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Effect of high-dosage cholecalciferol and extended physiotherapy on complications after hip fracture: a randomized controlled trial
Bischoff-Ferrari HA, Dawson-Hughes B, Platz A, Orav EJ, Stahelin HB, Willett WC, Can U, Egli A, Mueller NJ, Looser S, Bretscher B, Minder E, Vergopoulos A, Theiler R
Archives of Internal Medicine 2010 May 10;170(9):813-820
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Care of elderly patients after hip fracture is not well established. METHODS: We enrolled 173 patients with acute hip fracture who were 65 years or older (79.2% women; mean age 84 years; 77.4% living at home). Using a factorial design, we randomly allocated patients to extended physiotherapy (PT) (supervised 60 min/d during acute care plus an unsupervised home program) versus standard PT (supervised 30 min/d during acute care plus no home program; single-blinded), and to cholecalciferol therapy, 2,000 versus 800 IU/d (double-blinded). Primary outcome was rate of falls; secondary outcome was rate of hospital readmissions during the 12-month follow-up. All analyses included 173 individuals and used multivariate Poisson regression analyses. RESULTS: At baseline, 50.9% of participants had 25-hydroxyvitamin D levels of less than 12 ng/mL and 97.7% of less than 30 ng/mL. We documented 212 falls and 74 hospital readmissions. Because this was a factorial design trial, all analyses tested the main effect of each treatment while controlling for the other in 173 participants. Extended versus standard PT reduced the rate of falls by 25% (95% confidence interval (CI) -44% to -1%). Cholecalciferol treatment, 2,000 versus 800 IU/d, did not reduce falls (28%; 95% CI -4% to 68%), but reduced the rate of hospital readmissions by 39% (95% CI -62% to -1%). CONCLUSIONS: Extended PT was successful in reducing falls but not hospital readmissions, whereas cholecalciferol treatment, 2,000 IU/d, was successful in reducing hospital readmission but not falls. Thus, the 2 strategies may be useful together because they address 2 different and important complications after hip fracture. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00133640.

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