail elderly. INTRODUCTION: Institute of Medicine (IOM) guidelines recommend 800 IU vitamin D daily for older adults and maintaining serum 25-hydroxyvitamin D [25(OH) D] above 20 ng/ml for optimal skeletal health. The adequacy of IOM guidelines for sustaining function and reducing falls in frail elderly is unknown. METHODS: Female long-term care residents aged ≥65 enrolled in an osteoporosis clinical trial were included in this analysis (n = 137). Participants were classified based on baseline 25(OH) D levels as deficient (<20 ng/ml, n = 26), insufficient (20-30 ng/ml, n = 40), or sufficient (>30 ng/ml, n = 71). Deficient women were provided initial vitamin D repletion (50,000 IU D3 weekly for 8 weeks). All were supplemented with 800 IU vitamin D3 daily for 24 months. Annual functional assessments included Activities of Daily Living (ADLs), Instrumental ADL (IADL), physical performance test (PPT), gait speed, cognition (SPMSQ), and mental health (PHQ-9). We used linear mixed models for analysis of functional measures and logistic regression for falls. RESULTS: Daily supplementation maintained 25(OH) D levels above 20 ng/ml in 95% of participants. All groups demonstrated functional decline. Women initially deficient had a greater decline in physical function at 12 (IADL -2.0 ± 0.4, PPT -3.1 ± 0.7, both p < 0.01) and 24 months (IADL -2.5 ± 0.6, ADL -2.5 ± 0.6, both p < 0.01), a larger increase in cognitive deficits at 12 months (1.7 ± 0.4: p = 0.01) and more fallers (88.5%, p = 0.04) compared to those sufficient at baseline, despite supplementation to sufficient levels. CONCLUSIONS: IOM guidelines may not be adequate for frail elderly. Further study of optimal 25(OH) D levels for maintaining function and preventing falls is needed.

Lessons learned from an osteoporosis clinical trial in frail long-term care residents.

BACKGROUND: Although osteoporosis affects women of all ages, the impact is most pronounced in frail residents in long-term care. Nevertheless, few interventional trials have been performed in this population, and few data on therapeutic alternatives are available in this cohort. PURPOSE: We describe the challenges and lessons learned in developing and carrying out a trial in frail long-term-care residents. METHODS: The Zoledronic acid in frail Elders to STrengthen bone (ZEST) study was designed to examine the safety and efficacy of a single-dose therapy for osteoporosis in frail residents in long-term care in the Pittsburgh area. Women with osteoporosis who were 65 years of age and older and currently not on therapy were randomized in a blinded fashion to intravenous zoledronic acid or placebo. Follow-up of each participant was planned for 2 years. All participants received appropriate calcium and vitamin D supplementation. RESULTS: Seven hundred and thirty-three contacts were made with long-term care residents of nine participating facilities. Of 252 women screened, 181 were eligible, enrolled, and randomized. Multiple barriers to research in long-term-care facilities were encountered but overcome with direct communication, information sessions, in-service trainings, and social events. Lessons learned included designing the study in a manner that avoided placing an additional burden on an already overcommitted facility staff, a two-stage consent process to separate screening from randomization, and a flexible examination schedule to accommodate residents while obtaining the necessary outcome measurements. Furthermore, a mobile unit accessible to participants containing state-of-the-art dual x-ray absorptiometry (DXA), assessment for vertebral fractures, and phlebotomy equipment allows all assessments to be performed on-site at each facility. Serious adverse events are collected from affiliated hospitals in real time with a novel electronic surveillance system. LIMITATIONS: The major limitation is selection of outcomes that can be assessed at participating facilities and do not require transport of participants to hospitals or clinics. CONCLUSIONS: Clinical research for osteoporosis can be successfully and safely performed with frail residents in long-term care facilities. Lessons learned from this study may inform future investigations among frail elderly residents of these facilities.