Weekly oral alendronic acid in male osteoporosis

Paul D. Miller, Thomas Schnitzer, Ronald Emkey, Eric Orwoll, Clifford Rosen, Mark Ettinger, Kristel Vandormael, Anastasia Daifotis

Research output: Contribution to journalArticle

25 Scopus citations

Abstract

Objective: To evaluate the efficacy and tolerability of alendronic acid 70mg once weekly for the treatment of male osteoporosis. Patients and methods: This randomised, double-blind, placebo-controlled, 12-month trial compared the effect of alendronic acid 70mg once weekly or placebo (randomised 2:1) on bone mineral density (BMD) in 167 men with spine or hip BMD at least 2 standard deviations (SD) below the mean for young normal white males or nontraumatic fracture. All patients received calcium and vitamin D (colecalciferol). We measured lumbar spine, hip and total body BMD, and biochemical markers of bone turnover. Fractures were collected as adverse events. Results: Alendronic acid 70mg once weekly produced significant BMD increases from baseline of 4.3% at the spine, 2.1% at the femoral neck, 2.4% at the trochanter, and 1.4% at the total body, which were all significantly greater than placebo (p < 0.05). The increase at the lumbar spine was significant relative to baseline and placebo after 6 months of treatment (p < 0.001). The treatment effect was consistent regardless of BMD, age, height, weight, body mass index (BMI) and hypogonadal status at baseline. Alendronic acid significantly decreased biochemical markers of bone turnover relative to baseline and placebo. Alendronic acid was generally well tolerated, with an incidence of gastrointestinal adverse events similar to placebo. Conclusion: Alendronic acid 70mg administered once weekly is an effective and convenient alternative to daily dosing for the treatment of male osteoporosis.

Original languageEnglish (US)
Pages (from-to)333-341
Number of pages9
JournalClinical Drug Investigation
Volume24
Issue number6
DOIs
StatePublished - Jul 14 2004

ASJC Scopus subject areas

  • Pharmacology (medical)

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    Miller, P. D., Schnitzer, T., Emkey, R., Orwoll, E., Rosen, C., Ettinger, M., Vandormael, K., & Daifotis, A. (2004). Weekly oral alendronic acid in male osteoporosis. Clinical Drug Investigation, 24(6), 333-341. https://doi.org/10.2165/00044011-200424060-00003