Effects of Combination Therapy of Alendronate and Hormonal Therapy on Bone Mineral Density in Postmenopausal Korean Women: Multicenter, Randomized Controlled Clinical Trial

ABSTRACT

This study evaluated the effects of combination treatment with alendronate (ALEN) and hormone therapy (HT) on bone mineral density (BMD) in postmenopausal Korean women. This multicenter, randomized, controlled clinical trial enrolled 344 postmenopausal women with low BMD. The women received HT (0.625 mg/day of conjugated equine estrogen and 2.5 mg/day of medroxyprogesterone acetate) alone or in combination with ALEN (10 mg/day) for 1 year. Changes in BMD and biochemical markers of bone turnover were evaluated. Data from 203 women (HT alone, 99; combination treatment, 104) who completed this study were analyzed. BMD at the lumbar spine and total hip increased significantly in both treatment groups after 1 year. There were no significant differences between HT alone vs. the combination of ALEN and HT in mean BMD increase at the lumbar spine (6.9% vs. 7.9%) and total hip (3.7% vs. 3.8%). Combined therapy suppressed serum osteocalcin and urinary deoxypyridinoline to a greater extent than HT alone. In conclusion, compared to HT alone, combination treatment with ALEN and HT for 1 year did not offer a benefit in BMD in postmenopausal Korean women with low BMD.