Two Streams Merge into One Mighty River?
Abstract & Commentary
By Allan J. Wilke, MD, MA, Professor and Chair, Department of Integrative Medicine, Ross University (Bahamas) Limited, Freeport, Grand Bahama, The Bahamas. Dr. Wilke reports no financial relationship to this field of study.
Synopsis: Combining extended physical therapy and high-dose cholecalciferol can reduce two different complications of hip fracture: falls and hospital readmission.
Source: Bischoff-Ferrari HA, et al. Effect of high-dosage cholecalciferol and extended physiotherapy on complications after hip fracture. Arch Intern Med 2010;170:813-820.
Previous research has shown that supplementation with cholecalciferol (vitamin D3) can reduce falls1 and prevent first non-vertebral fractures in the elderly,2 but perhaps not provide secondary prevention.3 Physical therapy, aimed at muscle strengthening and balance retraining, is also effective in preventing falls.1 These researchers wondered what the effect of combining the two interventions would be. In this 2 × 2 factorial design, they randomized patients who had suffered a hip fracture to one of two doses of vitamin D3, 800 IU or 2000 IU per day, and to extended physical therapy (EPT) or standard physical therapy (SPT). Patients received SPT during the acute hospitalization for 30 minutes a day. EPT added an additional 30 minutes of home program instruction each day and encouragement at discharge to continue therapy at home for 30 minutes a day. The drug randomization was double-blind; physical therapy randomization was single-blind. Inclusion criteria were acute hip fracture, age ≥ 65 years, no dementia, no history of ipsilateral hip fracture, no metastatic cancer or chemotherapy in the last year, no hearing or visual impairment, adequate kidney function, ability to walk before the hip fracture, and no contraindication to vitamin D3 or calcium use. The study ran throughout 2005, during which 667 patients were prescreened. After applying the inclusion criteria and eliminating patients who refused to participate, 173 remained.
All patients took a combination of cholecalciferol 400 IU and elemental calcium 500 mg twice daily. The intervention group received an additional capsule of cholecalciferol 1200 IU daily. The patients were seen at 6 and 12 months, at which time the patients were interviewed and functionally assessed, and blood was drawn for 25-hydroxyvitamin D [25(OH)D]. They were phoned monthly and kept diaries to record falls and injuries. The outcomes of interest were falls, fall-related injuries, and hospital readmissions. Analysis was by intention-to-treat. The subjects were evenly matched at baseline. They averaged 84 years of age, were predominantly female (79%), were not obese, and were living at home. All but two individuals in both groups were vitamin D3-deficient with 25(OH)D levels averaging < 13 ng/mL.
Forty-five (45) patients dropped out, 20 of them dying. The patients in both groups reported > 90% medication adherence. At 6-month follow-up, the average 25(OH)D level in the 800 IU/d group was 37.7 ng/mL, and in the 2000 IU/d, 45.4 ng/mL. At 12-month follow-up, the values were 35.4 ng/mL and 44.7 ng/mL, respectively. The increases at both times were statistically significant. There was a total of 212 falls and 74 hospital readmissions. The rate of falls was slightly higher in the 2000 IU/d group (1.63 vs 1.25 falls per observed patient-year), but this did not reach statistical significance. Comparing the EPT and SPT groups, the rate of falls was significantly lower in the EPT group (1.21 vs 1.66). The rate of hospital readmission was significantly lower in the 2000 IU/d group than the 800 IU/d group (0.40 vs 0.59 readmissions per observed patient-year). This was driven by fewer fall-related injuries and fewer infections. The rate was also lower in the EPT group, but not significantly so (0.50 vs 0.51). Adverse reactions were limited to 3 cases of mild hypercalcemia. The two interventions did not affect the rates of death or of new nursing home admission.
Commentary
I was really hoping to see that the combination of these two easy interventions reduced mortality. Hip fractures cause excess mortality,4 so perhaps the damage had already been done, and I should not be surprised that the interventions had no effect on death rates. The study lasted only 12 months, so maybe we'll see an effect on mortality if they follow the patients a while longer. The good news is that the interventions reduced falls and hospital readmissions. What I found strange was that the authors did not compare the group of patients who received both therapies to the group that received neither.
Vitamin D deficiency is common in the elderly, and the usual supplementary dose (400 IU/d) is inadequate to reverse it.5,6 The American Geriatrics Society and the British Geriatrics Society updated their Clinical Practice Guideline: Prevention of Falls in Older Persons earlier this year.7 It has more than 40 recommendations, including "Vitamin D supplements of at least 800 IU per day should be provided to older persons with proven vitamin D deficiency ... [and] should be considered for people with suspected vitamin D deficiency or who are otherwise at increased risk for falls." The intervention dose used in this study (2000 IU daily) is considerably higher than that in the guideline, but, as this study showed, it is safe and effective, if you do not prescribe it to patients with a recent history of kidney stones, hypercalcemia, primary hyperparathyroidism, and sarcoidosis. However, once-a-year dosing of 500,000 IU results in increased falls and fractures.8 My experience as a nursing home director was that many patients who had suffered hip fractures arrived at our sub-acute unit without any vitamin D, calcium, or antiresorptive drug prescription. This experience has been confirmed in the literature.9 Just as Goldilocks, avoid too much and too little. Somewhere in the middle is just right.
References
1. Cameron ID, et al. Interventions for preventing falls in older people in nursing care facilities and hospitals. Cochrane Database Syst Rev 2010;(1):CD005465.
2. Bischoff-Ferrari HA, et al. Fracture prevention with vitamin D supplementation. JAMA 2005;293:2257-2264.
3. Grant AM, et al. Oral vitamin D3 and calcium for secondary prevention of low-trauma fractures in elderly people (Randomised Evaluation of Calcium Or vitamin D, RECORD). Lancet 2005;365:1621-1628.
4. Kannegaard PN, et al. Excess mortality in men compared with women following a hip fracture. National analysis of comedications, comorbidity and survival. Age Ageing 2010;39:203-209.
5. Orwoll E, et al. Vitamin D deficiency in older men. J Clin Endocrinol Metab 2009;94:1214-1222.
6. Janssen HC, et al. Muscle strength and mobility in vitamin D-insufficient female geriatric patients. Aging Clin Exp Res 2010;22:78-84.
7. American Geriatrics Society. Clinical Practice Guideline: Prevention of Falls in Older Persons. New York; 2010. Available at: www.americangeriatrics.org/health_care_professionals/clinical_practice/clinical_guidelines_recommendations/2010/. Accessed May 29, 2010.
8. Sanders KM, et al. Annual high-dose oral vitamin D and falls and fractures in older women. JAMA 2010;303: 1815-1822.
9. Jennings LA, et al. Missed opportunities for osteoporosis treatment in patients hospitalized for hip fracture. J Am Geriatr Soc 2010;58:650-657.