4351 : MONTHLY ORAL IBANDRONATE IS WELL TOLERATED AND SAFE IN POSTMENOPAUSAL OSTEOPOROSIS (PMO): 1-YEAR RESULTS FROM THE MOBILE STUDY

Author(s): 
Recker, Robert; Ettinger, M.; Miller P.
Text: 
Poster
Research Based
OBJECTIVE: Current daily and weekly bisphosphonates are generally well-tolerated, but some patients experience upper gastrointestinal (UGI) adverse events (AEs). By reducing chronic exposure of the UGI tract to the bisphosphonate, and allowing sufficient time between doses for oesophageal renewal, a monthly dosing regimen may improve upper GI tolerability. lbandronate is a potent bisphosphonate with proven antifracture efficacy in PMO when given daily and intermittently. The MOBILE (Monthly Oral iBandronate In LadiEs) study is investigating the safety and efficacy of monthly oral ibandronate.
METHODS: MOBILE is a randomized, double-blind non-inferiority trial comparing the safety and efficacy of monthly oral ibandronate (50mg daily x 2 days, 100mg and 150mg) with the proven oral daily regimen (2.5mg) in women with PMO. The AE profile of ibandronate was assessed at 1 year (confirmatory analysis scheduled after 2 years).
RESULTS: In general, oral monthly and daily ibandronate were both wel~ tolerated, with no apparent differences between the ibandronate groups with respect to type or frequency of AEs. After 1 year, AE-related discontinuation was similar for monthly ibandronate (50mg [6.3%), 100mg [9.1%) and 150mg [7.8%]) versus daily ibandronate (9.1%). No difference in the incidence of UGI AEs was observed (15.9%, 21.7% and 16.9% vs 18.0%, respectively). Compared with the monthly regimens, lower incidence of flu-like symptoms was seen with daily ibandronate (8.3%, 6.8% and 6.6% vs 2.8%, respectively). These events were generally mild, of short duration, and resolved without symptomatic treatment.
SUMMARY AND CONCLUSIONS: Like daily dosing, monthly oral ibandronate is well-tolerated, with an excellent safety profile.
Topic: Women's Health