Effect of Alendronate and Vitamin D 3 Treatment on Bone Turnover Markers in Postmenopausal Women with High Fracture Risk: a Double-blind, Randomized Controlled Trial.

Abstract

Background: Bone turnover markers (BTMs) are increased after menopause in women. BTMs are expected to decrease significantly after receiving anti-resorptive treatment in osteoporosis and they can be used to monitor the efficacy of the treatment. This study evaluated the changes of BTMs following alendronate (ALN) and vitamin D3 (VitD3 ) treatment in postmenopausal women (PMW) with high fracture risk (HFR). Materials and methods: PMW with HFR were recruited from Bope-Poddala MOH area and randomly assigned into the treatment (n = 30) and control (n = 30) groups. Treatment group received oral ALN (70 mg/week) with oral VitD3 (1000 IU/day). Control group received VitD3 (1000 IU/day) along with a matching placebo. Serum cross linked C-telopeptide of type I collagen (CTX; bone resorption marker) and procollagen type I N-propeptide (PINP; bone formation marker) were measured at baseline and after six months, using ELISA. BTMs levels before and after treatment were compared by paired t-test. Results: In the treatment group, mean CTX and PINP levels at baseline were 3.12 ng/mL and 262 pg/mL respectively while respective mean values for the control group were 2.66 ng/mL and 409 pg/mL. After six months, mean CTX and PINP levels in the treatment group were 1.24 ng/mL and 159 pg/mL respectively while in the control group, the respective mean values were 3.01 ng/mL and 412 pg/mL. In the treatment group, CTX and PINP levels were significantly decreased by 60% (p < 0.001) and 39% (p = 0.005) respectively after six months compared to the baseline levels. Significant differences were not observed in the control group for mean CTX (p = 0.43) and PINP (p = 0.97) after six months compared to baseline. Mean differences between treatment and control groups were not significant for CTX (p = 0.36) and PINP (p = 0.06). Conclusion: Combination of alendronate and vitamin D3 treatment