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Effects of adding alendronate to ongoing hormone therapy on bone mineral density in postmenopausal Korean women: a randomized, double-blind, placebo-controlled clinical trial

Min, Yong-Ki MD, PhD1; Lee, Dong-Yun MD, PhD2; Choi, Suk-Joo MD, PhD2; Kim, Joo Han PhD3; Choi, DooSeok MD, PhD2; Yoon, Byung-Koo MD, PhD2

doi: 10.1097/GME.0b013e31827b24af
Original Articles

Objective This study was conducted to evaluate the effects of adding the bisphosphonate alendronate (ALEN) to ongoing hormone therapy (HT) on bone mineral density (BMD) in postmenopausal Korean women.

Methods This randomized, double-blind, placebo-controlled clinical trial at a university hospital included a total of 139 postmenopausal women who had low BMD after HT lasting at least 1 year. Women received either ALEN (10 mg/d) or placebo in combination with HT for 1 year. Changes in BMD and biochemical markers of bone turnover were evaluated.

Results Lumbar spine and total hip BMDs increased significantly in both treatment groups after 1 year. The addition of ALEN, when compared with HT alone, did not produce a significant change in BMD at the lumbar spine (3.7% vs 4.3%) and total hip (2.2% vs 3.2%) after adjusting for controllable variables. Serum osteocalcin showed a similar change, but urinary deoxypyridinoline response differed between treatment groups.

Conclusions Compared with HT alone, the addition of ALEN to ongoing HT for 1 year does not make a difference in BMD among postmenopausal Korean women with low BMD.

From the Departments of 1Medicine and 2Obstetrics and Gynecology, Sungkyunkwan University School of Medicine, Seoul, Korea; and 3Department of Statistics, Chungnam University, Daejeon, Korea.

Received September 18, 2012; revised and accepted October 25, 2012.

Y.-.K.M. and D.-Y.L. contributed equally to this study.

Funding/support: This work was supported, in part, by the Samsung Medical Center Research Fund (PHO1000061) and the IN-SUNG Foundation for Medical Research (C-A5-811-1).

Financial disclosure/conflicts of interest: None reported.

Address correspondence to: Byung-Koo Yoon, MD, PhD, Department of Obstetrics and Gynecology, Sungkyunkwan University School of Medicine, 50 Ilwon-dong, Gangnam-gu, Seoul 135-710, Korea. E-mail: bkyoon@skku.edu

© 2013 by The North American Menopause Society.