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Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study

J-Y Reginster¹, S Adami², P Lakatos³, M Greenwald⁴, J J Stepan⁵, S L Silverman⁶, C Christiansen⁷, L Rowell⁸, N Mairon⁸, B Bonvoisin⁸, M K Drezner⁹, R Emkey¹⁰, D Felsenberg¹¹, C Cooper¹², P D Delmas¹³, P D Miller¹⁴

¹ University of Liège, Liège, Belgium
² University of Verona, Verona, Italy
³ Semmelweis University Medical School, Budapest, Hungary
⁴ Desert Medical Advances, Palm Desert, CA, USA
⁵ Charles University School of Medicine, Prague, Czech Republic
⁶ Cedars Sinai Medical Center, Los Angeles, CA, USA
⁷ Centre for Clinical and Basic Research, Ballerup, Denmark
⁸ F Hoffmann-La Roche Ltd, Basel, Switzerland
⁹ University of Wisconsin, Madison, WI, USA
¹⁰ Radiant Research, Wyomissing, PA, USA
¹¹ Charité-University Medicine Berlin, Campus Benjamin Franklin, Free University and Humboldt-University, Berlin, Germany
¹² MRC Epidemiology Resource Centre, University of Southampton, Southampton, UK
¹³ Claude Bernard University and INSERM Research Unit 403, Lyon, France
¹⁴ Colorado Center for Bone Research, Lakewood, CO, USA

Correspondence to:
Professor J-Y Reginster
Unité d’Exploration du Metabolisme de l’Os et du Cartilage, CHU Centre Ville, Liège, Belgium; jyreginster{at}ulg.ac.be

Background: Reducing bisphosphonate dosing frequency may improve suboptimal adherence to treatment and therefore therapeutic outcomes in postmenopausal osteoporosis. Once-monthly oral ibandronate has been developed to overcome this problem.

Objective: To confirm the 1 year results and provide more extensive safety and tolerability information for once-monthly dosing by a 2 year analysis.

Methods: MOBILE, a randomised, phase III, non-inferiority study, compared the efficacy and safety of once-monthly ibandronate with daily ibandronate, which has previously been shown to reduce vertebral fracture risk in comparison with placebo.

Results: 1609 postmenopausal women were randomised. Substantial increases in lumbar spine bone mineral density (BMD) were seen in all treatment arms: 5.0%, 5.3%, 5.6%, and 6.6% in the daily and once-monthly groups (50 + 50 mg, 100 mg, and 150 mg), respectively. It was confirmed that all once-monthly regimens were at least as effective as daily treatment, and in addition, 150 mg was found to be better (p<0.001). Substantial increases in proximal femur (total hip, femoral neck, trochanter) BMD were seen; 150 mg produced the most pronounced effect (p<0.05 versus daily treatment). Independent of the regimen, most participants (70.5–93.5%) achieved increases above baseline in lumbar spine or total hip BMD, or both. Pronounced decreases in the biochemical marker of bone resorption, sCTX, observed in all arms after 3 months, were maintained throughout. The 150 mg regimen consistently produced greater increases in BMD and sCTX suppression than the 100 mg and daily regimens. Ibandronate was well tolerated, with a similar incidence of adverse events across groups.

Conclusions: Once-monthly oral ibandronate is at least as effective and well tolerated as daily treatment. Once-monthly administration may be more convenient for patients and improve therapeutic adherence, thereby optimising outcomes.

Abbreviations: BMD, bone mineral density; CI, confidence interval; DXA, dual energy x ray absorptiometry; GI, gastrointestinal; ITT, intention to treat; MOBILE, Monthly Oral iBandronate In LadiEs; PP, per-protocol; sCTX, C-telopeptide of the -chain of type I collagen

Keywords: monthly; ibandronate; osteoporosis; bisphosphonate; non-inferiority

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