Recent epidemiological studies have demonstrated that more than half of postmenopausal women with osteoporosis (PWOP) treated with an antiresorptive drug plus calcium (Ca) and vitamin D, have serum levels of 25(OH)D3<
30ng/ml. Chronic low levels of vitamin D can contribute to the inefficiency of main antiresorptive treatment. A possible explanation for this phenomenon is the non-compliance with the daily supplementation of Ca and vitamin D. A fixed combination of Alendronate Once Weekly (OW) 70mg plus 2800 UI of cholecalciferol (AL+D) made its appearance in the market two years ago as a solution to this problem. The current study was designed to assess the efficacy of AL+D versus the old scheme of Alendronate 70 OW plus daily Ca 500mg + 400 UI of vitamin D (AL+S) on serum levels of 25(OH)D3. 100 randomly assigned PWOP treated already for 1 to 5 years with AL+S have changed their treatment to AL+D for one year. Serum levels of 25(OH)D3 (Biomedica.co.at/vitamind) has been measured before and after 12 months and also their BMD (Hologic Delphi), PTH, TSH, serum chemistry and hematology has been recorded for safety reasons. At the end of the study only 83 PWOP (MA=59,9±6,6 yrs) appeared for comparison. Our results are as follow:
The mean plasma level of 25(OH)D3 under AL+S treatment and before taking AL+D is 24,3±8,4 ng/mL and The plasma levels of 25(OH)D3 after 12 months of treatment with AL+D are 33,3±9 ng/mL. The paired t-test has been used to compare the levels of 25(OH)D3 between treatment groups. There is a highly important statistical difference (t=−8.989, df=82, p<
0,0001) between treatment groups. From the above data it can be concluded that fixed combination of AL+D can improve the 25(OH)D3 status over 12 months versus AL+S probably because it assures a better compliance of vitamin D.
