Gastrointestinal Side Effects More Common in Patients Receiving Oral Bisphosphonates for Osteoporosis: Presented at NAMS
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Gastrointestinal Side Effects More Common in Patients Receiving Oral Bisphosphonates for Osteoporosis: Presented at NAMS

By John Otrompke

SAN DIEGO -- October 6, 2009 -- Many patients receiving treatment for osteoporosis report gastrointestinal (GI) side effects, and those on oral bisphosphonates are up to twice as likely to report them, according to researchers here at the 20th Annual Meeting of the North American Menopause Society (NAMS).

GI side effects also decrease patient quality of life and may lead to reduced compliance, according to Claudine Woo, PhD, MPH, Department of Metabolic Bone, Scientific Affairs, Amgen, South San Francisco, California.

“We were identifying reported GI side effects among women on any kind of treatment, including oral bisphosphonates, specifically alendronate, risedronate, and ibandronate,” said Dr. Woo. “We also incorporated those receiving any treatment for osteoporosis, such as raloxifene, hormone therapy, calcitonin, or teriparatide or those taking calcium or vitamin D only,” continued Dr. Woo at a presentation on October 1.

In the study, patients in the ongoing Prospective Observational Scientific Study Investigating Bone Loss Experience US (POSSIBLE US) completed questionnaires for up to 3 years. Included at study entry were 1,174 patients new to monotherapy and 1,579 who were stable on monotherapy. Of those, 73% of the women new to monotherapy and 68% of those stable on monotherapy were taking bisphosphonates. About 20% of those in both the new and stable groups reported at least 1 side effect at study entry, including heartburn (approximately 10% to 11% of patients) and constipation. In the first 6 months, 12.5% of patients new to monotherapy and 9.7% of those who were stable on monotherapy reported constipation. At 6 months, 30.7% of patients new to monotherapy and 25.9% of patients stable on monotherapy reported GI side effects, whereas, at 12 months, 27.4% and 22.2%, respectively, reported side effects.

The study found that patients new to bisphosphonate treatment were 1.7 times more likely to report GI side effects than those receiving nonbisphosphonates at 6 months. At 12 months, patients stable on bisphosphonates were twice as likely to report such a side effect as those on nonbisphosphonates. The 81 women who reported any GI side effects were 1.4 times more likely to discontinue treatment.

“Side effects ranged from heartburn and nausea to painful swallowing, stomach ache, or upper abdominal pain,” Dr. Woo said. “For the lower GI tract, we captured constipation, diarrhoea, and lower abdominal pain.”

Funding for this study was provided by Amgen Inc.

[Presentation title: Gastrointestinal Side Effects Associated With Osteoporosis Therapy in Postmenopausal Women: 1-Year Findings From the POSSIBLE US Study. Abstract P-61]

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