Long-term Fracture Rates Seen with Continued Ibandronate Treatment: Pooled Analysis of DIVA and MOBILE Long-term Extension Studies

Overview

Journal Osteoporos Int

Specialties Endocrinology
Orthopedics

Date 2013 Oct 19

PMID 24136103

Citations 14

Authors

P D Miller

R R Recker

S Harris

S Silverman

D Felsenberg

J Reginster

B-M Day

C Barr

D Masanauskaite

Affiliations

Soon will be listed here.

Abstract

Unlabelled: Ibandronate reduces the risk of vertebral and non-vertebral fractures versus placebo in postmenopausal women with osteoporosis. This analysis, in which fractures were reported as safety events, showed that long-term use of ibandronate was associated with low fracture rates over 5 years of treatment.

Introduction: A previous post-hoc meta-analysis of 2-3 year studies found that ibandronate regimens with annual cumulative exposure (ACE) of ≥10.8 mg reduced the risk of vertebral and nonvertebral fractures (NVFs) versus placebo in postmenopausal women. This post-hoc analysis used individual patient data from the 2-year monthly oral ibandronate in ladies (MOBILE) and dosing intravenous administration (DIVA) studies, including the 3-year long-term extensions (LTEs), to assess fracture risk in patients treated with ibandronate for 5 years.

Methods: Patients treated for 2 years in MOBILE with monthly oral ibandronate 150 mg (n = 176) and in DIVA with IV ibandronate every 2 months 2 mg (n = 253) or quarterly 3 mg (n = 263) who continued on the same regimens for 3 additional years in the LTEs were included. Three-year placebo data (n = 1,924) were obtained from the ibandronate osteoporosis vertebral fracture trial in North America and Europe (BONE) and IV Fracture Prevention trials. The primary endpoint was clinical fracture rate; clinical fracture data were collected as adverse events. Time to fracture was analyzed using Kaplan-Meier and statistical analysis was conducted using the log-rank test. All clinical fractures included all NVFs and symptomatic vertebral fractures.

Results: For ibandronate regimens with ACE ≥10.8 mg, time to fracture was significantly longer for all clinical fractures, NVFs, and clinical vertebral fractures versus placebo (P = 0.005). For all fracture types, the rate of fracture appeared stable during the 5-year treatment period.

Conclusion: In women with postmenopausal osteoporosis, continuous treatment with ibandronate over 5 years results in low sustained clinical fracture rate.

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