The Effects of Combined Treatment of Alendronate Plus Active or Plain Vitamin D on the Vitamin D Metabolism and Bone Turnover Markers in Patients with Osteoporosis

ABSTRACT

BACKGROUND: The purpose of this study was to evaluate the effects of combined treatment with alendronate plus active or plain vitamin D on the vitamin D metabolism and bone turnover markers in patients with osteoporosis. METHODS: We investigated 297 osteoporosis outpatients who were treated with Maxmarvil(R) (alendronate 5 mg plus calcitriol 0.5 microg) daily or Fosamax Plus(R) (alendronate 70 mg plus cholecalciferol 2,800 IU) weekly for 1 year. The serum levels of 25(OH)D, parathyroid hormone (PTH), calcium, phosphorus, osteocalcin and N-telopeptide were measured at baseline and after 3, 6, and 12 months of treatment. RESULTS: The data of 72 of the 297 patients were analyzed. In the Maxmarvil(R) group (n = 45), the serum PTH significantly decreased by 17% from baseline at 6 months (microd = -6.10; +/- 0.85 SE; P < 0.05) and it remained suppressed to 12 months. The serum 25(OH)D tended to increase, but without significance. In the Fosamax Plus(R) group (n = 27), the serum 25(OH)D significantly increased by 77% from baseline at 3 months (microd = 9.87; +/- 2.32 SE; P < 0.05) and it remained significantly higher than baseline at 6 months (microd = 3.49; +/- 0.86 SE; P < 0.05) and 12 months (microd = 10.47; +/- 0.71 SE; P < 0.001). However, the serum PTH showed no significant decrease. In the Maxmarvil(R) group, the serum osteocalcin significantly decreased by 26% from baseline at 12 months (microd = -5.15; +/- 0.35 SE; P < 0.05), and in the Fosamax Plus(R) group, the serum osteocalcin significantly decreased by 19% from baseline at 6months (microd = -2.64; +/- 0.73 SE; P < 0.05) and it remained suppressed to 12 months (microd = -2.99; +/- 0.37 SE; P = 0.32) without significance. CONCLUSION: Maxmarvil(R) and Fosamax Plus(R) both improved the bone metabolism in Korean osteoporosis patients. Maxmarvil(R) significantly lowered the serum PTH levels, whereas Fosamax Plus(R) significantly elevated the serum 25(OH)D levels.