Safety and Tolerability of Oral Daily and Intermittent Ibandronate Are Not Influenced by Age

MARK P. ETTINGER, DIETER FELSENBERG, STEVEN T. HARRIS, RICHARD WASNICH, ARNE SKAG, VALERIE HILTBRUNNER, KATIE WILSON, RALPH C. SCHIMMER, and PAUL D. MILLER

ABSTRACT.

Objective. The risk of osteoporosis increases exponentially with age. Elderly patients, who are often frail, have declining functional status and take multiple medications, and require osteoporosis therapies that are not only effective, but also very well tolerated. Ibandronate is a potent nitrogen-containing bisphosphonate that can be given intermittently with extended between-dose intervals. Oral daily and intermittent ibandronate (interval between doses > 2 mo) was found to significantly reduce the risk of new morphometric vertebral fractures by 62% and 50%, respectively, compared with calcium and vitamin D supplementation alone. We investigated the effect of age on the safety profile of oral daily and intermittent ibandronate, with particular emphasis on the upper gastrointestinal (GI) safety profile of ibandronate.

Methods. A predefined subgroup analysis examined the tolerability of oral ibandronate in women aged < 70 and ≥ 70 years.

Results. The incidence of adverse events in patients aged ≥ 70 years receiving oral daily and intermittent ibandronate was similar and comparable to placebo. The incidence of upper GI adverse events, including dyspepsia and esophagitis, was also similar between the 2 treatment groups and placebo.

Conclusion. Older patients (≥ 70 yrs) receiving oral daily and intermittent ibandronate are at no greater risk of adverse events than older patients receiving placebo. Older patients were at no greater risk of upper GI adverse events than younger patients or patients receiving placebo. As a result of the good efficacy and tolerability observed in this trial, a once-monthly oral regimen of ibandronate is in late-stage clinical development. (J Rheumatol 2005;32:1968-74)

Key Indexing Terms:

IBANDRONATE
BISPHOSPHONATES
TOLERABILITY
OSTEOPOROSIS
ELDERLY

---

From Radiant Research and Regional Osteoporosis Center of South Florida, Stuart, Florida, USA; Universitätsklinikum Benjamin Franklin, Berlin, Germany; University of California, San Francisco, California, USA; Radiant Research, Honolulu, USA; Bergen Osteoporosesenter, Bergen, Norway; Roche Products Ltd., Welwyn Garden City, UK; F. Hoffmann-La Roche, Basel, Switzerland; and CCBR, Lakewood, Colorado, USA.

Supported by F. Hoffmann-La Roche Ltd., Basel, Switzerland.

M.P. Ettinger, MD, Medical Director Emeritus, Radiant Research and Regional Osteoporosis Center of South Florida; D. Felsenberg, MD, Universitätsklinikum Benjamin Franklin; S.T. Harris, MD, University of California, San Francisco; R. Wasnich, MD, Radiant Research, Honolulu; A. Skag, MD, Bergen Osteoporosesenter; V. Hiltbrunner, MD; K. Wilson, MSc; R.C. Schimmer, MD, F. Hoffmann-La Roche; P.D. Miller, MD, CCBR, Lakewood, Colorado.

Address reprint requests to Dr. M. Ettinger, Regional Osteoporosis Center, 2081 SE Ocean Boulevard, Suite 1A, Stuart, Florida. E-mail: markettinger@radiantresearch.com

Accepted for publication May 20, 2005.

---