The effect of alendronate on lipid profile of postmenopausal women with osteopenia and prediabetes: A randomized triple-blind clinical trial

Abstract

BACKGROUND: Prediabetes is a high-risk state for developing diabetes at an annual rate of 5-10. Early intervention can prevent further complications, including metabolic syndrome. Bisphosphonates are commonly used for osteoporotic postmenopausal women. The purpose of this study was to assess the effects of bisphosphonates on lipid profile including triglyceride (TG), total cholesterol, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) of prediabetic postmenopausal women with osteopenia. MATERIALS AND METHODS: In this triple-blind randomized controlled trial, sixty prediabetic, postmenopausal women with sufficient Vitamin D and osteopenia, aged 45-60 years, were randomly enrolled in two groups of intervention (receiving 70-mg alendronate for 12 weeks duration for maximum metabolic effect of bisphosphonates, n = 30) and control (receiving placebo, n = 30) according to a randomized block procedure of size 2 and 1:1 allocation ratio. The primary outcome of the study, the lipid profile, was evaluated before and after the interventions. The effect of the intervention was assessed using analysis of covariance. RESULTS: The lipid profiles showed no significant differences to the mean values at the baseline in both the groups (all P > 0.05). At the end of the study, the differences between the groups were not significant for 25(OH) D(3) (mean difference: -11.09, 95% confidence interval: -32.43-10.25), T (4.19, -30.58-38.97), cholesterol (8.13, -13.07-29.33), LDL-cholesterol (5.07, -10.18-20.31), and HDL-cholesterol (-0.86, -6.04-4.31) when the baseline values and confounders were adjusted (all P > 0.05). CONCLUSION: No statistically significant difference was detected in the serum lipid profile of prediabetic postmenopausal women with osteopenia as a result of alendronate intervention. More studies with larger sample sizes and longer intervention periods are recommended.