Safety and tolerability of oral daily and intermittent ibandronate are not
influenced by age.
Author(s): Ettinger MP(1), Felsenberg D, Harris ST, Wasnich R, Skag A, Hiltbrunner V, Wilson
K, Schimmer RC, Miller PD.
Affiliation(s): Author information:
(1)Radiant Research and Regional Osteoporosis Center of South Florida, 2081 SE
Ocean Boulevard, Stuart, FL, USA. markettinger@radiantresearch.com
Publication date & source: 2005, J Rheumatol. , 32(10):1968-74
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 > or = 70 years.
RESULTS: The incidence of adverse events in patients aged > or = 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 (> or = 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.
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