title: Efficacy of alfacalcidol and alendronate on lumbar bone mineral density in osteoporotic patients using proton pump inhibitors.
abstract: It has been indicated that proton pump inhibitor (PPI) use is associated with a loss of the anti-fracture efficacy of alendronate (AD). However, there are few prospective studies that have investigated the efficacy of AD on lumbar bone mineral density (BMD) in osteoporotic patients who are using PPIs. Thus, the aim of the present study was to investigate the efficacy of alfacalcidol (AC) and AD on lumbar BMD in osteoporotic patients using PPIs. A prospective, randomized, active control study enrolled such osteoporotic patients (age, ≥50 years). The patients were randomly assigned to receive AC (1 µg/day) or AD (35 mg/week) and were followed up for one year. Patient profiles were maintained, and lumbar BMD, bone-specific alkaline-phosphatase (BAP) and collagen type-I cross-linked N-telopeptide (NTX), upper gastrointestinal endoscopy results, and the frequency scale for the symptoms of gastroesophageal reflux disease (FSSG) were evaluated. Percentage changes in lumbar BMD, NTX, BAP, and change in FSSG score from baseline to the end of one year of treatment were investigated. Sixteen patients were eligible for analysis (eight assigned to receive AC, eight assigned to receive AD). The percentage change in lumbar BMD from baseline to the end of treatment was -0.4±4.0% for the AC group vs. 6.8±6.3% for the AD group (P=0.015). No significant percentage change of BAP and NTX between the two groups was observed. Subsequent to one year of treatment, the FSSG score did not change from the baseline values for either study group, and no new bone fractures or esophagitis were observed in either group of patients. The findings demonstrated that in osteoporotic patients using concomitant PPIs, there was a greater increase in lumbar BMD after one year of treatment with AD compared with AC. However, the number of study subjects was small; thus, further, large prospective studies are required to determine the effect of AD in osteoporotic patients using concomitant PPIs.
authors.affiliation: Department of Gastroenterology, School of Medicine, University of Juntendo, Tokyo 113-8421, Japan.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Asaoka
authors.affiliation: Department of Gastroenterology, Juntendo University Shizuoka Hospital, Shizuoka 410-2295, Japan.
authors.forename: Akihito
authors.initials: A
authors.lastname: Nagahara
authors.affiliation: Department of Gastroenterology, School of Medicine, University of Juntendo, Tokyo 113-8421, Japan.
authors.forename: Mariko
authors.initials: M
authors.lastname: Hojo
authors.affiliation: Department of Gastroenterology, School of Medicine, University of Juntendo, Tokyo 113-8421, Japan.
authors.forename: Kenshi
authors.initials: K
authors.lastname: Matsumoto
authors.affiliation: Department of Gastroenterology, School of Medicine, University of Juntendo, Tokyo 113-8421, Japan.
authors.forename: Hiroya
authors.initials: H
authors.lastname: Ueyama
authors.affiliation: Department of Gastroenterology, School of Medicine, University of Juntendo, Tokyo 113-8421, Japan.
authors.forename: Kohei
authors.initials: K
authors.lastname: Matsumoto
authors.affiliation: Department of Gastroenterology, School of Medicine, University of Juntendo, Tokyo 113-8421, Japan.
authors.forename: Kentaro
authors.initials: K
authors.lastname: Izumi
authors.affiliation: Department of Gastroenterology, School of Medicine, University of Juntendo, Tokyo 113-8421, Japan.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Takeda
authors.affiliation: Department of Gastroenterology, School of Medicine, University of Juntendo, Tokyo 113-8421, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Komori
authors.affiliation: Department of Gastroenterology, School of Medicine, University of Juntendo, Tokyo 113-8421, Japan.
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Akazawa
authors.affiliation: Department of Gastroenterology, Juntendo University Shizuoka Hospital, Shizuoka 410-2295, Japan.
authors.forename: Yuji
authors.initials: Y
authors.lastname: Shimada
authors.affiliation: Department of Gastroenterology, School of Medicine, University of Juntendo, Tokyo 113-8421, Japan.
authors.forename: Taro
authors.initials: T
authors.lastname: Osada
authors.affiliation: Department of Gastroenterology, School of Medicine, University of Juntendo, Tokyo 113-8421, Japan.
authors.forename: Sumio
authors.initials: S
authors.lastname: Watanabe
keywords: alendronate; alfacalcidol; osteoporosis; prospective; proton pump inhibitor; randomized