ICCBH2015 Poster Presentations (1) (201 abstracts)
1Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Shatin, Hong Kong; 2School of Pharmacy, The Chinese University of Hong Kong, Shatin, Hong Kong; 3Lee Hysan Clinical Research Laboratories, The Chinese University of Hong Kong, Shatin, Hong Kong.
Objectives: AIS is a prevalent three-dimensional spinal deformity associated with low bone mass which has been reported to be a significant prognostic factor for curve progression in AIS. If left untreated, low bone mass in AIS could persist into adulthood thus leading to subsequent health problems. This study aimed at evaluating the therapeutic effect of oral calcium plus Vit-D supplementation for low bone mass in skeletally immature AIS girls.
Methods: This was a randomized double-blinded placebo-controlled trial recruiting AIS girls (1114 years old, Tanner < IV) with BMD z-scores<0 and Cobb angle >15°. 330 subjects were randomly allocated to group1 (placebo), group2 (600 mg Calcium+400 IU Vit-D3 per day) and group 3 (600 mg Calcium+800 IU Vit-D3 per day). The study period was 2 years. At baseline (T0) and 24-month (T1) time-point, aBMD and BMC at bilateral femoral necks were measured with dual-energy x-ray absorptiometry (DXA); and serum 25(OH) Vit-D level with liquid chromatography tandem mass spectrometry. intention-to-treat principle was followed. ANOVA and generalized estimating equations were used for analyses.
Results: The baseline data at T0 are shown in Table 1. The corresponding mean % increases at T1 are shown in Table 2. The gain in right and left aBMD and BMC were significantly greater in the treatment group than the placebo group (Table 2).
mean±S.D. at T0 | ||||
Group 1 N=110 | Group 2 N=110 | Group 3 N=110 | P# | |
Age | 13.0±0.86 | 12.9±0.91 | 12.7±0.88 | 0.142 |
25(OH) Vit-D3 | 41.4±13.3 | 42.3±14.3 | 39.4±15.4 | 0.306 |
Left BMD | 0.683±0.059 | 0.677±0.071 | 0.673±0.066 | 0.500 |
Right BMD | 0.694±0.064 | 0.681±0.068 | 0.677±0.065 | 0.126 |
Left BMC | 1.917±0.221 | 1.924±0.237 | 1.904±0.232 | 0.810 |
Right BMC | 1.960±0.254 | 1.940±0.244 | 1.928±0.217 | 0.601 |
#P-value from analysis using one-way ANOVA |
Percentage increase at T1 mean±S.D. | P* | |||||
Group 1 N=91 | Group 2 N=91 | Group 3 N=88 | Group 1 vs group 2 | Group 1 vs group 3 | Group 2 vs group 3 | |
25(OH) Vit-D3 | 22.3±47.0 | 62.4±65.1 | 97.0±88.0 | <0.001 | <0.001 | <0.001 |
Left BMD | 10.7±6.7 | 13.0±7.0 | 13.6±8.3 | 0.0237 | 0.0055 | >0.20 |
Right BMD | 10.3±6.7 | 12.8±7.0 | 13.4±8.3 | 0.029 | 0.020 | >0.20 |
Left BMC | 13.8±8.8 | 16.0±8.6 | 17.9±11.3 | 0.0421 | 0.0013 | >0.20 |
Right BMC | 12.5±8.5 | 15.5±10.0 | 16.8±10.4 | 0.0366 | 0.0018 | >0.20 |
*P-value from analysis using generalized estimating equations |
Conclusion: The results provided strong evidences that treatment with 600 mg calcium+400/800 IU Vit-D3 was effective for treating low bone mass in AIS subjects having z-score<0. Given the suboptimal 25(OH) Vit-D levels detected in this study and the association between AIS and low bone mass, Vit-D status and bone mineral density should be assessed and be followed as indicated by calcium+Vit-D supplementation for all AIS subjects.
Funding source: This study was partially funded by an Investigator Initiated Research grant from Pfizer Inc (IIR Grant No. WI 174540).
Disclosure: The authors declared no competing interests.