Once-monthly oral ibandronate compared with weekly oral alendronate in postmenopausal osteoporosis: results from the head-to-head MOTION study.

Abstract

OBJECTIVE:

Oral ibandronate 150 mg is the first bisphosphonate approved for once-monthly treatment of postmenopausal osteoporosis. To investigate whether once-monthly ibandronate 150 mg increases lumbar spine and total hip bone mineral density (BMD) to the same degree as weekly alendronate 70 mg.

RESEARCH DESIGN AND METHODS:

This was a 12-month, randomised, multinational, multicentre, double-blind, double-dummy, parallel-group, non-inferiority trial, conducted in 65 centres in North America, Latin America, Europe and South Africa. The study included postmenopausal women, mean lumbar spine (L2-L4) BMD T-score < -2.5 and > or = -5.0. Patients received either ibandronate 150 mg once monthly or alendronate 70 mg once weekly.

MAIN OUTCOME MEASURES:

Co-primary efficacy endpoints were 12-month change (%) from baseline in mean lumbar spine and total hip BMD. Changes (%) from baseline in trochanter and femoral neck BMD were also evaluated. Adverse events were monitored throughout. Once-monthly ibandronate was considered non-inferior to weekly alendronate if the lower boundary of the one-sided 97.5% confidence interval (CI) (or two-sided 95% CI) was > or = -1.41% for lumbar spine and > or = -0.87% for total hip.

RESULTS:

Mean relative 12-month changes were 5.1% and 5.8% (95% CI for difference, -1.13, -0.23) in lumbar spine and 2.9% and 3.0% (95% CI for difference, -0.38, 0.18) in total hip BMD with once-monthly ibandronate and weekly alendronate, respectively; meeting the non-inferiority criteria at both sites. Gains in trochanter and femoral neck BMD were similar with both treatments. Both regimens were well tolerated.

TRIAL REGISTRATION:

The MOTION study is registered with the International Federation of Pharmaceutical Manufacturers and Associations trial portal, under the ID number MM17385.

CONCLUSIONS:

Once-monthly ibandronate was shown to be clinically comparable to weekly alendronate at increasing BMD after 12 months in both the lumbar spine and total hip.

• Authors: Paul D Miller, Sol Epstein, Farhad Sedarati, Jean-Yves Reginster
• Journal: Current medical research and opinion (Curr Med Res Opin) Vol. 24 Issue 1 Pg. 207-13 (Jan 2008) ISSN: 1473-4877 [Electronic] England
• PMID: 18042311 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Bone Density Conservation Agents
• Diphosphonates
• Ibandronic Acid
• Alendronate

Topics

• Administration, Oral
• Aged
• Aged, 80 and over
• Alendronate (administration & dosage, adverse effects)
• Algorithms
• Bone Density (drug effects)
• Bone Density Conservation Agents (administration & dosage)
• Diphosphonates (administration & dosage, adverse effects)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Humans
• Ibandronic Acid
• Middle Aged
• Osteoporosis, Postmenopausal (drug therapy)
• Treatment Outcome