Objectives The purpose of this study was to evaluate the effect of four different treatment modalities on bone mineral density (BMD) in postmenopausal osteoporosis.
Methods 170 postmenopausal women BMD (measured by dual energy X-Ray absorptiometry-DXA) T scores at least ?2,5 SD below the peak young adult mean were included in the study. The patients were randomised to four groups. 40 patients were treated with alendronate (10 mg/daily) + alfacalcidol (0,5 μg/daily) and 40 patients were treated alendronate (10 mg/daily) and 60 patients were treated alfalcidol (0,5 μg/daily) for two years. All patients received 500 mg/daily supplemental calcium to ensure adequate calcium intake. Only 500 mg of calcium were given to the control group of 30 patients. BMD was measured by total body dual-energy X-Ray absorptiometry (DPX-Lunar) in the lumbar spine and in proximal segments of the femur (neck, ward?s triangle, trochanter, inter and total hip). BMD was evalvated at baseline and after 12 and 24 months. The patients followed up for two years.
Results After two years of treatment, we found significant increase of femoral neck, trochanter, ward?s triangle and lumbar spine density in alendronate + alfacalcidol group and alone alendronate group (p < 0.05). Also, in the second year of treatment, the combination of alendronate + alfacalcidol showed BMD increases that were significantly higher than for alendronate (p < 0.05). In the alfacalcidol group, BMD no increased significantly (p > 0.05).
In the placebo group (only calcium 500 mg/daily), BMD decreased significantly (p < 0.05).
No adverse effect were observed during the two years of the study, in particular with respect to renal function and the gastrointestinal system.
Conclusion These results showed that combined treatment with alfacalcidol + alendronate was more effective than therapy with alendronate alone.
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