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_References_whiresultscad - CALCIUM VITAMIN D AND THE RISK...

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Unformatted text preview: CALCIUM, VITAMIN D, AND THE RISK OF FRACTURES A Total Hip Mean Change in BMD from Year 1 (96) Year 3 Year 6 Annual Visit Mean Change in BMD from Year 1 (96) Year 1 Year 3 Year 6 Annual Visit Mean Change in BMD from Year 1 (96) Year 1 Year 3 Year 6 Annual Visit Minimum No. CaD Placebo 1181 1162 1067 1079 949 933 Figure 2. Hip, Spine, and Total-Body Bone Mineral Density (BMD). P values for the comparison between the group assigned to calcium with vitamin D supplementation and the placebo group were <0.001, <0.001, and 0.01 at years 3, 6, and 9, respectively, for total-hip values and 0.02 at year 3 for whole-body values, according to linear models adjusted for clinical center and race or ethnic group. The numbers of participants shown below the graphs are the minimum sample sizes for comparison between the visit year and year 1. N ENGL) MED 354:7 www,NE)M.onc cent at annual visit 3, 0.86 percent at annual visit 6, and 1.06 percent at annual visit 9. Nonsignifi- cant differences favoring the calcium with vita- min D group were observed in spine and whole- body bone mineral density. HIP AND OTHER FRACTURES During a mean of 7.0 years of follow-up, there were 2102 fractures (including 175 hip fractures) among women assigned to calcium with vitamin D and 2158 fractures (including 199 hip frac- tures) among women assigned to placebo (fable 2). Annualized fracture rates per 10,000 person-years in the calcium with vitamin D and placebo groups, respectively, were as follows: hip fracture, 14 and 16; fracture of the lower arm or wrist, 44 and 44; clinical vertebral fracture, 14 and 15; and total fractures, 164 and 170. Table 2. Eflict of Calcium with Vitamin D Supplementation on Clinical Outcomes, According to Randomly Assigned Group.* Calcium 4- Analysis Vitamin D Placebo lntention-to-treat analysis 7.01114 Follow-up time — yr 7.0:1.4 Rate of fracture — no. of cases (annualized %) Hip 175 (0.14) 131 (0.14) 565 (0.44) 2102 (1.64) 199 (0.16) 197 (0.15) 557 (0.44) 2158 (1.70) Clinical vertebral Lower arm or wrist Total Analysis excluding follow-up time for participants 6 mo after nonadherence detected Follow-up time — yr Rate of fracture — no. of cases (annualized %) Hip Clinical vertebral 68 (0.10) 91 (0.13) 312 (0.45) 1119 (1.63) 99 (0.14) 104 (0.15) 303 (0.43) 1222 (1.72) Lower arm or wrist Total Hazard Ratio (95% an 0.88 (0.72—1.03) 0.90 (0.74—1.10) 1.01 (0.90—1.14) 0.96 (0.91—1.02) 0.71 (0.52—0.97) 0.89 (0.67—1.19) 1.05 (0.90—1.23) 0.94 (0.37—1.02) * Plus—minus values are means 15D. CI denotes confidence interval. 1' The hazard ratios are for the group assigned to calcium with vitamin D as compared with the placebo group. Hazard ratios, 95 percent confidence inter- vals, and P values were calculated in Cox proportional-hazards analyses strati- fied according to age; randomization assignment in the Hormone Therapy and Dietary Modification trials; and presence or absence of prior fracture. FEBRUARY 16. 2006 Downloaded from www.nejm.or at UC SHARED JOURNAL COLLECTION on April 27, 2006 . Copyright © 2006 assachusetts Medical Society. All rights reserved. 675 ...
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