Gastrointestinal side effects in postmenopausal women using osteoporosis therapy: 1-year findings in the POSSIBLE US study.

Abstract

OBJECTIVE:

To characterize gastrointestinal side effects (GI SEs) and its associations with medication discontinuation, health-related quality of life (HRQoL), and treatment) satisfaction in postmenopausal women prescribed osteoporosis (OP) therapies.

METHODS:

Prospective Observational Scientific Study Investigating Bone Loss Experience (POSSIBLE US*) participants enrolled October 27, 2004 - January 25, 2007 and complete questionnaires for up to 3 years. GI SEs for women new to or stable on therapy at entry were characterized at 6 and 12 months. Adjusted odds of experiencing GI SEs; mean HRQoL and treatment satisfaction scores; and risk of discontinuing therapy for bisphosphonate (BP) versus non-BP users were compared with logistic and generalized linear models.

RESULTS:

About 20% of women reported >or=1 GI SE at entry. GI SEs at month 6 were more common in BP than non-BP users (new: OR = 1.5, 95% CI: 1.2-2.0; stable: OR = 1.7, 95% CI: 1.3-2.1). Women new to OP therapy with GI SEs at month 6 had lower LS Mean HRQoL (OPAQ-SV Emotional Status: 72.3 vs. 78.2, p = 0.005) and treatment satisfaction scores (SEs: 71.4 vs. 82.9;

EFFICACY:

58.6 vs. 65.6; Global: 55.0 vs. 64.4; all p <or= 0.02) than those without GI SEs. Women reporting any GI SE had higher therapy discontinuation than those without GI SEs (6-month OR = 1.39, 95% CI: 1.05-1.84; 12-month OR = 1.30, 95% CI: 1.03-1.63; both p <or= 0.03).

CONCLUSION:

GI SEs were common among women on OP therapy, were more common in BP than non-BP users, and were associated with increased therapy discontinuation. Lower HRQoL and treatment satisfaction associated with GI SEs may influence medication discontinuation.

• Authors: Claudine Woo, Guozhi Gao, Sally Wade, Marc C Hochberg
• Journal: Current medical research and opinion (Curr Med Res Opin) Vol. 26 Issue 4 Pg. 1003-9 (Apr 2010) ISSN: 1473-4877 [Electronic] England
• PMID: 20201623 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Bone Density Conservation Agents
• Diphosphonates
• Parathyroid Hormone
• Selective Estrogen Receptor Modulators
• Calcitonin
• Calcium

Topics

• Aged
• Bone Density Conservation Agents (adverse effects)
• Calcitonin (adverse effects)
• Calcium (adverse effects)
• Diphosphonates (adverse effects)
• Estrogen Replacement Therapy (adverse effects)
• Female
• Gastrointestinal Diseases (chemically induced)
• Humans
• Medication Adherence
• Middle Aged
• Osteoporosis (drug therapy)
• Parathyroid Hormone (adverse effects)
• Patient Satisfaction
• Prospective Studies
• Quality of Life
• Regression Analysis
• Selective Estrogen Receptor Modulators (adverse effects)
• United States