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result sql = Bones and Crohn's: no benefit of adding sodium fluoride or ibandronate to calcium and vitamin D.
Bones and Crohn's: no benefit of adding sodium fluoride or ibandronate to calcium and vitamin D.
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char = /;code = 47
char = >;code = 62
char = <;code = 60
char = b;code = 98
char = >;code = 62
char = R;code = 82
char = E;code = 69
char = S;code = 83
char = U;code = 85
char = L;code = 76
char = T;code = 84
char = S;code = 83
char = ;code = 32
char = :;code = 58
char = ;code = 32
char = <;code = 60
char = /;code = 47
char = b;code = 98
char = >;code = 62
char = O;code = 79
char = n;code = 110
char = e;code = 101
char = ;code = 32
char = h;code = 104
char = u;code = 117
char = n;code = 110
char = d;code = 100
char = r;code = 114
char = e;code = 101
char = d;code = 100
char = ;code = 32
char = a;code = 97
char = n;code = 110
char = d;code = 100
char = ;code = 32
char = t;code = 116
char = w;code = 119
char = e;code = 101
char = n;code = 110
char = t;code = 116
char = y;code = 121
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = r;code = 114
char = e;code = 101
char = e;code = 101
char = ;code = 32
char = (;code = 40
char = 8;code = 56
char = 3;code = 51
char = .;code = 46
char = 1;code = 49
char = %;code = 37
char = );code = 41
char = ;code = 32
char = p;code = 112
char = a;code = 97
char = t;code = 116
char = i;code = 105
char = e;code = 101
char = n;code = 110
char = t;code = 116
char = s;code = 115
char = ;code = 32
char = c;code = 99
char = o;code = 111
char = m;code = 109
char = p;code = 112
char = l;code = 108
char = e;code = 101
char = t;code = 116
char = e;code = 101
char = d;code = 100
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = e;code = 101
char = ;code = 32
char = f;code = 102
char = i;code = 105
char = r;code = 114
char = s;code = 115
char = t;code = 116
char = ;code = 32
char = y;code = 121
char = e;code = 101
char = a;code = 97
char = r;code = 114
char = ;code = 32
char = f;code = 102
char = o;code = 111
char = r;code = 114
char = ;code = 32
char = i;code = 105
char = n;code = 110
char = t;code = 116
char = e;code = 101
char = n;code = 110
char = t;code = 116
char = i;code = 105
char = o;code = 111
char = n;code = 110
char = -;code = 45
char = t;code = 116
char = o;code = 111
char = -;code = 45
char = t;code = 116
char = r;code = 114
char = e;code = 101
char = a;code = 97
char = t;code = 116
char = ;code = 32
char = (;code = 40
char = I;code = 73
char = T;code = 84
char = T;code = 84
char = );code = 41
char = ;code = 32
char = a;code = 97
char = n;code = 110
char = a;code = 97
char = l;code = 108
char = y;code = 121
char = s;code = 115
char = i;code = 105
char = s;code = 115
char = .;code = 46
char = ;code = 32
char = N;code = 78
char = i;code = 105
char = n;code = 110
char = e;code = 101
char = t;code = 116
char = y;code = 121
char = ;code = 32
char = t;code = 116
char = w;code = 119
char = o;code = 111
char = ;code = 32
char = (;code = 40
char = 6;code = 54
char = 2;code = 50
char = .;code = 46
char = 2;code = 50
char = %;code = 37
char = );code = 41
char = ;code = 32
char = p;code = 112
char = a;code = 97
char = t;code = 116
char = i;code = 105
char = e;code = 101
char = n;code = 110
char = t;code = 116
char = s;code = 115
char = ;code = 32
char = c;code = 99
char = o;code = 111
char = m;code = 109
char = p;code = 112
char = l;code = 108
char = e;code = 101
char = t;code = 116
char = e;code = 101
char = d;code = 100
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = e;code = 101
char = ;code = 32
char = s;code = 115
char = e;code = 101
char = c;code = 99
char = o;code = 111
char = n;code = 110
char = d;code = 100
char = ;code = 32
char = y;code = 121
char = e;code = 101
char = a;code = 97
char = r;code = 114
char = ;code = 32
char = a;code = 97
char = n;code = 110
char = d;code = 100
char = ;code = 32
char = 7;code = 55
char = 1;code = 49
char = ;code = 32
char = (;code = 40
char = 4;code = 52
char = 7;code = 55
char = .;code = 46
char = 8;code = 56
char = %;code = 37
char = );code = 41
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = e;code = 101
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = i;code = 105
char = r;code = 114
char = d;code = 100
char = ;code = 32
char = y;code = 121
char = e;code = 101
char = a;code = 97
char = r;code = 114
char = ;code = 32
char = a;code = 97
char = v;code = 118
char = a;code = 97
char = i;code = 105
char = l;code = 108
char = a;code = 97
char = b;code = 98
char = l;code = 108
char = e;code = 101
char = ;code = 32
char = f;code = 102
char = o;code = 111
char = r;code = 114
char = ;code = 32
char = p;code = 112
char = e;code = 101
char = r;code = 114
char = -;code = 45
char = p;code = 112
char = r;code = 114
char = o;code = 111
char = t;code = 116
char = o;code = 111
char = c;code = 99
char = o;code = 111
char = l;code = 108
char = ;code = 32
char = (;code = 40
char = P;code = 80
char = P;code = 80
char = );code = 41
char = ;code = 32
char = a;code = 97
char = n;code = 110
char = a;code = 97
char = l;code = 108
char = y;code = 121
char = s;code = 115
char = i;code = 105
char = s;code = 115
char = .;code = 46
char = ;code = 32
char = W;code = 87
char = i;code = 105
char = t;code = 116
char = h;code = 104
char = ;code = 32
char = a;code = 97
char = ;code = 32
char = s;code = 115
char = i;code = 105
char = g;code = 103
char = n;code = 110
char = i;code = 105
char = f;code = 102
char = i;code = 105
char = c;code = 99
char = a;code = 97
char = n;code = 110
char = t;code = 116
char = ;code = 32
char = i;code = 105
char = n;code = 110
char = c;code = 99
char = r;code = 114
char = e;code = 101
char = a;code = 97
char = s;code = 115
char = e;code = 101
char = ;code = 32
char = i;code = 105
char = n;code = 110
char = ;code = 32
char = T;code = 84
char = -;code = 45
char = s;code = 115
char = c;code = 99
char = o;code = 111
char = r;code = 114
char = e;code = 101
char = ;code = 32
char = o;code = 111
char = f;code = 102
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = e;code = 101
char = ;code = 32
char = l;code = 108
char = u;code = 117
char = m;code = 109
char = b;code = 98
char = a;code = 97
char = r;code = 114
char = ;code = 32
char = s;code = 115
char = p;code = 112
char = i;code = 105
char = n;code = 110
char = e;code = 101
char = ;code = 32
char = b;code = 98
char = y;code = 121
char = ;code = 32
char = +;code = 43
char = 0;code = 48
char = .;code = 46
char = 2;code = 50
char = 8;code = 56
char = ;code = 32
char = &;code = 38
char = #;code = 35
char = 1;code = 49
char = 7;code = 55
char = 7;code = 55
char = ;;code = 59
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 3;code = 51
char = 5;code = 53
char = ;code = 32
char = [;code = 91
char = 9;code = 57
char = 5;code = 53
char = %;code = 37
char = ;code = 32
char = c;code = 99
char = o;code = 111
char = n;code = 110
char = f;code = 102
char = i;code = 105
char = d;code = 100
char = e;code = 101
char = n;code = 110
char = c;code = 99
char = e;code = 101
char = ;code = 32
char = i;code = 105
char = n;code = 110
char = t;code = 116
char = e;code = 101
char = r;code = 114
char = v;code = 118
char = a;code = 97
char = l;code = 108
char = ;code = 32
char = (;code = 40
char = C;code = 67
char = I;code = 73
char = );code = 41
char = :;code = 58
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 1;code = 49
char = 6;code = 54
char = 2;code = 50
char = -;code = 45
char = 0;code = 48
char = .;code = 46
char = 4;code = 52
char = 6;code = 54
char = 0;code = 48
char = ,;code = 44
char = ;code = 32
char = P;code = 80
char = ;code = 32
char = <;code = 60
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 0;code = 48
char = 1;code = 49
char = ];code = 93
char = ,;code = 44
char = ;code = 32
char = +;code = 43
char = 0;code = 48
char = .;code = 46
char = 3;code = 51
char = 3;code = 51
char = ;code = 32
char = &;code = 38
char = #;code = 35
char = 1;code = 49
char = 7;code = 55
char = 7;code = 55
char = ;;code = 59
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 4;code = 52
char = 9;code = 57
char = ;code = 32
char = (;code = 40
char = 9;code = 57
char = 5;code = 53
char = %;code = 37
char = ;code = 32
char = C;code = 67
char = I;code = 73
char = :;code = 58
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 1;code = 49
char = 0;code = 48
char = 9;code = 57
char = -;code = 45
char = 0;code = 48
char = .;code = 46
char = 5;code = 53
char = 5;code = 53
char = 8;code = 56
char = ,;code = 44
char = ;code = 32
char = P;code = 80
char = ;code = 32
char = <;code = 60
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 0;code = 48
char = 1;code = 49
char = );code = 41
char = ,;code = 44
char = ;code = 32
char = +;code = 43
char = 0;code = 48
char = .;code = 46
char = 4;code = 52
char = 3;code = 51
char = ;code = 32
char = &;code = 38
char = #;code = 35
char = 1;code = 49
char = 7;code = 55
char = 7;code = 55
char = ;;code = 59
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 4;code = 52
char = 7;code = 55
char = ;code = 32
char = (;code = 40
char = 9;code = 57
char = 5;code = 53
char = %;code = 37
char = ;code = 32
char = C;code = 67
char = I;code = 73
char = :;code = 58
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 1;code = 49
char = 4;code = 52
char = 7;code = 55
char = -;code = 45
char = 0;code = 48
char = .;code = 46
char = 7;code = 55
char = 0;code = 48
char = 8;code = 56
char = ,;code = 44
char = ;code = 32
char = P;code = 80
char = ;code = 32
char = <;code = 60
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 0;code = 48
char = 1;code = 49
char = );code = 41
char = ;code = 32
char = i;code = 105
char = n;code = 110
char = ;code = 32
char = g;code = 103
char = r;code = 114
char = o;code = 111
char = u;code = 117
char = p;code = 112
char = ;code = 32
char = A;code = 65
char = ,;code = 44
char = ;code = 32
char = +;code = 43
char = 0;code = 48
char = .;code = 46
char = 2;code = 50
char = 2;code = 50
char = ;code = 32
char = &;code = 38
char = #;code = 35
char = 1;code = 49
char = 7;code = 55
char = 7;code = 55
char = ;;code = 59
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 3;code = 51
char = 3;code = 51
char = ;code = 32
char = (;code = 40
char = 9;code = 57
char = 5;code = 53
char = %;code = 37
char = ;code = 32
char = C;code = 67
char = I;code = 73
char = :;code = 58
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 1;code = 49
char = 2;code = 50
char = 5;code = 53
char = -;code = 45
char = 0;code = 48
char = .;code = 46
char = 3;code = 51
char = 2;code = 50
char = 1;code = 49
char = ,;code = 44
char = ;code = 32
char = P;code = 80
char = ;code = 32
char = <;code = 60
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 0;code = 48
char = 1;code = 49
char = );code = 41
char = ;;code = 59
char = ;code = 32
char = +;code = 43
char = 0;code = 48
char = .;code = 46
char = 4;code = 52
char = 7;code = 55
char = ;code = 32
char = &;code = 38
char = #;code = 35
char = 1;code = 49
char = 7;code = 55
char = 7;code = 55
char = ;;code = 59
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 6;code = 54
char = 0;code = 48
char = ;code = 32
char = (;code = 40
char = 9;code = 57
char = 5;code = 53
char = %;code = 37
char = ;code = 32
char = C;code = 67
char = I;code = 73
char = :;code = 58
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 2;code = 50
char = 6;code = 54
char = 2;code = 50
char = -;code = 45
char = 0;code = 48
char = .;code = 46
char = 6;code = 54
char = 7;code = 55
char = 6;code = 54
char = ,;code = 44
char = ;code = 32
char = P;code = 80
char = ;code = 32
char = <;code = 60
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 0;code = 48
char = 1;code = 49
char = );code = 41
char = ,;code = 44
char = ;code = 32
char = +;code = 43
char = 0;code = 48
char = .;code = 46
char = 5;code = 53
char = 1;code = 49
char = ;code = 32
char = &;code = 38
char = #;code = 35
char = 1;code = 49
char = 7;code = 55
char = 7;code = 55
char = ;;code = 59
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 4;code = 52
char = 4;code = 52
char = ;code = 32
char = (;code = 40
char = 9;code = 57
char = 5;code = 53
char = %;code = 37
char = ;code = 32
char = C;code = 67
char = I;code = 73
char = :;code = 58
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 3;code = 51
char = 3;code = 51
char = 8;code = 56
char = -;code = 45
char = 0;code = 48
char = .;code = 46
char = 6;code = 54
char = 8;code = 56
char = 2;code = 50
char = ,;code = 44
char = ;code = 32
char = P;code = 80
char = ;code = 32
char = <;code = 60
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 0;code = 48
char = 1;code = 49
char = );code = 41
char = ;code = 32
char = i;code = 105
char = n;code = 110
char = ;code = 32
char = g;code = 103
char = r;code = 114
char = o;code = 111
char = u;code = 117
char = p;code = 112
char = ;code = 32
char = B;code = 66
char = ;code = 32
char = a;code = 97
char = n;code = 110
char = d;code = 100
char = ;code = 32
char = +;code = 43
char = 0;code = 48
char = .;code = 46
char = 2;code = 50
char = 2;code = 50
char = ;code = 32
char = &;code = 38
char = #;code = 35
char = 1;code = 49
char = 7;code = 55
char = 7;code = 55
char = ;;code = 59
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 3;code = 51
char = 8;code = 56
char = ;code = 32
char = (;code = 40
char = 9;code = 57
char = 5;code = 53
char = %;code = 37
char = ;code = 32
char = C;code = 67
char = I;code = 73
char = :;code = 58
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 1;code = 49
char = 1;code = 49
char = 1;code = 49
char = -;code = 45
char = 0;code = 48
char = .;code = 46
char = 3;code = 51
char = 2;code = 50
char = 9;code = 57
char = ,;code = 44
char = ;code = 32
char = P;code = 80
char = ;code = 32
char = <;code = 60
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 0;code = 48
char = 1;code = 49
char = );code = 41
char = ,;code = 44
char = ;code = 32
char = +;code = 43
char = 0;code = 48
char = .;code = 46
char = 3;code = 51
char = 6;code = 54
char = ;code = 32
char = &;code = 38
char = #;code = 35
char = 1;code = 49
char = 7;code = 55
char = 7;code = 55
char = ;;code = 59
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 5;code = 53
char = 3;code = 51
char = ;code = 32
char = (;code = 40
char = 9;code = 57
char = 5;code = 53
char = %;code = 37
char = ;code = 32
char = C;code = 67
char = I;code = 73
char = :;code = 58
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 1;code = 49
char = 4;code = 52
char = 7;code = 55
char = -;code = 45
char = 0;code = 48
char = .;code = 46
char = 5;code = 53
char = 7;code = 55
char = 8;code = 56
char = ,;code = 44
char = ;code = 32
char = P;code = 80
char = ;code = 32
char = <;code = 60
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 0;code = 48
char = 1;code = 49
char = );code = 41
char = ,;code = 44
char = ;code = 32
char = +;code = 43
char = 0;code = 48
char = .;code = 46
char = 4;code = 52
char = 1;code = 49
char = ;code = 32
char = &;code = 38
char = #;code = 35
char = 1;code = 49
char = 7;code = 55
char = 7;code = 55
char = ;;code = 59
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 4;code = 52
char = 8;code = 56
char = ;code = 32
char = (;code = 40
char = 9;code = 57
char = 5;code = 53
char = %;code = 37
char = ;code = 32
char = C;code = 67
char = I;code = 73
char = :;code = 58
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 2;code = 50
char = 3;code = 51
char = 8;code = 56
char = -;code = 45
char = 0;code = 48
char = .;code = 46
char = 5;code = 53
char = 7;code = 55
char = 6;code = 54
char = ,;code = 44
char = ;code = 32
char = P;code = 80
char = ;code = 32
char = <;code = 60
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 0;code = 48
char = 1;code = 49
char = );code = 41
char = ;code = 32
char = i;code = 105
char = n;code = 110
char = ;code = 32
char = g;code = 103
char = r;code = 114
char = o;code = 111
char = u;code = 117
char = p;code = 112
char = ;code = 32
char = C;code = 67
char = ,;code = 44
char = ;code = 32
char = r;code = 114
char = e;code = 101
char = s;code = 115
char = p;code = 112
char = e;code = 101
char = c;code = 99
char = t;code = 116
char = i;code = 105
char = v;code = 118
char = e;code = 101
char = l;code = 108
char = y;code = 121
char = ,;code = 44
char = ;code = 32
char = d;code = 100
char = u;code = 117
char = r;code = 114
char = i;code = 105
char = n;code = 110
char = g;code = 103
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = e;code = 101
char = ;code = 32
char = 1;code = 49
char = .;code = 46
char = 0;code = 48
char = ,;code = 44
char = ;code = 32
char = 2;code = 50
char = .;code = 46
char = 2;code = 50
char = 5;code = 53
char = ;code = 32
char = a;code = 97
char = n;code = 110
char = d;code = 100
char = ;code = 32
char = 3;code = 51
char = .;code = 46
char = 5;code = 53
char = ;code = 32
char = y;code = 121
char = e;code = 101
char = a;code = 97
char = r;code = 114
char = ;code = 32
char = p;code = 112
char = e;code = 101
char = r;code = 114
char = i;code = 105
char = o;code = 111
char = d;code = 100
char = s;code = 115
char = ;code = 32
char = (;code = 40
char = P;code = 80
char = P;code = 80
char = ;code = 32
char = a;code = 97
char = n;code = 110
char = a;code = 97
char = l;code = 108
char = y;code = 121
char = s;code = 115
char = i;code = 105
char = s;code = 115
char = );code = 41
char = ,;code = 44
char = ;code = 32
char = n;code = 110
char = o;code = 111
char = ;code = 32
char = t;code = 116
char = r;code = 114
char = e;code = 101
char = a;code = 97
char = t;code = 116
char = m;code = 109
char = e;code = 101
char = n;code = 110
char = t;code = 116
char = ;code = 32
char = r;code = 114
char = e;code = 101
char = g;code = 103
char = i;code = 105
char = m;code = 109
char = e;code = 101
char = n;code = 110
char = ;code = 32
char = w;code = 119
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char = n;code = 110
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result sql = AIM : To compare the effect of calcium and cholecalciferol alone and along with additional sodium fluoride or ibandronate on bone mineral density (BMD) and fractures in patients with Crohn's disease (CD).

METHODS : Patients (n =148) with reduced BMD (T-score < -1) were randomized to receive cholecalciferol (1000 IU) and calcium citrate (800 mg) daily alone(group A, n = 32) or along with additional sodium fluoride (25 mg bid) (group B, n = 62) or additional ibandronate (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. Fracture-assessment included visual reading of X-rays and quantitative morphometry of vertebral bodies (T4-L4).

RESULTS : One hundred and twenty three (83.1%) patients completed the first year for intention-to-treat (ITT) analysis. Ninety two (62.2%) patients 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 vertebral fracture in the sodium fluoride group was detected. Study medication was safe and well tolerated.

CONCLUSION : Additional sodium fluoride or ibandronate had no benefit over calcium and cholecalciferol alone in managing reduced BMD in CD.

Publication: World J. Gastroenterol. 2011 Jan 21 ;17(3)::334-42. :doi: 10.3748/wjg.v17.i3.334.
Publication Date: 2011 Jan 21
Study Author(s): Klaus, Jochen;Reinshagen, Max;Herdt, Katharina;Schröter, Christoph;Adler, Guido;von Boyen, Georg Bt;von Tirpitz, Christian;
Institution: Department of Internal Medicine I, University of Ulm, Albert Einstein Allee 23, 89081 Ulm, Germany. jochen.klaus@uniklinik-ulm.de
Shortcut link to this study:
AIM : To compare the effect of calcium and cholecalciferol alone and along with additional sodium fluoride or ibandronate on bone mineral density (BMD) and fractures in patients with Crohn's disease (CD).

METHODS : Patients (n =148) with reduced BMD (T-score < -1) were randomized to receive cholecalciferol (1000 IU) and calcium citrate (800 mg) daily alone(group A, n = 32) or along with additional sodium fluoride (25 mg bid) (group B, n = 62) or additional ibandronate (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. Fracture-assessment included visual reading of X-rays and quantitative morphometry of vertebral bodies (T4-L4).

RESULTS : One hundred and twenty three (83.1%) patients completed the first year for intention-to-treat (ITT) analysis. Ninety two (62.2%) patients 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 vertebral fracture in the sodium fluoride group was detected. Study medication was safe and well tolerated.

CONCLUSION : Additional sodium fluoride or ibandronate had no benefit over calcium and cholecalciferol alone in managing reduced BMD in CD.
PMID: 21253392

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