Safety and tolerability of oral daily and intermittent ibandronate are not influenced by age.
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.


CONCLUSIONS
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.
Ettinger
Mark P
MP
Radiant Research and Regional Osteoporosis Center of South Florida, 2081 SE Ocean Boulevard, Stuart, FL, USA. markettinger@radiantresearch.com
Felsenberg
Dieter
D
Harris
Steven T
ST
Wasnich
Richard
R
Skag
Arne
A
Hiltbrunner
Valerie
V
Wilson
Katie
K
Schimmer
Ralph C
RC
Miller
Paul D
PD
D000284:Administration, Oral; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004164:Diphosphonates / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced* / Q000473:pathology; D006801:Humans; D000077557:Ibandronic Acid; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000503:physiopathology; D041742:Upper Gastrointestinal Tract / Q000187:drug effects* / Q000473:pathology
D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D000077557:Ibandronic Acid