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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.