Bones and Crohn's: no benefit of adding @entity3163 or @entity7923 to XXXX and vitamin D.

@entity1 @entity3163 @entity174 @entity3875 @entity7923 @entity13621 @entity79 @entity460 @entity30
AIM: To compare the effect of @entity460 and @entity3875 alone and along with additional @entity3163 or @entity7923 on @entity79 ( @entity79 ) and @entity174 in @entity1 with @entity30 ( @entity30 ). METHODS: @entity1 (n =148) with reduced @entity79 (T-score < -1) were randomized to receive @entity3875 (1000 IU) and @entity13621 (800 mg) daily alone(group A, n = 32) or along with additional @entity3163 (25 mg bid) (group B, n = 62) or additional @entity7923 (1 mg iv/3-monthly) (group C, n = 54). Dual energy X-ray absorptiometry of the lumbar spine (L1-L4) and proximal right femur and X-rays of the spine were performed at baseline and after 1.0, 2.25 and 3.5 years. @entity174 -assessment included visual reading of X-rays and quantitative morphometry of vertebral bodies (T4-L4). RESULTS: One hundred and twenty three (83.1%) @entity1 completed the first year for intention-to-treat (ITT) analysis. Ninety two (62.2%) @entity1 completed the second year and 71 (47.8%) the third year available for per-protocol (PP) analysis. With a significant increase in T-score of the lumbar spine by +0.28    0.35 [95% confidence interval (CI): 0.162-0.460, P < 0.01], +0.33    0.49 (95% CI: 0.109-0.558, P < 0.01), +0.43    0.47 (95% CI: 0.147-0.708, P < 0.01) in group A, +0.22    0.33 (95% CI: 0.125-0.321, P < 0.01); +0.47    0.60 (95% CI: 0.262-0.676, P < 0.01), +0.51    0.44 (95% CI: 0.338-0.682, P < 0.01) in group B and +0.22    0.38 (95% CI: 0.111-0.329, P < 0.01), +0.36    0.53 (95% CI: 0.147-0.578, P < 0.01), +0.41    0.48 (95% CI: 0.238-0.576, P < 0.01) in group C, respectively, during the 1.0, 2.25 and 3.5 year periods (PP analysis), no treatment regimen was superior in any in- or between-group analyses. In the ITT analysis, similar results in all in- and between-group analyses with a significant in-group but non-significant between-group increase in T-score of the lumbar spine by 0.38    0.46 (group A, P < 0.01), 0.37    0.50 (group B, P < 0.01) and 0.35    0.49 (group C, P < 0.01) was observed. Follow-up in ITT analysis was still 2.65 years. One @entity174 in the @entity3163 group was detected. Study medication was safe and well tolerated. CONCLUSION: Additional @entity3163 or @entity7923 had no benefit over @entity460 and @entity3875 alone in managing reduced @entity79 in @entity30 .
