Gastrointestinal tolerability with ibandronate after previous weekly bisphosphonate treatment

Abstract

Data from two open-label trials (PRIOR and CURRENT) of women with postmenopausal osteoporosis or osteopenia were evaluated to assess whether monthly oral and quarterly intravenous (IV) ibandronate dosing improved self-reported gastrointestinal (GI) tolerability for patients who had previously experienced GI irritation with bisphosphonate (BP) use. In PRIOR, women who had discontinued daily or weekly BP treatment due to GI intolerance received monthly oral or quarterly IV ibandronate for 12 months. The CURRENT subanalysis included women receiving weekly BP treatment who switched to monthly oral ibandronate for six months. GI symptom severity and frequency were assessed using the Osteoporosis Patient Satisfaction Questionnaire™. In PRIOR, mean GI tolerability scores increased significantly at month 1 from screening for both treatment groups (oral: 79.3 versus 54.1; IV: 84.4 versus 51.0; p < 0.001 for both). Most patients reported improvement in GI symptom severity and frequency from baseline at all post-screening assessments (>90% at Month 10). In the CURRENT subanalysis >60% of patients reported improvements in heartburn or acid reflux and >70% indicated improvement in other stomach upset at month 6. Postmenopausal women with GI irritability with daily or weekly BPs experienced improvement in symptoms with extended dosing monthly or quarterly ibandronate compared with baseline.

Keywords:

• ibandronate
• osteoporosis
• bisphosphonate
• gastrointestinal

Acknowledgments

The authors thank Andrew Cooper, BSc, of Envision Pharma, Southport, CT for his editorial assistance with this manuscript and Bann-mo Day, PhD, of Roche, Nutley, NJ, who performed the analyses.

Disclosures

This study was supported and funded by Roche and GlaxoSmithKline. Dr Derman has received research grants from Bristol-Myers Squibb, Procter and Gamble, and Wyeth; and is a consultant/speaker for Ortho-McNeil, Merck, Roche, Solvay, and Wyeth. Dr Kohles is an employee of Roche. Dr Babbitt has been on the speakers’ bureau at Merck, Procter and Gamble, GlaxoSmithKline, Lilly, and Kyphon; and has received research grants from Merck, Procter and Gamble, GlaxoSmithKline, and Lilly. This material was presented at the 56th Annual Meeting of the American College of Obstetricians and Gynecologists; May 3–7, 2008; New Orleans, LA, USA.