Alendronate and indapamide alone or in combination in the management of hypercalciuria associated with osteoporosis: a randomized controlled trial of two drugs and three treatments.

Background. The role of bisphosphonates (BPs) in the management of patients with hypercalciuria (HC) associated with osteoporosis is still uncertain. The aim of the study was to evaluate the effect of alendronate and indapamide alone or in combination on bone mineral density (BMD) and 24-h urinary calcium excretion (24-CaU) in post-menopausal women with HC and low BMD. Methods. A total of 77 post-menopausal women with HC (24-CaU > 4mg/kg/day) and low BMD [T-score Results. Overall 67 women completed the study and were included in the final analysis. Patients in the three groups were similar with regard to baseline characteristics. BMD did not significantly change from baseline after 1 year of treatment with indapamide (LS: +1 ± 3.1%; FN: −0.3 ± 3.5%; TH: −0.4 ± 3.1%), while it showed a significant increase from baseline in the other two groups (ALN; LS: +5.8 ± 4.2%, P P = 0.018; TH: +2 ± 3.6%, P = 0.006) (ALN + IND; LS: +8.2 ± 5.3%, P P = 0.007; TH: +2.9 ± 4.2%, P = 0.004). Patients in the combination group showed a significantly higher increase of BMD at LS compared to ALN (P = 0.04). After 1 year, 24-CaU values significantly decreased from baseline in all groups (IND, 239 ± 78 versus 364 ± 44, P P P P P = 0.012). Conclusions. These results show a benefit, in terms of BMD improvement and 24-CaU reduction, associated with BPs’ therapy in combination with indapamide in HC associated with osteoporosis. The combination therapy demonstrated a reduction of 24-CaU and an increase in LS BMD superior to that observed with alendronate alone. Our results support a new potential approach with BPs associated with thiazide diuretics or indapamide in the management of post-menopausal women with HC and associated bone loss. Studies on the larger sample size are needed to demonstrate the efficacy on the fracture outcome. [ABSTRACT FROM AUTHOR]