Efficacy and safety of monthly ibandronate in men with low bone density

Eric Orwoll, Neil C. Binkley, E. Michael Lewiecki, Ugis Gruntmanis, Michael A. Fries, Gorana Dasic

Research output: Contribution to journalArticle

62 Scopus citations


Introduction: Monthly oral ibandronate is indicated for the prevention and treatment of osteoporosis in postmenopausal women. The STudy Researching Osteoporosis iN Guys (STRONG) investigated the efficacy and safety of 150-mg monthly oral ibandronate in men with primary, idiopathic, or hypogonadism-related low bone density. Methods: STRONG was a 1-year, placebo-controlled, randomized (2 ibandronate: 1 placebo), double-blind study that enrolled ambulatory men > 30 years with baseline femoral neck (FN) bone mineral density (BMD) T-scores > 4.0 at any site assessed by dual-energy X-ray absorptiometry. The primary endpoint was mean percent change from baseline in LS BMD at 1 year (intent-to-treat [ITT] population). Secondary endpoints included mean BMD changes from baseline at the FN, total hip (TH), and trochanter (TR) and changes in bone turnover markers (BTMs), as measured by the bone resorption marker serum C-terminal telopeptide of type 1 collagen (sCTX) and the bone formation marker bone-specific alkaline phosphatase (BSAP). All men received twice daily calcium carbonate (1000 mg/day) and vitamin D (400 IU/day). Changes in BMD for treatment groups were compared using analysis of covariance with treatment, investigative site, and baseline testosterone as factors and baseline BMD as a covariate. Results: The ITT population consisted of 132 men; 47 received placebo and 85 received monthly ibandronate. Men who received ibandronate achieved greater increases in LS BMD at 12 months than those who received placebo (3.5% vs. 0.9%, respectively; difference, 2.6; p

Original languageEnglish (US)
Pages (from-to)970-976
Number of pages7
Issue number4
Publication statusPublished - Apr 2010



  • Bone density
  • Ibandronate
  • Men
  • Osteoporosis
  • Treatment

ASJC Scopus subject areas

  • Physiology
  • Endocrinology, Diabetes and Metabolism
  • Histology

Cite this

Orwoll, E., Binkley, N. C., Lewiecki, E. M., Gruntmanis, U., Fries, M. A., & Dasic, G. (2010). Efficacy and safety of monthly ibandronate in men with low bone density. Bone, 46(4), 970-976. https://doi.org/10.1016/j.bone.2009.12.034