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. 2009:4:357-65.
doi: 10.2147/cia.s5637. Epub 2009 Oct 12.

Gastrointestinal tolerability with ibandronate after previous weekly bisphosphonate treatment

Richard Derman  1 , Joseph D Kohles, Ann Babbitt
Affiliations

Gastrointestinal tolerability with ibandronate after previous weekly bisphosphonate treatment

Richard Derman et al. Clin Interv Aging. 2009.

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: bisphosphonate; gastrointestinal; ibandronate; osteoporosis.

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Figures

Figure 1
Figure 1
Questions from the Osteoporosis Patient Satisfaction Questionnaire™ (OPSAT-Q™) used to assess gastrointestinal symptoms in the PRIOR and CURRENT studies. Notes: *Question numbers refer to the numbers in the complete OPSAT-Q™. © for the OPSAT-Q Roche Laboratories, Inc. All Rights Reserved.
Figure 2
Figure 2
PRIOR: Change in self-reported gastrointestinal symptoms for patients with gastrointestinal symptoms at baseline (score of 1–4 on at least 1 of Osteoporosis Patient Satisfaction Questionnaire™ questions 11, 12, 13, 14, 15, 16) at Month 10.
Figure 3
Figure 3
CURRENT: Change in self-reported gastrointestinal symptoms for patients with gastrointestinal symptoms at baseline (score of 1–4 on at least 1 of Osteoporosis Patient Satisfaction Questionnaire™ questions 11, 12, 14, 15) at Month 6.
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