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Curr Med Res Opin. 2008 Jan;24(1):237-45.

Ibandronate and the risk of non-vertebral and clinical fractures in women with postmenopausal osteoporosis: results of a meta-analysis of phase III studies.

Author information

1
University of California, San Francisco, CA 94155-3044, USA. steve.harris@ucsf.edu

Abstract

OBJECTIVE:

The marketed doses of ibandronate, 150 mg once-monthly oral and 3 mg quarterly intravenous (IV) injection, produce greater increases in lumbar spine bone mineral density than treatment with the 2.5 mg oral daily dose. This meta-analysis assessed whether these doses also reduce fracture risk relative to placebo.

STUDY DESIGN AND METHODS:

Individual patient data from the intent-to-treat populations of the BONE, IV fracture prevention, MOBILE, and DIVA studies were grouped into three dose levels based on annual cumulative exposure (ACE), defined as the annual dose (mg) x bioavailability (0.6%, oral; 100%, IV) or placebo. Six key non-vertebral fractures (NVFs) (clavicle, humerus, wrist, pelvis, hip, and leg), all NVFs, and all clinical fractures were examined.

RESULTS:

This meta-analysis included 8710 patients. Cox proportional-hazards models estimated the adjusted relative risk (RR) for fracture with ibandronate versus placebo, and time to fracture was compared using log-rank tests. The high-dose group (ACE > or = 10.8 mg) showed significant reductions in the adjusted RR of key NVFs (34.4%, p = 0.032), all NVFs (29.9%, p = 0.041), and clinical fractures (28.8%, p = 0.010) relative to placebo. The high-dose group also had significantly longer time to fracture versus placebo for key NVFs (p = 0.031), all NVFs (p = 0.025), and clinical fractures (p = 0.002). Study limitations included: not all studies were placebo-controlled; a limited number of baseline characteristics were available for multivariate analyses.

CONCLUSION:

Ibandronate at dose levels of ACE > or = 10.8 mg, which includes the marketed 150 mg once-monthly oral and 3 mg quarterly IV injection regimens, may provide significant non-vertebral and clinical fracture efficacy.

PMID:
18047776
DOI:
10.1185/030079908X253717
[Indexed for MEDLINE]

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